EU Local Number	Report Type	EV Gateway Receipt Date	Primary Source Qualification	Primary Source Country for Regulatory Purposes	Literature Reference	Patient Age Group	Patient Age Group (as per reporter)	Parent Child Report	Patient Sex	Reaction List PT (Duration - Outcome - Seriousness Criteria)	Suspect/interacting Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route])	Concomitant/Not Administered Drug List (Drug Char - Indication PT - Action taken - [Duration - Dose - Route])	ICSR Form	Vaccine	Downloaddate	Seriousness	Severity
EU-EC-10007281773	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281774	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Vaccination site joint swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - 300mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281799	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site erythema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281852	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281872	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281945	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007282020	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007282020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007282060	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (0d - Recovered/Resolved - );Tachycardia paroxysmal (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007282060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007282648	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Drug hypersensitivity (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007282648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007282654	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling of eyelid (n/a - Not Recovered/Not Resolved - );Throat irritation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IRON [IRON] (C - n/a - n/a - [n/a - n/a - n/a])|[BUTALBITAL, PARACETAMOL, CAFFEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METRONIDAZOLE, METRONIDAZOLE BENZOATE, METRONIDAZOLE BP, METRONIDAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007282654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007282743	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Nasal congestion (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007282743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007282884	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (2d - Not Recovered/Not Resolved - );Vaccination site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007282884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283044	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [31d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283056	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersomnia (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BIKTARVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - HIV infection - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Panic disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007283058	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hemiparesis (0d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (0d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ischaemic stroke (0d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007283332	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007283522	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Female	Local reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283526	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283527	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283528	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain (2d - Not Recovered/Not Resolved - );Asthenia (3d - Not Recovered/Not Resolved - );Chills (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Limb discomfort (2d - Not Recovered/Not Resolved - );Local reaction (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Nausea (2d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283740	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283744	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Genital herpes (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007283748	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Local reaction (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007283748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007284177	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (2d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - );Sensitive skin (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007284177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007284721	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Laryngeal oedema (1d - Recovered/Resolved - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	HUMIRA [ADALIMUMAB] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007284721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007285120	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007285120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007285404	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007285404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007286820	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Respiratory arrest (1d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007286875	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286878	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286879	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Product after taste (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007286881	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Arthralgia (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TRANDOLAPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286883	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematemesis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Upper gastrointestinal haemorrhage (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENZYDAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - 5mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Lower urinary tract symptoms - n/a - [n/a - n/a - n/a])|[TEMAZEPAM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007286884	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (1d - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007286885	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Circulatory collapse (n/a - Recovered/Resolved - );Hypersomnia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LINAGLIPTIN [LINAGLIPTIN] (C - Glucose tolerance impaired - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL, DONEPEZIL HYDROCHLORIDE] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286888	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Narcolepsy (1d - Recovered/Resolved - Disabling);Sleep attacks (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007286901	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Heart rate increased (1d - Recovered/Resolved - );Influenza like illness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ACETYLSALICYLIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007286911	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (n/a - Unknown - Other Medically Important Condition);Malaise (2d - Unknown - Other Medically Important Condition);Pulse abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Cerebrovascular accident prophylaxis - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007286916	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Disabling);Epilepsy (n/a - Recovered/Resolved - Disabling);Eye movement disorder (n/a - Unknown - Disabling);Feeling abnormal (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Unknown - Disabling);Loss of consciousness (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Unknown - Disabling);Tremor (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])|[FERROUS GLUCONATE] (C - Blood iron decreased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007286955	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Paraesthesia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286959	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysphonia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007286966	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Limb discomfort (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 5mL - Parenteral])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007286970	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pruritus (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site swelling (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286974	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (24h - Recovered/Resolved - );Fatigue (48h - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Nausea (72h - Recovered/Resolved - );Vaccination site joint pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - Bronchiectasis - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[FROVATRIPTAN] (C - Migraine - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286975	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vaccination site warmth (25min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007286976	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286978	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])|[CALCITRIOL] (C - Blood calcium decreased - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Blood calcium decreased - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007286979	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (1d - Recovered/Resolved - Other Medically Important Condition);Dysphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (11d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007286980	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Deep vein thrombosis - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286982	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Conjunctivitis viral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286983	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007286990	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ENOXAPARIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286992	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hypoaesthesia oral (1d - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Swollen tongue (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[VALSARTAN] (C - Hypertension - n/a - [n/a - 120mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286993	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286994	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling cold (1d - Recovered/Resolved - );Headache (n/a - Unknown - );Myalgia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007286998	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007286998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287000	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287002	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Headache (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[COLESTIPOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287003	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287004	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urosepsis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLOROCRESOL, CHLOROCRESOL, CETOSTEARYL ALCOHOL, LIQUID PARAFFIN, PARAFFIN, PARAFFIN WHITE SOFT] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287006	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	HRT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287007	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Disabling);Back pain (n/a - Recovered/Resolved With Sequelae - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (4d - Recovered/Resolved - Disabling);Pulmonary pain (n/a - Recovered/Resolved With Sequelae - Disabling);Vaccination site cellulitis (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling);Vaccination site pruritus (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Palpitations - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Depressed mood - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10007287008	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Blister (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287009	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Oropharyngeal erythema (n/a - Unknown - );Oropharyngeal pain (n/a - Recovered/Resolved - );Tonsillar hypertrophy (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287010	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287011	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (2d - Recovered/Resolved - );Vertigo (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287012	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287013	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1mL - Intramuscular])	IRON [IRON] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287014	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287016	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287018	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287020	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (3d - Recovered/Resolved - );Eye pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Migraine (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Recovering/Resolving - );Vaccination site joint movement impairment (n/a - Recovering/Resolving - );Vaccination site joint swelling (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287021	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (6h - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (6h - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007287022	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - );Rash macular (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - Rectal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287023	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Hot flush (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|BUMETANIDE [BUMETANIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287024	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287025	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Aerophagia (n/a - Unknown - Other Medically Important Condition);Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Crying (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (n/a - Recovered/Resolved - Other Medically Important Condition);Retching (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287026	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287028	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site mass (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287029	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (2d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287032	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Vaccination site erythema (3d - Recovered/Resolved - );Vaccination site induration (3d - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - );Vaccination site pruritus (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287033	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Epistaxis (1d - Recovered/Resolved - );Muscle spasms (n/a - Recovering/Resolving - );Vaginal haemorrhage (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Rotator cuff syndrome - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthritis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthritis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287034	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Unknown - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Unknown - Disabling);Joint stiffness (n/a - Unknown - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Malaise (4d - Unknown - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287036	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - .3mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287040	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flank pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287041	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287042	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal distension (n/a - Not Recovered/Not Resolved - );Abdominal pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287043	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Unresponsive to stimuli (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	BUPRENORPHINE [BUPRENORPHINE] (C - Back pain - n/a - [n/a - n/a - n/a])|DABIGATRAN ETEXILATE [DABIGATRAN ETEXILATE] (C - Cardioactive drug level - n/a - [n/a - n/a - n/a])|RISPERIDONE [RISPERIDONE] (C - Psychotic disorder - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007287044	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swollen tongue (n/a - Recovering/Resolving - );Tongue discomfort (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287046	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FERRITIN] (C - Iron deficiency - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287047	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287050	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Headache (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Speech disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287051	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Allergy to vaccine (n/a - Recovering/Resolving - );Erythema (n/a - Unknown - );Feeling hot (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pruritus (n/a - Unknown - );Swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287052	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mouth ulceration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - Parenteral])	[CLOBAZAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287053	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287054	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287055	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287056	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Adverse drug reaction (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287059	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Recovering/Resolving - );Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287060	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287062	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Recovered/Resolved - );Hypotension (1d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287063	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin hypertrophy (n/a - Not Recovered/Not Resolved - );Skin induration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	APIXABAN [APIXABAN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|MIRABEGRON [MIRABEGRON] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TROSPIUM, TROSPIUM CHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287064	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysstasia (n/a - Unknown - Disabling, Other Medically Important Condition);Gait disturbance (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Illness (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pain (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007287065	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287081	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287082	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287083	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287084	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Unknown - );Cough (n/a - Unknown - );Erythema (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Unknown - );Illness (n/a - Recovered/Resolved With Sequelae - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007287086	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Vaccination site discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FENOFIBRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287087	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287094	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Acute myocardial infarction (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - Deep vein thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007287095	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	COMBINED ORAL CONTRACEPTIVE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007287103	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Female	Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site discomfort (n/a - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287104	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287105	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Recovering/Resolving - Other Medically Important Condition);Rash maculo-papular (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287106	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLONAZEPAM] (C - Myoclonus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287107	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287108	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Headache (2d - Recovered/Resolved - );Lethargy (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287111	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	NOT AVAILABLE [AQUEOUS CREAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LIQUID PARAFFIN, PARAFFIN, LIGHT LIQUID, PARAFFIN, LIGHT LIQUID, PARAFFIN WHITE SOFT] (C - n/a - n/a - [n/a - n/a - n/a])|[PARAFFIN, LIGHT LIQUID, PARAFFIN WHITE SOFT, LANOLIN, PARAFFIN, LIGHT LIQUID, PARAFFIN WHITE SOFT, WOOL FAT, ANHYDROUS, PARAFFIN, LIGHT LIQUID, WOOL FAT, ANHYDROUS, WHITE SOFT PARAFFIN BP, WOOL FAT, ANHYDROUS, WHITE SOFT PARAFFIN BP, LIQUID PARAFFIN PH. EUR] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287112	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Muscle spasms (11d - Recovered/Resolved - );Myalgia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287113	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287116	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blister (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rash maculo-papular (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Renal hypertension - n/a - [n/a - 75mg - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Renal hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287118	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Feeling of body temperature change (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Illness (n/a - Recovering/Resolving - Disabling);Muscle spasms (n/a - Recovering/Resolving - Disabling);Pain (n/a - Recovering/Resolving - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	MENOPACE [BIOTIN, CHROMIUM, COPPER, IODINE, IRON, MAGNESIUM, MANGANESE, NIACIN, PABA, RIBOFLAVIN, SELENIUM, SOYA ISOFLAVONES, THIAMIN, VITAMIN A, VITAMIN B6, VITAMIN C, VITAMIN D, VITAMIN E, ZINC] (C - Menopause - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - 200mg - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 10mg - n/a])|[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM PHOSPHATE, COLECALCIFEROL, TRICALCIUMPHOSPHAT PH.EUR.] (C - Vitamin D - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007287120	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287123	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287124	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Asthenia (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Lymphoedema (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287125	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood test abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Painful respiration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METHADONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287126	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287127	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287129	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Female	Dry mouth (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Oral mucosal exfoliation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287130	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007287131	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287134	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry mouth (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Flushing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymph node pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiration abnormal (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Crohn's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287135	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287138	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Erythema (5d - Recovered/Resolved - );Urticaria (5d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	EDOXABAN [EDOXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287139	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287140	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );Back pain (1d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Renal pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287141	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287142	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [11d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007287145	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (30min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287147	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007287149	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Not applicable - [1d - n/a - n/a])	GLYCOPYRRONIUM BROMIDE [GLYCOPYRRONIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|MIDAZOLAM [MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM CARBONATE] (C - Ill-defined disorder - n/a - [59d - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [1d - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[DALTEPARIN] (C - n/a - n/a - [20d - n/a - n/a])|[DICLOFENAC DIETHYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOMEPROMAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[METOCLOPRAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [200d - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIPTORELIN, TRIPTORELIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WATER FOR INJECTION] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287152	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Fatigue (n/a - Unknown - );Pain (n/a - Unknown - );Palpitations (n/a - Unknown - );Pruritus (n/a - Unknown - );Pyrexia (5d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287153	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Delirium (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287154	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	COVID-19 (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[NORETHISTERONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287155	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (2min - Recovered/Resolved - );Syncope (2min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287156	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|ZOLEDRONIC ACID [ZOLEDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[EXEMESTANE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287157	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287161	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287162	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flushing (1d - Recovered/Resolved - );Oropharyngeal discomfort (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Depression - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287163	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Injection site pain (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287164	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - Disabling);Chills (1d - Recovered/Resolved - Disabling);Feeling abnormal (1d - Recovered/Resolved - Disabling);Feeling hot (1d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Lethargy (n/a - Unknown - Disabling);Somnolence (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287165	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Malaise (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287167	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Depressed mood (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287168	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body fat disorder (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Skin reaction (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287169	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Allergy to vaccine (1d - Recovered/Resolved - );Breath sounds abnormal (n/a - Unknown - );Urticaria (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	OLANZAPINE [OLANZAPINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287170	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pruritus (48h - Recovered/Resolved - );Rash (48h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	UNSPECIFIED DRUG [NOT AVAILABLE] (C - Back pain - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Back pain - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287171	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pustule (n/a - Unknown - );Rash papular (6d - Recovered/Resolved - );Vaccination site erythema (n/a - Unknown - );Vaccination site mass (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287172	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (20min - Recovered/Resolved - );Palpitations (20min - Recovered/Resolved - );Paraesthesia (20min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287173	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypotension (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Atrophic vulvovaginitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287183	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Paraesthesia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287193	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CARBOCISTEINE] (C - Asthma - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287194	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Headache (4h - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287197	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287198	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (24h - Recovered/Resolved - );Myalgia (24h - Recovered/Resolved - );Nausea (24h - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Vitamin D decreased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287199	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Unknown - Disabling);Diarrhoea (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287201	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287202	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (3d - Recovered/Resolved - );Tension headache (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287204	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Decreased appetite (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Palpitations (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Urticaria - n/a - [n/a - n/a - n/a])|[CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - Spinal pain - n/a - [n/a - n/a - n/a])|[LIDOCAINE HYDROCHLORIDE] (C - Urticaria - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287205	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287207	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Limb discomfort (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Back pain - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Back pain - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 125mg - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - 2{DF} - n/a])|[OMEPRAZOLE] (C - Gastrointestinal disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287210	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pityriasis rosea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287214	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Diarrhoea (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287216	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287217	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287223	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );Musculoskeletal stiffness (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287225	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blister (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287227	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria papular (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287228	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287230	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Back pain - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - Back pain - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287233	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287234	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007287237	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (6d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287238	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287239	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287240	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Contusion (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site inflammation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287241	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash papular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287242	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287243	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FERROUS FUMARATE] (C - Anaemia - n/a - [n/a - n/a - n/a])|[LACIDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287244	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287245	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Spinal pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[DIPHENHYDRAMINE] (C - Insomnia - n/a - [n/a - n/a - n/a])|[DROSPIRENONE, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287246	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Disabling);Lethargy (1d - Recovered/Resolved - Disabling);Nausea (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007287249	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Back pain (2d - Recovered/Resolved With Sequelae - );Chills (3d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	COSENTYX [SECUKINUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - Psoriasis - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BENDROFLUAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[KLEBSIELLA PNEUMONIAE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007287250	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287251	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Thinking abnormal (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287252	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Fatigue (5d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287254	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Swelling (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287255	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287256	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ETHINYLESTRADIOL, NORGESTIMATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007287258	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Joint swelling (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287259	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287260	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287261	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Diarrhoea (8d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Intramuscular])	TICAGRELOR [TICAGRELOR] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287262	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287263	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Anal incontinence (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Prostatectomy - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007287264	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Burning sensation (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007287267	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash maculo-papular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DEXAMETHASONE [DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|LENALIDOMIDE [LENALIDOMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACICLOVIR, ACICLOVIR SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[CLODRONATE DISODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCUSATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPOETIN ALFA] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287273	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Labyrinthitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007287274	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Erythema (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287275	Spontaneous	2020-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287291	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Nausea (1d - Recovered/Resolved - );Vertigo (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287292	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Diarrhoea (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007287293	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (24h - Recovered/Resolved - Other Medically Important Condition);Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007287294	Spontaneous	2020-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (2d - Recovered/Resolved - );Hypoaesthesia (1d - Recovered/Resolved - );Hypoaesthesia oral (2d - Recovered/Resolved - );Neck pain (1d - Recovered/Resolved - );Oropharyngeal discomfort (3d - Recovered/Resolved - );Tremor (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007287294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007273115	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007273115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007274284	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Hypotension (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007274284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007274342	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Nasal congestion (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007274342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007275113	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lip pruritus (90min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Throat irritation (90min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007275187	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Abdominal pain lower (n/a - Unknown - );Blood urine present (n/a - Unknown - );Headache (n/a - Unknown - );Local reaction (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pharyngeal inflammation (n/a - Unknown - );Vaccination site rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007275385	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hypoaesthesia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007275421	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007275545	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (0d - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (0d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (0d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007275766	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Face injury (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007275768	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Unknown - );Anxiety (n/a - Unknown - );Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Restlessness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[FLUTICASONE PROPIONATE] (C - Seasonal allergy - n/a - [n/a - n/a - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007275791	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - Other Medically Important Condition);Periorbital swelling (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007275806	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007275976	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain lower (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007275982	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007275998	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007275998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007276002	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site rash (n/a - Not Recovered/Not Resolved - );Injection site urticaria (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007276002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007276176	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007276176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007276795	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myocardial infarction (0d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) COMIRNATY [TOZINAMERAN] (S - SARS-CoV-2 test positive - Not applicable - [n/a - .3mL - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - Dose not changed - [n/a - 10mg - Oral])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 60mg - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - Chronic obstructive pulmonary disease - Dose not changed - [n/a - 20mg - Oral - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007276795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007277313	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Borderline personality disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277314	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277315	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277316	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277317	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site erythema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277318	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Skin discolouration (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277319	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Cold sweat (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277320	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Breast mass (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[NITROFURANTOIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277321	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vulvovaginal candidiasis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Menopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277322	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Epistaxis (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277323	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[LYMECYCLINE] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277324	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	HRT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - 50mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277325	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Malaise (1d - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277326	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary mass (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277327	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277328	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hypoaesthesia (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277329	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Erythema (n/a - Unknown - );Rash pruritic (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	CIMZIA [CERTOLIZUMAB PEGOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277330	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277331	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277332	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - Vertigo - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277334	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Migraine with aura (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Cardiac murmur - n/a - [n/a - n/a - n/a])|[VARICELLA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277335	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277336	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (4d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277337	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277338	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nasal disorder (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Throat tightness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277339	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Agitation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dysarthria (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007277341	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM CARBONATE, LIGHT, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277342	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Dyspepsia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277343	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - );Rash (1d - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277344	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Gastrointestinal sounds abnormal (n/a - Unknown - );Lethargy (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Tension headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277345	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - );Wheezing (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277347	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Hot flush (12h - Recovered/Resolved - );Musculoskeletal stiffness (12h - Recovered/Resolved - );Nausea (12h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277348	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Mood altered (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277350	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Burning sensation (n/a - Recovering/Resolving - );Facial pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Premenstrual syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277352	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (4d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277353	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Grip strength decreased (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277354	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes simplex reactivation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277355	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277356	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Joint lock (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277357	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dissociation (5d - Recovered/Resolved - );Memory impairment (5d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277358	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Musculoskeletal stiffness (4d - Recovered/Resolved - Other Medically Important Condition);Taste disorder (4d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TAMOXIFEN, TAMOXIFEN CITRATE] (C - Breast cancer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277359	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277360	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Brain fog (1d - Recovered/Resolved - Other Medically Important Condition);Confusional state (1d - Recovered/Resolved - Other Medically Important Condition);Slow response to stimuli (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277361	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Vertigo (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007277363	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277364	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277365	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277366	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277367	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Influenza like illness (1d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277368	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cluster headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277369	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Essential tremor - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277370	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PARACETAMOL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277371	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277372	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Blood potassium abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Haemoglobin decreased (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Pharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition);Secretion discharge (n/a - Unknown - Other Medically Important Condition);Sinus pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);White blood cell count decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277373	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277374	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Contusion (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277375	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysgeusia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277376	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Hypoxia (n/a - Unknown - Life Threatening);Myalgia (n/a - Unknown - Life Threatening);Pyrexia (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007277377	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277378	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277379	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nausea (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277380	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - );Cough (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	LINACLOTIDE [LINACLOTIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277381	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277382	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Induration (n/a - Unknown - );Lymph node palpable (n/a - Unknown - );Lymphoedema (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277383	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277384	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Brain fog (n/a - Unknown - );Dysphagia (n/a - Unknown - );Dyspnoea (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007277385	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CYANOCOBALAMIN, VITAMIN B12] (C - Vitamin B12 deficiency - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277387	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277389	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HORMONE REPLACEMENT THERAPY [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 100ug - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 1000mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277390	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Unknown - );Pruritus (1d - Recovered/Resolved - );Rash macular (1d - Recovered/Resolved - );Skin irritation (n/a - Unknown - );Swelling (1d - Recovered/Resolved - );Vaccination site erythema (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277391	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Lethargy (n/a - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Polycystic ovarian syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277392	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LORATADINE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277395	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site bruising (n/a - Unknown - );Vaccination site pain (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277396	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277397	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Migraine (1d - Recovered/Resolved - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vision blurred (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277398	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277400	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277402	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277403	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasal dryness (n/a - Recovering/Resolving - );Rhinalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Familial risk factor - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277404	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chills (2d - Recovered/Resolved - );Contusion (n/a - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277405	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Gingivitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277406	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMALOG [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])|LEVEMIR [INSULIN DETEMIR] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277407	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277408	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277409	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277410	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[IBUPROFEN LYSINE] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277411	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Female	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277412	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Lymph node pain (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Unknown - Disabling);Pain of skin (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277414	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277415	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site discolouration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277416	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277417	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (1d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Heart rate irregular (1d - Recovered/Resolved - Disabling);Pain in extremity (2d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[HEPATITIS B VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[INFLUENZA VIRUS] (C - Asthma - n/a - [1d - n/a - n/a])|[MEASLES, MUMPS AND RUBELLA VACCINE (LIVE)] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007277418	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277419	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (18h - Recovered/Resolved - );Headache (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277420	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site induration (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277421	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness postural (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277422	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Delirium (1d - Recovered/Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ocular hyperaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Sinonasal obstruction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PROGESTERONE] (C - Menstrual disorder - n/a - [7d - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007277423	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site inflammation (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277424	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277425	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bone pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain of skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site joint movement impairment (n/a - Unknown - Other Medically Important Condition);Vaccination site joint pain (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LAMOTRIGINE] (C - Cerebral cavernous malformation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277426	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nasopharyngitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277427	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277428	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277429	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277430	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Hypoaesthesia oral (3h - Recovered/Resolved - Disabling);Muscular weakness (n/a - Recovering/Resolving - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Photophobia (n/a - Recovering/Resolving - Disabling);Vision blurred (3h - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277431	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277432	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Female	Electric shock sensation (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277433	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Mouth ulceration (n/a - Recovering/Resolving - Other Medically Important Condition);Tongue ulceration (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Pain in extremity - n/a - [n/a - n/a - n/a])|[CASSIA] (C - Constipation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[MELOXICAM] (C - Pain - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[QUININE] (C - Muscle spasms - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277434	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dry mouth (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (1d - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	FIASP [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|LEVEMIR [INSULIN DETEMIR] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007277435	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 150mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277436	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperacusis (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Photophobia (n/a - Unknown - );Photopsia (n/a - Unknown - );Swelling face (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277437	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Herpes zoster (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277438	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (6d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CAFFEINE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, ANHYDROUS CAFFEINE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277439	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277440	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Heart rate increased (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277441	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Anxiety (n/a - Unknown - Other Medically Important Condition);Hallucination, visual (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	RANOLAZINE [RANOLAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277443	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277445	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277446	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277449	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal distension (n/a - Unknown - );Diarrhoea (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Palpitations (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - );Swelling (n/a - Unknown - );Tenderness (n/a - Unknown - );Vaccination site induration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277450	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277451	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277452	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277453	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Somnolence (12h - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277454	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cluster headache (n/a - Not Recovered/Not Resolved - Disabling);Cough (n/a - Recovering/Resolving - Disabling);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277455	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277456	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );COVID-19 (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PEPPERMINT OIL] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277457	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (48h - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277458	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277460	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007277461	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277462	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Rash erythematous (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277463	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277464	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Papule (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277465	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277466	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277468	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Petechiae (n/a - Recovering/Resolving - );Vaccination site joint discomfort (24h - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277469	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277470	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277471	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ENTYVIO [VEDOLIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[CO-TRIMOXAZOLE, SULFAMETHOXAZOLE, TRIMETHOPRIM, TRIMETHOPRIM BP, SULFAMETHOXAZOLE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277474	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Balance disorder (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Oedema - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277475	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Swelling face (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277476	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277479	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Neck mass (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277480	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	BETMIGA [MIRABEGRON] (C - Hypertonic bladder - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Tendonitis - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277481	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depressed mood - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277482	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Muscle fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277483	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Chills (36h - Recovered/Resolved - );Headache (36h - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (36h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277484	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Epistaxis (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277485	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277486	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TERBUTALINE SULFATE, TERBUTALINE SULFATE PH. EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277487	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Sinus headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277488	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[CYANOCOBALAMIN, VITAMIN B12] (C - Pernicious anaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007277490	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277491	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277492	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277493	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	AZARGA [BRINZOLAMIDE, TIMOLOL, TIMOLOL MALEATE, BRINZOLAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|LATANOPROST [LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277494	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Sneezing (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277496	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry skin (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277497	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277499	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovering/Resolving - );Motion sickness (3d - Recovered/Resolved - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277500	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain (7d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Nausea (n/a - Unknown - );Pyrexia (6d - Recovered/Resolved - );Skin exfoliation (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277504	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277506	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Exercise tolerance decreased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277507	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dizziness (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277509	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Confusional state (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (7d - Recovered/Resolved - Other Medically Important Condition);Migraine (3d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Multiple allergies - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Ehlers-Danlos syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Ehlers-Danlos syndrome - n/a - [n/a - n/a - n/a])|[TERBINAFINE, TERBINAFINE HYDROCHLORIDE] (C - Nail infection - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277510	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Epistaxis (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Unknown - );Tenderness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277684	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (2d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277685	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277686	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Injection site erythema (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|RISPERIDONE [RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARMELLOSE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUDROCORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[MEMANTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277687	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277688	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphoedema (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277689	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoporosis prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277691	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[NORTRIPTYLINE, NORTRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277692	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Confusional state (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277693	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277694	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277695	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277696	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Decreased activity - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277698	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Influenza (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Sneezing (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[DESOGESTREL] (C - Endometriosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277699	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abdominal pain upper (n/a - Unknown - );Chills (n/a - Recovered/Resolved - );Cluster headache (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277701	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovering/Resolving - );Tension (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277702	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Peripheral swelling (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Unknown - );Vaccination site induration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277704	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Glycosylated haemoglobin increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277705	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Pain in jaw (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277706	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277707	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277708	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash pruritic (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277709	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277710	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site inflammation (n/a - Not Recovered/Not Resolved - );Vaccination site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277711	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (n/a - Unknown - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277712	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277713	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277715	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (5d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277716	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	VINFLUNINE [VINFLUNINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277717	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277718	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pain (n/a - Not Recovered/Not Resolved - );Rhinalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277720	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - Disabling);Body temperature (1d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007277721	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277722	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277723	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277724	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Erythema (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277725	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site induration (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277727	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DUORESP SPIROMAX [BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277728	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal discomfort (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277729	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (5d - Recovered/Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	PIOGLITAZONE [PIOGLITAZONE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277730	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Anxiety (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovering/Resolving - );Miliaria (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277731	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277732	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Recovering/Resolving - );Brain fog (1d - Recovered/Resolved - );Parosmia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277733	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Feeling hot (n/a - Recovering/Resolving - );Vaccination site induration (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277734	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - );Rash papular (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277735	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Blood pressure decreased (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Recovering/Resolving - );Neck pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277736	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cellulitis (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Unknown - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL MONOHYDRATE, BETAMETHASONE, CALCIPOTRIOL] (C - Psoriasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277737	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277738	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277739	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277740	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Asthenia (n/a - Not Recovered/Not Resolved - );Burns second degree (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277741	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (9d - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depressed mood - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007277742	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (3d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	ANTIBIOTICS [NOT AVAILABLE] (C - Lower respiratory tract infection - n/a - [7d - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Lower respiratory tract infection - n/a - [7d - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277743	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277744	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	INHALER [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277745	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rhinitis (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LAMOTRIGINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277746	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FELODIPINE] (C - Hypotension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007277747	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Headache (23h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277753	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (15min - Recovered/Resolved - );Feeling hot (15min - Recovered/Resolved - );Nausea (15min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277754	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash pruritic (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277755	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tongue ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277756	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277757	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysphagia (n/a - Not Recovered/Not Resolved - );Odynophagia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovering/Resolving - );Sensation of foreign body (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - Postural orthostatic tachycardia syndrome - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277758	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Influenza like illness (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (3d - Recovering/Resolving - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277759	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - n/a])	[DYDROGESTERONE, ESTRADIOL, DYDROGESTERONE, ESTRADIOL HEMIHYDRATE, ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Menopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277760	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (5d - Recovering/Resolving - );Pain in extremity (5d - Recovering/Resolving - );Rash erythematous (5d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277761	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277762	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[CODEINE] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277763	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - 40mg - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277764	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Thyroiditis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypotension - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Thyroiditis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277765	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Brain fog (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nervousness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277767	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (4d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	POLYANTIBIOTIC [BACITRACIN, BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN SULPHATE, SODIUM OCTANOATE] (C - Sinusitis - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Chronic sinusitis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277768	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - );Lethargy (2d - Recovered/Resolved - );Night sweats (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277769	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277770	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (20min - Recovered/Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277772	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pharyngitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277774	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277775	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Delirium (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - n/a])	[CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007277778	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007277780	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007277780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278087	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site lymphadenopathy (13d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278088	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - 15mg - n/a])|[MELOXICAM] (C - Ill-defined disorder - n/a - [n/a - 7.5mg - n/a])|[RAMIPRIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007278089	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278090	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Hypothermia (1d - Recovered/Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278091	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007278092	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278093	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278094	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Temperature regulation disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278095	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (1d - Recovering/Resolving - );Feeling of body temperature change (n/a - Unknown - );Headache (n/a - Unknown - );Lethargy (1d - Recovering/Resolving - );Limb discomfort (n/a - Unknown - );Malaise (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278096	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Thirst (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278098	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278099	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OZEMPIC [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278100	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278101	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Nausea (3d - Recovered/Resolved - Disabling);Vomiting (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBOCISTEINE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, SALMETEROL XINAFOATE, FLUTICASONE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278102	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - );Eye swelling (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Muscle spasms (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007278103	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278104	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278105	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - );Vaccination site pruritus (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278106	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Bone pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278107	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278109	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry mouth (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Mixed anxiety and depressive disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278110	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Inflammation - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278112	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (1d - Recovered/Resolved - );Chills (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278113	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Breast pain (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Anxiety - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278114	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278115	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dysgeusia (3d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007278116	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ETHINYLESTRADIOL, GESTODENE] (C - Contraception - n/a - [n/a - n/a - n/a])|[HEPATITIS B VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278117	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278118	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	COVID-19 (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278121	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278122	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278123	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (n/a - Recovering/Resolving - );Peripheral coldness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278128	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Recovering/Resolving - Disabling);Erythema (6d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278131	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in jaw (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278138	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278141	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278142	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278143	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Angioedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Swollen tongue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HYOSCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007278145	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278146	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	COVID-19 pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007278154	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Renal pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|HYDROXYCARBAMIDE [HYDROXYCARBAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007278156	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278157	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Aura (n/a - Unknown - );Generalised tonic-clonic seizure (1d - Recovered/Resolved - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - 1500mg - n/a])|ZONEGRAN [ZONISAMIDE] (C - Epilepsy - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007278158	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278160	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278162	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Unknown - Disabling);Bone pain (n/a - Unknown - Disabling);Chills (n/a - Unknown - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278164	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278165	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278167	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278169	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Fibromyalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal stoma complication (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - Pain - n/a - [n/a - n/a - n/a])|[NORTRIPTYLINE, NORTRIPTYLINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])|[PROMETHAZINE, PROMETHAZINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278171	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Routine health maintenance - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007278172	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Parenteral])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278173	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ESTRADIOL, MICRONIZED] (C - Postmenopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278177	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Wheezing (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Neck pain - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007278178	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278179	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	VIAGRA [SILDENAFIL, SILDENAFIL CITRATE] (C - Erectile dysfunction - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278180	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold urticaria (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])|[LITHIUM CARBONATE, LITHIUM CITRATE, LITHIUM CITRATE TETRAHYDRATE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278183	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Contusion (7d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|SECUKINUMAB [SECUKINUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278186	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278237	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278240	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278241	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Flushing (1d - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	HRT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278242	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Back pain (n/a - Unknown - );Eye swelling (n/a - Unknown - );Feeling abnormal (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Unknown - );Swelling face (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278243	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278244	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Plantar fasciitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - Rhinitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278247	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	0-1 Month	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[LYMECYCLINE] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278248	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Delirium (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007278249	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278250	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Body temperature (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278251	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278252	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature abnormal (2d - Recovered/Resolved - Disabling);Hypotension (2d - Recovered/Resolved - Disabling);Syncope (2d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007278256	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278257	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278258	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Oropharyngeal pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278259	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hot flush (4h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278261	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site joint pain (24h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	DABIGATRAN ETEXILATE [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278262	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278264	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Chills (3h - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Tenderness (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[BRIMONIDINE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[BUDESONIDE, BUDESONIDE, MICRONISED] (C - Asthma - n/a - [n/a - n/a - n/a])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FORMOTEROL, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278269	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Parenteral])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278270	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278273	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	SPIRONOLACTONE [SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278274	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Contusion (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278275	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vasculitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[MEMANTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278276	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	[TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Liver transplant - n/a - [n/a - n/a - n/a])|[URSODEOXYCHOLIC ACID] (C - Liver transplant - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278278	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Breast swelling (n/a - Not Recovered/Not Resolved - );Fluid imbalance (n/a - Not Recovered/Not Resolved - );Localised oedema (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278279	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vertigo positional (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278280	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278281	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278282	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278284	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278285	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278286	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Vision blurred (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278287	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278291	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	UNSPECIFIED DRUG [NOT AVAILABLE] (C - Pain - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278292	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Disorientation (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Night sweats (1d - Recovered/Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278294	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 30mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278295	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary mass (n/a - Unknown - );Inflammation (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278296	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Burning sensation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278297	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278298	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278299	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cough (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007278300	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness postural (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007278303	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007278306	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Vaccination site discomfort (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278704	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - );General physical health deterioration (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278706	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278711	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278715	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278721	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007278725	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007278725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007279595	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Bradycardia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	[LORATADINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007279595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007279917	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007279917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280146	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280411	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Bronchitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Skin discolouration (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007280628	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007280630	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Sinus tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007280632	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (30min - Recovered/Resolved - );Flushing (30min - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280633	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280634	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280635	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280636	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (1d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280638	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280639	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280641	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Muscle discomfort (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280642	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007280645	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280647	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (0d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280648	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280649	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (2d - Recovered/Resolved - );Eye pain (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280650	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007280859	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Muscular weakness (1d - Recovered/Resolved - );Nervousness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007280861	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Multiple organ dysfunction syndrome (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007280862	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007280862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281064	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Unknown - );Flushing (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Hypoaesthesia oral (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Muscle tightness (n/a - Unknown - );Pain in jaw (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007281167	Spontaneous	2020-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281227	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281233	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pyrexia (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007281247	Spontaneous	2020-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007281247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007265390	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (36h - Recovered/Resolved - );Hallucination (36h - Recovered/Resolved - Other Medically Important Condition);Headache (36h - Recovered/Resolved - );Pain in extremity (36h - Recovered/Resolved - );Pyrexia (36h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007265390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007265397	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Headache (0d - Recovered/Resolved - );Lethargy (0d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BRIVIACT [BRIVARACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])|CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007265397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007265895	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007265895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007265955	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (0d - Recovered/Resolved - );Hypotension (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pallor (0d - Recovered/Resolved - );Somnolence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007265955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007266017	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007266017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007266731	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORTALIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLONIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIPHENHYDRAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007266731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007266761	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007266761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007266763	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007266763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007266770	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flushing (n/a - Unknown - );Immunodeficiency (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007266770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007266854	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007266854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007267038	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Movement disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267756	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267835	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Life Threatening);Blood lactic acid increased (n/a - Unknown - Life Threatening);Nausea (n/a - Unknown - Life Threatening);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Vomiting (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007267836	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Hot flush (1d - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Throat irritation (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267837	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Oedema peripheral (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[CODEINE] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - Muscle spasms - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267838	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in jaw (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TOPIRAMATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267839	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267840	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Circulatory collapse (1d - Recovered/Resolved - );Cold sweat (1d - Recovered/Resolved - );Pallor (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	INFLIXIMAB [INFLIXIMAB] (C - Inflammatory bowel disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007267841	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Hot flush (1d - Recovered/Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267842	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Urticaria (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007267855	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267856	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Unknown - );Nausea (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267861	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267864	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267865	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007267866	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Ocular discomfort (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267873	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267875	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267878	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Discomfort (n/a - Unknown - );Rash (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267879	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Ear discomfort (n/a - Unknown - );Lip swelling (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - );Pharyngeal paraesthesia (n/a - Unknown - );Swelling face (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267880	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Female	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267881	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Recovered/Resolved - );Taste disorder (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267882	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[HEPATITIS B VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[MEASLES, MUMPS AND RUBELLA VACCINE (LIVE)] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pyrexia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007267883	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Antiplatelet therapy - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267884	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267886	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267887	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267888	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Panic attack - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267889	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebellar infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007267890	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood test abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Rhabdomyolysis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DESCOVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267891	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267892	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Erythema (1d - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267893	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267894	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267896	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267897	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267898	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267900	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - );Contusion (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267901	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Disturbance in attention (1d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (1d - Recovered/Resolved - Other Medically Important Condition);Hangover (1d - Recovered/Resolved - Other Medically Important Condition);Muscle swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition);Somnolence (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267902	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - .3mL - n/a])	HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - Vitamin B12 deficiency - n/a - [n/a - n/a - n/a])|MEMANTINE HYDROCHLORIDE [MEMANTINE HYDROCHLORIDE] (C - Dementia - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007267903	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007267904	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash pruritic (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267905	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Glossitis (n/a - Recovering/Resolving - );Glossodynia (n/a - Not Recovered/Not Resolved - );Plicated tongue (n/a - Unknown - );Tongue coated (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267909	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pruritus (n/a - Recovering/Resolving - );Eyelid margin crusting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267910	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267911	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267912	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267913	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267914	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267916	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267917	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling hot (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267918	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ROPINIROLE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267919	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267920	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267922	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	COVID-19 (n/a - Recovering/Resolving - );Cough (n/a - Unknown - );Oropharyngeal pain (3d - Recovered/Resolved - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ANASTROZOLE] (C - Breast cancer - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267923	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (3d - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved With Sequelae - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007267924	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007267925	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Brain fog (n/a - Recovered/Resolved - );Disturbance in attention (n/a - Recovered/Resolved - );Dry eye (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (24h - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Menopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007267926	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007267927	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Vaccination site joint pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267928	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	TRULICITY [DULAGLUTIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Nerve compression - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267929	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267930	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Oedema (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267931	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Chronic kidney disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267933	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Faeces discoloured (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267935	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Unknown - );Vaccination site inflammation (n/a - Unknown - );Vaccination site mass (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Unknown - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267937	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Coronavirus infection (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267939	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267940	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (1d - Recovered/Resolved - );Pallor (1d - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267943	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Palpitations (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - n/a])	[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007267944	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267945	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007267946	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	International normalised ratio increased (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007267947	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Joint noise (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - Skin infection - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267948	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysmenorrhoea (n/a - Unknown - );Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	NOVORAPID [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Diabetic neuropathy - n/a - [n/a - n/a - n/a])|TOUJEO [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (C - Menstruation irregular - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267949	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267950	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	PIRFENIDONE [PIRFENIDONE] (C - n/a - n/a - [n/a - 9{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267951	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Anosmia (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007267952	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007267953	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007267953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007268365	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[SAMBUCUS NIGRA FRUIT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007268367	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (0d - Recovered/Resolved - Other Medically Important Condition);Palpitations (0d - Recovered/Resolved - Other Medically Important Condition);Supraventricular tachycardia (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007268374	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ataxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Delirium (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Incontinence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007268413	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry throat (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007268435	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007268436	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Immune system disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Night sweats (30min - Recovered/Resolved - Other Medically Important Condition);Pyrexia (30min - Recovered/Resolved - Other Medically Important Condition);Tachycardia (40min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007268475	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Agitation (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ESOMEPRAZOLE MAGNESIUM [ESOMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|FENTANYL [FENTANYL, FENTANYL CITRATE] (C - Spinal fracture - n/a - [n/a - n/a - n/a])|FENTANYL [FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|MISOPROSTOL [MISOPROSTOL] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007268547	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Recovered/Resolved - );Sleep disorder (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007268559	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007268561	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site pruritus (n/a - Unknown - );Vaccination site urticaria (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007268561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007271120	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007271138	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Sensation of foreign body (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007271144	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Drug ineffective (n/a - Unknown - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007271149	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vomiting (330min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Complex regional pain syndrome - n/a - [n/a - 30mg - Oral])|[IBUPROFEN, NAPROXEN, NAPROXEN SODIUM] (C - Back pain - n/a - [n/a - 220mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007271327	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lip swelling (0d - Recovered/Resolved - Other Medically Important Condition);Oral pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Throat irritation (n/a - Recovered/Resolved - Other Medically Important Condition);Tongue pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 50ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007271612	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007271615	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007271618	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007271618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272416	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	INVOKANA [CANAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[GEMFIBROZIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272558	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Unknown - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nasal obstruction (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272560	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272563	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dry eye (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Eye pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	IMRALDI [ADALIMUMAB] (C - Axial spondyloarthritis - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272564	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest discomfort (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysphagia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007272565	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Migraine (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272567	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007272570	Spontaneous	2020-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007272570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007273183	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Heart rate increased (n/a - Recovering/Resolving - );Hot flush (15min - Recovered/Resolved - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[LEVOTHYROXINE SODIUM] (S - Hypothyroidism - Unknown - [n/a - .125mg - n/a])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Tooth infection - n/a - [n/a - 1500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007273183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007273397	Spontaneous	2020-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Oral discomfort (n/a - Unknown - );Paraesthesia (0d - Recovered/Resolved - );Paraesthesia oral (0d - Recovered/Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007273397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258085	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258093	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness neurosensory (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[GLIPIZIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 2000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258100	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258109	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007258112	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258115	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Unknown - Other Medically Important Condition);Pharyngeal swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258122	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258132	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258138	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Flushing (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258144	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[DESVENLAFAXINE, DESVENLAFAXINE SUCCINATE MONOHYDRATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Seasonal allergy - n/a - [n/a - 10mg - n/a])|[OMEPRAZOLE, PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258149	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Abdominal rigidity (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258152	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258154	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Throat irritation (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258180	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Hypoacusis (n/a - Recovered/Resolved - );Rash erythematous (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258181	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Respiratory distress (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007258182	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258193	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactoid reaction (1d - Recovered/Resolved - Life Threatening);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - );Wheezing (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 40mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 2000mg - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 180mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007258195	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Mouth swelling (0d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (0d - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (0d - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258201	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COBAMAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258290	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XOLAIR [OMALIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007258293	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Emotional disorder (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypersomnia (1d - Recovered/Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (2d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulse abnormal (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (1d - Recovered/Resolved - );Visual impairment (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007258299	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Autoimmune disorder (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007258301	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007258305	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Brain fog (n/a - Recovered/Resolved - Other Medically Important Condition);Dysgeusia (n/a - Recovered/Resolved - );Flushing (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CELECOXIB [CELECOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007258305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007259598	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259711	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Recovered/Resolved - );Flushing (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACRIVASTINE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE] (C - n/a - n/a - [n/a - 25mg - Oral])|[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259737	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - );Condition aggravated (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007259897	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry throat (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Pharyngeal swelling (n/a - Recovering/Resolving - Life Threatening);Urticaria (n/a - Recovering/Resolving - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007259898	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259927	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259928	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Swelling face (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259929	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007259931	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259932	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259937	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Hangover (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007259939	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bell's palsy (n/a - Unknown - );Eye disorder (n/a - Unknown - );Facial paralysis (n/a - Unknown - );Nausea (n/a - Unknown - );Taste disorder (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 25mg - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 25ug - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 1000mg - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - 20mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007259940	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Dose not changed - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259941	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Myalgia (12h - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259942	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259944	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );Dysgeusia (1d - Recovered/Resolved - );Hyperaesthesia teeth (1d - Recovered/Resolved - );Lethargy (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Restlessness (2d - Recovered/Resolved - );Toothache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[ESTRADIOL HEMIHYDRATE, ESTRADIOL VALERATE] (C - Menopausal symptoms - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007259945	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259946	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE SOLUTION] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007259947	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259948	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Rash erythematous (7d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Cardiac disorder - n/a - [n/a - 10mg - n/a])|[CEFRADINE] (C - Urinary tract infection - n/a - [n/a - 250mg - n/a])|[FOSCARNET, FOSCARNET SODIUM HEXAHYDRATE] (C - Asthma - n/a - [n/a - 200mg - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 15mg - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259950	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Bone pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Head discomfort (2d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Productive cough (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Routine health maintenance - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Routine health maintenance - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Routine health maintenance - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259951	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysphonia (n/a - Unknown - );Eye swelling (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Unknown - );Swollen tongue (n/a - Unknown - );Throat irritation (n/a - Not Recovered/Not Resolved - );Throat tightness (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Unknown - );Wheezing (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259955	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259957	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259965	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007259966	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Female	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Respiratory rate decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259967	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259970	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259972	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259973	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259975	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259976	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Trigeminal nerve disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007259977	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal chest pain (12h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259979	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood glucose decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	NOVORAPID [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259980	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259982	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259984	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007259985	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Burning sensation (n/a - Not Recovered/Not Resolved - );Chapped lips (n/a - Not Recovered/Not Resolved - );Glossodynia (n/a - Not Recovered/Not Resolved - );Oral pain (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007259986	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Agitation (n/a - Unknown - Other Medically Important Condition);Contusion (2d - Recovered/Resolved - Other Medically Important Condition);Joint swelling (1d - Recovered/Resolved - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007259986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007261106	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diabetic ketoacidosis (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMALOG [INSULIN LISPRO] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007261106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007262515	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (22h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007262515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007262525	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Malaise (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Asthma, Hypersensitivity - n/a - [n/a - 10mg - Oral])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Rosacea - n/a - [n/a - 50mg - Oral])|[ERGOCALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Sciatica - n/a - [n/a - 1200mg - Oral])|[GLIPIZIDE] (C - Diabetes mellitus - n/a - [n/a - 5mg - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension, Swelling - n/a - [n/a - 25mg - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 2000mg - Oral])|[NICOTINAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PSEUDOEPHEDRINE] (C - Sinus congestion - n/a - [n/a - 120mg - Oral])|[RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RIBOFLAVIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol abnormal - n/a - [n/a - 5mg - Oral])|[SUCRALFATE] (C - Reflux gastritis - n/a - [n/a - n/a - Oral])|[THIAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Procedural pain - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007262525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007263023	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007263023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007263957	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Recovering/Resolving - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Throat irritation (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007263957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007263971	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Breast tenderness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007263971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007263973	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Periorbital swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007263973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007264335	Spontaneous	2020-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Hyperventilation (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - 150mg - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007264335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007264390	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hot flush (3min - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007264390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007264580	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Illness (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007264580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007264808	Spontaneous	2020-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007264808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255474	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Herpes zoster (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255475	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255476	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Recovering/Resolving - );Injection site erythema (n/a - Recovering/Resolving - );Injection site pruritus (n/a - Recovering/Resolving - );Vaccination site abscess (n/a - Recovering/Resolving - );Vaccination site rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Palpitations - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255477	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255479	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Asthma (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Unknown - );Cough (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Arthritis - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthritis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TIOTROPIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255480	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255481	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255482	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[TAMOXIFEN, TAMOXIFEN CITRATE] (C - Breast cancer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255483	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255484	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Hot flush (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255486	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Back pain (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sciatica (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255487	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Throat irritation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Throat tightness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wheezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255489	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255490	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[THEOPHYLLINE, THEOPHYLLINE ANHYDROUS, THEOPHYLLINE MONOHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255492	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation);Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Subcutaneous])	[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255493	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Injection site mass (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255494	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pruritus (n/a - Unknown - Other Medically Important Condition);Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255495	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lip swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255496	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255497	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Uvulitis (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255499	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BARICITINIB PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255500	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255501	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Unknown - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255502	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Chest discomfort (n/a - Unknown - );Flushing (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Unknown - );Pharyngeal paraesthesia (n/a - Unknown - );Rash papular (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255503	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255504	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTRADIOL, NORETHISTERONE ACETATE, ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255506	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	CLOPIDOGREL BESILATE [CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255507	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site haemorrhage (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255508	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Throat tightness (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255509	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255510	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovering/Resolving - );Vaccination site joint erythema (n/a - Recovering/Resolving - );Vaccination site joint warmth (n/a - Recovering/Resolving - );Vision blurred (2h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255513	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Infection prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255514	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255516	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255517	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255518	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255521	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255522	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site mass (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255523	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain upper (5min - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Hepatic artery embolism (n/a - Unknown - );Hepatic enzyme increased (n/a - Recovering/Resolving - );Orthopnoea (n/a - Unknown - );Prostatomegaly (n/a - Unknown - );Urinary retention (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 3.75mg - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - 100ug - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - n/a])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 8mg - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 400ug - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Atrial fibrillation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255524	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255525	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255528	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[QUININE] (C - Muscle spasms - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255529	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255531	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255532	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255533	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Central venous pressure (n/a - Unknown - );Erythema (n/a - Unknown - );Pruritus (n/a - Unknown - );Swelling face (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255534	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspepsia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255535	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Hypertension (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	ERELZI [ETANERCEPT, ETANERCEPT, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 50mg - n/a])|FIASP [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|LEVEMIR [INSULIN DETEMIR] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255536	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1h - Recovered/Resolved - );Fatigue (n/a - Unknown - );Hypoglycaemia (1d - Recovered/Resolved - );Nervousness (1h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255537	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - );Paraesthesia (1d - Recovered/Resolved - );Swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255538	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	FLUTICASONE FUROATE [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARAFFIN, LIGHT LIQUID, PARAFFIN WHITE SOFT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255546	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255550	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255551	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Female	Asthenia (n/a - Unknown - Disabling, Other Medically Important Condition);Balance disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Cerebrovascular accident (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Muscle tone disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Speech disorder (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Hypertension - n/a - [n/a - n/a - n/a])|[QUETIAPINE FUMARATE] (C - Behaviour disorder - n/a - [n/a - n/a - n/a])|[QUININE] (C - Muscle spasms - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007255553	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Discomfort (1d - Recovered/Resolved - );Pharyngeal hypoaesthesia (1d - Recovered/Resolved - );Pharyngeal paraesthesia (1d - Recovered/Resolved - );Pharyngeal swelling (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255554	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255555	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255556	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIDRA [INSULIN GLULISINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255558	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold sweat (n/a - Unknown - Disabling);Dizziness (1d - Recovered/Resolved - Disabling);Dyspnoea (40min - Recovered/Resolved - Disabling);Fatigue (24h - Recovered/Resolved - Disabling);Heart rate increased (n/a - Unknown - Disabling);Pallor (n/a - Unknown - Disabling);Palpitations (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007255559	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255561	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Night sweats (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .4mL - Parenteral])	[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255562	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Cold sweat (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255563	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling hot (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site induration (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255564	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Fatigue (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255565	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Discoloured vomit (1d - Recovered/Resolved - );Migraine (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255566	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cough (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Hypersensitivity (n/a - Unknown - Life Threatening);Sensory loss (n/a - Unknown - Life Threatening);Swelling face (n/a - Unknown - Life Threatening);Swollen tongue (n/a - Unknown - Life Threatening);Vaccination site hypoaesthesia (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007255567	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Palpitations (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255568	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Unknown - );Vaccination site induration (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Paraesthesia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255569	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Nausea (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Urinary incontinence (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255570	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255571	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255572	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255574	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Angina pectoris (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255575	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensation of foreign body (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255576	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Pain in extremity (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255577	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - );Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255578	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255579	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255580	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Paraesthesia oral (n/a - Not Recovered/Not Resolved - );Vomiting (1d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Blood iron decreased - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255582	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255583	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Coronavirus infection - Not applicable - [1d - n/a - n/a])	[BALSALAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255584	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255585	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Nausea (1d - Recovered/Resolved - );Pallor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255586	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255589	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactoid reaction (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255591	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255592	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Eye disorder (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007255593	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Eye ulcer (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255594	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Rash (n/a - Unknown - );Skin reaction (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	CLOPIDOGREL HYDROGEN SULFATE [CLOPIDOGREL HYDROGEN SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ANASTROZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255596	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Disorientation (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Retching (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255599	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255600	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255601	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Arthritis - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255602	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255603	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Hot flush (n/a - Unknown - );Hypoaesthesia oral (1d - Recovered/Resolved - );Lip swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[SULFASALAZINE] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255604	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255605	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Headache (1d - Recovered/Resolved - );Photophobia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255606	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Circumoral swelling (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255607	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255608	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pruritus (2d - Recovered/Resolved - );Injection site warmth (4d - Recovered/Resolved - );Pain (5d - Recovered/Resolved - );Peripheral swelling (4d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255610	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255611	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255612	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site mass (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site pruritus (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DESOGESTREL, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])|[PAROXETINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007255613	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE MALEATE] (C - Pruritus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255614	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Diarrhoea (n/a - Unknown - );Eye pruritus (1d - Recovered/Resolved - );Lacrimation increased (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255616	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[MORPHINE, MORPHINE HYDROCHLORIDE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255618	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255620	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, OLODATEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255621	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255622	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 1.5mg - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255623	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination site swelling (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255624	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Limb discomfort (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Paraesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255625	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[PROPAFENONE, PROPAFENONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 150mg - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - 7.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007255626	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255628	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255629	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255630	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255631	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (4d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255632	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Headache - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Obsessive thoughts - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255633	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - );Vaccination site bruising (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Unknown - );Vaccination site mass (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255634	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255635	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Burning sensation (1d - Recovered/Resolved - );Tenderness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255636	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255637	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pain in extremity (5d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255638	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling abnormal (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255641	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Oral herpes (n/a - Not Recovered/Not Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255642	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Confusional state (n/a - Unknown - );Feeling abnormal (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255643	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255644	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood glucose decreased (n/a - Unknown - Other Medically Important Condition);Blood glucose increased (24h - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255645	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255650	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255651	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rectal haemorrhage (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CHLORPHENAMINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255653	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[PIZOTIFEN, PIZOTIFEN MALATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255654	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	International normalised ratio decreased (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCUSATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYALURONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE PHEUR, CALCIUM CARBONATE PH. EUR., SODIUM ALGINATE PH. EUR., SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255655	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255656	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255683	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site induration (n/a - Not Recovered/Not Resolved - );Vaccination site inflammation (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255684	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Lethargy (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255685	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Heart rate increased (n/a - Recovering/Resolving - );Wheezing (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255686	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255687	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Recovering/Resolving - Other Medically Important Condition);Balance disorder (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Urinary incontinence (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC DIETHYLAMINE, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255688	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255689	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dry mouth (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Flushing (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral coldness (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255690	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (5min - Recovered/Resolved - );Feeling hot (5min - Recovered/Resolved - );Hypersensitivity (1d - Recovered/Resolved - );Palpitations (5min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255691	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Feeling cold (n/a - Unknown - );Nervousness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	UNSPECIFIED MEDICATION [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255692	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007255694	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Nervousness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255695	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Discomfort (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Poor peripheral circulation (n/a - Unknown - );Sensory loss (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255696	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dyspnoea (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	NOT AVAILABLE [PARACETAMOL COATED 90%] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255698	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255699	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255700	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255703	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Limb discomfort (2d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255705	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255709	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255710	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255711	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Poor quality sleep (n/a - Unknown - );Temperature regulation disorder (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255712	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Limb discomfort (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255714	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255715	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255716	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255717	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255718	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255720	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255724	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Heart rate - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255726	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255727	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Illness (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	ZONISAMIDE [ZONISAMIDE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - Illness - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255729	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - COVID-19 - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - COVID-19 - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TIOTROPIUM] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - COVID-19 - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255730	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (1d - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255731	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly, Other Medically Important Condition);Haematemesis (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly, Other Medically Important Condition);Pyrexia (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007255732	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Unknown - Other Medically Important Condition);Burning sensation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255733	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tonsillar hypertrophy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FINASTERIDE] (C - Androgenetic alopecia - n/a - [n/a - 1mg - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255734	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Unknown - );Heart rate increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255735	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255736	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Life Threatening);Circulatory collapse (n/a - Recovered/Resolved - Life Threatening);Hyperventilation (n/a - Recovered/Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007255738	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL HYDROGEN SULFATE [CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255739	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Sneezing (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255740	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Dizziness exertional (1d - Recovered/Resolved - );Exertional headache (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255741	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Hyperhidrosis (n/a - Unknown - Disabling);Malaise (2d - Recovered/Resolved - Disabling);Myalgia (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255742	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255744	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255745	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Hypertension (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255747	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255748	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	COVID-19 (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255749	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - );Tenderness (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255751	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - 40mg - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255752	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (30min - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (30min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - 1{DF} - Respiratory (inhalation)])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255753	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Head discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255754	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255755	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold sweat (n/a - Unknown - );Cough (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - );Productive cough (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255756	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255758	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Central vision loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemorrhage intracranial (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Posterior reversible encephalopathy syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Upper gastrointestinal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|VACCINE [NOT AVAILABLE] (C - Urinary tract infection - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CEFALEXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007255760	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Lethargy (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (2d - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Tremor (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007255761	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255762	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Viral pharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255763	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255766	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Acute myocardial infarction (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN HUMAN, INSULIN HUMAN, INSULIN INJECTION SOLUBLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULPHATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALMETEROL] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255769	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Female	Lymphadenopathy (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Peripheral swelling (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Unknown - Disabling);Vomiting (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007255770	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255771	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injected limb mobility decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255772	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Flushing (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255774	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactoid reaction (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255775	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255777	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Autoimmune disorder - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255778	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Injection site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255779	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nasopharyngitis (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255781	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Menstrual disorder (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255782	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BENEPALI [ETANERCEPT] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255783	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255785	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255787	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[CLOSTRIDIUM TETANI] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255788	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Retching (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255790	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007255791	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255792	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255794	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Unknown - );Pain of skin (n/a - Unknown - );Vaccination site movement impairment (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007255795	Spontaneous	2020-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Malaise (n/a - Unknown - );Seizure (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ANTIBIOTICS [NOT AVAILABLE] (C - Ear infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007255796	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007255797	Spontaneous	2020-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007255797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007248971	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007248971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249723	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Circulatory collapse (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertension (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007249725	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Photophobia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249727	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249728	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Malaise (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Back pain - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - Dizziness - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Prophylaxis against gastrointestinal ulcer - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249729	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (n/a - Unknown - Other Medically Important Condition);Injection site pain (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249730	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE, ESTRADIOL, MICRONIZED] (C - n/a - n/a - [n/a - 2mg - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249733	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LYMECYCLINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[NORETHISTERONE ACETATE, ESTRADIOL, NORETHISTERONE ACETATE, ESTRADIOL HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249735	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Headache - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249736	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249738	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Recovering/Resolving - );Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE] (C - Asthma - n/a - [n/a - 200ug - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249739	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249740	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Malaise (1h - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	BUDESONIDE [BUDESONIDE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, ASCORBIC ACID, BIOTIN, FOLIC ACID, NICOTINAMIDE, PHYTOMENADIONE, RIBOFLAVIN, ZINC, CALCIUM, IODINE, PANTOTHENIC ACID, POTASSIUM, PYRIDOXINE HYDROCHLORIDE, URIDINE, CYTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249742	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249747	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249749	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysgeusia (1d - Recovered/Resolved - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249752	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Eye disorder (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249753	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (5d - Recovered/Resolved - );Influenza like illness (n/a - Unknown - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	PROPRANOLOL HYDROCHLORIDE [PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249754	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dermatitis allergic (1d - Recovered/Resolved - );Rash macular (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249755	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249756	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Recovering/Resolving - );Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249757	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249758	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249762	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249768	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249769	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249771	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249775	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Taste disorder (n/a - Recovered/Resolved - );Tongue oedema (n/a - Recovering/Resolving - );Urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249776	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANTIHYPERTENSIVES [NOT AVAILABLE] (C - Hypertension - n/a - [n/a - n/a - n/a])|UNSPECIFIED MEDICATION [NOT AVAILABLE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|UNSPECIFIED MEDICATION [NOT AVAILABLE] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007249778	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007249780	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249782	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249783	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249785	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249786	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Diarrhoea (1d - Recovered/Resolved - );Enuresis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249787	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - 300mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 1.25mg - Oral])|[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[ENOXAPARIN] (C - n/a - n/a - [n/a - 40mg - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007249788	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (1d - Recovered/Resolved - );Dizziness (4h - Unknown - );Dysmenorrhoea (n/a - Unknown - );Heavy menstrual bleeding (n/a - Unknown - );Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - );Menstruation irregular (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249789	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	AVAMYS [FLUTICASONE FUROATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CARBOMER] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PROPYLENE GLYCOL, CETOSTEARYL ALCOHOL, SORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM CROMOGLICATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249791	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash pruritic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|RISPERIDONE [RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|TRULICITY [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007249792	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007249793	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Gingival blister (n/a - Not Recovered/Not Resolved - );Oral mucosal blistering (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Perioral dermatitis - n/a - [n/a - n/a - n/a])|[NORETHISTERONE ACETATE, ESTRADIOL, NORETHISTERONE, ESTRADIOL HEMIHYDRATE] (C - Premature menopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249794	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249796	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hypoaesthesia (1d - Recovered/Resolved - );Hypoaesthesia oral (1d - Recovered/Resolved - );Rash macular (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249797	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Diarrhoea (1d - Recovered/Resolved - );Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTROGENS CONJUGATED, ESTRONE SODIUM SULFATE, EQUILIN SULFATE SODIUM] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[ESTROGENS CONJUGATED] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[ETODOLAC] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249798	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Parenteral])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - 2{DF} - Respiratory (inhalation)])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 125ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249799	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Dysgeusia (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249800	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - );Nervousness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249801	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary mass (n/a - Unknown - );Breast swelling (n/a - Unknown - );Pain (n/a - Unknown - );Papule (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249802	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Angioedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007249803	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Rash erythematous (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Unknown - [n/a - n/a - Intramuscular])	[CYANOCOBALAMIN, VITAMIN B12] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249804	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249805	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249806	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Vaccination site discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249808	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249810	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249812	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Labyrinthitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FERROUS SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249813	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Skin reaction (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249814	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249817	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249818	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249819	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Musculoskeletal stiffness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007249820	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249821	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash morbilliform (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249822	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249823	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (1d - Recovered/Resolved - Disabling);Dizziness (n/a - Recovered/Resolved - Disabling);Malaise (1d - Recovering/Resolving - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Vomiting (1d - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TIBOLONE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007249824	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249826	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CINNARIZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAFLUPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249828	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249829	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ETHINYLESTRADIOL, GESTODENE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249830	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Haemoptysis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249831	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (n/a - Unknown - );Swollen tongue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249832	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site mass (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site rash (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[HYDROXYCHLOROQUINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249834	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249835	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249836	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Flushing (n/a - Unknown - Caused/Prolonged Hospitalisation);Throat tightness (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007249837	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Vertigo (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249838	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249840	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Night sweats (2d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249841	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Confusional state (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Defaecation urgency (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling drunk (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neck pain (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in jaw (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pruritus (1d - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Rash macular (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Tension headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007249842	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249843	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249844	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249845	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249846	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Inflammation (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249847	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SOLIFENACIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249848	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dizziness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249849	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tachycardia (5min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249850	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249851	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Inflammation (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249852	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lip swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249853	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Gingival bleeding (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249855	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Toothache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249856	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249857	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249859	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site warmth (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Swelling - n/a - [n/a - n/a - n/a])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249860	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myoclonus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETORICOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249862	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Syncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249864	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249866	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoglycaemia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	INSULIN ASPART [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[BEZAFIBRATE] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthritis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249867	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Body temperature increased (n/a - Unknown - );Fatigue (n/a - Unknown - );Migraine (n/a - Unknown - );Pain (n/a - Unknown - );Syncope (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249868	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249870	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249871	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tonsillitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249872	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Mouth ulceration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249874	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249876	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249877	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Hypokinesia (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Unknown - Disabling);Limb discomfort (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007249878	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249879	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site mass (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249880	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Malaise (2d - Recovered/Resolved - );Polymenorrhoea (n/a - Not Recovered/Not Resolved - );Vulvovaginal candidiasis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249881	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249882	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (2h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249884	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249885	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pain (5d - Not Recovered/Not Resolved - );Eye pruritus (5d - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pharyngeal swelling (n/a - Not Recovered/Not Resolved - );Pruritus (5d - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mL - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249886	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|HORMONE THERAPY [NOT AVAILABLE] (C - Prostate cancer - n/a - [n/a - 1{DF} - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostate cancer stage III - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249887	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Mouth ulceration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVONORGESTREL, LEVONORGESTREL MICRONISED] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249888	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249890	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Lymphoedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249891	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (4h - Recovered/Resolved - );Hypoglycaemia (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LINAGLIPTIN [LINAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - 5mg - n/a])|[ACETYLSALICYLIC ACID] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249893	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Limb discomfort (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Peripheral coldness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249894	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Thirst (12h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	[IMIPRAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249895	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cough (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249897	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Recovering/Resolving - );Swelling (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249898	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aura (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Retinal migraine (1d - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249899	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pruritus (1d - Recovered/Resolved - Other Medically Important Condition);Flushing (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	NOVORAPID [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249900	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (2d - Recovered/Resolved With Sequelae - );Eye swelling (2d - Recovered/Resolved With Sequelae - );Swelling face (n/a - Unknown - );Swelling of eyelid (2d - Recovered/Resolved With Sequelae - );Wheezing (2d - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007249901	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249904	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249905	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249906	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Pneumonia (1d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Sepsis (n/a - Unknown - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007249907	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Unknown - );Swollen tongue (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TEMAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249908	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Hyposmia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249909	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Recovering/Resolving - Disabling);Headache (2d - Recovered/Resolved - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Peripheral swelling (2d - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007249910	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	STATIN [NOT AVAILABLE] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249911	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249912	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[CEFALEXIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Hormone therapy - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Hernia - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Erythema - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007249913	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	PREGABALIN MYLAN [PREGABALIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[FLUOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[MEBEVERINE HYDROCHLORIDE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE SODIUM] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])|[PEPPERMINT OIL] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249914	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007249915	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249917	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249918	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Petechiae (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LIOTHYRONINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249919	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[TRIMETHOPRIM] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249921	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition);Hyperventilation (1d - Recovered/Resolved - Other Medically Important Condition);Panic attack (1d - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LACTULOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAFTIDROFURYL, NAFTIDROFURYL OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007249923	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249924	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007249925	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vaccination site rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007249925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250139	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Glossodynia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250141	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspepsia (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	HRT [NOT AVAILABLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OENOTHERA BIENNIS] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250142	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Dysgeusia (1d - Recovered/Resolved - );Hypoaesthesia oral (1d - Recovered/Resolved - );Pharyngeal paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007250143	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (3d - Recovered/Resolved - );Feeling hot (n/a - Unknown - );Influenza like illness (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Migraine (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250146	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250147	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Influenza like illness (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	PROPRANOLOL HYDROCHLORIDE [PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250148	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Lethargy (n/a - Recovering/Resolving - );Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastroenteritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250149	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Facial spasm (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007250150	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250151	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling);Peripheral swelling (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL [UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007250152	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Neonate (Preterm and Term newborns)	No	Female	Night sweats (n/a - Recovering/Resolving - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Spinal disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250153	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Feeling hot (n/a - Recovering/Resolving - );Periorbital swelling (n/a - Recovering/Resolving - );Rash macular (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250154	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - );Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250155	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007250156	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250157	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (15min - Unknown - );Rash macular (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250158	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dysphonia (1wk - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007250161	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Muscle twitching (0d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250164	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250166	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Eye swelling (n/a - Unknown - );Swelling face (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250167	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature abnormal (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007250169	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250175	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250176	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250178	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Anaphylactic reaction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007250179	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[PIZOTIFEN, PIZOTIFEN MALATE] (C - Cluster headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250183	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Lower respiratory tract infection (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Lower respiratory tract infection - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007250187	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007250188	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling of body temperature change (1d - Recovered/Resolved - );Migraine (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250189	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250190	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007250191	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007250192	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250193	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007250194	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN CALCIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007250199	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Bladder discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007250199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007251311	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dysphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Throat tightness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007251311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007251825	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007251825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007251828	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Hot flush (n/a - Unknown - Other Medically Important Condition);Memory impairment (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Staring (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007251828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007251832	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	GLYXAMBI [LINAGLIPTIN, EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 1{DF} - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 1000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007251832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007251837	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007251837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007252514	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Back pain (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007252514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007252586	Spontaneous	2020-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (1d - Recovered/Resolved - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (1d - Recovered/Resolved - );Vaccination site coldness (1d - Recovered/Resolved - );Vaccination site hypoaesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007252586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007252589	Spontaneous	2020-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (0d - Recovered/Resolved - Other Medically Important Condition);Rash macular (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007252589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241941	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1[iU] - Parenteral])	[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241943	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241944	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007241947	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest discomfort (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241949	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ADAPALENE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FROVATRIPTAN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241950	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE TARTRATE, PARACETAMOL, PARACETAMOL BP, DIHYDROCODEINE TARTRATE BP, PARACETAMOL, DIHYDROCODEINE TARTRATE BP] (C - Pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241951	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[NORTRIPTYLINE, NORTRIPTYLINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[PROPANOL] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241952	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FOLIC ACID] (C - Hereditary spherocytosis - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241953	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - Other Medically Important Condition);Pustule (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241955	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (1d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007241956	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Generalised tonic-clonic seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007241958	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Pleuritic pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007241959	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pH increased (1d - Recovering/Resolving - );Dizziness (n/a - Unknown - );Feeling abnormal (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241960	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241962	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007241963	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Delirium (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Ischaemic stroke - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[DONEPEZIL, DONEPEZIL HYDROCHLORIDE] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007241964	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Oropharyngeal pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007241965	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007241967	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site bruising (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site discolouration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241969	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Polycystic ovarian syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241970	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241971	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241972	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Unknown - Other Medically Important Condition);Palpitations (30min - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	STALEVO [CARBIDOPA, ENTACAPONE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - 150mg - n/a])|[AMANTADINE HYDROCHLORIDE] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[ROPINIROLE, ROPINIROLE HYDROCHLORIDE] (C - Parkinson's disease - n/a - [n/a - 18mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007241973	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Unknown - );Illness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241974	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nasal congestion (n/a - Unknown - Disabling);Sneezing (n/a - Unknown - Disabling);Urticaria (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007241976	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Viral labyrinthitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241977	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Product administration error (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[INFLUENZA VIRUS] (S - n/a - Not applicable - [1d - n/a - n/a])	BUMETANIDE [BUMETANIDE] (C - n/a - n/a - [n/a - n/a - n/a])|SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007241978	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241979	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Decreased appetite (4d - Recovered/Resolved - Other Medically Important Condition);Nausea (10min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - 15mg - n/a])|SEMAGLUTIDE [SEMAGLUTIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 80mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 500mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 1.25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241980	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Decreased appetite (n/a - Unknown - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007241981	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Herpes zoster (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007241982	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	DRONEDARONE [DRONEDARONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007241984	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241985	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Productive cough (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241986	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Erythema (n/a - Unknown - );Fixed eruption (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Unknown - );Pruritus (n/a - Unknown - );Skin lesion (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241987	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241988	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Unknown - );Chills (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - );Swelling (n/a - Unknown - );Tonsillar inflammation (n/a - Unknown - );Tonsillitis (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241989	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site bruising (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241990	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241991	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007241993	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[CYCLIZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241994	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Tri-iodothyronine decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007241995	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007241996	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Syncope (1d - Recovered/Resolved - );Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007241997	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Migraine (n/a - Unknown - Disabling);Vomiting (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - Left ventricular failure - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007241998	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007241999	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007241999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242000	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Axillary pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Induration (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242001	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Allergy to vaccine (n/a - Recovering/Resolving - );Dry skin (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - 100mg - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 4mg - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 100mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242002	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash (n/a - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242003	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242005	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (1d - Recovered/Resolved - Life Threatening);Erythema (n/a - Unknown - Life Threatening);Paraesthesia oral (1d - Recovered/Resolved - Life Threatening);Pharyngeal paraesthesia (1d - Recovered/Resolved - Life Threatening);Rash (1d - Recovered/Resolved - Life Threatening);Speech disorder (1d - Recovered/Resolved - Life Threatening);Swollen tongue (1d - Recovered/Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007242006	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007242007	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - );Breast pain (n/a - Unknown - );Breast swelling (n/a - Unknown - );Erythema (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242008	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ANTIHYPERTENSIVE [NOT AVAILABLE] (C - Hypertension - n/a - [n/a - n/a - n/a])|UNSPECIFIED DRUG [NOT AVAILABLE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|UNSPECIFIED DRUG [NOT AVAILABLE] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007242009	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Burning sensation (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Dermatitis (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242010	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Disabling);Chest discomfort (n/a - Unknown - Disabling);Chills (n/a - Unknown - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Unknown - Disabling);Pain in extremity (2d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242012	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242013	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242014	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - 1.25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007242015	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242016	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242018	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Monoplegia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242019	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Injection site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242020	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Confusional state (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	MEMANTINE HYDROCHLORIDE [MEMANTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN SANDOZ GMBH [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242022	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242025	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242026	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - Results in Death);Epistaxis (n/a - Unknown - Results in Death);Haematemesis (n/a - Unknown - Results in Death);Haemoptysis (n/a - Unknown - Results in Death);Headache (n/a - Unknown - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - Hypovitaminosis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10007242027	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cheilitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242028	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pain in jaw (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - n/a])	NEORECORMON [EPOETIN BETA] (C - Anaemia - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - Palpitations - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242029	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242031	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242032	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pain (n/a - Unknown - );Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	HORMONE REPLACEMENT THERAPY [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242033	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ROTIGOTINE [ROTIGOTINE] (C - Restless legs syndrome - n/a - [n/a - 3mg - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Restless legs syndrome - n/a - [n/a - 600mg - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242034	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242036	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (56h - Recovered/Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[SOLIFENACIN SUCCINATE] (C - Hypertonic bladder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242037	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242038	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Abdominal pain (n/a - Recovering/Resolving - Disabling);Diarrhoea (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242190	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary mass (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242193	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Myalgia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242194	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242196	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242197	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242198	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242200	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242201	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysgeusia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242202	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Back pain (1d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|UNSPECIFIED MEDICATION [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIMETHYL SULFONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LACTULOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242204	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (1d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242205	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Enlarged uvula (1d - Recovered/Resolved - );Swelling face (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242206	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Dizziness (20min - Recovered/Resolved - );Hyperhidrosis (20min - Recovered/Resolved - );Paraesthesia (20min - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - );Tremor (20min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Ehlers-Danlos syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242209	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Peripheral coldness (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242211	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242213	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash macular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242214	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - Other Medically Important Condition);Disorientation (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242215	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tachycardia (1min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007242216	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CONTRACEPTIVE IUD NOS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242218	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Meniere's disease - n/a - [n/a - n/a - n/a])|[BETAHISTINE DIHYDROCHLORIDE] (C - Meniere's disease - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242220	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Lymph node pain (n/a - Unknown - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Unknown - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - COVID-19 pneumonia - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242222	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242223	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242224	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Influenza like illness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242225	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242226	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Bone pain (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007242227	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242228	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242229	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chromaturia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242230	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242231	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Lethargy (1d - Recovered/Resolved - );Photophobia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242232	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Chills (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tension headache (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FELODIPINE] (C - Blood pressure measurement - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242233	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242234	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Peripheral swelling (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242236	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242237	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007242238	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242239	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Ageusia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE, ESTRADIOL, MICRONIZED] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242240	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242243	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lip swelling (1d - Recovered/Resolved - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242244	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CICLOSPORIN [CICLOSPORIN] (C - Psoriasis - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TRANEXAMIC ACID] (C - Heavy menstrual bleeding - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Borderline personality disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242246	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[FELODIPINE] (C - n/a - n/a - [n/a - 5mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242247	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242249	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Breast pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242250	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242251	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	IRBESARTAN HYDROCHLORIDE [IRBESARTAN HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SITAGLIPTIN PHOSPHATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242252	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242254	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BUMETANIDE [BUMETANIDE] (C - Diuretic therapy - n/a - [n/a - n/a - n/a])|TELMISARTAN [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - Pain - n/a - [n/a - n/a - n/a])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[DABIGATRAN] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE, CHONDROITIN] (C - Nutritional supplementation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Urine output - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, ASCORBIC ACID, BIOTIN, FOLIC ACID, NICOTINAMIDE, PHYTOMENADIONE, RIBOFLAVIN, ZINC, CALCIUM, IODINE, PANTOTHENIC ACID, POTASSIUM, PYRIDOXINE HYDROCHLORIDE, URIDINE, CYTIDINE] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242255	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[EMTRICITABINE, TENOFOVIR] (C - Prophylaxis against HIV infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242256	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Injection site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242257	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242258	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242259	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Decreased activity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242261	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Syncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242262	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Inflammation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242263	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BIMATOPROST [BIMATOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BRIMONIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242266	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dysphagia (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hot flush (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242268	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUPRENORPHINE] (C - Pain - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242269	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242271	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242273	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Recovering/Resolving - );Tenderness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - n/a - n/a - [n/a - n/a - n/a])|HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - Pernicious anaemia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 125ug - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242274	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - );Rash macular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, COLECALCIFEROL CONCENTRATE (POWDER FORM) (SDS), COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242278	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242280	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pallor (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242281	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242282	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE PH. EUR.] (C - Adrenal suppression - n/a - [n/a - n/a - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - Antibiotic prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242283	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242284	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[ISOPROPYL ALCOHOL] (C - Anxiety - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242285	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Groin pain - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])|[PROCHLORPERAZINE, PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE BP, PROCHLORPERAZINE MESILATE] (C - Nausea - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242286	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (2d - Recovered/Resolved - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242287	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242288	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fall (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242593	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242594	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oral mucosal eruption (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242595	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint stiffness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242598	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Dysgeusia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242599	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Back pain (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242600	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Unknown - );Hypotension (n/a - Recovering/Resolving - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	NUTRITIONAL SUPPLEMENT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])|[IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|[ISPAGHULA HUSK BP, MEBEVERINE HYDROCHLORIDE, ISPAGHULA HUSK] (C - Constipation - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242601	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242602	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Acute myocardial infarction - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Acute myocardial infarction - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242603	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242604	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242605	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Autoimmune hypothyroidism - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242609	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242610	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242612	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling cold (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242613	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242614	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL] (C - Premature menopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242615	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242616	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	HRT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242617	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site erythema (n/a - Unknown - );Injection site pruritus (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242618	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|REPATHA [EVOLOCUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|TOUJEO [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|VICTOZA [LIRAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242620	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Thirst (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242621	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242622	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242623	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	CLOPIDOGREL HYDROCHLORIDE [CLOPIDOGREL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|DUAKLIR GENUAIR [FORMOTEROL FUMARATE DIHYDRATE, ACLIDINIUM BROMIDE, FORMOTEROL FUMARATE, ACLIDINIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242625	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242626	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site induration (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	STATIN [NOT AVAILABLE] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242627	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242628	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242629	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - Disabling);Headache (1d - Recovered/Resolved - Disabling);Lymphadenopathy (2d - Recovering/Resolving - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Vomiting (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ISOPROPYL ALCOHOL] (C - Headache - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242630	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Headache (4d - Recovered/Resolved - Other Medically Important Condition);Injury corneal (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep attacks (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[ETORICOXIB] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242631	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Paraesthesia (n/a - Recovered/Resolved - );Paraesthesia oral (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242632	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242634	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007242635	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METHYLPREDNISOLONE ACETATE] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE, METHYLPREDNISOLONE ACETATE] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242636	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242638	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DUORESP SPIROMAX [BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE, ESTRADIOL, MICRONIZED] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242639	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (2min - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Palpitations (1min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242641	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242642	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242643	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash pruritic (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242644	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Oral candidiasis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242645	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (1d - Recovering/Resolving - );Paraesthesia (1d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242646	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242647	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Lip swelling (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLCYSTEINE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - Osteoporosis - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoporosis - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Pain - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[PRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[TAPENTADOL] (C - Pain - n/a - [n/a - n/a - n/a])|[TEMAZEPAM] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242648	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242650	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242651	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242652	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242653	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242654	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242656	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cough (20min - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Peripheral coldness (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242657	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242658	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Heat oedema (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Rash macular (6d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242659	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|SITAGLIPTIN [SITAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242660	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242661	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Recovered/Resolved - );Lip swelling (n/a - Unknown - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242662	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242663	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242665	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Submandibular gland enlargement (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242666	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007242667	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUPROPION HYDROCHLORIDE] (C - Mental disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242668	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242669	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242671	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242673	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[GOSERELIN] (C - Breast cancer female - n/a - [n/a - n/a - n/a])|[TAMOXIFEN, TAMOXIFEN CITRATE] (C - Breast cancer female - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242674	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242675	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242676	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242677	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242678	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Head discomfort (3d - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (3d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242679	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Maculopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Metamorphopsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FERROUS FUMARATE] (C - Iron deficiency anaemia - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242680	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TRANEXAMIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242681	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ESTRADIOL HEMIHYDRATE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242682	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242683	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Injection site hypoaesthesia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINE, NICOTINE BITARTRATE DIHYDRATE, NICOTINE RESINATE] (C - Ex-tobacco user - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242684	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling of body temperature change (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242685	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Purpura (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CANAGLIFLOZIN [CANAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMYLASE, LIPASE, PROTEASE, PANCREALIPASE, PANCREAS POWDER, PANCREAS POWDER FROM PORCINE, PANCREATIN, PANCREATIN BP, PANCRELIPASE AMYLASE, PANCRELIPASE PROTEASE, LIPASE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEMANTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242686	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Malaise (n/a - Unknown - );Pallor (n/a - Unknown - );Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242687	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242689	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[FUROSEMIDE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242690	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242691	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242692	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pruritus (n/a - Unknown - );Fatigue (2d - Recovered/Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242707	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Depersonalisation/derealisation disorder (n/a - Recovering/Resolving - );Palpitations (1d - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242708	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination site pain (44h - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242709	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242710	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242711	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242712	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hypoaesthesia (15min - Recovered/Resolved - );Paraesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242715	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242716	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Body temperature increased (n/a - Unknown - );Headache (n/a - Unknown - );Influenza (n/a - Recovering/Resolving - );Lethargy (n/a - Unknown - );Myalgia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242717	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242718	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242719	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Crying (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Skin erosion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site infection (n/a - Unknown - Other Medically Important Condition);Vaccination site ulcer (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[BENDROFLUAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242720	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Hot flush (n/a - Unknown - );Presyncope (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242722	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Sneezing (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242723	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry skin (n/a - Unknown - );Rash macular (n/a - Recovering/Resolving - );Skin discolouration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242725	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[NORETHISTERONE] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242726	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Cerebellar stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Antiplatelet therapy - n/a - [n/a - n/a - n/a])|LUMIGAN [BIMATOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[BETAHISTINE HYDROCHLORIDE] (C - Vertigo - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[DOMPERIDONE] (C - Prophylaxis of nausea and vomiting - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007242727	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (1d - Recovered/Resolved - Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Disorientation (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thunderclap headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007242728	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Decreased appetite (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Feeling cold (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Heart rate increased (n/a - Unknown - );Hypersensitivity (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Sweating fever (1d - Recovered/Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242729	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LYMECYCLINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242730	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Lethargy (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242731	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Glossodynia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (1h - Recovered/Resolved - Other Medically Important Condition);Tongue movement disturbance (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242732	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Blister (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (5min - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (1d - Recovered/Resolved - Other Medically Important Condition);Local reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242733	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242735	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ONDANSETRON] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242736	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242737	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007242738	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Fatigue (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242739	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242740	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242741	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242742	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site bruising (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242746	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - Calcium deficiency - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007242747	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007242748	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Musculoskeletal stiffness (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Rash macular (n/a - Not Recovered/Not Resolved - );Tension headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007242748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007244845	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007244845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007245444	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Product preparation issue (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007245444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007245460	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypertension (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007245460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007245492	Spontaneous	2020-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Mental impairment (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - );Tachycardia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007245492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007246431	Spontaneous	2020-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007246431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007231486	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Disease recurrence (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Palpitations (0d - Recovered/Resolved - );Tremor (0d - Recovered/Resolved - );Ventricular extrasystoles (0d - Recovered/Resolved - )	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CLONIDINE] (C - n/a - n/a - [n/a - .02mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007231486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007232741	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening);Circulatory collapse (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007232743	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Facial pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232746	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Feeling cold (n/a - Unknown - );Headache (1d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Tremor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232747	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL HEMIHYDRATE, ESTRADIOL VALERATE] (C - Premature menopause - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (C - Ovarian failure - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232748	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Unknown - );Movement disorder (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site bruising (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232749	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hypoacusis (n/a - Not Recovered/Not Resolved - );Paraesthesia (1d - Recovered/Resolved - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232750	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Paraesthesia oral (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232751	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232752	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Decreased appetite (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232753	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mouth ulceration (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232754	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (20min - Recovered/Resolved - Other Medically Important Condition);Sensory disturbance (20min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232755	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (2min - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (2min - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (17min - Recovered/Resolved - Other Medically Important Condition);Malaise (2min - Recovered/Resolved - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007232756	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232757	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature abnormal (24h - Recovering/Resolving - Disabling, Other Medically Important Condition);Nausea (24h - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (24h - Recovering/Resolving - Disabling, Other Medically Important Condition);Torticollis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007232758	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ear discomfort (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232759	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Throat irritation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232760	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysgeusia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232762	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymph node palpable (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232763	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Anaphylactic reaction (1d - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007232766	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232767	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Breath odour (n/a - Recovering/Resolving - );Dysgeusia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232768	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blister (n/a - Recovered/Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Papule (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|INFLIXIMAB [INFLIXIMAB] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL CONJUGATE VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232769	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232770	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Retching (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232771	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Lethargy (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232773	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232774	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232776	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232777	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232778	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (1d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232779	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232782	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007232785	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ANTICOAGULANT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232786	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232787	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232790	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232792	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232794	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Skin tightness (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232795	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232797	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232798	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232806	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blister (n/a - Recovering/Resolving - );Erythema (n/a - Unknown - );Skin lesion (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232807	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232808	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232809	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Unknown - Caused/Prolonged Hospitalisation);Presyncope (n/a - Unknown - Caused/Prolonged Hospitalisation);Unresponsive to stimuli (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007232810	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Melaena (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Peripheral vascular disorder - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Peripheral vascular disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007232811	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232812	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007232813	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232817	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232819	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Balance disorder (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232827	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232829	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Influenza like illness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232832	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IMIQUIMOD [IMIQUIMOD] (C - n/a - n/a - [n/a - n/a - n/a])|[CLINDAMYCIN, CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN PHOSPHATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232833	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232834	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Arthritis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Barrett's oesophagus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232902	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Crying (n/a - Recovered/Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CHLORHEXIDINE DIHYDROCHLORIDE, NEOMYCIN SULFATE] (C - Cautery to nose - n/a - [n/a - n/a - n/a])|[TRANEXAMIC ACID] (C - Epistaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232904	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007232905	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232907	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Asthma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vein rupture (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007232908	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Hypoaesthesia oral (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232909	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Feeling cold (n/a - Unknown - );Hypertension (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CHOLESTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Anaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232911	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232919	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232922	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232924	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - );Discoloured vomit (n/a - Unknown - );Erythema (n/a - Unknown - );Illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232925	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232926	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232928	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232929	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232930	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232931	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232932	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Life Threatening);Insomnia (4d - Recovered/Resolved - Life Threatening);Myalgia (3d - Recovered/Resolved - Life Threatening);Pyrexia (1d - Recovered/Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007232933	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Liquid product physical issue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232934	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETORICOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232935	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[PHENOXYMETHYLPENICILLIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232939	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232942	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232949	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Motion sickness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL ZENTIVA [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Embolic stroke - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Tricuspid valve disease - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232951	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Limb discomfort (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232952	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in jaw (n/a - Unknown - );Parotid gland enlargement (n/a - Unknown - );Parotitis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232954	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Phonophobia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232955	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Hypersensitivity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastric ulcer - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Cardiac failure congestive - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232956	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Blood pressure increased (n/a - Unknown - );Eyelid irritation (1d - Recovered/Resolved - );Heart rate increased (n/a - Unknown - );Palpitations (1d - Recovering/Resolving - );Paraesthesia oral (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232959	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232960	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007232961	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232963	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Body temperature increased (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Dry mouth (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Migraine (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007232964	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Tension headache (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007232965	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Sinus pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232966	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Dehydration (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	TRIUMEQ [ABACAVIR, LAMIVUDINE, DOLUTEGRAVIR] (C - HIV test positive - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrointestinal disorder - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232968	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232971	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (1d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007232972	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PROCHLORPERAZINE] (C - Migraine - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232973	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Recovering/Resolving - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007232974	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007232975	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232976	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Influenza like illness (n/a - Unknown - );Migraine (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232978	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eructation (n/a - Unknown - Disabling);Vomiting (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Insulin-requiring type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - Insulin-requiring type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Insulin-requiring type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Varices oesophageal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007232979	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	EDOXABAN [EDOXABAN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CARMELLOSE SODIUM, GLYCEROL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, TRIAMTERENE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232981	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (2d - Recovered/Resolved - );Feeling abnormal (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Stress - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232982	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Hypersomnia (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MIRABEGRON [MIRABEGRON] (C - Urinary incontinence - n/a - [n/a - n/a - n/a])|ROTIGOTINE [ROTIGOTINE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BECLOMETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - Pain - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232983	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Unknown - );Hyperglycaemia (4d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232985	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (n/a - Recovering/Resolving - Disabling);Chest discomfort (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Cutaneous lupus erythematosus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007232986	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eyelids pruritus (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Swelling of eyelid (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232987	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007232988	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232992	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Injection site pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232995	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Chest pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232996	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[METHOTREXATE, METHOTREXATE DISODIUM, METHOTREXATE SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007232997	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Skin disorder (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007232999	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007232999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233000	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233152	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (n/a - Unknown - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233153	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233155	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Eye swelling (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANTIHISTAMINES [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233158	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233159	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold sweat (1d - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[DROSPIRENONE, ETHINYLESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233161	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Furuncle (n/a - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Nasal discomfort (2d - Recovered/Resolved - );Sensitive skin (n/a - Unknown - );Swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233163	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Life Threatening);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening);Hallucination (n/a - Not Recovered/Not Resolved - Life Threatening);Hyporeflexia (n/a - Unknown - Life Threatening);Hypotension (n/a - Unknown - Life Threatening);Sepsis (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUAD [A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMC X-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/DARWIN/6/2021, IVR-227), MF59C.1, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENOXAPARIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - Nipple disorder - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - n/a - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007233166	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dyspepsia (n/a - Unknown - );Oral discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233170	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Presyncope (10min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233171	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - );Lethargy (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[MEASLES, MUMPS AND RUBELLA VACCINE (LIVE)] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233173	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash pruritic (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233174	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233175	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Pain in extremity (n/a - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233176	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233177	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233178	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233179	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Unknown - );Migraine (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233180	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Insomnia (n/a - Unknown - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|SITAGLIPTIN [SITAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233181	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash pruritic (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233184	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash pruritic (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233185	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash macular (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233186	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site joint movement impairment (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233188	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233190	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold sweat (n/a - Unknown - Other Medically Important Condition);Flushing (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (2h - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Hypermobility syndrome - n/a - [n/a - n/a - n/a])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, BETACAROTENE, BIOTIN, ERGOCALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, PYRIDOXINE, RIBOFLAVIN, THIAMINE, ZINC, CALCIUM, CHROMIUM, COPPER, IODINE, IRON, MAGNESIUM, MANGANESE, PANTOTHENIC ACID, PHOSPHORUS, POTASSIUM, SELENIUM, TOCOPHERYL ACETATE, MOLYBDENUM, ASCORBIC ACID, BETACAROTENE, ERGOCALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, PYRIDOXINE, RIBOFLAVIN, THIAMINE, ZINC, CALCIUM, CHROMIUM, COPPER, IODINE, IRON, MAGNESIUM, MANGANESE, PANTOTHENIC ACID, PHOSPHORUS, POTASSIUM, SELENIUM, MOLYBDENUM, DL-ALPHA TOCOPHEROL ACETATE, D-BIOTIN, ERGOCALCIFEROL, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE PH. EUR., POTASSIUM BICARBONATE USP, POTASSIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233191	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cellulite (n/a - Unknown - );Pruritus (n/a - Unknown - );Swelling (n/a - Unknown - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233192	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLESTYRAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233193	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007233196	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia oral (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vein disorder (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007233197	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tension headache (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233198	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007233199	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007233200	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233201	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233202	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Polycystic ovarian syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233203	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233204	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233206	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233207	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[PSEUDOEPHEDRINE] (C - Sinus congestion - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233208	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233210	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Loss of consciousness (1d - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Gastrointestinal haemorrhage - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233212	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233214	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Balance disorder (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233217	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233218	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Influenza like illness (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	FLUTICASONE FUROATE [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AZELASTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233219	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Breast pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[HYDROXYCHLOROQUINE SULFATE] (C - Antiphospholipid syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007233222	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007233225	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (2d - Recovered/Resolved - );Hypoaesthesia (2d - Recovered/Resolved - );Neck pain (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - );Sensory disturbance (2d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233228	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233230	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233231	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Haemorrhage urinary tract (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaginal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007233232	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007233238	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Blood glucose increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007233238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007234469	Spontaneous	2020-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate decreased (n/a - Unknown - Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007234469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007235993	Spontaneous	2020-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Female	Throat irritation (n/a - Unknown - Other Medically Important Condition);Tongue pruritus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007235993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223699	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223700	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Restlessness (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223701	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Palpitations (2d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223702	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - Migraine - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223703	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223704	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chronic fatigue syndrome (n/a - Recovering/Resolving - );Condition aggravated (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Chronic fatigue syndrome - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Fatigue - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223705	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dysgeusia (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lip blister (1d - Recovered/Resolved - Other Medically Important Condition);Lip swelling (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia oral (n/a - Recovering/Resolving - Other Medically Important Condition);Pharyngeal paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223706	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DEXAMETHASONE [DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEFOPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223707	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash macular (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223708	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223709	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Malaise (n/a - Unknown - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223711	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223712	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223713	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	HRT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223714	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223715	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Allergy to vaccine (1d - Recovered/Resolved - );Erythema (n/a - Unknown - );Flushing (n/a - Unknown - );Pruritus (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223716	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223717	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Body temperature fluctuation (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COLESEVELAM [COLESEVELAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223718	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal distension (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Hidradenitis - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223719	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LIRAGLUTIDE [LIRAGLUTIDE] (C - Weight decreased - n/a - [n/a - n/a - n/a])|[ACETAZOLAMIDE] (C - Idiopathic intracranial hypertension - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Carpal tunnel decompression - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[MOMETASONE] (C - Sinus congestion - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223720	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - Pernicious anaemia - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Neuropathy peripheral - n/a - [n/a - n/a - n/a])|[NAPROXEN SODIUM] (C - Arthritis - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223721	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Breast pain (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Recovering/Resolving - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Unknown - );Swelling (n/a - Unknown - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223722	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223723	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenia (25min - Recovered/Resolved - );Cold sweat (25min - Recovered/Resolved - );Dizziness (25min - Recovered/Resolved - );Presyncope (25min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223724	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CEFALEXIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223725	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223726	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - Parenteral])	CONTRACEPTIVE PILL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - 25mg - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 225mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223727	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (1h - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Epistaxis (1d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Tachycardia (1h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223728	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Wheezing (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223730	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - );Vaccination site movement impairment (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223731	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (5d - Recovered/Resolved - Other Medically Important Condition);Fatigue (5d - Recovered/Resolved - Other Medically Important Condition);Headache (5d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Lethargy (5d - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (48h - Recovered/Resolved - Other Medically Important Condition);Nausea (5d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site joint movement impairment (48h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	INHALERS [NOT AVAILABLE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007223733	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac arrest (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cold sweat (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pallor (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Unresponsive to stimuli (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 1.25mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 400ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007223735	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[LETROZOLE] (C - Breast cancer - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223736	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223737	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Unknown - );Hot flush (n/a - Recovering/Resolving - );Rash (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223739	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223740	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Chills (1d - Recovered/Resolved - );Pain (4d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223741	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Stoma site discharge (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Lung disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223742	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223745	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223746	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223747	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (3d - Recovering/Resolving - );Lymphadenopathy (3d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223748	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN HUMAN, INSULIN HUMAN, INSULIN INJECTION SOLUBLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223749	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Mobility decreased (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007223750	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Parenteral])	PROPRANOLOL HYDROCHLORIDE [PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223751	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest pain (n/a - Recovered/Resolved - );Disturbance in attention (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223753	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (48h - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Cardiac failure - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223754	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223756	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223757	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abnormal dreams (1d - Recovered/Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling of body temperature change (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223758	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223759	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223761	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Enteritis (n/a - Recovering/Resolving - );Faeces discoloured (n/a - Unknown - );Stoma site extravasation (n/a - Unknown - );Stoma site haemorrhage (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[DONEPEZIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223763	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (5d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007223764	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223765	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tonsillar hypertrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[DESOGESTREL, ETHINYLESTRADIOL] (C - Oral contraception - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223769	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[DOSULEPIN, DOSULEPIN HYDROCHLORIDE, DOSULEPIN HYDROCHLORIDE BP] (C - Migraine - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223770	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Allergy to vaccine (1d - Recovered/Resolved - );Feeling hot (35min - Recovered/Resolved - );Nausea (35min - Recovered/Resolved - );Paraesthesia oral (35min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223771	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIPTORELIN, TRIPTORELIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223772	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Swollen tongue (1d - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223773	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223774	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (10min - Recovered/Resolved - );Cold sweat (10min - Recovered/Resolved - );Feeling hot (10min - Recovered/Resolved - );Pallor (10min - Recovered/Resolved - );Paraesthesia (10min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223775	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition);Hemiparesis (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10007223776	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Gingival pain (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223777	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223778	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hot flush (1d - Recovered/Resolved - Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Sinus bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Swollen tongue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223779	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Contusion (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CYPROTERONE ACETATE, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])|[ISOTRETINOIN] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223781	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vertigo (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Systemic lupus erythematosus - n/a - [n/a - n/a - n/a])|[IBUPROFEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223782	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/60/2008, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008, B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008-LIKE VIRUS, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, NIB-121), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/DARWIN/6/2021, IVR-227), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223783	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223784	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOTRETINOIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223787	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223788	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223789	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223790	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - Disabling);Pallor (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - n/a])	[DICLOFENAC DIETHYLAMINE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[HYPROMELLOSE] (C - n/a - n/a - [16d - 2{DF} - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 1{DF} - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223791	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pruritus (1d - Not Recovered/Not Resolved - );Rash macular (1d - Not Recovered/Not Resolved - );Vaccination site erythema (1d - Not Recovered/Not Resolved - );Vaccination site inflammation (n/a - Unknown - );Vaccination site swelling (1d - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223792	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Unknown - );Injection site erythema (n/a - Unknown - );Peripheral swelling (n/a - Recovering/Resolving - );Pruritus (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223793	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223794	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Epilepsy (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Generalised tonic-clonic seizure (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007223795	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223796	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE, ESTRADIOL, MICRONIZED] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223797	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Blood pressure increased (1d - Recovered/Resolved - );Dizziness (2h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223798	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition);Throat tightness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223799	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Heart rate increased (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Throat tightness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007223800	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (1d - Recovered/Resolved - );Chest discomfort (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223801	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223802	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure systolic increased - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223803	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223807	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223808	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash erythematous (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Palpitations - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223809	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Recovering/Resolving - );Chills (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Neck pain (1d - Recovered/Resolved With Sequelae - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007223810	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Asthenia (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223811	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PROPRANOLOL HYDROCHLORIDE [PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[DICLOFENAC SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|[FEXOFENADINE HYDROCHLORIDE] (C - Multiple allergies - n/a - [n/a - n/a - n/a])|[IMIPRAMINE] (C - Pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223812	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Blood pressure increased (n/a - Unknown - );Dizziness (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223813	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Vaccination site haemorrhage (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Immunisation - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Anaemia - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223815	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dysphonia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Miliaria (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Swollen tongue (n/a - Unknown - Other Medically Important Condition);Throat irritation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223816	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223817	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Limb discomfort (n/a - Unknown - );Rash macular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223818	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CHLORPHENAMINE MALEATE] (C - Urticaria - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223819	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LACIDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223820	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LIDOCAINE, LIDOCAINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 100ug - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007223821	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoglycaemia (72h - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223822	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223823	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Recovering/Resolving - );Rash papular (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Leriche syndrome - n/a - [n/a - n/a - n/a])|HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|RANOLAZINE [RANOLAZINE] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223825	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	[ETORICOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223826	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (7h - Recovering/Resolving - );Myalgia (7h - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	BENEPALI [ETANERCEPT] (C - Psoriatic arthropathy - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223828	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223829	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Unknown - );Rash pruritic (n/a - Recovering/Resolving - );Skin swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223830	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007223831	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Thyroid disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223832	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Pyrexia (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223834	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Scrotal erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Scrotal exfoliation (n/a - Recovering/Resolving - Other Medically Important Condition);Scrotal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Scrotal swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223835	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BETAHISTINE DIHYDROCHLORIDE] (C - Tinnitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223836	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223838	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (3d - Recovered/Resolved - Disabling);Fatigue (1wk - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223839	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	FENTANYL [FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223840	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223841	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Pruritus (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223842	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - );Muscle fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MINOCYCLINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223843	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved With Sequelae - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007223844	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Brain fog (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Menopause - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223845	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223847	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Photophobia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007223848	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Back injury - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223849	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223850	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223851	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223852	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Anticoagulant therapy - n/a - [n/a - 5mg - n/a])|BUMETANIDE [BUMETANIDE] (C - Fluid retention - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Vitamin D - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223853	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Paraesthesia oral (1d - Recovered/Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223854	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Frequent bowel movements (n/a - Unknown - Other Medically Important Condition);Hypoglycaemia (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223855	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223856	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223857	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223858	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 30ug - Intramuscular])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223859	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223860	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223861	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Thirst (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223862	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Peripheral swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223863	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223864	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TAMOXIFEN, TAMOXIFEN CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223865	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223866	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|ROBERTS MULTIVITAMIN AND MINERAL [CALCIUM HYDROGEN PHOSPHATE, DRIED FERROUS SULPHATE, DRIED MAGNESIUM SULPHATE, ZINC SULPHATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223867	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223868	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Lip swelling (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Swollen tongue (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBIMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10007223869	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hot flush (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia oral (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Chest pain - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007223870	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Migraine (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223871	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Malaise (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223872	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007223873	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Insomnia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BUDESONIDE [BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223874	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Ear swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223875	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Allergy to vaccine (1d - Recovered/Resolved - );Cough (30min - Recovering/Resolving - );Erythema (30min - Recovering/Resolving - );Feeling hot (30min - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 30ug - Intramuscular])	[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223876	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Pharyngeal hypoaesthesia (n/a - Unknown - );Throat tightness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223877	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223878	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site joint pain (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE, GLUCOSAMINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[TURMERIC] (C - n/a - n/a - [n/a - n/a - n/a])|[UBIDECARENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007223879	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - );Dysphagia (n/a - Unknown - );Speech disorder (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	STATIN [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223880	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223881	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Unknown - );Facial paresis (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Unknown - );Paraesthesia oral (n/a - Unknown - );Salivary hypersecretion (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[TRIMETHOPRIM] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223882	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition);Vaccination site bruising (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007223883	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Ocular hyperaemia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - );Pharyngeal hypoaesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223884	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223885	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Chills (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223886	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Recovering/Resolving - Disabling);Headache (4d - Recovered/Resolved - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Pain in extremity (1d - Recovered/Resolved - Disabling);Peripheral swelling (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007223887	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223888	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IMMUNOMODULATOR UNSPECIFIED [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223889	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CLEMIZOLE PENICILLIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223890	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (1d - Recovered/Resolved - );Muscular weakness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223891	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223893	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223894	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223895	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223896	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Stent placement - n/a - [n/a - n/a - n/a])|[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFUZOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HYDROCHLORIDE] (C - Meniere's disease - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007223897	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007223898	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVONORGESTREL, LEVONORGESTREL MICRONISED] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007223898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224187	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - Migraine - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224188	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in jaw (n/a - Recovering/Resolving - );Swollen tongue (n/a - Recovering/Resolving - );Tongue dry (n/a - Unknown - );Vaccination site joint pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224189	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224190	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])|[PIZOTIFEN, PIZOTIFEN MALATE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224191	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Female	Dermatitis allergic (1d - Recovered/Resolved - Disabling);Dizziness (n/a - Unknown - Disabling);Flushing (n/a - Unknown - Disabling);Tremor (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007224192	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224193	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Motion sickness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224194	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224195	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224196	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness postural (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Vision blurred (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ESTRIOL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224198	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007224199	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Confusional state (n/a - Unknown - Other Medically Important Condition);Ear pain (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes virus infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Neuralgia (2d - Recovered/Resolved - Other Medically Important Condition);Oral herpes (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site joint erythema (6d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (6d - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (6d - Recovered/Resolved - Other Medically Important Condition);Vaccination site warmth (6d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [1d - 1{DF} - Parenteral])	HORMONE REPLACEMENT THERAPY [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007224200	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cold sweat (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224201	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Dyspnoea (1d - Recovered/Resolved - );Feeling hot (n/a - Unknown - );Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Subcutaneous])	HRT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224202	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224203	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224204	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224205	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Facial spasm (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224206	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224207	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224208	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lip swelling (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Swelling face (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	FENTANYL [FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007224209	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - );Nasal discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	HORMONE REPLACEMENT THERAPY [NOT AVAILABLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE, CHONDROITIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224211	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Night sweats (n/a - Unknown - );Nightmare (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224212	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site movement impairment (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ETONOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Eczema - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224213	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[LEVONORGESTREL, LEVONORGESTREL MICRONISED] (C - Adenomyosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224214	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Suspected COVID-19 (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224215	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224217	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling abnormal (1d - Recovered/Resolved - Other Medically Important Condition);Vertigo (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[AZITHROMYCIN, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN HYDRATE] (C - n/a - n/a - [n/a - 250mg - n/a])|[COLISTIMETHATE SODIUM, COLISTIN SULFATE] (C - Respiratory disorder - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - .5mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 75mg - n/a])|[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - n/a - n/a - [n/a - 2mL - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (C - Respiratory disorder - n/a - [n/a - 5mg - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - 10mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Respiratory disorder - n/a - [n/a - 2.5mL - n/a])|[SALINE, SODIUM CHLORIDE] (C - Respiratory disorder - n/a - [n/a - 4mL - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224218	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALMOTRIPTAN MALATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224220	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 16mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224222	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Gastroenteritis (1d - Recovered/Resolved - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224223	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Flushing (n/a - Recovering/Resolving - );Influenza like illness (n/a - Unknown - );Malaise (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224224	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cough (1d - Recovered/Resolved - );Dizziness postural (1d - Recovered/Resolved - );Feeling abnormal (1d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224225	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Feeling hot (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANTIHYPERTENSIVES [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224226	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Transient ischaemic attack (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007224227	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224229	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Influenza like illness (n/a - Unknown - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224230	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224231	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224232	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Unknown - );Infection (n/a - Not Recovered/Not Resolved - );Pain of skin (n/a - Unknown - );Skin warm (n/a - Unknown - );Vaccination site mass (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224233	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lip swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224234	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224235	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Unknown - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALFUZOSIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[GOSERELIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TIOTROPIUM BROMIDE MONOHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224236	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Throat irritation (n/a - Recovering/Resolving - );Wheezing (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	INHALERS [NOT AVAILABLE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224238	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224239	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Joint swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224240	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224241	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])|[DIPHENHYDRAMINE HYDROCHLORIDE, MELATONIN] (C - Insomnia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224242	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224243	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Photophobia (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224244	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224245	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Night sweats (3d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Recovering/Resolving - );Vaccination site warmth (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224246	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Muscle spasms (n/a - Unknown - );Syncope (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224247	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tonsillitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224249	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry throat (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224250	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224253	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diplopia (n/a - Unknown - );Vision blurred (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - Oral contraception - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Premenstrual syndrome - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224254	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Angioedema (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224256	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Female	Flushing (1d - Recovered/Resolved - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224257	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224259	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224260	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Immune-mediated adverse reaction (1d - Recovered/Resolved - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224262	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Adult	No	Female	Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224263	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224264	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224265	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Vision blurred (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224266	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - );Chest pain (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224267	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Lip pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224268	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224269	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Hypertonic bladder (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224270	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ANTIBIOTIC [NOT AVAILABLE] (C - Asthma - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Lower respiratory tract infection - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Supraventricular tachycardia - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Atopy - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007224271	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Vaccination site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224272	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flushing (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CONTRACEPTIVES NOS [NOT AVAILABLE] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224273	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Flushing (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224274	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (2d - Recovered/Resolved - );Vaccination site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224275	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224276	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224277	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224278	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Pallor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224279	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224280	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	FORXIGA [DAPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETIC ACID, GLACIAL, DEXAMETHASONE SODIUM PHOSPHATE PH. EUR., NEOMYCIN SULPHATE PH. EUR., NEOMYCIN SULFATE, DEXAMETHASONE, ACETIC ACID, GLACIAL, NEOMYCIN SULFATE, DEXAMETHASONE, GLACIAL ACETIC ACID BP] (C - Ear infection - n/a - [n/a - n/a - Auricular (otic)])|[ATORVASTATIN] (C - Low density lipoprotein - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Anaemia - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224281	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site inflammation (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224282	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224283	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224284	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Gastrointestinal pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EDOXABAN [EDOXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224285	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224310	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Pallor (1d - Unknown - );Rash macular (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224312	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007224313	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling jittery (n/a - Unknown - Caused/Prolonged Hospitalisation);Flushing (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash macular (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007224314	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Paraesthesia oral (1h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224315	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007224316	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - );Arthritis reactive (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Unknown - );Rash erythematous (n/a - Recovered/Resolved - );Rash macular (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224317	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2h - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Nerve compression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224319	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Influenza like illness (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224321	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Influenza like illness (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224322	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Vision blurred (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ETHINYLESTRADIOL, GESTODENE] (C - Unwanted pregnancy - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007224325	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diabetes mellitus inadequate control (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224326	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Abdominal pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224327	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007224328	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007224329	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Sinus tachycardia - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007224330	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovering/Resolving - );Injection site pain (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007224330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007226956	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	[TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007226956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007226959	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Swollen tongue (n/a - Unknown - Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007226959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007226962	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Limb discomfort (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007226962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007226964	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tracheomalacia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|NUCALA [MEPOLIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[BIOTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLOBENZAPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCODONE BITARTRATE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCORTISONE ACETATE, PRAMOCAINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[IPRATROPIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, ACETYLSALICYLIC ACID, CAFFEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE, IPRATROPIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007226964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007227864	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007227864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007227879	Spontaneous	2020-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	[TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007227879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007228255	Spontaneous	2020-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Flushing (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACRIVASTINE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007228255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007213764	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (10min - Recovered/Resolved - );Paraesthesia (10min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213766	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Female	Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213772	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213773	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dermatitis allergic (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213775	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213777	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213778	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Myocardial ischaemia - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007213779	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213783	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Nutritional supplementation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213785	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diplopia (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Menopausal symptoms - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213787	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007213791	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213793	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Unknown - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Oesophagitis - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Rhinitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213794	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lip swelling (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213795	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ABILIFY [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - 5mg - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213797	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007213798	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213802	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Labyrinthitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vestibular neuronitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007213803	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213806	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213807	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213809	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling of eyelid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007213810	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|RISPERIDONE [RISPERIDONE] (C - Hallucination - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Palpitations - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213813	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213814	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Condition aggravated (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213815	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Photophobia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213817	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213819	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (1d - Recovered/Resolved - );Hypoaesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213821	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ACITRETIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007213822	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213824	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COMBINED ORAL CONTRACEPTIVE [NOT AVAILABLE] (C - Contraception - n/a - [n/a - n/a - n/a])|[BECLOMETASONE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007213825	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Feeling hot (n/a - Unknown - );Hypersensitivity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213832	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213835	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213836	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nodule (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213847	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (1d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Vomiting (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007213853	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Incision site pain (3d - Recovered/Resolved - Other Medically Important Condition);Joint range of motion decreased (3d - Recovered/Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sputum purulent (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007213854	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Aphonia (n/a - Unknown - );COVID-19 (n/a - Recovering/Resolving - );Productive cough (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213858	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Unknown - Other Medically Important Condition);Hypoacusis (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Photosensitivity reaction (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007213859	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hallucination, olfactory (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007213860	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - Disabling);Diarrhoea (1d - Recovered/Resolved - Disabling);Headache (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007213862	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Neck pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007213862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214059	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia oral (n/a - Recovering/Resolving - );Migraine with aura (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007214060	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Limb discomfort (n/a - Unknown - );Pain in extremity (2d - Recovered/Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007214061	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Affective disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Polycystic ovaries - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007214062	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214065	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214072	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Eye pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214075	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Ebstein's anomaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214077	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214078	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Papule (n/a - Recovered/Resolved With Sequelae - );Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - );Throat irritation (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007214082	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthenopia (n/a - Recovered/Resolved - );Fluid retention (n/a - Recovered/Resolved - );Headache (n/a - Unknown - );Swelling face (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Urticaria - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214086	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Vaccination site joint pain (2d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[SERTRALINE] (C - Stress - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007214087	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [10y - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007214088	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Ear pain (n/a - Not Recovered/Not Resolved - );Pain (1d - Recovered/Resolved - );Paraesthesia oral (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214090	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (1d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007214092	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Presyncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214096	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DROSPIRENONE, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214097	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Fatigue (1d - Recovered/Resolved - );Oropharyngeal pain (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214098	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214099	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Erythema (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214101	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214102	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214109	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Swelling (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214112	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Eye pruritus (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214114	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214119	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Chills (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007214121	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214123	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Wheezing (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214125	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Nausea (2d - Recovered/Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Sinusitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214126	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dyspnoea (n/a - Unknown - );Wheezing (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007214127	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature fluctuation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214128	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Liver transplant - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[URSODEOXYCHOLIC ACID] (C - Liver transplant - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214131	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214133	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214134	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LATANOPROST [LATANOPROST] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|MELATONIN [MELATONIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[DOCUSATE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TIOTROPIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214136	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214139	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Disturbance in attention (4d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Parenteral])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LYSINE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10007214141	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flushing (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214142	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Flushing (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscle fatigue (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Skin burning sensation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214145	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Allergy to vaccine (1d - Recovered/Resolved - );Blood pressure abnormal (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Not applicable - [1d - n/a - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ANHYDROUS CHOLESTYRAMINE, COLESTYRAMINE, COLESTYRAMINE ANHYDROUS] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE TARTRATE, PARACETAMOL, PARACETAMOL BP, DIHYDROCODEINE TARTRATE BP, PARACETAMOL, DIHYDROCODEINE TARTRATE BP] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE PHEUR, CALCIUM CARBONATE PH. EUR., SODIUM ALGINATE PH. EUR., SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214146	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Abdominal pain (6d - Recovered/Resolved - );Diarrhoea (6d - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Neck pain (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|ORLISTAT [ORLISTAT] (C - n/a - n/a - [n/a - n/a - n/a])|SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPINEPHRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007214147	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CHLORPHENAMINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214150	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL, ETHINYLESTRADIOL, ETHINYLESTRADIOL PH. EUR., DESOGESTREL B.P.] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007214151	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Nerve compression - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Nerve compression - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Nerve compression - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214153	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovering/Resolving - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214156	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214157	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007214158	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214159	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214161	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214167	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214168	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214169	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Dry mouth (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ESSENTIAL OIL OF PEPPERMINT, PEPPERMINT OIL] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214172	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[IBUPROFEN, IBUPROFEN BP, IBUPROFEN LYSINE, IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - Pain in extremity - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007214173	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - 150mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007214174	Spontaneous	2020-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Joint stiffness (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007214180	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (1d - Recovered/Resolved - );Hypoaesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007214184	Spontaneous	2020-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007214184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206126	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash papular (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALVERINE CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE TARTRATE, PARACETAMOL, PARACETAMOL BP, DIHYDROCODEINE TARTRATE BP, PARACETAMOL, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206127	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Erythema (n/a - Not Recovered/Not Resolved - );Joint warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206128	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Migraine (n/a - Recovering/Resolving - );Nausea (n/a - Unknown - );Photophobia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206130	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (1h - Recovered/Resolved - );Erythema (1h - Recovered/Resolved - );Pharyngeal swelling (1h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206131	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206132	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lethargy (n/a - Recovering/Resolving - );Local reaction (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206134	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Decreased appetite (3d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Pain in extremity (2d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Vaccination site erythema (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007206137	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site joint pain (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206143	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypersensitivity (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206144	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206145	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206146	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206147	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206148	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206149	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206150	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[NORETHISTERONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206151	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Body temperature increased (n/a - Unknown - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Oesophageal achalasia - n/a - [n/a - n/a - n/a])|OLANZAPINE [OLANZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|SODIUM OXYBATE [SODIUM OXYBATE] (C - Cataplexy - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007206152	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Oral herpes (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206153	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206157	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206158	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206159	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PYRIDOSTIGMINE BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206161	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206162	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Lethargy (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206164	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206165	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	BLOOD PRESSURE MEDICATION [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206173	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abnormal dreams (6h - Recovered/Resolved - );Dizziness (6h - Recovered/Resolved - );Sensory disturbance (6h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[CODEINE] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Sarcoidosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206181	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Bradycardia (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206182	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Epistaxis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Facial pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia oral (n/a - Unknown - Caused/Prolonged Hospitalisation);Oral pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Skin warm (n/a - Unknown - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007206184	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206190	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007206191	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Back pain (n/a - Unknown - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206192	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206193	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	SPIRONOLACTONE [SPIRONOLACTONE] (C - Diuretic therapy - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - Antacid therapy - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Blood iron decreased - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrointestinal haemorrhage - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007206197	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Unknown - );Vaccination site rash (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206199	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cellulitis (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Unknown - );Rash erythematous (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206201	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1.8mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206202	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Diarrhoea (1d - Recovered/Resolved - );Dizziness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206203	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Myalgia (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206206	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206208	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Not Recovered/Not Resolved - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206209	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206210	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypersensitivity (1d - Recovered/Resolved - );Lip disorder (n/a - Recovering/Resolving - );Tension headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206211	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206212	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (1d - Recovered/Resolved With Sequelae - );Nausea (1d - Recovered/Resolved With Sequelae - );Vomiting (1d - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007206213	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PIZOTIFEN, PIZOTIFEN MALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206215	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CONTRACEPTIVE PILL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206216	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vaccination site cellulitis (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206219	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Blood pressure increased (n/a - Unknown - );Chest pain (1d - Recovered/Resolved - );Dizziness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206278	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007206280	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL, ETHINYLESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206284	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Rash erythematous (n/a - Recovering/Resolving - );Skin mass (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - Ill-defined disorder - Unknown - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206285	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007206286	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Chills (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Photophobia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007206287	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[DIETHYLAMINE SALICYLATE, MYRTECAINE, DIETHYLAMINE SALICYLATE, MYRTECAINE, SALICYLIC ACID, DIETHYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206289	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling of body temperature change (1d - Recovered/Resolved - Disabling);Hyperhidrosis (1d - Recovered/Resolved - Disabling);Malaise (1d - Recovered/Resolved - Disabling);Pain (1d - Recovered/Resolved - Disabling);Piloerection (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[HYDROXYCHLOROQUINE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007206291	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206296	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oral mucosa erosion (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206297	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206298	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Recovering/Resolving - );Feeling hot (n/a - Unknown - );Hyperhidrosis (n/a - Recovering/Resolving - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HORMONE REPLACEMENT THERAPY NOS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206299	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Illness (2d - Recovered/Resolved - Disabling);Palpitations (n/a - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling);Rash (n/a - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007206301	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (2d - Recovered/Resolved - );Rash erythematous (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206307	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Salivary hypersecretion (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1mL - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206310	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Mouth ulceration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Endometriosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206313	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206316	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (1d - Recovered/Resolved - Other Medically Important Condition);Rash (2h - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206318	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry mouth (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206322	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Ageusia (2d - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Tongue discomfort (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022, IVR-238)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206323	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Dyspnoea (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007206324	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206327	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206331	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Depressed mood (n/a - Unknown - );Dyspnoea exertional (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007206340	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition);Skin tightness (n/a - Unknown - Other Medically Important Condition);Skin warm (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition);Type IV hypersensitivity reaction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206341	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206344	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hyperglycaemia (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE MAGNESIUM DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206345	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (4d - Recovered/Resolved - );Livedo reticularis (n/a - Not Recovered/Not Resolved - );Malaise (4d - Recovered/Resolved - );Migraine (3d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Pain (n/a - Unknown - );Rash papular (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])|[NORELGESTROMIN] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206346	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BACILLUS CALMETTE-GUERIN VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206348	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Glossodynia (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206349	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Abnormal faeces (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206352	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007206354	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Muscle spasms (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007206357	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - Hypertonic bladder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206358	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206359	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206360	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (n/a - Unknown - Other Medically Important Condition);Dysphonia (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007206361	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nipple pain (n/a - Unknown - );Nipple swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206362	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Diarrhoea (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007206363	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (1d - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007206365	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - .5mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206369	Spontaneous	2020-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007206370	Spontaneous	2020-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (n/a - Unknown - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007206370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007197474	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Mouth ulceration (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FENTANYL [FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007197474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199789	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling hot (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia oral (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash erythematous (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007199792	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN HUMAN, INSULIN HUMAN (RDNA)] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007199794	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Catarrh (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Dry mouth (n/a - Not Recovered/Not Resolved - );Dry throat (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Unknown - );Lip dry (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007199798	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Hypotension (n/a - Unknown - );Paraesthesia oral (1d - Recovered/Resolved - );Swollen tongue (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199800	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199804	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007199805	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site oedema (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIPHTHERIA, TETANUS AND HEPATITIS B (RDNA) VACCINE (ADSORBED)] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[TUBERCULIN PURIFIED PROTEIN DERIVATIVE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199807	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Generalised anxiety disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007199809	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site rash (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CONTRACEPTIVE PILL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007199810	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199811	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199812	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METRONIDAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007199814	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199817	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199819	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flushing (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Throat tightness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199820	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199825	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199826	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199827	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DROSPIRENONE, ETHINYLESTRADIOL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199828	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ARIPIPRAZOLE SANDOZ [ARIPIPRAZOLE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])|[CLONAZEPAM] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199829	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Feeling drunk (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash erythematous (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007199830	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Feeling hot (n/a - Unknown - );Hypotension (n/a - Recovering/Resolving - );Syncope (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007199834	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (2d - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Peripheral swelling (2d - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Therapeutic response unexpected (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199835	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Cellulitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199836	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199840	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	USTEKINUMAB [USTEKINUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007199845	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199848	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANTIHISTAMINES [NOT AVAILABLE] (C - Urticaria - n/a - [n/a - 1{DF} - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - Pain in extremity - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199849	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199850	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hyperglycaemia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	HUMALOG [INSULIN LISPRO] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Autoimmune thyroiditis - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - Self-medication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199851	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2922d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199852	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199855	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199857	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lip swelling (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199859	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Back pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pain in extremity (1d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199869	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199871	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199872	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199890	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (1d - Recovering/Resolving - );Rash macular (1d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199936	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Body temperature increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Back disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007199937	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007199939	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Syncope (n/a - Recovered/Resolved With Sequelae - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007199939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007200045	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FENTANYL] (C - n/a - n/a - [n/a - n/a - n/a])|[GEMEPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[ISPAGHULA HUSK BP, MEBEVERINE HYDROCHLORIDE, ISPAGHULA HUSK] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200051	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200061	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200073	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200074	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200086	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200089	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Faeces pale (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200090	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200095	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Formication (n/a - Unknown - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200106	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200107	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200109	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	ADALIMUMAB [ADALIMUMAB] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200110	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200112	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200116	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200117	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Frequent bowel movements (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Joint stiffness (n/a - Recovering/Resolving - );Mouth ulceration (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FENTANYL [FENTANYL, FENTANYL CITRATE] (C - Back pain - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Bone density decreased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200122	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dermatitis allergic (n/a - Recovering/Resolving - );Pruritus (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE SODIUM] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])|[SITAGLIPTIN PHOSPHATE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200123	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dry mouth (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200125	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200126	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200128	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Gastritis (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Retching (n/a - Recovering/Resolving - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007200129	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest discomfort (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VICTOZA [LIRAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM (AMORPHOUS)] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200132	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200133	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site induration (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CONTRACEPTIVE PILL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200134	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	VARENICLINE [VARENICLINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200135	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Dizziness (1d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - );Pallor (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007200137	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200141	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal discomfort (n/a - Unknown - );Frequent bowel movements (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Salivary hypersecretion (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EVRA [ETHINYLESTRADIOL, NORELGESTROMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200146	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Aphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - Nasal])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 25mg - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - 10mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200149	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness postural (n/a - Recovering/Resolving - );Sinus headache (n/a - Recovering/Resolving - );Sneezing (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007200151	Spontaneous	2020-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007200152	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007200153	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovered/Resolved With Sequelae - );Fatigue (2d - Recovered/Resolved - );Heavy menstrual bleeding (n/a - Unknown - );Nausea (1d - Recovered/Resolved - );Presyncope (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007200154	Spontaneous	2020-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007200154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191169	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191171	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Tremor (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191172	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Urticaria (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191179	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[TAMOXIFEN, TAMOXIFEN CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191186	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191188	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191189	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191190	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Illness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191191	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007191198	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191205	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[NEFOPAM] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191206	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191207	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191208	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTROGENS CONJUGATED] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191209	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (1d - Recovered/Resolved - );Lip swelling (1d - Recovered/Resolved - );Periorbital swelling (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191212	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191213	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191215	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007191218	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cough (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191224	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye swelling (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Swelling of eyelid (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191225	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MIRTAZAPINE] (C - Depressed mood - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191228	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Supraventricular tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007191229	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007191231	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191234	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191235	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191236	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191237	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191238	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191240	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal discomfort (2d - Recovered/Resolved - );Diarrhoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191243	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Acne - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TIOTROPIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191244	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191245	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE SULFATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191248	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Axillary mass (n/a - Unknown - );Axillary pain (n/a - Unknown - );Erythema (n/a - Unknown - );Folliculitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191250	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191251	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191254	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191418	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood urine present (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUOXETINE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[RANITIDINE, RANITIDINE HYDROCHLORIDE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191419	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191422	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (1d - Recovered/Resolved - );Hypoaesthesia oral (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Rash erythematous (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191424	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191427	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191432	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191434	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Oropharyngeal pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191436	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Anxiety (1d - Recovered/Resolved - );Chest discomfort (n/a - Unknown - );Palpitations (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191437	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Hypersensitivity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191440	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191443	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastric haemorrhage - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191446	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007191447	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191452	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Tenderness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191455	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Epistaxis (1d - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007191456	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure decreased (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191457	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Dehydration (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Recovering/Resolving - );Paraesthesia (1d - Recovered/Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Recovering/Resolving - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191458	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (31d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10007191459	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191460	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Palpitations (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191461	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191465	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191468	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191470	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191474	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (3d - Recovered/Resolved - Disabling);Headache (3d - Recovered/Resolved - Disabling);Hypersensitivity (3d - Recovered/Resolved - Disabling);Limb discomfort (n/a - Recovered/Resolved - Disabling);Nausea (3d - Recovered/Resolved - Disabling);Neck pain (3d - Recovered/Resolved - Disabling);Pain in extremity (3d - Recovered/Resolved - Disabling);Peripheral swelling (3d - Recovered/Resolved - Disabling);Pharyngeal swelling (3d - Recovered/Resolved - Disabling);Swelling face (3d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Multiple allergies - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[MELOXICAM] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007191477	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry mouth (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191478	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191479	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Asthma (n/a - Not Recovered/Not Resolved - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Recovered/Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Recovering/Resolving - Disabling);Tachycardia (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10007191482	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191483	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Depression (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain of skin (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191547	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myofascial pain syndrome (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191548	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191549	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Balance disorder (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Feeling drunk (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LOFEPRAMINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007191550	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[MEFENAMIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191551	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness postural (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191552	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191553	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Post concussion syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007191554	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007191555	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Paraesthesia oral (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Deep vein thrombosis - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191556	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MEDROXYPROGESTERONE ACETATE] (C - Contraception - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191559	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[NORETHISTERONE ACETATE, ESTRADIOL, NORETHISTERONE ACETATE, ESTRADIOL HEMIHYDRATE] (C - Hormone replacement therapy - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191560	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191562	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191564	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Unknown - );Feeling cold (n/a - Unknown - );Headache (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191567	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191568	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191569	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACICLOVIR, ACICLOVIR SODIUM] (C - Genital herpes simplex - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[FLUORIDE] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[GLUCOSE OXIDASE] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[HYPROMELLOSE] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LACTOFERRIN] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[LACTOPEROXIDASE] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[LYSOZYME] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[MUCIN] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[XYLITOL] (C - Sicca syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191570	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Injection site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191571	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191572	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191575	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (n/a - Unknown - );Nightmare (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191576	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, VITAMIN B12] (C - Vitamin B12 deficiency - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191583	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191585	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Vision blurred (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191591	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191592	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191593	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Depression - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191594	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191595	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])|[AZATHIOPRINE SODIUM] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Vitamin D - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, VITAMIN B12] (C - Hypovitaminosis - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191596	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Rash erythematous (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191599	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Restlessness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191602	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191603	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypertension (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191605	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling jittery (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Hypoaesthesia oral (n/a - Unknown - );Lip swelling (1d - Recovered/Resolved - );Peripheral coldness (1d - Recovered/Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191606	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Muscle twitching (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[DESOGESTREL] (C - Endometriosis - n/a - [n/a - 75ug - n/a])|[HYDROXYCHLOROQUINE SULFATE] (C - Pulmonary sarcoidosis - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Pulmonary sarcoidosis - n/a - [n/a - 1mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191607	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymph node pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191608	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypertension (1d - Recovered/Resolved - );Sinus tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191609	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[EVENING PRIMROSE OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191610	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Back pain (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007191611	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site mass (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191613	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Disorientation (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007191615	Spontaneous	2020-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	CIMZIA [CERTOLIZUMAB PEGOL] (C - Psoriasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007191618	Spontaneous	2020-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007191618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183001	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Hypersensitivity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183002	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chest pain (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183009	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183015	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea haemorrhagic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007183016	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dry mouth (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hot flush (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007183019	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FLUTICASONE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183020	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (n/a - Recovered/Resolved With Sequelae - );Limb discomfort (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10007183025	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematemesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	BIRTH CONTROL PILLS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183029	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183031	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183032	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10007183033	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lip swelling (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183035	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183036	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Female	Flushing (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007183042	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183044	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183045	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183047	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183049	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Anaphylactoid reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183050	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening);Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10007183051	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Miliaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depressed mood - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183052	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain (n/a - Unknown - );Feeling of body temperature change (n/a - Unknown - );Flushing (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183054	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183055	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chest pain (n/a - Unknown - Other Medically Important Condition);Dermatitis allergic (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183057	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash maculo-papular (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183059	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Mouth ulceration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Lower respiratory tract infection - n/a - [n/a - n/a - n/a])|[IBUPROFEN, PARACETAMOL PH. EUR.] (C - Headache - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Lower respiratory tract infection - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183060	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypersensitivity (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Peripheral coldness (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - 25mg - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Dermatitis contact - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183064	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Unknown - );Tachycardia (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183068	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183069	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (1d - Recovered/Resolved - );Dermatitis allergic (1d - Recovered/Resolved - );Wheezing (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183070	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (30min - Recovered/Resolved - );Hypersensitivity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183072	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183073	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183074	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ISOTRETINOIN] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183075	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymph node pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183084	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Immunisation - n/a - [n/a - n/a - n/a])|[FLUOXETINE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183087	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (1d - Recovered/Resolved - );Dizziness (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183088	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovered/Resolved - );Hypersensitivity (1d - Recovered/Resolved - );Lip swelling (n/a - Recovered/Resolved - );Paraesthesia oral (n/a - Recovered/Resolved - );Respiration abnormal (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183096	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Female	Fatigue (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183097	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - );Feeling cold (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183102	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007183104	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FERROUS FUMARATE] (C - Blood iron decreased - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183105	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183106	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sweating fever (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183108	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain lower (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183109	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183110	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007183116	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (1d - Recovered/Resolved - );Rash pruritic (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183118	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183120	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183123	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Feeling of body temperature change (n/a - Unknown - );Hyperhidrosis (n/a - Recovering/Resolving - );Limb discomfort (n/a - Unknown - );Nausea (n/a - Unknown - );Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183125	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (n/a - Unknown - );Feeling hot (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183126	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Dizziness (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183127	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183128	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Unknown - );Feeling cold (n/a - Unknown - );Feeling hot (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183129	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Hypertension (n/a - Recovered/Resolved - );Lip disorder (n/a - Recovering/Resolving - );Lip swelling (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	NUTRITIONAL SUPPLEMENT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183131	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Cold sweat (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Nervousness (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Recovered/Resolved - Disabling);Restlessness (n/a - Unknown - Disabling);Throat irritation (n/a - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007183132	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183133	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183134	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183135	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183136	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183137	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Chills (n/a - Unknown - );Cold sweat (n/a - Unknown - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183141	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypersensitivity (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183142	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183143	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183151	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183152	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	HUMALOG [INSULIN LISPRO] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007183155	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Eye disorder (n/a - Unknown - );Fatigue (n/a - Unknown - );Paraesthesia (n/a - Recovering/Resolving - );Periorbital swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])|[CARBIMAZOLE] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183164	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Alcohol interaction (n/a - Unknown - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007183168	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183170	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Chills (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183171	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (1d - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183172	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[PROGESTERONE, PROGESTERONE, MICRONISED] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183176	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183193	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Diarrhoea (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BACLOFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183194	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Vaccination site induration (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183197	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10007183198	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Nervousness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Back pain - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE SODIUM] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007183204	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183206	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dysgeusia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183213	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183214	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Unknown - );Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (1d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183217	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[A/H1N1 INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183225	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Recovered/Resolved - );Balance disorder (1d - Recovered/Resolved - );Disorientation (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Indifference (1d - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Hidradenitis - n/a - [n/a - 100mg - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Anxiety - n/a - [n/a - 20mg - n/a])|[PRIMULA] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183226	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183228	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Lethargy (n/a - Unknown - );Myalgia (n/a - Unknown - );Nasal congestion (n/a - Unknown - );Nausea (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183229	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Arthralgia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183236	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183238	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183243	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DYDROGESTERONE, ESTRADIOL, DYDROGESTERONE, ESTRADIOL HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[TOLTERODINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183246	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183249	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183252	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183253	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Nausea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183256	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Sinus tachycardia (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183257	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Photopsia (n/a - Recovering/Resolving - );Vitreous floaters (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183262	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007183263	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Conjunctival haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAMETHASONE, BETAMETHASONE VALERATE, BETAMETHASONE VALERATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[CLARITHROMYCIN CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLINDAMYCIN, CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN PHOSPHATE] (C - Cellulitis - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - Urinary tract infection - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007183264	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007183271	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183273	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183284	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Flushing (n/a - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183287	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007183288	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[MEASLES, MUMPS AND RUBELLA VACCINE (LIVE)] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183290	Spontaneous	2020-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ALFACALCIDOL] (C - n/a - n/a - [n/a - 1.75ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007183291	Spontaneous	2020-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Hypertension (n/a - Recovering/Resolving - );Rash erythematous (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BACLOFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007183291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007173957	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Erythema (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007173957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10007173960	Spontaneous	2020-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dry eye (n/a - Recovering/Resolving - );Dry mouth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007173960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007173987	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site movement impairment (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CYPROTERONE ACETATE, ETHINYLESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LYMECYCLINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007173987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007173997	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007173997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007174000	Spontaneous	2020-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Flushing (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Sensory disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (10min - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANTIHISTAMINES [NOT AVAILABLE] (C - Dermatitis - n/a - [n/a - n/a - n/a])|IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - 150mg - n/a])|STEROID [NOT AVAILABLE] (C - Dermatitis - n/a - [n/a - n/a - Topical])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007174004	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007174008	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007174056	Spontaneous	2020-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Female	Dyspnoea (2.5h - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (2.5h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - 2mg - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Tension headache - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypertension - n/a - [n/a - 60mg - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LIOTHYRONINE] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10007174082	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Erythema (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007174085	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Feeling hot (30min - Recovered/Resolved - );Heart rate increased (30min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007174087	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Female	Blood pressure increased (5min - Recovered/Resolved - );Dizziness (5min - Recovered/Resolved - );Feeling hot (5min - Recovered/Resolved - );Respiratory rate increased (5min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10007174106	Spontaneous	2020-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Female	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007174144	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Axillary pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Not Recovered/Not Resolved - );Flushing (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007174153	Spontaneous	2020-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - Prophylaxis of nausea and vomiting - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - Pain - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Planning to become pregnant - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - Pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007174153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10007166737	Spontaneous	2020-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Female	Tachycardia (n/a - Unknown - );Wheezing (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10007166737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011128486	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (70d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011128590	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Resuscitation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011128595	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128640	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (40d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011128641	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammatory pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128649	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011128675	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128685	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128686	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128690	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128716	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved With Sequelae - Disabling);Traumatic fracture (n/a - Recovered/Resolved With Sequelae - Disabling);Vertigo (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011128730	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Life Threatening);Hiccups (n/a - Recovering/Resolving - Life Threatening);Intestinal pseudo-obstruction (n/a - Recovering/Resolving - Life Threatening);Myalgia (n/a - Recovering/Resolving - Life Threatening);Paraesthesia (n/a - Recovering/Resolving - Life Threatening);Pyrexia (n/a - Recovering/Resolving - Life Threatening);Tremor (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011128732	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011128741	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128746	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cataract (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011128748	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011128760	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved With Sequelae - Disabling);Chest discomfort (n/a - Recovered/Resolved With Sequelae - Disabling);Dizziness (n/a - Recovered/Resolved With Sequelae - Disabling);Limb discomfort (n/a - Recovered/Resolved With Sequelae - Disabling);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011128771	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011128787	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Injury (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/AUSTRIA/1359417/2021 HAEMAGGLUTININ ANTIGEN, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022, IVR-238), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022, IVR-238), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED] (C - Influenza immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011128859	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Paralysis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 30ug - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011128869	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysgeusia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Productive cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011128872	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (32d - Fatal - Results in Death);Diarrhoea (32d - Fatal - Results in Death);Pyrexia (32d - Fatal - Results in Death);Respiratory failure (32d - Fatal - Results in Death);Vaccination failure (32d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011128890	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011128900	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral coldness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128905	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenopia (n/a - Not Recovered/Not Resolved - );Eye inflammation (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128909	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011128918	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoacusis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011128931	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011128935	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128939	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011128954	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pleural effusion (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129002	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (19d - Recovered/Resolved - Other Medically Important Condition);Headache (19d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (19d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129015	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphthous ulcer (n/a - Not Recovered/Not Resolved - Disabling);Behcet's syndrome (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011129019	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011129050	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129082	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129090	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129095	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chorioretinopathy (175d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011129098	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129101	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening);Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Life Threatening);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011129141	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129142	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129147	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129149	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129150	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129159	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129231	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129233	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129236	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129237	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129238	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129248	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129252	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129256	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129257	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129311	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129327	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129330	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129462	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129477	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129483	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129509	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Premature baby (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011129676	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly);Foetal growth restriction (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011129678	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	FORSTEO [TERIPARATIDE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|HUMIRA [ADALIMUMAB] (C - n/a - n/a - [n/a - 40mg - Subcutaneous])|LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 2[drp] - Oral])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - n/a - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - 4mg - Oral])|[TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129679	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129684	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011129723	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129724	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (35d - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011129725	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129736	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129741	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011129783	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash papular (n/a - Recovering/Resolving - Other Medically Important Condition);Rash vesicular (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011129795	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011129834	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011129834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011130051	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Contusion (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (9d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130052	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011130058	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Pyrexia (23h - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130068	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dementia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011130079	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130082	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130216	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011130485	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130492	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure timing unspecified (n/a - Unknown - Other Medically Important Condition);Tachycardia foetal (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011130494	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130499	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011130504	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130543	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011130547	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Loss of personal independence in daily activities (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011130672	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Formication (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - );Photopsia (0d - Recovered/Resolved - );Retching (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011130902	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (1min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011130902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131019	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011131123	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011131124	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombophlebitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011131171	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Impaired quality of life (n/a - Unknown - );Musculoskeletal discomfort (n/a - Unknown - );Neuralgia (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Respiration abnormal (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131172	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131177	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Other Medically Important Condition);Respiratory disorder (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Status epilepticus (n/a - Fatal - Results in Death, Other Medically Important Condition);Ventricular arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ZONISAMIDE [ZONISAMIDE] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[CLOBAZAM] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[PHENYTOIN, PHENYTOIN SODIUM] (C - Epilepsy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011131186	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131191	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (5min - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131193	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Peripheral vein thrombosis (n/a - Recovering/Resolving - );Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Vasodilatation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TRULICITY [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[IPRAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131206	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (21d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Swelling (21d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011131208	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Herpes zoster (10d - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011131212	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cyanosis (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Pulseless electrical activity (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - );Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Ventricular arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011131219	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011131221	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131236	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac hypertrophy (n/a - Unknown - );Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131238	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Depressed level of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011131240	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131245	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Menstruation irregular (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Thyroiditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011131251	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131282	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011131290	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011131296	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - );Vaccination site haematoma (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011131323	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011131331	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011131351	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (1mo - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (1mo - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (1mo - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate increased (1mo - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypertension (1mo - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Muscle spasms (1mo - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vertigo (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011131375	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131386	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Migraine (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Anxiety - n/a - [n/a - n/a - n/a])|[BUPROPION] (C - Seasonal affective disorder - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131388	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131471	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - );Musculoskeletal stiffness (2d - Recovered/Resolved - );Myocarditis (60d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011131494	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011131499	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131505	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Juvenile idiopathic arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011131531	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011131562	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (6d - Fatal - Results in Death, Other Medically Important Condition);Hypoxia (6d - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011131642	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - Intramuscular])	SILODYX [SILODOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - 5{DF} - Oral])|UROREC [SILODOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - 10{DF} - Oral])|[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011131720	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (2wk - Unknown - Other Medically Important Condition);Chest pain (2wk - Unknown - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131748	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011131847	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011131967	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011131967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011132147	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericardial effusion (55d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (55d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (55d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011132212	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .2mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011132233	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132240	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Skin burning sensation (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132246	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .2mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132247	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Peritonsillar abscess (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .2mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132254	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132282	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011132419	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Essential hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye irritation (1wk - Recovered/Resolved - Other Medically Important Condition);Malaise (1wk - Recovered/Resolved - Other Medically Important Condition);Vertigo (1wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CLARITHROMYCIN, OMEPRAZOLE, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[SABAL SERRULATA EXTRACT, SERENOA REPENS] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011132533	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011132567	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );SARS-CoV-2 antibody test negative (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Dose not changed - [n/a - n/a - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132856	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132860	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	SARS-CoV-2 antibody test negative (n/a - Not Recovered/Not Resolved - )	CELLCEPT [MYCOPHENOLATE MOFETIL] (S - Myasthenia gravis - Unknown - [n/a - n/a - Unknown])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132879	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011132922	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [20s - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011132922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133010	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011133165	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133182	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening);Pain in extremity (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011133195	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011133424	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011133732	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Catatonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - );Dehydration (n/a - Unknown - Caused/Prolonged Hospitalisation);Disorientation (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypersomnia (n/a - Unknown - );Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Lip discolouration (n/a - Unknown - Caused/Prolonged Hospitalisation);Nail discolouration (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Skin discolouration (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])|[IBUPROFEN] (S - Product used for unknown indication - Unknown - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011133798	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011133805	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011133880	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011133922	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syphilis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133931	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM PICOFOSFATE, SODIUM PICOSULFATE, SODIUM PICOSULFATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SORBITOL (E420), FIG] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011133940	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[ACENOCOUMAROL] (S - Anticoagulant therapy - Not applicable - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011133942	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Bacterial infection (n/a - Fatal - Results in Death);Cellulitis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chronic obstructive pulmonary disease (n/a - Fatal - Results in Death);Disseminated intravascular coagulation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011133943	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133945	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea exertional (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133946	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133947	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133948	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Unknown - Other Medically Important Condition);Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - );Head injury (n/a - Unknown - );Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Pneumothorax (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Respiratory rate decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011133949	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133956	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133957	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133961	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133964	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sinusitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011133965	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Furuncle (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133966	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COAPROVEL [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011133979	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133981	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133983	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011133987	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133988	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011133992	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011133992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134079	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature abnormal (n/a - Unknown - );Malaise (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134363	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - );Increased insulin requirement (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134382	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011134551	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heart rate increased (n/a - Unknown - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Nervousness (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011134553	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134555	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Premature baby (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 5mg - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134561	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134572	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (54h - Recovered/Resolved - );Nasopharyngitis (233h - Recovered/Resolved - );Pyrexia (54h - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134573	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Muscle twitching (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134585	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134588	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134590	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Therapeutic response unexpected (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134598	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Head discomfort (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134607	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134608	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Fall (n/a - Unknown - );Head injury (n/a - Unknown - );Headache (n/a - Unknown - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Mood swings (n/a - Unknown - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134609	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Hypersomnia (n/a - Unknown - );Mental impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134618	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Sleep disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134624	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Knee arthroplasty (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134631	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (2wk - Recovered/Resolved - Other Medically Important Condition);Erythema (2wk - Recovered/Resolved - );Hypersensitivity (2wk - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (2wk - Recovered/Resolved - Other Medically Important Condition);Pruritus (2wk - Recovered/Resolved - );Vaccination site erythema (2wk - Recovered/Resolved - );Vaccination site induration (2wk - Recovered/Resolved - );Vaccination site swelling (2wk - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134632	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Exposure during pregnancy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Foetal hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Premature baby (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011134637	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134638	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphoma (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011134648	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Confusional state (n/a - Unknown - );Dizziness (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134662	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Deafness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Depression (n/a - Unknown - );Electric shock sensation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011134663	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134668	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fluid retention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Lethargy (n/a - Not Recovered/Not Resolved - );Narcolepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011134702	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011134728	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011134804	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134830	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134834	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Feeling cold (n/a - Unknown - );Feeling hot (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134859	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011134868	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Joint swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011134868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135175	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Dyskinesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye movement disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135180	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Pallor (n/a - Unknown - );Pyrexia (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135182	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Gastrointestinal disorder (n/a - Unknown - Other Medically Important Condition);Infantile colic (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135183	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[OXCARBAZEPINE] (C - Epilepsy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135191	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Jeong, J.. Sudden sensorineural hearing loss after COVID-19 vaccination. International Journal of Infectious Diseases. 2021;113:341-343. doi:10.1016/j.ijid.2021.10.025	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Deafness neurosensory (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135201	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Injected limb mobility decreased (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011135202	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135206	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 25mg - n/a])|[SILDENAFIL] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135293	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135337	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135339	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135347	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypersomnia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Photosensitivity reaction (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135349	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135350	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Septic shock (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachypnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011135351	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135355	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135359	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Exercise tolerance decreased (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135510	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011135516	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral haematoma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135531	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135533	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135548	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135550	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011135552	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135554	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - );Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135562	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135567	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ventricular extrasystoles (48h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135569	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135570	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135585	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135586	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fibrin D dimer increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135610	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135617	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135620	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011135622	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135627	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135630	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Abortion induced (n/a - Fatal - Results in Death);Chromosome analysis abnormal (n/a - Unknown - Congenital Anomaly);Ultrasound foetal abnormal (n/a - Unknown - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011135631	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Granuloma annulare (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135642	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hallucination, visual (35d - Recovered/Resolved - Other Medically Important Condition);Visual impairment (35d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - Unknown - [n/a - n/a - n/a])|[PYGEUM AFRICANUM, PYGEUM AFRICANUM EXTRACT] (C - Benign prostatic hyperplasia - Unknown - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011135643	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Respiratory distress (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	ENTRESTO 24 MG/26 MG FILM-COATED TABLETS [VALSARTAN, SACUBITRIL] (C - Dilated cardiomyopathy - Unknown - [n/a - n/a - n/a])|XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Dilated cardiomyopathy - Unknown - [n/a - n/a - n/a])|[AMIODARONE HYDROCHLORIDE] (C - Ventricular arrhythmia - Unknown - [n/a - n/a - n/a])|[BISOPROLOL HEMIFUMARATE] (C - Dilated cardiomyopathy - Unknown - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Dilated cardiomyopathy - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135649	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|LUCENTIS 10 MG/ML SOLUTION FOR INJECTION [RANIBIZUMAB] (S - Age-related macular degeneration - Drug withdrawn - [1d - n/a - Intravenous drip])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135651	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cholangiocarcinoma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Jaundice (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135652	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypervigilance (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [38d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135655	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasticity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135664	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135665	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135667	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mesenteric vein thrombosis (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Portal vein thrombosis (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135678	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis transverse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135700	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135706	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135708	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135711	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135712	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011135717	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135722	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135731	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135734	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Superior vena cava syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135740	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tongue oedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[IBUPROFEN] (S - n/a - n/a - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135747	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guillain-Barre syndrome (3mo - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011135752	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011135757	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (15d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (15d - Recovered/Resolved - Other Medically Important Condition);Headache (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	AERIUS [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135809	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135810	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (14d - Recovering/Resolving - );Vaccination site reaction (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135815	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135820	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood thyroid stimulating hormone increased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135821	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011135830	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135831	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [32d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135851	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135870	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135875	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Thyroid disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135879	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011135880	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011135885	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135889	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Torticollis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135894	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011135900	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135912	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Feeling drunk (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011135914	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135918	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135919	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (6wk - Recovered/Resolved - );Neuralgia (6wk - Recovered/Resolved - );Paraesthesia (6wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135933	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135934	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135941	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135959	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135961	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135965	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011135976	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135978	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135980	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Neuralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135986	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011135992	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011135992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136000	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Hot flush (1d - Recovered/Resolved - );Oral pain (n/a - Not Recovered/Not Resolved - );Pharyngeal paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	STELARA 90 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [USTEKINUMAB] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136009	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Product used for unknown indication - n/a - )|[CLOPIDOGREL] (C - Product used for unknown indication - n/a - )|[METFORMIN EMBONATE] (C - Product used for unknown indication - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136013	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136017	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136018	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hyperacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136072	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136082	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (53d - Recovered/Resolved - );Immunisation reaction (53d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[METHOTREXATE] (C - Rheumatoid arthritis - Drug withdrawn - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011136098	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136099	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136104	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136110	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136117	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136121	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136145	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster reactivation (3wk - Recovered/Resolved - );Immunisation reaction (3wk - Recovered/Resolved - );Vision blurred (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136149	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2wk - Recovered/Resolved - );Vision blurred (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136160	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovering/Resolving - );General physical health deterioration (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136164	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (10d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136174	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	EMTRIVA 200 MG HARD CAPSULES [EMTRICITABINE] (C - HIV infection - Unknown - [n/a - n/a - n/a])|ISENTRESS [RALTEGRAVIR, RALTEGRAVIR POTASSIUM] (C - HIV infection - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136182	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136189	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [225d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136196	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136197	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136211	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (18d - Recovered/Resolved - );Eye pain (19d - Recovered/Resolved - );Lung disorder (18d - Recovered/Resolved - );Vaccination site pain (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011136224	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136230	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (6mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136242	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136247	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136248	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136250	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136253	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136391	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011136394	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ADAPALENE, BENZOYL PEROXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORHEXIDINE DIGLUCONATE SOLUTION, CHLORHEXIDINE DIGLUCONATE SOLUTION PHEUR, CHLORHEXIDINE GLUCONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PAPAVERINE, PAPAVERINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136402	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Reflux gastritis (n/a - Unknown - Disabling, Other Medically Important Condition);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (S - Influenza immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011136517	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136527	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136580	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (7h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (7h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood pressure decreased (7h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Bradycardia (7h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed level of consciousness (7h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (7h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011136788	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011136888	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Infection (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011136889	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal loss of weight (4mo - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (4mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011136926	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Rheumatological examination (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Unknown - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011136978	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthropathy (n/a - Unknown - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011136978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011137033	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011137065	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (8wk - Recovered/Resolved - Other Medically Important Condition);Atrial fibrillation (8wk - Recovered/Resolved - Other Medically Important Condition);Myocarditis (8wk - Recovered/Resolved - Other Medically Important Condition);Palpitations (8wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011137222	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011137282	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2h - Recovered/Resolved - );Injection site pain (48h - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011137304	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011137307	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011137317	Spontaneous	2021-12-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011137325	Spontaneous	2021-12-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011137325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113071	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113874	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113879	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113897	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113905	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114078	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114099	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114137	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114192	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site haematoma (n/a - Not Recovered/Not Resolved - );Vaccination site oedema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114209	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Initial insomnia (n/a - Not Recovered/Not Resolved - );Middle insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114273	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114284	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	General physical health deterioration (74d - Fatal - Results in Death);Pneumonia (74d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011114286	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (0d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (0d - Recovered/Resolved - Other Medically Important Condition);Type I hypersensitivity (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114288	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Grip strength decreased (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011114292	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114293	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Movement disorder (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114297	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune thyroiditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114304	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	[FOLIC ACID] (C - Microcytic anaemia - n/a - [n/a - 5mg - Oral])|[VITAMIN D] (C - Vitamin D deficiency - n/a - [n/a - 1000{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114305	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood fibrinogen increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Protein C increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Red blood cell sedimentation rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 20mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114307	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114313	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anal haemorrhage (n/a - Recovered/Resolved With Sequelae - Disabling);Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Colitis ulcerative (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011114322	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114330	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotensive crisis (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114336	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114338	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114340	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114345	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Venous thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114358	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphthous ulcer (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114366	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoacusis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114368	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114370	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Labile blood pressure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114372	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114379	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mucous stools (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polypectomy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114381	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011114393	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acariasis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Varicella zoster virus infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114397	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114401	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114404	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114433	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114445	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011114446	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114455	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114459	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011114468	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114477	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Squamous cell carcinoma of skin (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011114490	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114498	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Renal pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114507	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011114508	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (202d - Recovered/Resolved - Other Medically Important Condition);Neuropathy peripheral (202d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (202d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114515	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal artery occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011114520	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114524	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Epistaxis (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114528	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114529	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Psychomotor hyperactivity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114534	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114541	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114544	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hypertension (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011114549	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Limb discomfort (n/a - Fatal - Results in Death);Myelopathy (n/a - Fatal - Results in Death);Thrombocytopenia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[HYDROXYCARBAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011114551	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Derealisation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disorientation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114556	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114576	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Apicectomy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumothorax (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114579	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114580	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (13d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114581	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint effusion (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Periarticular disorder (n/a - Not Recovered/Not Resolved - Disabling);Tendonitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011114603	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Life Threatening);Migraine (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Recall phenomenon - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011114610	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling jittery (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperthyroidism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114612	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal tear (n/a - Unknown - Other Medically Important Condition);Vitreous detachment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011114614	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bone marrow failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114616	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114617	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114633	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Confusional state (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011114634	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114662	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oral dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114665	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114674	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114677	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Bloody discharge (n/a - Not Recovered/Not Resolved - Disabling);Confusional state (n/a - Not Recovered/Not Resolved - Disabling);Diplegia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Gait inability (n/a - Not Recovered/Not Resolved - Disabling);Rash macular (n/a - Not Recovered/Not Resolved - Disabling);Sepsis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011114679	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Brain fog (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Cerebral ischaemia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ocular hyperaemia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - Parkinsonism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011114689	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure fluctuation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114742	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011114760	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114803	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011114963	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114965	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011114985	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Echocardiogram (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011114985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115015	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011115092	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );SARS-CoV-2 antibody test negative (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Dose not changed - [n/a - n/a - Intramuscular])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - )|MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - )|RITUXIMAB [RITUXIMAB] (C - Immunosuppressant drug therapy - n/a - [n/a - n/a - n/a])|[CYCLOPHOSPHAMIDE] (C - n/a - n/a - )|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011115098	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115100	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bronchospasm (n/a - Unknown - );Cough (n/a - Unknown - );Dizziness (n/a - Unknown - );Inflammation (n/a - Unknown - );Oedema (n/a - Unknown - );Pain (n/a - Unknown - );Pruritus (n/a - Unknown - );Pyrexia (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - );Vaccination site paraesthesia (n/a - Unknown - );Wheezing (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115126	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115128	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011115134	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115137	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011115139	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115145	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Fibromyalgia (n/a - Unknown - );Immunodeficiency (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115151	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Nervousness (3d - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Tremor (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011115152	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Nausea (n/a - Unknown - );Pain (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115158	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ANASTROZOLE] (C - Breast cancer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115161	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011115163	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebrovascular disorder (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition);Seizure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011115167	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011115169	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011115172	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115180	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[TESTOSTERONE ENANTATE] (C - n/a - n/a - [67d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115188	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);International normalised ratio decreased (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	VEDOLIZUMAB [VEDOLIZUMAB] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Antithrombin III deficiency - n/a - [10181d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10011115195	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115203	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115211	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115212	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Dizziness (n/a - Unknown - );Feeling hot (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neurogenic shock (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115214	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115215	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115217	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115222	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115233	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hot flush (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115267	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115311	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (1d - Recovered/Resolved - );Cold sweat (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115312	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115360	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Joint swelling (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling);Vaccination site swelling (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011115597	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease progression (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonitis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product use issue (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Squamous cell carcinoma of lung (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Unknown])|COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [1d - n/a - Unknown])	PEMBROLIZUMAB [PEMBROLIZUMAB] (C - Squamous cell carcinoma of lung - Unknown - [n/a - n/a - Unknown])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[FERROUS FUMARATE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[OMEPRAZOLE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[RAMIPRIL] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[SALBUTAMOL SULFATE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[SIMVASTATIN] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011115630	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Breast pain (4d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - Unknown])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115739	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011115740	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gout (3mo - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011115741	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011115883	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011115976	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011115979	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovered/Resolved - Other Medically Important Condition);Discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115982	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115985	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Recovering/Resolving - Other Medically Important Condition);Aphonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011115990	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011115990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116001	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (0d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (5d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116002	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Areflexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyporeflexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116010	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Eructation (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Heart rate abnormal (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116012	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomegaly (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116014	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [3wk - 500mg - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011116017	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116019	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116023	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Ischaemic stroke (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Lethargy (n/a - Unknown - Disabling, Other Medically Important Condition);Peroneal nerve palsy (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011116026	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116029	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116032	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116034	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac flutter (61d - Recovered/Resolved - Other Medically Important Condition);Palpitations (6wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116037	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116042	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116043	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ear infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116064	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116120	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116124	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116129	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116130	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116133	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116262	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116264	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116273	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116274	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116275	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116276	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011116277	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116279	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [n/a - 1{DF} - Intramuscular])|[TRAMADOL HYDROCHLORIDE] (S - Lumbar spinal stenosis - Not applicable - [15d - n/a - Oral])	[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [15d - n/a - Unknown])|[ASCORBIC ACID, RIBOFLAVIN, DEXTRIN, TOCOPHERYL ACETATE, CASEIN, SODIUM SALT] (C - Feeding disorder - n/a - [13d - n/a - Unknown])|[HYDROXYANTHRACENE GLYCOSIDES, SENNOSIDES] (C - Constipation - n/a - [15d - n/a - Unknown])|[TAK 438] (C - Gastrointestinal disorder - n/a - [15d - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116280	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116282	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116285	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116288	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116290	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116317	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116321	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116322	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116330	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic dissection (n/a - Fatal - Results in Death);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116333	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (46d - Recovered/Resolved With Sequelae - Disabling);Arthritis (46d - Recovered/Resolved With Sequelae - Disabling);Back pain (46d - Recovered/Resolved With Sequelae - Disabling);Bedridden (46d - Recovered/Resolved With Sequelae - Disabling);Immobilisation syndrome (46d - Recovered/Resolved With Sequelae - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Movement disorder (46d - Recovered/Resolved With Sequelae - Disabling);Pain (46d - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (46d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011116341	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116343	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116472	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Other Medically Important Condition);Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure congestive (n/a - Fatal - Results in Death);Chronic obstructive pulmonary disease (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Hypercapnia (n/a - Unknown - );Hypertension (n/a - Fatal - Results in Death);Hypoxia (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Fatal - Results in Death);Oxygen saturation decreased (n/a - Unknown - );Respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Unknown - Other Medically Important Condition);Respiratory rate increased (n/a - Unknown - );Tachypnoea (n/a - Unknown - );Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BUDESONIDE [BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|BUMETANIDE [BUMETANIDE] (C - n/a - n/a - [n/a - 1mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[UMECLIDINIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116517	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116552	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Encephalitis (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011116566	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116571	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116573	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011116580	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116685	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Unknown - );Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );COVID-19 (n/a - Unknown - );Chills (n/a - Recovered/Resolved - );Cough (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Eye pain (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Hepatic mass (n/a - Unknown - );Immune system disorder (n/a - Unknown - );Insomnia (18d - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Night sweats (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011116687	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116689	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116700	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[CALCIUM CARBONATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116703	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116712	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116724	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LYRICA [PREGABALIN] (C - Mental disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011116725	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (1d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011116726	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116728	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Nystagmus (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116730	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011116734	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Atrioventricular block (4d - Recovered/Resolved - Other Medically Important Condition);Orthostatic hypotension (4d - Recovered/Resolved - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	GUANFACINE [GUANFACINE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116742	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bedridden (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116743	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116753	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116755	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116763	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116764	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Lymphadenopathy (21d - Recovered/Resolved - );Mastoiditis (21d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011116768	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116770	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed mood (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Paranoia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Personality change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitamin D abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011116774	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ETHINYLESTRADIOL, NORGESTIMATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116788	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperventilation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011116790	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116801	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash macular (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IMATINIB [IMATINIB, IMATINIB MESILATE] (C - Chronic myeloid leukaemia - n/a - [n/a - 400mg - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116810	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (1d - Recovered/Resolved - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tonsillitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116812	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011116819	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Life Threatening);Bone pain (n/a - Unknown - Life Threatening);Chest pain (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Myalgia (n/a - Unknown - Life Threatening);Serum sickness (n/a - Unknown - Life Threatening);Swelling (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011116820	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116831	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011116836	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011116840	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Skin warm (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Rash - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116841	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011116848	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116858	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116859	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone marrow disorder (n/a - Unknown - Life Threatening);Diarrhoea (n/a - Unknown - Life Threatening);Headache (n/a - Unknown - Life Threatening);Pyrexia (n/a - Unknown - Life Threatening);Taste disorder (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011116933	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (36h - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011116984	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116989	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116995	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011116996	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011116996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117008	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site haematoma (n/a - Unknown - );COVID-19 immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117010	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117012	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117015	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117168	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117231	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia oral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011117235	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal loss of weight (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspepsia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011117240	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117243	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Alopecia (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011117244	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011117246	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Chills (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspepsia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Meningitis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain of skin (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011117262	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Body temperature abnormal (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Sinus pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011117273	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117278	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117279	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Recovering/Resolving - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (2d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Barrett's oesophagus - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117283	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Unknown - );Chills (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117290	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117295	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117296	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Disabling, Other Medically Important Condition);Menstruation irregular (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011117300	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117309	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117310	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Pain management - n/a - [n/a - 60mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011117311	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117313	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011117315	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011117321	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117323	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117329	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomegaly (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011117442	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Cold sweat (2d - Recovered/Resolved - );Pyrexia (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - )|[COD-LIVER OIL] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )|[ZINC] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117483	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - );Chills (n/a - Unknown - );Spontaneous haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117492	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epididymitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Mononeuropathy multiplex (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pelvic inflammatory disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash pruritic (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011117499	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (n/a - Not Recovered/Not Resolved - );Fear (n/a - Not Recovered/Not Resolved - );Hyperventilation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117501	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117550	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - [n/a - n/a - n/a])|[MENATETRENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011117573	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[HUMAN COAGULATION FACTOR IX] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117576	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117578	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[TESTOSTERONE] (C - Blood testosterone decreased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117579	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117581	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Hyperhidrosis (n/a - Recovering/Resolving - );Metamorphopsia (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011117650	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011117651	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117661	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011117696	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011117705	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117871	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011117903	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117909	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011117911	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011117961	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117962	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117979	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117980	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011117983	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011117983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011118030	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011118031	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011118139	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastroenteritis viral (n/a - Unknown - );Infection susceptibility increased (4d - Unknown - );Laryngitis (1wk - Unknown - );Malaise (4d - Unknown - );Meningitis viral (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011118142	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aplastic anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011118187	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011118188	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011118190	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vena cava thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - )|[CANDESARTAN] (C - n/a - n/a - )|[LITHIUM ACETATE, LITHIUM CARBONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011118193	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011118194	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011118198	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011118204	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011118577	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - Arrhythmia - Dose not changed - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - Arrhythmia - Dose increased - [n/a - n/a - n/a])|[TESTOSTERONE DECANOATE, TESTOSTERONE ISOCAPROATE, TESTOSTERONE PHENYLPROPIONATE, TESTOSTERONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011118671	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011118758	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (24h - Recovered/Resolved - );Lymphadenopathy (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011118775	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011118797	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011118809	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (30h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011118819	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lower motor neurone lesion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	EUCREAS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [2836d - 1{DF} - Oral])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[GLICLAZIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011118826	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (11d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011118868	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (2wk - Recovered/Resolved - );Myalgia (2wk - Recovered/Resolved - );Pain in extremity (2wk - Recovered/Resolved - );Swelling (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011118875	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2wk - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hydrothorax (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle spasms (2wk - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	AUBAGIO 14 MG [TERIFLUNOMIDE] (C - Multiple sclerosis - n/a - [n/a - 14mg - Oral])|[RISPERIDONE] (C - Mental disorder - n/a - [n/a - n/a - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 100mg - Oral])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Mental disorder - n/a - [n/a - 75mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011118931	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011118949	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011118959	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011118959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011119000	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011119002	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011119035	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011119043	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011119046	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011119058	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011119087	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011119088	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011119141	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011119219	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Extrasystoles (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (34d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011119321	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Back pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011119367	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (3d - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011119466	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011119501	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tenosynovitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011119502	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011119582	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011119589	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure fluctuation (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral coldness (n/a - Recovering/Resolving - Other Medically Important Condition);Sick leave (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011119732	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011119733	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011119736	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (3wk - Recovering/Resolving - );Balance disorder (3wk - Recovering/Resolving - );Disturbance in attention (3wk - Recovering/Resolving - );Dizziness (3wk - Recovering/Resolving - );Fatigue (3wk - Recovering/Resolving - );Headache (3wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011119770	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (21d - Recovered/Resolved - );Vaccination failure (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011119848	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1wk - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Choking (1wk - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (1wk - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011119912	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011119964	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011119964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120031	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysphagia (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120033	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neurodermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120034	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Joint swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120035	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120038	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Monoplegia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120075	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Altered state of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Aphasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120111	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120114	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Urinary tract infection (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011120120	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120122	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120126	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120127	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - Disabling);Tinnitus (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011120139	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Goitre, Thyroid operation - n/a - [n/a - 50mg - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011120141	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Delusional perception (n/a - Fatal - Results in Death);Drowning (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Suspected suicide (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011120145	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011120146	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120148	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Photosensitivity reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120150	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - );Myocarditis (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011120154	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - Oral])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120155	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myalgia (0d - Recovered/Resolved - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120159	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120162	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120163	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120164	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (1mo - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120168	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angiopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blindness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Brain fog (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Brain stem syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);CSF protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diplopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysgeusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Poor peripheral circulation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Throat irritation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vascular pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120169	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic reaction (1875min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (1875min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (1875min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (1875min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (1875min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120180	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - );Brain natriuretic peptide increased (n/a - Unknown - );Delirium febrile (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Erythema (n/a - Unknown - );Gastrointestinal disorder (n/a - Unknown - );Headache (n/a - Unknown - );Inflammation (n/a - Unknown - );Kawasaki's disease (n/a - Unknown - Other Medically Important Condition);Mucosal disorder (n/a - Unknown - );Multisystem inflammatory syndrome in children (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ocular hyperaemia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Systemic inflammatory response syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120184	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|TRAJENTA [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120193	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Drowning (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011120198	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Photopsia (n/a - Unknown - Other Medically Important Condition);Rhinitis (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120211	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Conversion disorder (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120232	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatinine increased (n/a - Recovering/Resolving - );Blood lactate dehydrogenase increased (n/a - Recovering/Resolving - );Blood uric acid increased (n/a - Recovering/Resolving - );Erythema multiforme (n/a - Recovering/Resolving - Other Medically Important Condition);Gamma-glutamyltransferase increased (n/a - Recovering/Resolving - );Haemorrhage subcutaneous (n/a - Recovering/Resolving - Other Medically Important Condition);Internal haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);International normalised ratio increased (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Venous thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])|[WARFARIN, WARFARIN SODIUM] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120246	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (C - Immunisation - n/a - [1d - n/a - Intramuscular])|[INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120248	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Viral myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120250	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Posterior interosseous syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120252	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120283	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotonic-hyporesponsive episode (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120351	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis atopic (58d - Recovering/Resolving - );Rash (58d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011120358	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120364	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (111d - Not Recovered/Not Resolved - );Fatigue (111d - Not Recovered/Not Resolved - );Listless (111d - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (111d - Not Recovered/Not Resolved - );Somnolence (111d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011120369	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (62d - Recovering/Resolving - );Seasonal allergy (62d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011120371	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (42d - Recovering/Resolving - );Fatigue (42d - Recovering/Resolving - );Hot flush (42d - Recovering/Resolving - );Influenza (42d - Recovering/Resolving - );Injection site pain (42d - Recovering/Resolving - );Limb discomfort (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011120435	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (10d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [3wk - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120454	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (48d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011120469	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Osteoarthritis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120473	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Muscular weakness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120543	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );COVID-19 immunisation (n/a - Not Recovered/Not Resolved - );Increased upper airway secretion (n/a - Not Recovered/Not Resolved - );Nasal discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011120550	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120579	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120598	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (51d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011120605	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Unknown - Other Medically Important Condition);Renal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120630	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120634	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011120635	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120637	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle twitching (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (1290min - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120638	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120641	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Purpura (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120642	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120644	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Intermenstrual bleeding (4d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120647	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120648	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia supraventricular (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myopericarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120649	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120653	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011120662	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Panic reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120667	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematochezia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120672	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120673	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011120676	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctival haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120677	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Hot flush (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ISPAGHULA HUSK BP, MEBEVERINE HYDROCHLORIDE, ISPAGHULA HUSK] (C - Constipation - n/a - [22d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120680	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Status epilepticus (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011120689	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120695	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120704	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120709	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120710	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120713	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120714	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthropod bite (48d - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011120719	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle contractions involuntary (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120726	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120737	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Unknown - Disabling, Other Medically Important Condition);Multiple sclerosis (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011120740	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120751	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Poor quality sleep (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120755	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Unknown - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120762	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120769	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sciatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120772	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACICLOVIR, ACICLOVIR SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120786	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120788	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Movement disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011120794	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120795	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011120796	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120798	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120806	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia oral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lacunar infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lacunar stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - 1{DF} - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|EXENATIDE [EXENATIDE] (C - Diabetes mellitus - n/a - [n/a - 2{DF} - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac disorder - n/a - [n/a - 1{DF} - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - 1{DF} - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120808	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Insomnia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure increased - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120809	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011120810	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Generalised anxiety disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120813	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Extrasystoles (n/a - Unknown - Other Medically Important Condition);Heart rate abnormal (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Extrasystoles - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120817	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hangover (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Initial insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Muscle tightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120818	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120820	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait inability (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011120823	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	SITAGLIPTIN [SITAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120829	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (705min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	KEPPRA [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011120834	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011120835	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint stiffness (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120854	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body mass index increased (n/a - Unknown - );Erectile dysfunction (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Spontaneous penile erection (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 32mg - n/a])|[FLUTICASONE] (C - Asthma - n/a - [n/a - 125ug - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - 2.5mg - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 30mg - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALMETEROL] (C - Asthma - n/a - [n/a - 25ug - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Asthma - n/a - [n/a - 18ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120856	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tendon pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120867	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120868	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120878	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011120885	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (4d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120904	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120907	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120909	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011120953	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011120953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121071	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - );Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121143	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121146	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121148	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121150	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121155	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121156	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121158	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Alanine aminotransferase abnormal (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - );Blood urea increased (n/a - Unknown - );COVID-19 immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121159	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121166	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121171	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121172	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121180	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121209	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Nasal congestion (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (1d - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (1d - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Testicular pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121217	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Hot flush (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphoedema (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121222	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Joint swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121228	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011121236	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121238	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011121243	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121248	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle tightness (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Poor peripheral circulation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121269	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Confusional state (5min - Recovered/Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011121281	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121283	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121413	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac fibrillation (3mo - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121416	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Antibody test abnormal (n/a - Unknown - );Coordination abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - );Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - );Neurological symptom (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121443	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Feeling hot (4d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Influenza (4d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121465	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121485	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (34d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121488	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (4d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121513	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Retching (0d - Recovered/Resolved - );Seizure (0d - Recovered/Resolved - Other Medically Important Condition);Skin warm (0d - Recovered/Resolved - );Unresponsive to stimuli (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121517	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121559	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121573	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121574	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (18d - Not Recovered/Not Resolved - );Dyspnoea (18d - Not Recovered/Not Resolved - );Fatigue (18d - Not Recovered/Not Resolved - );Hypotonia (18d - Not Recovered/Not Resolved - );Somnolence (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121575	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Laryngeal discomfort (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - );Palpitations (3d - Not Recovered/Not Resolved - );Visual impairment (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121583	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Feeling hot (29d - Recovering/Resolving - );Hot flush (29d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011121601	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121614	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (73d - Not Recovered/Not Resolved - Other Medically Important Condition);Menstrual disorder (73d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121617	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Not Recovered/Not Resolved - );Rash (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121620	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (69d - Not Recovered/Not Resolved - );Rheumatic disorder (69d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011121629	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (1d - Not Recovered/Not Resolved - );Disturbance in attention (3d - Not Recovered/Not Resolved - );Intestinal obstruction (2d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121630	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (39d - Not Recovered/Not Resolved - );Fatigue (39d - Not Recovered/Not Resolved - );Hyperhidrosis (39d - Not Recovered/Not Resolved - );Pain in extremity (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011121637	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121638	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011121641	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121645	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121675	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121713	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121716	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121717	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121719	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Optic disc oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Splenomegaly (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121739	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121740	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121741	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Joint swelling (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121755	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swelling (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121766	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (1d - Recovering/Resolving - );Chills (1d - Recovering/Resolving - );Dizziness (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121774	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121775	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Sarcoidosis (n/a - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121777	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest discomfort (35d - Recovered/Resolved - );Dyspnoea (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121785	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (36d - Recovered/Resolved With Sequelae - );Injection site pain (2d - Recovered/Resolved - );Malaise (36d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011121790	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Vaccination site erythema (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - );Vaccination site warmth (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121795	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (53d - Not Recovered/Not Resolved - );Dyspnoea (53d - Not Recovered/Not Resolved - );Infection susceptibility increased (53d - Not Recovered/Not Resolved - );Nasopharyngitis (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121798	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Oedema (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121803	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Paraesthesia (15d - Not Recovered/Not Resolved - );Rash (26d - Recovering/Resolving - );Urticaria (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011121810	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	No	Male	Coronary artery disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011121817	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121829	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pruritus (n/a - Recovered/Resolved - );Target skin lesion (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - );Vaccination site rash (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121833	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121837	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Incorrect route of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [4812min - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011121850	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121851	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1wk - Recovered/Resolved - );Interchange of vaccine products (n/a - Recovered/Resolved - );Myalgia (1wk - Recovered/Resolved - );Off label use (n/a - Recovered/Resolved - );Pain (1wk - Recovered/Resolved - );Pain in extremity (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121853	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - );Rosacea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121863	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121872	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Fatal - Results in Death, Other Medically Important Condition);Abnormal faeces (n/a - Fatal - Results in Death);Anaemia (n/a - Fatal - Results in Death);Anaphylactic reaction (n/a - Fatal - Results in Death, Other Medically Important Condition);Defaecation disorder (n/a - Fatal - Results in Death, Other Medically Important Condition);Dizziness (n/a - Fatal - Results in Death, Other Medically Important Condition);Fatigue (n/a - Fatal - Results in Death);Lung disorder (n/a - Fatal - Results in Death);Myocarditis (n/a - Fatal - Results in Death, Other Medically Important Condition);Nerve injury (n/a - Fatal - Results in Death);Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Shock (n/a - Fatal - Results in Death, Other Medically Important Condition);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011121876	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed mood (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Wound (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121884	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121893	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Fatal - Results in Death);Condition aggravated (n/a - Fatal - Results in Death);Delirium (n/a - Not Recovered/Not Resolved - Life Threatening);Encephalitis viral (n/a - Unknown - Life Threatening, Other Medically Important Condition);Encephalomyelitis viral (n/a - Unknown - Life Threatening);Epilepsy (0d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Meningoencephalitis viral (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL, METHENAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BROMAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LISINOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[URAPIDIL, URAPIDIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011121910	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121914	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Haematoma (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - );Skin maceration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011121924	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (12d - Recovering/Resolving - );Rash (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121928	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121932	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Breast discomfort (2d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121935	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011121936	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121949	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Seizure (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121973	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121979	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Eructation (n/a - Unknown - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011121983	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121987	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Listless (n/a - Not Recovered/Not Resolved - );Platelet count decreased (n/a - Not Recovered/Not Resolved - );Platelet morphology abnormal (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121989	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Rash (n/a - Unknown - );Retinal migraine (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011121999	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Joint swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sensory disturbance (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011121999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011122008	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Depressed mood (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122017	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Hypersomnia (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122025	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chills (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011122032	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122038	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122039	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122041	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122046	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122048	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Heart rate irregular (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122052	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (11d - Recovered/Resolved - );Migraine (11d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122054	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovering/Resolving - );Headache (7d - Recovering/Resolving - );Limb discomfort (7d - Recovering/Resolving - );Myalgia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122059	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (17d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Cardiac discomfort (17d - Recovered/Resolved With Sequelae - );Dyspnoea (12d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011122069	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (14d - Recovered/Resolved - );Limb discomfort (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122071	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (25d - Not Recovered/Not Resolved - );Malaise (25d - Not Recovered/Not Resolved - );Menstrual disorder (25d - Not Recovered/Not Resolved - );Nausea (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122075	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (2d - Recovered/Resolved - );Cough (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (62d - Recovered/Resolved - );Inappropriate affect (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Muscular weakness (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Respiratory tract irritation (2d - Recovered/Resolved - );Vaccination site irritation (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122085	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (24d - Not Recovered/Not Resolved - );Dizziness (24d - Not Recovered/Not Resolved - );Dyspnoea (24d - Not Recovered/Not Resolved - );Gastrointestinal pain (24d - Not Recovered/Not Resolved - );Panic reaction (24d - Not Recovered/Not Resolved - );Somnolence (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122088	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (2d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122097	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122098	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovered/Resolved - );Loss of consciousness (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122102	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (18d - Not Recovered/Not Resolved - );Decreased appetite (18d - Not Recovered/Not Resolved - );Disturbance in attention (18d - Not Recovered/Not Resolved - );Dizziness (18d - Not Recovered/Not Resolved - );Fatigue (18d - Not Recovered/Not Resolved - );Headache (18d - Not Recovered/Not Resolved - );Tinnitus (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122121	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (48d - Not Recovered/Not Resolved - );Headache (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122127	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovered/Resolved - );Rash (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122130	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis acneiform (17d - Recovering/Resolving - );Erythema (17d - Recovering/Resolving - );Rash (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122131	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Hypotonia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Somnolence (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122132	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (24d - Not Recovered/Not Resolved - );Rash (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122135	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122137	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (8d - Not Recovered/Not Resolved - );Cough (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122141	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122143	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (53d - Unknown - Other Medically Important Condition);Injection site pain (53d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122153	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (21d - Recovering/Resolving - );Fatigue (21d - Recovering/Resolving - );Oropharyngeal erythema (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122156	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (10d - Recovered/Resolved - );Rash (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122158	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (36d - Recovered/Resolved With Sequelae - );Listless (36d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011122161	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122168	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspepsia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vaccination site joint movement impairment (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122175	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Not Recovered/Not Resolved - );Feeling hot (1d - Recovered/Resolved - );Hyperaesthesia (4d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122188	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122190	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Recovering/Resolving - );Diarrhoea (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Herpes zoster (14d - Recovered/Resolved - );Influenza (4d - Recovering/Resolving - );Limb discomfort (4d - Recovering/Resolving - );Pyrexia (4d - Recovering/Resolving - );Rash (14d - Recovered/Resolved - );Rash pruritic (14d - Recovered/Resolved - );Vomiting (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122192	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Trigeminal neuralgia (110d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122199	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122200	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (28d - Recovered/Resolved With Sequelae - );Rash (28d - Recovered/Resolved With Sequelae - );Skin burning sensation (28d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011122205	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Recovering/Resolving - );Rash (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122215	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (4d - Recovered/Resolved - );Tachycardia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122217	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122224	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (54d - Not Recovered/Not Resolved - );Paraesthesia (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122225	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122227	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (27d - Recovered/Resolved - );Asthenia (26d - Recovered/Resolved - );Heart rate increased (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Myalgia (26d - Recovered/Resolved - );Paraesthesia (27d - Recovered/Resolved - );Peripheral nerve paresis (27d - Recovered/Resolved - );Sensory disturbance (27d - Recovered/Resolved - );Somnolence (1d - Recovering/Resolving - );Vaccination site movement impairment (26d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122228	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (18d - Recovering/Resolving - );Dizziness (18d - Recovering/Resolving - );Fatigue (18d - Recovering/Resolving - );Headache (18d - Recovering/Resolving - );Limb discomfort (18d - Recovering/Resolving - );Liver function test increased (18d - Recovering/Resolving - );Nausea (18d - Recovering/Resolving - );Pyrexia (18d - Recovering/Resolving - );Splenomegaly (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122229	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122231	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (14d - Not Recovered/Not Resolved - Other Medically Important Condition);Parapsoriasis (14d - Not Recovered/Not Resolved - );Pityriasis rosea (14d - Not Recovered/Not Resolved - );Rash (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122232	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Fatigue (8d - Not Recovered/Not Resolved - );Hyperhidrosis (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122235	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122254	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122255	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122269	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotonia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122276	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (53d - Not Recovered/Not Resolved - );Neurological symptom (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122278	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (8d - Recovered/Resolved - );Limb discomfort (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122279	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122289	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (15d - Unknown - );Pain in extremity (15d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122294	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Injection site swelling (7d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Muscle spasms (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122297	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122300	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - );Visual impairment (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122313	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint effusion (73d - Not Recovered/Not Resolved - );Limb discomfort (73d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122317	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122318	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Hot flush (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122319	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (46d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Atrial fibrillation (46d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Auditory disorder (46d - Recovered/Resolved With Sequelae - );Chills (16d - Not Recovered/Not Resolved - );Fatigue (16d - Not Recovered/Not Resolved - );Sudden hearing loss (46d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tinnitus (46d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011122320	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (27d - Recovering/Resolving - );Rash (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122326	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Recovered/Resolved - );Rash pruritic (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122329	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (10min - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122334	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011122343	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (2d - Not Recovered/Not Resolved - );Chills (1d - Recovering/Resolving - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Swelling (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122348	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122352	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - );Influenza (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Oropharyngeal pain (6d - Not Recovered/Not Resolved - );Pyrexia (6d - Not Recovered/Not Resolved - );Throat irritation (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122356	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (30d - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved With Sequelae - );Retinal vein thrombosis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011122363	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122369	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired work ability (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122373	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Insomnia (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Restless legs syndrome (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122376	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (1d - Unknown - );Malaise (1d - Unknown - );Paraesthesia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122381	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchial disorder (41d - Not Recovered/Not Resolved - );Cough (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122404	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (88d - Not Recovered/Not Resolved - );Cough (88d - Not Recovered/Not Resolved - );Dyspnoea (88d - Not Recovered/Not Resolved - );Exercise tolerance decreased (88d - Not Recovered/Not Resolved - );Headache (88d - Not Recovered/Not Resolved - );Pain (88d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122407	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - );Thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011122408	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (2d - Unknown - );Headache (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122409	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122410	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (10d - Not Recovered/Not Resolved - );Dizziness (10d - Not Recovered/Not Resolved - );Gait disturbance (10d - Not Recovered/Not Resolved - );Nausea (10d - Not Recovered/Not Resolved - );Paraesthesia (10d - Not Recovered/Not Resolved - );Vomiting (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122411	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122415	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122417	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Eschar (n/a - Unknown - );Fatigue (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Injection site erythema (n/a - Unknown - );Injection site pain (n/a - Unknown - );Insomnia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122421	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (26d - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Limb discomfort (26d - Recovering/Resolving - );Pulmonary embolism (26d - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122422	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Granuloma (102d - Not Recovered/Not Resolved - );Hypersensitivity (102d - Not Recovered/Not Resolved - );Rash (102d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122425	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122439	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (12d - Recovered/Resolved - );Hypersensitivity (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122440	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122447	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharospasm (7d - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122457	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122461	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (56d - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (56d - Not Recovered/Not Resolved - );Hypertension (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pulmonary embolism (56d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122472	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122474	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (2d - Unknown - );Disorientation (2d - Unknown - );Dizziness (2d - Unknown - );Malaise (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122475	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Heart rate increased (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122476	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (15d - Recovered/Resolved - );Myositis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122481	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site haemorrhage (2d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122485	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - );Nasopharyngitis (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122489	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Recovering/Resolving - );Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Malaise (1d - Not Recovered/Not Resolved - );Mental disorder (1d - Not Recovered/Not Resolved - );Panic attack (1d - Not Recovered/Not Resolved - );Restlessness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122502	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (14d - Unknown - );Dyspnoea (14d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122503	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122520	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Recovering/Resolving - );Influenza (2d - Not Recovered/Not Resolved - );Nasal dryness (2d - Not Recovered/Not Resolved - );Nasopharyngitis (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122522	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122527	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (83d - Not Recovered/Not Resolved - );Night sweats (83d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122540	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (1d - Recovered/Resolved - );Rash erythematous (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122543	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (27d - Not Recovered/Not Resolved - );Limb discomfort (15d - Not Recovered/Not Resolved - );Vaccination site joint pain (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122546	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (51d - Recovered/Resolved - );Headache (47d - Recovered/Resolved - );Migraine (46d - Recovering/Resolving - );Paraesthesia (46d - Recovering/Resolving - );Photophobia (47d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122553	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abscess limb (10d - Not Recovered/Not Resolved - );Dyspnoea (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - );Rash (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122559	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (14d - Not Recovered/Not Resolved - );Fatigue (14d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122607	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Unknown - );Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122631	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122634	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Lip swelling (1d - Recovered/Resolved - );Swelling face (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122637	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (3d - Recovering/Resolving - );Chills (0d - Recovered/Resolved - );Diarrhoea (3d - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122638	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122639	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (7d - Recovering/Resolving - );Pyrexia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122645	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (22d - Recovering/Resolving - );Thrombosis (22d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122652	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (17d - Not Recovered/Not Resolved - );Rash (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122662	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122663	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Skin discomfort (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122666	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (35d - Not Recovered/Not Resolved - );Paraesthesia (35d - Not Recovered/Not Resolved - );Restless legs syndrome (35d - Not Recovered/Not Resolved - );Sleep disorder (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122668	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (65d - Not Recovered/Not Resolved - );Toothache (65d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011122671	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (9d - Not Recovered/Not Resolved - );Influenza like illness (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122672	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Heart rate increased (1d - Not Recovered/Not Resolved - );Hyperhidrosis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122682	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122684	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011122685	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011122700	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Disabling);Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Fall (n/a - Not Recovered/Not Resolved - Disabling);Major depression (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011122743	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Matsumura, A.. Immune thrombocytopenia after BNT162b2 mRNA COVID-19 vaccination. The Japanese Journal of Clinical Hematology. 2021;62:1639-1642	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122744	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Agarwal, A.. Covid-19-related multisystem inflammatory syndrome in adults: An uncommon case. Journal, Indian Academy of Clinical Medicine. 2021;22(3-4):147-150	18-64 Years	Not Specified	No	Male	Multisystem inflammatory syndrome in adults (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122749	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122753	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomegaly (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lethargy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung consolidation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Right atrial enlargement (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Right atrial volume abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular dysfunction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011122758	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122759	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011122768	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electric shock sensation (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011122771	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122773	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (1d - Unknown - Other Medically Important Condition);Rhinorrhoea (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122774	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anaphylactic shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122779	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (558h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122788	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122789	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122790	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dermatitis exfoliative generalised (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - );Skin exfoliation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - 3{DF} - Oral])|[NAPROXEN] (C - Tumour associated fever - n/a - [n/a - 3{DF} - Oral])|[SODIUM FERROUS CITRATE] (C - Iron deficiency anaemia - n/a - [n/a - n/a - Oral])|[ZINC OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122800	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Jeong , J.. Sudden sensorineural hearing loss and its worsening: 3 case reports. Drug Safety : ADR Case Report. 2021;1-5 Jeong , J.. Sudden sensorineural hearing loss after COVID-19 vaccination. International Journal of Infectious Diseases. 2021;113:341-343. doi:10.1016/j.ijid.2021.10.025	18-64 Years	Not Specified	No	Male	Deafness neurosensory (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122928	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (94d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122929	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122930	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122932	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122934	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122935	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral sensorimotor neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [24d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122946	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122947	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122950	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [61d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122953	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122968	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122969	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardio-respiratory arrest (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011122976	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema multiforme (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011122981	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (7wk - Recovered/Resolved - );Pericarditis (7wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011122982	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122986	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122994	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011122996	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza like illness (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011122996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011123018	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [201d - 3{DF} - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - Unknown - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123021	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123025	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123027	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation reaction (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123030	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovered/Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysphonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Obstructive sleep apnoea syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123031	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011123037	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123040	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123041	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123043	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Recovered/Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011123050	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (6d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (6d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123081	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123129	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pleuropericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011123137	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pemphigoid (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123141	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123142	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[SIMVASTATIN, EZETIMIBE] (S - Dyslipidaemia - Dose not changed - [n/a - 1{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011123147	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Ischaemic stroke (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - n/a - Dose not changed - [n/a - 300mg - Oral])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [63d - 2{DF} - Intramuscular])|[ALPRAZOLAM] (C - n/a - Dose not changed - [n/a - .5mg - Oral])|[HYDROXYZINE DIHYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 25mg - Oral])|[LORMETAZEPAM] (C - n/a - Dose not changed - [n/a - 2mg - Oral])|[MIANSERIN HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 30mg - Oral])|[SODIUM VALPROATE] (C - n/a - Dose not changed - [n/a - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011123149	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (3mo - Recovered/Resolved - );Vertigo (3mo - Recovered/Resolved - Other Medically Important Condition);Vomiting (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123191	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (3h - Recovered/Resolved - );Swelling of eyelid (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123192	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123198	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovering/Resolving - );Urinary incontinence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	TRULICITY [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123205	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea exertional (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123213	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	VIIIth nerve lesion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123216	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123217	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123224	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123231	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (15d - Recovered/Resolved - );Burning sensation (15d - Recovered/Resolved - );Dyspnoea (15d - Recovered/Resolved - );Palpitations (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123232	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123235	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - );Gait disturbance (94d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123240	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123286	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123296	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (4d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123306	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123310	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123326	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123335	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123349	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123350	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site inflammation (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - );Vaccination site warmth (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123356	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123361	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site dysaesthesia (n/a - Unknown - );Vaccination site hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123365	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123387	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123402	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (1d - Recovered/Resolved - );Clonus (1d - Recovered/Resolved - );Confusional state (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123403	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123407	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE] (C - Cardiac failure - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123417	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123449	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (20d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123458	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123459	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123460	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123472	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Laryngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123483	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parapsoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123529	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - );Oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123544	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123545	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Mental disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pneumonia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011123549	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123583	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (S - Hypertension - Dose not changed - [n/a - 5mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011123585	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Disturbance in attention (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011123640	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123642	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovering/Resolving - Other Medically Important Condition);C-reactive protein increased (n/a - Unknown - );Chills (1d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Haemoglobin increased (n/a - Unknown - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Mean platelet volume decreased (n/a - Unknown - );Pyrexia (1d - Recovering/Resolving - );Red blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123647	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (62d - Not Recovered/Not Resolved - );Fatigue (62d - Not Recovered/Not Resolved - );Headache (62d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Middle insomnia (62d - Not Recovered/Not Resolved - );Paraesthesia (62d - Not Recovered/Not Resolved - );Sleep disorder (62d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123651	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (n/a - Unknown - );Postmenopausal haemorrhage (n/a - Unknown - Other Medically Important Condition);Premenstrual syndrome (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123660	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Migraine (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123661	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123663	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Epistaxis (0d - Unknown - );Fatigue (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123669	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (0d - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Dyspnoea (0d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Hypoaesthesia (15d - Recovered/Resolved - );Injection site pain (15d - Recovered/Resolved - );Lung disorder (0d - Recovering/Resolving - );Lymphadenopathy (14d - Recovered/Resolved - );Mobility decreased (15d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pain in extremity (15d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Testicular swelling (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123673	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (86d - Not Recovered/Not Resolved - );Disturbance in attention (86d - Not Recovered/Not Resolved - );Dyspnoea (86d - Not Recovered/Not Resolved - );Fatigue (86d - Not Recovered/Not Resolved - );Headache (86d - Not Recovered/Not Resolved - );Malaise (86d - Not Recovered/Not Resolved - );Migraine (86d - Not Recovered/Not Resolved - );Palpitations (86d - Not Recovered/Not Resolved - );Paraesthesia (86d - Not Recovered/Not Resolved - );Pyrexia (86d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123678	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123682	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovering/Resolving - );Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123694	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (56d - Recovered/Resolved With Sequelae - );Paraesthesia (56d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011123699	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Unknown - );Tenderness (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123702	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Somnolence (1d - Recovering/Resolving - );Vaccination site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123709	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123721	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (23d - Not Recovered/Not Resolved - );Myalgia (23d - Not Recovered/Not Resolved - );Rash (12d - Recovering/Resolving - );Spinal pain (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123723	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123725	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (37d - Not Recovered/Not Resolved - );Limb discomfort (37d - Not Recovered/Not Resolved - );Pain in extremity (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123728	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (8d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Muscle contractions involuntary (60d - Recovering/Resolving - );Myalgia (7d - Recovered/Resolved - );Paraesthesia (60d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123729	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Eczema nummular (n/a - Not Recovered/Not Resolved - );Influenza (77d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Somnolence (77d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123746	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123753	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123754	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (33d - Recovered/Resolved - );Thyroiditis (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123760	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123762	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123780	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123785	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (3d - Recovering/Resolving - );Angina pectoris (20d - Unknown - Other Medically Important Condition);Bursitis (42d - Not Recovered/Not Resolved - );Dizziness (3d - Recovering/Resolving - );Fatigue (62d - Recovering/Resolving - );Feeling hot (62d - Not Recovered/Not Resolved - );Limb discomfort (42d - Not Recovered/Not Resolved - );Tachycardia (20d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123787	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (4d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123792	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Head discomfort (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123810	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (67d - Not Recovered/Not Resolved - );Exercise tolerance decreased (67d - Not Recovered/Not Resolved - );Limb discomfort (67d - Not Recovered/Not Resolved - );Myalgia (67d - Not Recovered/Not Resolved - );Paraesthesia (67d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123817	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Unknown - );Hot flush (3d - Unknown - );Limb discomfort (3d - Unknown - );Nausea (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123829	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (83d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123830	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123832	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (17d - Not Recovered/Not Resolved - );Arthralgia (17d - Not Recovered/Not Resolved - );Asthenia (17d - Not Recovered/Not Resolved - );Dizziness (17d - Not Recovered/Not Resolved - );Fatigue (17d - Not Recovered/Not Resolved - );Muscle twitching (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123855	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Not Recovered/Not Resolved - );Tongue coated (2d - Not Recovered/Not Resolved - );Tongue discomfort (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123862	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (61d - Not Recovered/Not Resolved - );Pustule (61d - Not Recovered/Not Resolved - );Rash (61d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123863	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Erythema (42d - Not Recovered/Not Resolved - );Pruritus (42d - Not Recovered/Not Resolved - );Rash (42d - Not Recovered/Not Resolved - );Skin fissures (42d - Not Recovered/Not Resolved - );Skin warm (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123867	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123870	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (44d - Recovered/Resolved With Sequelae - );Fatigue (44d - Recovered/Resolved With Sequelae - );Headache (44d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011123901	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure fluctuation (21d - Not Recovered/Not Resolved - );Dizziness (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123902	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (41d - Not Recovered/Not Resolved - );Headache (41d - Not Recovered/Not Resolved - );Palpitations (41d - Not Recovered/Not Resolved - );Tinnitus (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123903	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (1d - Not Recovered/Not Resolved - );Vomiting (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123908	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Recovering/Resolving - );Fatigue (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123915	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Not Recovered/Not Resolved - );Dyspnoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Nasopharyngitis (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123918	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (26d - Recovering/Resolving - );Language disorder (26d - Recovering/Resolving - );Paraesthesia (26d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123925	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Exercise tolerance decreased (70d - Recovered/Resolved With Sequelae - );Fatigue (70d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011123929	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - );Respiratory tract irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123931	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123934	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - );Headache (2d - Unknown - );Nausea (2d - Unknown - );Visual impairment (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123936	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123946	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aggression (41d - Recovering/Resolving - );Arrhythmia (69d - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (41d - Recovering/Resolving - );Heart rate increased (41d - Recovering/Resolving - );Lymphadenopathy (13d - Recovered/Resolved - );Malaise (41d - Recovering/Resolving - );Nervousness (41d - Recovering/Resolving - );Palpitations (69d - Recovering/Resolving - );Paraesthesia (65d - Recovering/Resolving - );Tachycardia (28d - Recovering/Resolving - );Tinnitus (65d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011123957	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (107d - Not Recovered/Not Resolved - );Heart rate increased (107d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011123963	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Contusion (2d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Myalgia (3d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - );Yellow skin (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123975	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (0d - Not Recovered/Not Resolved - );Influenza (1d - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123988	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011123989	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (54d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011123992	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (28d - Not Recovered/Not Resolved - );Coagulopathy (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011123992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124001	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124004	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124010	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Influenza (0d - Unknown - );Lymphadenopathy (n/a - Unknown - );Nasopharyngitis (0d - Unknown - );Pyrexia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124012	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Vision blurred (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124019	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (16d - Not Recovered/Not Resolved - );Headache (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124020	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124021	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124027	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124028	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Hypoaesthesia oral (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Oral pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Tongue discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124035	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124038	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124056	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124061	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124077	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Feeling hot (100d - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Paraesthesia (100d - Not Recovered/Not Resolved - );Tachycardia (100d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124082	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (6d - Recovered/Resolved - );Headache (5d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124084	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (5d - Recovered/Resolved With Sequelae - );Fatigue (5d - Recovered/Resolved With Sequelae - );Head discomfort (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124089	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Unknown - );Limb discomfort (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Tenderness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124093	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124099	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124101	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (74d - Not Recovered/Not Resolved - );Dizziness (74d - Not Recovered/Not Resolved - );Dyspnoea (74d - Not Recovered/Not Resolved - );Dyspnoea exertional (74d - Not Recovered/Not Resolved - );Immunisation (74d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124102	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124105	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (32d - Unknown - );Headache (32d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124122	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Oropharyngeal discomfort (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124127	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (20d - Not Recovered/Not Resolved - );Depressed mood (20d - Not Recovered/Not Resolved - );Listless (20d - Not Recovered/Not Resolved - );Malaise (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124139	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Erythema (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Flushing (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Skin discolouration (0d - Recovered/Resolved - );Somnolence (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124149	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (35d - Not Recovered/Not Resolved - );Fatigue (35d - Not Recovered/Not Resolved - );Headache (35d - Not Recovered/Not Resolved - );Influenza (10d - Unknown - );Muscle spasms (35d - Not Recovered/Not Resolved - );Muscular weakness (35d - Not Recovered/Not Resolved - );Paraesthesia (12d - Not Recovered/Not Resolved - );Tachycardia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124152	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphonia (6d - Recovering/Resolving - );Headache (6d - Recovering/Resolving - );Influenza (6d - Recovering/Resolving - );Nasopharyngitis (6d - Recovering/Resolving - );Oral pain (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124153	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (11d - Not Recovered/Not Resolved - );Dyspnoea (11d - Not Recovered/Not Resolved - );Malaise (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124154	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Facial paralysis (3d - Recovered/Resolved - Other Medically Important Condition);Rash (3d - Recovered/Resolved - );Urticaria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124155	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124159	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - );Peripheral swelling (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124163	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124166	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site reaction (2d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124167	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124171	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Paraesthesia (5d - Unknown - );Tinnitus (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124182	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (1d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124183	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124185	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124197	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (44d - Not Recovered/Not Resolved - );Neuralgia (44d - Not Recovered/Not Resolved - );Tinnitus (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124204	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (13d - Not Recovered/Not Resolved - );Hot flush (13d - Not Recovered/Not Resolved - );Hypoaesthesia (13d - Not Recovered/Not Resolved - );Influenza like illness (13d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Paraesthesia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124206	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Seasonal allergy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124208	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (65d - Not Recovered/Not Resolved - );Nausea (65d - Not Recovered/Not Resolved - );Tinnitus (65d - Not Recovered/Not Resolved - );Vertigo (65d - Not Recovered/Not Resolved - );Vomiting (65d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124217	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (21d - Unknown - );Pyrexia (21d - Unknown - );Sleep disorder (21d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124220	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Influenza (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (3d - Unknown - );Myalgia (3d - Unknown - );Rash (2d - Recovering/Resolving - );Urticaria (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124227	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (26d - Not Recovered/Not Resolved - );Urticaria (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124233	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124236	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124239	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124247	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124248	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124249	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disorientation (7d - Recovered/Resolved - );Disturbance in attention (7d - Recovered/Resolved - );Dizziness (7d - Recovered/Resolved - );Paraesthesia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124261	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation (90d - Recovered/Resolved With Sequelae - );Limb discomfort (90d - Recovered/Resolved With Sequelae - );Rheumatic disorder (90d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124263	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (33d - Not Recovered/Not Resolved - );Dizziness (33d - Not Recovered/Not Resolved - );Dyspnoea (33d - Not Recovered/Not Resolved - );Gait disturbance (33d - Not Recovered/Not Resolved - );Paraesthesia (33d - Not Recovered/Not Resolved - );Vision blurred (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124265	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Antibiotic prophylaxis (20d - Not Recovered/Not Resolved - );Cystitis noninfective (20d - Not Recovered/Not Resolved - );Pyrexia (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124268	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Muscle spasms (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Sleep disorder (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124278	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (n/a - Unknown - );Injection site pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124283	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124285	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Muscle spasms (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Sleep disorder (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124289	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124327	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (5d - Not Recovered/Not Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Rash (5d - Not Recovered/Not Resolved - );Skin warm (5d - Not Recovered/Not Resolved - );Swelling (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124332	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (4d - Not Recovered/Not Resolved - );Cough (4d - Not Recovered/Not Resolved - );Dyspnoea (4d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124335	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124347	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124351	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124352	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124353	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Local reaction (3d - Recovering/Resolving - );Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124359	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (33d - Not Recovered/Not Resolved - );Muscle strain (n/a - Not Recovered/Not Resolved - );Tendon discomfort (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124361	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124363	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (14d - Not Recovered/Not Resolved - );Immunisation (14d - Not Recovered/Not Resolved - );Limb discomfort (14d - Not Recovered/Not Resolved - );Myalgia (14d - Not Recovered/Not Resolved - );Pain in extremity (14d - Not Recovered/Not Resolved - );Paraesthesia (14d - Not Recovered/Not Resolved - );Swelling (14d - Not Recovered/Not Resolved - );Vaccination site pain (14d - Not Recovered/Not Resolved - );Vaccination site swelling (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124365	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (0d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124384	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Ear pain (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Limb discomfort (7d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124385	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Thyroid disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124390	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (30d - Recovered/Resolved - );Cardiovascular disorder (30d - Recovered/Resolved - );Heart rate increased (30d - Recovered/Resolved - );Pleurisy (42d - Recovering/Resolving - );Tachycardia (30d - Recovered/Resolved - );Vaccination site reaction (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124392	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Influenza (6d - Recovered/Resolved With Sequelae - );Limb discomfort (6d - Recovered/Resolved With Sequelae - );Pain (6d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124404	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124406	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Headache (5d - Recovering/Resolving - );Malaise (5d - Recovering/Resolving - );Retching (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124414	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Sleep disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124422	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (30d - Not Recovered/Not Resolved - );Influenza like illness (67d - Not Recovered/Not Resolved - );Limb discomfort (30d - Not Recovered/Not Resolved - );Malaise (67d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124424	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Iritis (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124433	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspepsia (1d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124438	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124448	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (47d - Recovered/Resolved With Sequelae - );Pain in extremity (47d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124454	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (56d - Not Recovered/Not Resolved - );Pruritus (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124470	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124473	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Rhinorrhoea (5d - Recovered/Resolved - );Sinusitis (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124489	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (8d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Malaise (8d - Not Recovered/Not Resolved - );Tinnitus (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124495	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (38d - Recovered/Resolved With Sequelae - );Myalgia (38d - Recovered/Resolved With Sequelae - );Pain in extremity (38d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124497	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124503	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124509	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Analgesic therapy (3d - Recovering/Resolving - );Head discomfort (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Immunisation (3d - Recovering/Resolving - );Pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124510	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (23d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124511	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124526	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (34d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124532	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (70d - Unknown - );Immunisation (70d - Unknown - );Muscular weakness (70d - Unknown - );Myalgia (70d - Unknown - );Neck pain (70d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124534	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124537	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Asthenia (3d - Recovering/Resolving - );Back pain (n/a - Not Recovered/Not Resolved - );Chills (3d - Recovering/Resolving - );Headache (18d - Not Recovered/Not Resolved - );Influenza (3d - Recovering/Resolving - );Joint swelling (n/a - Recovered/Resolved With Sequelae - );Limb discomfort (17d - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011124539	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (5d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (5d - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124542	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchial disorder (0d - Recovering/Resolving - );Cough (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124566	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Hot flush (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124570	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (8d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Head discomfort (14d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - );Palpitations (8d - Not Recovered/Not Resolved - );Paraesthesia (0d - Not Recovered/Not Resolved - );Tachycardia (8d - Not Recovered/Not Resolved - );Vaccination site paraesthesia (0d - Not Recovered/Not Resolved - );Vaccination site reaction (0d - Not Recovered/Not Resolved - );Vestibular disorder (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124580	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124607	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011124608	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124641	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124741	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124746	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124750	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011124753	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus congestion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124756	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124758	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124759	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124762	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124766	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124770	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124776	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124786	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124791	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124792	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124795	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124797	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124798	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124802	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124807	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124810	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124813	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124832	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	No	Not Specified	Foetal growth restriction (n/a - Fatal - Results in Death, Life Threatening, Congenital Anomaly, Other Medically Important Condition);Maternal exposure timing unspecified (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011124834	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Vaccination site oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[BUDESONIDE, BUDESONIDE, MICRONISED] (C - n/a - n/a - [n/a - 3mg - Oral])|[MAGNESIUM CARBONATE, LIGHT, MAGNESIUM OXIDE, LIGHT, MAGNESIUM CARBONATE, MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - 365mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - 1000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124836	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	TRAJENTA [LINAGLIPTIN] (C - n/a - n/a - [n/a - 5mg - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMISULPRIDE] (C - n/a - n/a - [n/a - 50mg - Oral])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 4mg - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 2000mg - Oral])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - Oral])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - 80mg - Oral])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124855	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124876	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124877	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124883	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - );Peripheral swelling (n/a - Unknown - );Pyrexia (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124884	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Breast swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124895	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (3d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011124904	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rheumatoid arthritis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124908	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (195min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124920	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in jaw (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011124924	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FINASTERIDE] (C - Androgenetic alopecia - n/a - [n/a - n/a - n/a])|[VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011124950	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124951	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124955	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (3d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124968	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Pain (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Thrombosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011124986	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011124992	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (44d - Not Recovered/Not Resolved - );Dizziness (44d - Not Recovered/Not Resolved - );Ear discomfort (44d - Not Recovered/Not Resolved - );Headache (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011124995	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (30d - Recovered/Resolved - );Injection site pruritus (30d - Recovered/Resolved - );Injection site swelling (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011124995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125001	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood glucose increased (10d - Not Recovered/Not Resolved - );Cardiovascular disorder (10d - Not Recovered/Not Resolved - );Dyspnoea (10d - Not Recovered/Not Resolved - );Malaise (10d - Not Recovered/Not Resolved - );Oxygen saturation decreased (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125004	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (n/a - Unknown - );Immunisation (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pre-existing condition improved (n/a - Unknown - );Seasonal allergy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125008	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125009	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal distension (37d - Not Recovered/Not Resolved - );Abdominal pain upper (37d - Not Recovered/Not Resolved - );Fatigue (37d - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Menstrual disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125014	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (147d - Not Recovered/Not Resolved - );Fatigue (147d - Not Recovered/Not Resolved - );Limb discomfort (147d - Not Recovered/Not Resolved - );Memory impairment (147d - Not Recovered/Not Resolved - );Pain in extremity (147d - Not Recovered/Not Resolved - );Swelling (147d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125015	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125025	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125031	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125041	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry skin (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125044	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125045	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Headache (0d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125054	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - );Vaccination site reaction (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125056	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Paranasal sinus discomfort (2d - Recovering/Resolving - );Pharyngeal inflammation (2d - Recovering/Resolving - );Tonsillar inflammation (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125060	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature fluctuation (28d - Not Recovered/Not Resolved - );Body temperature increased (28d - Not Recovered/Not Resolved - );Dizziness (28d - Not Recovered/Not Resolved - );Fatigue (28d - Unknown - );Feeling hot (28d - Not Recovered/Not Resolved - );Hot flush (28d - Unknown - );Hyperhidrosis (28d - Unknown - );Immunisation (28d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (28d - Not Recovered/Not Resolved - );Tachycardia (28d - Recovering/Resolving - );Weight bearing difficulty (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125063	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (49d - Not Recovered/Not Resolved - );Influenza (49d - Not Recovered/Not Resolved - );Nasopharyngitis (49d - Not Recovered/Not Resolved - );Neurodermatitis (49d - Not Recovered/Not Resolved - );Rash (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125067	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - );Pain in extremity (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125075	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (90d - Not Recovered/Not Resolved - );Headache (90d - Not Recovered/Not Resolved - );Inflammation (90d - Not Recovered/Not Resolved - );Limb discomfort (90d - Not Recovered/Not Resolved - );Myalgia (89d - Not Recovered/Not Resolved - );Rash (90d - Not Recovered/Not Resolved - );Sensory disturbance (90d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125092	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125097	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (81d - Recovering/Resolving - );Paraesthesia (81d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125098	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Feeling hot (4d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125103	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125124	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125128	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - );Skin burning sensation (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125135	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (58d - Not Recovered/Not Resolved - );Rash (58d - Not Recovered/Not Resolved - );Swelling face (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125137	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (15d - Recovering/Resolving - );Dizziness (15d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Immunisation (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125138	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125153	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Recovered/Resolved - );Fatigue (8d - Recovered/Resolved - );Headache (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125166	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal discomfort (3d - Recovering/Resolving - );Chills (3d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125188	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125190	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry throat (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Throat irritation (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125195	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Mouth cyst (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125198	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (11d - Not Recovered/Not Resolved - );Limb discomfort (11d - Not Recovered/Not Resolved - );Myalgia (11d - Not Recovered/Not Resolved - );Pyrexia (11d - Not Recovered/Not Resolved - );Sinus congestion (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125214	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (24d - Not Recovered/Not Resolved - );Dizziness (24d - Not Recovered/Not Resolved - );Fatigue (24d - Not Recovered/Not Resolved - );Head discomfort (24d - Not Recovered/Not Resolved - );Nervous system disorder (24d - Not Recovered/Not Resolved - );Weight bearing difficulty (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125218	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (54d - Not Recovered/Not Resolved - );Paraesthesia (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125219	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125223	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125224	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Fatigue (2d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Influenza (2d - Recovering/Resolving - );Injection site erythema (2d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Oropharyngeal discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125231	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (32d - Recovering/Resolving - );Blood glucose increased (32d - Recovering/Resolving - );Dysphonia (32d - Recovering/Resolving - );Hyperhidrosis (32d - Recovering/Resolving - );Hypertension (32d - Recovering/Resolving - );Malaise (38d - Recovering/Resolving - );Myalgia (38d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125233	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Restless legs syndrome (139d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125261	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (54d - Recovered/Resolved With Sequelae - );Limb discomfort (54d - Recovered/Resolved With Sequelae - );Myalgia (54d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011125265	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (40d - Not Recovered/Not Resolved - );Gastrointestinal pain (40d - Not Recovered/Not Resolved - );Injection site pain (40d - Not Recovered/Not Resolved - );Nausea (40d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125274	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site bruise (8d - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site swelling (8d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Migraine (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125275	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125290	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (32d - Not Recovered/Not Resolved - );Myalgia (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125306	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125314	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125326	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Joint swelling (12d - Not Recovered/Not Resolved - );Peripheral swelling (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125327	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125345	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125350	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperaesthesia (0d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125351	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (12d - Not Recovered/Not Resolved - );Pyrexia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125353	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125358	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Parosmia (3d - Not Recovered/Not Resolved - );Stomatitis (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125365	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125369	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Injection site pain (3d - Not Recovered/Not Resolved - );Tinnitus (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125376	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125382	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125383	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Parosmia (81d - Recovering/Resolving - );Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125386	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125394	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired healing (n/a - Unknown - );Inflammation (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125411	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (14d - Recovered/Resolved - );Head discomfort (18d - Recovered/Resolved - );Headache (20d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (21d - Recovered/Resolved - );Muscle twitching (18d - Recovered/Resolved - );Visual acuity reduced (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125413	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125415	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (0d - Recovered/Resolved With Sequelae - );Pyrexia (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011125420	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125424	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes virus infection (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125425	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125439	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125452	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dermatitis allergic (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125458	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125465	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Recovered/Resolved - );Pruritus (1d - Unknown - );Rash (1d - Unknown - );Skin swelling (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125473	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (8d - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (8d - Not Recovered/Not Resolved - );Headache (8d - Recovered/Resolved - );Hot flush (8d - Recovering/Resolving - );Influenza (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125485	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125492	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (5d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (5d - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125497	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Conjunctivitis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hordeolum (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125500	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Somnolence (2d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125501	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125509	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125518	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Limb discomfort (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011125527	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (20d - Not Recovered/Not Resolved - );Headache (20d - Not Recovered/Not Resolved - );Nasal congestion (20d - Not Recovered/Not Resolved - );Sinusitis (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125528	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125543	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125565	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (23d - Not Recovered/Not Resolved - );Erythema (7d - Recovering/Resolving - );Fatigue (7d - Recovering/Resolving - );Hot flush (7d - Recovering/Resolving - );Immunisation (7d - Recovering/Resolving - );Insomnia (1d - Recovering/Resolving - );Lymphadenopathy (7d - Recovering/Resolving - );Productive cough (23d - Not Recovered/Not Resolved - );Pyrexia (7d - Recovering/Resolving - );Rash (7d - Recovering/Resolving - );Swelling (1d - Recovering/Resolving - );Swelling face (1d - Recovering/Resolving - );Throat irritation (23d - Not Recovered/Not Resolved - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125566	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disorientation (44d - Not Recovered/Not Resolved - );Dizziness (n/a - Unknown - );Fatigue (44d - Not Recovered/Not Resolved - );Headache (44d - Not Recovered/Not Resolved - );Memory impairment (44d - Not Recovered/Not Resolved - );Pyrexia (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125567	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Body temperature increased (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125569	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Influenza (4d - Recovering/Resolving - );Movement disorder (4d - Recovering/Resolving - );Somnolence (4d - Recovering/Resolving - );Vaccination site pain (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125578	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (34d - Not Recovered/Not Resolved - );Fatigue (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125589	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125594	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125605	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (44d - Not Recovered/Not Resolved - );Fatigue (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125607	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (147d - Not Recovered/Not Resolved - );Fatigue (147d - Not Recovered/Not Resolved - );Joint swelling (147d - Not Recovered/Not Resolved - );Limb discomfort (147d - Not Recovered/Not Resolved - );Memory impairment (147d - Not Recovered/Not Resolved - );Pain in extremity (147d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125608	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125613	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (13d - Not Recovered/Not Resolved - );Hypoaesthesia (13d - Recovering/Resolving - );Paraesthesia (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125619	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (5d - Not Recovered/Not Resolved - );Myalgia (5d - Not Recovered/Not Resolved - );Pain in extremity (5d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125620	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Trigeminal neuralgia (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125622	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - );Lymphadenopathy (2d - Unknown - );Nausea (2d - Unknown - );Vomiting (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125623	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125643	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Not Recovered/Not Resolved - );Injection site swelling (n/a - Unknown - );Vaccination site erythema (1d - Not Recovered/Not Resolved - );Vaccination site hypersensitivity (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125652	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125656	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (92d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125661	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125662	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Antiviral treatment (21d - Not Recovered/Not Resolved - );Fatigue (21d - Not Recovered/Not Resolved - );Herpes zoster (21d - Not Recovered/Not Resolved - );Immunisation (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125670	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (2d - Recovering/Resolving - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Painful respiration (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125674	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125682	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (46d - Not Recovered/Not Resolved - );Dyspnoea (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125685	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125691	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (2d - Recovered/Resolved - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125709	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125710	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (26d - Recovering/Resolving - );Fatigue (30d - Recovering/Resolving - );Swelling face (26d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125720	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Hot flush (2d - Not Recovered/Not Resolved - );Pain (2d - Not Recovered/Not Resolved - );Somnolence (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125722	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125745	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125747	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125754	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry eye (10d - Not Recovered/Not Resolved - );Dyspnoea (10d - Not Recovered/Not Resolved - );Eye discharge (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - );Hypersensitivity (10d - Not Recovered/Not Resolved - );Sneezing (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125768	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - );Tachycardia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125769	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (130d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125777	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (20d - Not Recovered/Not Resolved - );Disturbance in attention (20d - Not Recovered/Not Resolved - );Dizziness (20d - Not Recovered/Not Resolved - );Dyspnoea (20d - Not Recovered/Not Resolved - );Fatigue (20d - Not Recovered/Not Resolved - );Heart rate decreased (20d - Not Recovered/Not Resolved - );Hyperacusis (20d - Not Recovered/Not Resolved - );Influenza (20d - Not Recovered/Not Resolved - );Neck pain (20d - Not Recovered/Not Resolved - );Photophobia (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125780	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (46d - Recovered/Resolved With Sequelae - );Malaise (46d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011125781	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (92d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125783	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6d - Not Recovered/Not Resolved - );Cough (6d - Not Recovered/Not Resolved - );Hot flush (6d - Not Recovered/Not Resolved - );Influenza (6d - Not Recovered/Not Resolved - );Pyrexia (6d - Not Recovered/Not Resolved - );Vomiting (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125802	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Diarrhoea (13d - Not Recovered/Not Resolved - );Facial paralysis (13d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125806	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammatory bowel disease (5d - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125807	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovering/Resolving - );Hypothermia (1d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125816	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - Other Medically Important Condition);Cardiac discomfort (2d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - );Injection site pain (9d - Recovered/Resolved - );Lymphadenopathy (9d - Recovered/Resolved - );Malaise (5d - Recovering/Resolving - );Myalgia (12d - Recovering/Resolving - );Paraesthesia (5d - Recovering/Resolving - );Rash (13d - Not Recovered/Not Resolved - );Sensory disturbance (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125827	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Liver function test abnormal (22d - Recovered/Resolved With Sequelae - );Lymphadenopathy (22d - Recovered/Resolved With Sequelae - );Ophthalmoplegia (22d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011125829	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (2d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125831	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - );Musculoskeletal discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125833	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (56d - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125841	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (34d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125843	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Facial paralysis (2d - Recovered/Resolved - Other Medically Important Condition);Swelling face (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125854	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Circulatory collapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125860	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125863	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammatory bowel disease (5d - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125866	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema multiforme (10d - Recovered/Resolved - Other Medically Important Condition);Rash (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125867	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125869	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (26d - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (26d - Recovering/Resolving - );Influenza (26d - Recovering/Resolving - );Limb discomfort (26d - Recovering/Resolving - );Pyrexia (26d - Recovering/Resolving - );Restlessness (26d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125880	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125884	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Circulatory collapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125885	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (n/a - Unknown - );Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125888	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual field defect (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125889	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Omphalitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Phlebitis (n/a - Recovered/Resolved - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125890	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Decreased appetite (9d - Not Recovered/Not Resolved - );Dizziness (9d - Not Recovered/Not Resolved - );Epilepsy (9d - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (7d - Not Recovered/Not Resolved - );Petit mal epilepsy (9d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011125892	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Recovered/Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125898	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Unknown - Other Medically Important Condition);Chest discomfort (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125902	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pelvic venous thrombosis (n/a - Unknown - Other Medically Important Condition);Peripheral vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125905	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pelvic venous thrombosis (n/a - Unknown - Other Medically Important Condition);Peripheral vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125906	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (46d - Recovering/Resolving - );Face injury (0d - Not Recovered/Not Resolved - );Fall (0d - Not Recovered/Not Resolved - );Fatigue (46d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Retrograde amnesia (0d - Not Recovered/Not Resolved - );Syncope (0d - Not Recovered/Not Resolved - Other Medically Important Condition);Tooth loss (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125917	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (19d - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (19d - Recovering/Resolving - );Dyspnoea (19d - Recovering/Resolving - );Exercise tolerance decreased (19d - Recovering/Resolving - );Fatigue (19d - Recovering/Resolving - );Somnolence (19d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125918	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pelvic venous thrombosis (n/a - Unknown - Other Medically Important Condition);Peripheral vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125920	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Unknown - Other Medically Important Condition);Chest pain (3d - Unknown - );Chills (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125924	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (0d - Recovering/Resolving - );Chills (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125930	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (41d - Recovering/Resolving - Other Medically Important Condition);Dizziness (41d - Recovering/Resolving - );Immunisation (41d - Recovered/Resolved - );Sudden hearing loss (41d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125932	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pelvic venous thrombosis (n/a - Unknown - Other Medically Important Condition);Peripheral vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125939	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (19d - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (19d - Not Recovered/Not Resolved - );Cough (28d - Not Recovered/Not Resolved - );Fatigue (31d - Not Recovered/Not Resolved - );Lymphadenopathy (23d - Not Recovered/Not Resolved - );Paraesthesia (31d - Not Recovered/Not Resolved - );Respiration abnormal (19d - Not Recovered/Not Resolved - );Tachycardia (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011125954	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125964	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation (26d - Not Recovered/Not Resolved - );Paraesthesia (26d - Not Recovered/Not Resolved - );Visual impairment (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125966	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Nail growth abnormal (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Onychoclasis (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125972	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Vaccination site movement impairment (4d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125974	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (14d - Not Recovered/Not Resolved - );Dizziness (14d - Not Recovered/Not Resolved - );Fatigue (14d - Not Recovered/Not Resolved - );Headache (15d - Not Recovered/Not Resolved - );Hypoaesthesia (12d - Not Recovered/Not Resolved - );Limb discomfort (12d - Not Recovered/Not Resolved - );Muscle spasms (14d - Not Recovered/Not Resolved - );Myalgia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125985	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125986	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling hot (n/a - Unknown - );Headache (n/a - Unknown - );Influenza (n/a - Unknown - );Injection site pain (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011125987	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (7d - Recovering/Resolving - );Gastrointestinal pain (7d - Recovering/Resolving - );Headache (7d - Recovering/Resolving - );Hyperhidrosis (7d - Recovering/Resolving - );Myalgia (7d - Recovering/Resolving - );Nausea (7d - Recovering/Resolving - );Night sweats (7d - Recovering/Resolving - );Sleep disorder (7d - Recovering/Resolving - );Somnolence (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011125989	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (23d - Not Recovered/Not Resolved - );Myalgia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011125992	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (2d - Unknown - );Fatigue (5d - Unknown - );Injection site pain (2d - Unknown - );Limb discomfort (5d - Unknown - );Malaise (5d - Unknown - );Myalgia (5d - Unknown - );Paraesthesia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011125992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126003	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126020	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - );Pleurisy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ORTHICA MULTI MAX TABLET [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|VOEDINGSSUPPLEMENT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126057	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|NOVORAPID 100 E/ML, OPLOSSING VOOR INJECTIE IN FLACON. [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|TRULICITY 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CETOMACROGOL 1000] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011126114	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyposmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126142	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011126143	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126158	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011126165	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011126171	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Faeces soft (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011126174	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Transverse sinus thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011126206	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bowel movement irregularity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperventilation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Impaired driving ability (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Muscle spasms (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Panic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011126218	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Diplopia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);IIIrd nerve paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nasopharyngitis (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011126226	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Diarrhoea (17d - Not Recovered/Not Resolved - );Dizziness (17d - Recovering/Resolving - );Dyspnoea (17d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (9d - Recovering/Resolving - );Limb discomfort (17d - Not Recovered/Not Resolved - );Myalgia (17d - Not Recovered/Not Resolved - );Pain (17d - Not Recovered/Not Resolved - );Pain in extremity (17d - Not Recovered/Not Resolved - );Paraesthesia (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126252	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126255	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Poor peripheral circulation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126279	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neoplasm malignant (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011126315	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126317	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126320	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011126325	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126330	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Feeling hot (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011126351	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126370	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011126378	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Nasopharyngitis (2d - Not Recovered/Not Resolved - );Oropharyngeal pain (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - );Sneezing (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126383	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011126393	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle insomnia (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126405	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011126441	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (3d - Not Recovered/Not Resolved - );Neuralgia (3d - Not Recovered/Not Resolved - );Tinnitus (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126446	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126459	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (5d - Recovered/Resolved - );Migraine (5d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126473	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (30d - Not Recovered/Not Resolved - );Migraine (30d - Not Recovered/Not Resolved - );Visual impairment (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126478	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (47d - Unknown - );Dizziness (47d - Unknown - );Hyperhidrosis (47d - Unknown - );Palpitations (47d - Unknown - );Tachycardia (47d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126482	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovered/Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126489	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Adult	No	Male	Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126493	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126495	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126506	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Facial paralysis (3d - Recovered/Resolved - Other Medically Important Condition);Rash (3d - Recovered/Resolved - );Urticaria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011126508	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agitation (1d - Recovered/Resolved - );Chest discomfort (3d - Not Recovered/Not Resolved - );Dyspnoea (3d - Not Recovered/Not Resolved - );Dyspnoea exertional (3d - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Restlessness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126519	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (32d - Not Recovered/Not Resolved - );Insomnia (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126522	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126529	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (16d - Recovered/Resolved - );Rash pruritic (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126533	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126539	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (53d - Not Recovered/Not Resolved - );Dyspnoea (23d - Not Recovered/Not Resolved - );Hypersensitivity (53d - Not Recovered/Not Resolved - );Neurodermatitis (53d - Not Recovered/Not Resolved - );Rash (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126541	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (140d - Recovering/Resolving - );Fatigue (140d - Recovering/Resolving - );Malaise (140d - Recovering/Resolving - );Nasopharyngitis (140d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126561	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126567	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (17d - Not Recovered/Not Resolved - );Dyspepsia (17d - Not Recovered/Not Resolved - );Pain (17d - Not Recovered/Not Resolved - );Tachycardia (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126576	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126584	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126590	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema multiforme (28d - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (31d - Not Recovered/Not Resolved - );Rash (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011126595	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (31d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126598	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (14d - Recovered/Resolved - );Head discomfort (18d - Recovered/Resolved - );Headache (20d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (21d - Recovered/Resolved - );Muscle twitching (18d - Recovered/Resolved - );Visual acuity reduced (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126601	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (15d - Recovering/Resolving - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126604	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (22d - Not Recovered/Not Resolved - );Myalgia (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126605	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (2d - Recovered/Resolved - );Skin odour abnormal (n/a - Recovered/Resolved - );Vertigo (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126624	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (47d - Not Recovered/Not Resolved - );Limb discomfort (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011126638	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126645	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126650	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (18d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126657	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Cardiovascular disorder (0d - Recovered/Resolved - );Cyanosis (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126660	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126664	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (3d - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126681	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126713	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126735	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (19d - Not Recovered/Not Resolved - Other Medically Important Condition);Blood creatine phosphokinase MB (19d - Not Recovered/Not Resolved - );Blood creatine phosphokinase increased (19d - Not Recovered/Not Resolved - );Chest pain (19d - Not Recovered/Not Resolved - );Fibrin D dimer increased (19d - Not Recovered/Not Resolved - );Myalgia (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011126758	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (65d - Recovered/Resolved With Sequelae - );Dizziness (65d - Recovered/Resolved With Sequelae - );Headache (65d - Recovered/Resolved With Sequelae - );Hot flush (65d - Recovered/Resolved With Sequelae - );Hyperhidrosis (65d - Recovered/Resolved With Sequelae - );Influenza (65d - Recovered/Resolved With Sequelae - );Malaise (65d - Recovered/Resolved With Sequelae - );Oropharyngeal pain (65d - Recovered/Resolved With Sequelae - );Paraesthesia (65d - Recovered/Resolved With Sequelae - );Visual impairment (65d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011126761	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Weight bearing difficulty (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126764	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (50d - Not Recovered/Not Resolved - );Chills (50d - Not Recovered/Not Resolved - );Dizziness (50d - Not Recovered/Not Resolved - );Hot flush (50d - Not Recovered/Not Resolved - );Limb discomfort (50d - Not Recovered/Not Resolved - );Muscle spasms (50d - Not Recovered/Not Resolved - );Nausea (50d - Not Recovered/Not Resolved - );Pain in extremity (50d - Not Recovered/Not Resolved - );Vomiting (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126766	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126786	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nocturia (n/a - Not Recovered/Not Resolved - );Thirst (n/a - Not Recovered/Not Resolved - );Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011126792	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Not Recovered/Not Resolved - );Depression (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Irritability (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126799	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Immunisation (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126823	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - );Influenza (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Oropharyngeal pain (6d - Not Recovered/Not Resolved - );Pyrexia (6d - Not Recovered/Not Resolved - );Throat irritation (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126827	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (0d - Recovered/Resolved - );Hot flush (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pallor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126830	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Feeling abnormal (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011126840	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Paresis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011126848	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urethritis (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126855	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011126861	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126866	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (12d - Not Recovered/Not Resolved - );Muscle twitching (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126912	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (3d - Recovered/Resolved - );Feeling hot (2d - Unknown - );Influenza (5d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Injection site swelling (7d - Recovered/Resolved - );Oral herpes (5d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011126920	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126928	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126940	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126942	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126949	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Anxiety (25d - Not Recovered/Not Resolved - );Arthralgia (25d - Not Recovered/Not Resolved - );Back pain (25d - Not Recovered/Not Resolved - );Blood pressure increased (25d - Not Recovered/Not Resolved - );Breast pain (25d - Not Recovered/Not Resolved - );Dizziness (25d - Not Recovered/Not Resolved - );Feeling hot (25d - Not Recovered/Not Resolved - );Muscle twitching (n/a - Unknown - );Pain in extremity (25d - Not Recovered/Not Resolved - );Palpitations (25d - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - );Sensory disturbance (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011126964	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011126977	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011126977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011127015	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127016	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127023	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011127024	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypokinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Induration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nodule (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sensitive skin (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011127030	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127037	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (2d - Not Recovered/Not Resolved - );Diarrhoea (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127054	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127055	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127059	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127064	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - );Temperature perception test decreased (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127095	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (121d - Not Recovered/Not Resolved - );Dizziness (121d - Not Recovered/Not Resolved - );Dyspnoea (121d - Not Recovered/Not Resolved - );Palpitations (121d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011127096	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127118	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (50d - Not Recovered/Not Resolved - );Dyspnoea (50d - Not Recovered/Not Resolved - );Paraesthesia (50d - Not Recovered/Not Resolved - );Presyncope (50d - Not Recovered/Not Resolved - );Somnolence (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011127124	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - );Insomnia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127130	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (2d - Recovered/Resolved - Other Medically Important Condition);Eye swelling (2d - Recovered/Resolved - );Lip swelling (2d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - );Swelling face (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127150	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011127173	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127179	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (33d - Not Recovered/Not Resolved - );Rash (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011127188	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Joint effusion (13d - Not Recovered/Not Resolved - );Lymphadenopathy (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127208	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Necrotising ulcerative gingivostomatitis (9d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127242	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (8d - Not Recovered/Not Resolved - );Atrial fibrillation (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011127257	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (206d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain (206d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011127267	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127372	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011127425	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127432	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[FINASTERIDE] (C - Alopecia - n/a - [n/a - n/a - Oral])|[VITAMINS NOS] (C - Nutritional supplementation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127455	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Increased tendency to bruise (7d - Recovered/Resolved - );Malaise (8d - Recovered/Resolved - );Nausea (8d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127503	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127510	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Varicose vein (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127544	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127546	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Periarthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127580	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127651	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127666	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011127703	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Makhlouf AT, Van Alphen MU, Manzano GS, Freudenreich O. A Seizure After COVID-19 Vaccination in a Patient on Clozapine. J-Clin-Psychopharmacol 2021;41(6):689-690.	18-64 Years	Adult	No	Male	Generalised tonic-clonic seizure (20min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - n/a - Unknown])|[CLOZAPINE] (S - Schizophrenia - Unknown - [n/a - 400mg - Unknown])	[GABAPENTIN] (C - Neuropathy peripheral - n/a - [n/a - n/a - Unknown])|[GLYCOPYRRONIUM BROMIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[LORAZEPAM] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[RISPERIDONE] (C - Schizophrenia - n/a - [n/a - n/a - Unknown])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011127772	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127827	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011127863	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011127901	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127902	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127905	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011127928	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lung cancer metastatic (n/a - Fatal - Results in Death);Streptococcal infection (n/a - Fatal - Results in Death);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011127928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011128092	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011128096	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128099	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011128118	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128124	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011128148	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128153	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Otitis externa (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011128177	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128179	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011128180	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - Nasopharyngitis - Not applicable - [4d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128187	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128192	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011128196	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011128210	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COLIRCUSI ANESTESICO 5 MG/ML + 0,5 MG/ML COLIRIO EN SOLUCION 1 FRASCO DE 10 ML [NOT AVAILABLE] (C - Pain - n/a - [n/a - n/a - n/a])|XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Deep vein thrombosis - n/a - [n/a - n/a - n/a])|[MOXIFLOXACIN HYDROCHLORIDE] (C - Blindness - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011128211	Spontaneous	2021-12-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011128233	Spontaneous	2021-12-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011128233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101086	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Burning sensation (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Congenital myopathy (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Limb discomfort (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011101288	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101293	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101302	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Diarrhoea (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Injection site pain (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011101305	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Stupor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101340	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101347	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (197d - Recovered/Resolved - );Malaise (197d - Recovered/Resolved - );Nausea (197d - Recovered/Resolved - );Paraesthesia (197d - Recovered/Resolved - );Tremor (197d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101350	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101354	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101360	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101365	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Asthenia (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Eye irritation (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CEFTRIAXONE, CEFTRIAXONE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101368	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101394	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101402	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101407	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Apathy (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101411	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Hypertensive crisis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101426	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101428	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101437	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101451	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Herpes zoster (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101459	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101466	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Middle cerebral artery stroke (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORMETAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011101477	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011101517	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eosinophilia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101518	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101524	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema multiforme (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Skin burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 1.25mg - n/a])|[LISINOPRIL ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101532	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101546	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101560	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011101563	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101595	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101605	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Subdural haematoma (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101610	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011101618	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[BETAMETHASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101620	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - );Tachyarrhythmia (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101640	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101646	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperthermia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011101651	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Peripheral coldness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101676	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101677	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101690	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101691	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011101701	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure fluctuation (n/a - Unknown - Disabling);Disorientation (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Hot flush (n/a - Unknown - Disabling);Tinnitus (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011101709	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Psoriasis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101721	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Pain of skin (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101724	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Dysuria (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pollakiuria (n/a - Recovering/Resolving - );Renal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101729	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101749	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101759	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal lymphadenopathy (n/a - Recovering/Resolving - );Abdominal pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101767	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctival hyperaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Corneal dystrophy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Night sweats (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011101770	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101775	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101786	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101799	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101816	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Not Recovered/Not Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011101829	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhage intracranial (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[METOPROLOL TARTRATE, METOPROLOL TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIMOLOL, TIMOLOL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101840	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - Prostatitis - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - Goitre - n/a - [n/a - 100ug - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011101842	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Spondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011101869	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101874	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Dysphonia (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nocturia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011101878	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Phlebitis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011101880	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - Life Threatening);Vertigo (n/a - Recovered/Resolved With Sequelae - Life Threatening);Vomiting (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101883	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coronary artery occlusion (n/a - Recovering/Resolving - Life Threatening);Infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011101888	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011101893	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - [n/a - 60mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011101914	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Disabling);Lymphadenopathy (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011101939	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011101944	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011101947	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101948	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101950	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011101958	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101961	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011101983	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011101983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011102085	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102099	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102211	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102220	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - );Gait inability (n/a - Not Recovered/Not Resolved - Disabling);Muscle tightness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011102221	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Cardio-respiratory arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011102406	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102407	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102411	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Carotid artery dissection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102415	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - .1mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011102416	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dental plaque (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gingival bleeding (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102417	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102420	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102422	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (2mo - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (2mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102428	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymph node pain (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Sluggishness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102433	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102437	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102438	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102439	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain fog (n/a - Recovered/Resolved - Other Medically Important Condition);Confusional state (n/a - Recovered/Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nightmare (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pH abnormal - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Blood pH abnormal - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastritis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Micturition urgency - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Blood pH abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102441	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102442	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102446	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102448	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Adjustment disorder (n/a - Recovered/Resolved - );Aggression (n/a - Recovering/Resolving - Life Threatening);Altered state of consciousness (0d - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Life Threatening, Other Medically Important Condition);Irritability (n/a - Unknown - );Malaise (30h - Recovered/Resolved - );Neutropenia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Oxygen saturation decreased (30h - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Physical deconditioning (n/a - Unknown - Life Threatening, Other Medically Important Condition);Suicide attempt (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESLORATADINE] (C - Rhinitis allergic - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011102450	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102452	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102454	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood potassium increased (n/a - Unknown - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102456	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product use issue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102457	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102469	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Diplopia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Subdural haematoma (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102471	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102473	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102475	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunology test abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Jaundice (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ocular icterus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urine analysis abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102477	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Constipation (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Urinary retention (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102478	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood glucose abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Disorientation (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Haematocrit decreased (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011102484	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102486	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011102488	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck mass (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep disorder due to general medical condition, insomnia type (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CODEINE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102490	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011102495	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (1d - Recovered/Resolved - Disabling);Cognitive disorder (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	VEDOLIZUMAB [VEDOLIZUMAB] (C - Crohn's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011102496	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (98h - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011102497	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Constipation (n/a - Unknown - Other Medically Important Condition);Urinary retention (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102662	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011102670	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102677	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Liver function test abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102679	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102689	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102692	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102699	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Cognitive disorder (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (4d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LOSARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102702	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102713	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102717	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Asthma - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102725	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Trigger finger (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102731	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102732	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102737	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102744	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102745	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (2d - Recovered/Resolved - Disabling);Decreased appetite (n/a - Unknown - Disabling);Headache (n/a - Recovered/Resolved - Disabling);Hyperaesthesia (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Night sweats (2d - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Syncope (0d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011102747	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphoma (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102750	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition);Ocular hyperaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102754	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Coordination abnormal (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paralysis (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011102764	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102771	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - );Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011102772	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102774	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011102936	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102938	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102939	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102940	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011102941	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011102941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103091	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103096	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103097	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103098	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103099	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103100	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103102	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103117	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103118	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103125	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103128	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103129	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103131	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103132	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103133	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103135	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103137	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103140	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103141	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103242	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103245	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103246	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103250	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103252	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103258	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103260	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103262	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103271	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103274	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103281	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103367	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103370	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Life Threatening);Oropharyngeal pain (n/a - Recovered/Resolved With Sequelae - Life Threatening);Pneumonia (n/a - Recovered/Resolved With Sequelae - Life Threatening);Vaccination site oedema (n/a - Recovered/Resolved With Sequelae - Life Threatening);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011103495	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103504	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103507	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103508	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103510	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103512	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103515	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103517	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103525	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103526	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103533	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103536	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103537	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103538	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103539	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103540	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103618	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103631	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103645	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (21d - Unknown - );Rash (21d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011103648	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103664	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103672	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103688	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103698	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103716	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103719	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103724	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103727	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103729	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103730	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103733	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103736	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103747	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103751	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011103754	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103763	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103765	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103769	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103772	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103774	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103779	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103797	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103809	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103827	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011103833	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011103835	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103844	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103847	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103849	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103850	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103856	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Depression (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103857	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103865	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103870	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Electric shock sensation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Formication (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Libido decreased (n/a - Not Recovered/Not Resolved - );Mental impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103872	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation delayed (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103873	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Chest pain (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103875	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103886	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Muscular weakness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103888	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103892	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103893	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103896	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103899	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Restlessness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103911	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest pain (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103917	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood glucose increased (n/a - Recovered/Resolved - Other Medically Important Condition);Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemangioma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (161h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Unresponsive to stimuli (9630min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103924	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103933	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103936	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Knee deformity (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Postictal state (n/a - Unknown - Caused/Prolonged Hospitalisation);Salivary hypersecretion (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103938	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pharyngitis (n/a - Unknown - Other Medically Important Condition);Tonsillar hypertrophy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103941	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103947	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103955	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (65d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (65d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (65d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103956	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103957	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103971	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Irritability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103972	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103973	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Inflammation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103982	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011103983	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103985	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011103987	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Meningitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103988	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103991	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Encephalopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011103992	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103995	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - Other Medically Important Condition);Vaccination site abscess (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011103996	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (7d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011103996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104005	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104015	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea paroxysmal nocturnal (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104023	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site discomfort (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104025	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed mood (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tendon pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104029	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104030	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104040	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104042	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Overdose (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104053	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Death (n/a - Fatal - Results in Death, Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104054	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Leukocytosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104055	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Postural orthostatic tachycardia syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104059	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104121	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening);Sleep disorder (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011104126	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Unknown - Life Threatening);Heart rate increased (n/a - Unknown - Life Threatening);Hypertension (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011104137	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104146	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104189	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104191	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104197	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104200	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104202	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104205	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104210	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104217	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104220	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104227	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104229	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104230	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104236	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104244	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104248	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104336	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104337	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104340	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Pain (n/a - Unknown - );Sensitive skin (n/a - Unknown - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104344	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104347	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104348	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104359	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104364	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104367	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104368	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Inflammation (n/a - Unknown - );Irritability (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site oedema (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104370	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Accidental overdose (n/a - Unknown - );Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Unknown - );Headache (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104389	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104391	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Cardiomyopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104393	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Angioedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104394	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104397	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Overdose (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104399	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (42d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (42d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104405	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cellulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Left ventricular failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104407	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104408	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Mitral valve prolapse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104412	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pain (n/a - Unknown - );Spinal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Spinal stenosis - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Spinal stenosis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - Spinal stenosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011104414	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104428	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104431	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Sepsis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011104432	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Stevens-Johnson syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104435	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104437	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104439	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Immune-mediated thyroiditis (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104490	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104492	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104494	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104495	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104500	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104507	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104508	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104509	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104510	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104511	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Carotid artery stenosis (134d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (134d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104513	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104517	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104519	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104525	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104527	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104530	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104541	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104546	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104551	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104558	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104560	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angina pectoris (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Muscle twitching (89d - Recovered/Resolved - Life Threatening);Myocarditis (29d - Recovered/Resolved - Life Threatening);Swelling (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011104564	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemolytic anaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104589	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Accidental overdose (n/a - Unknown - );Incorrect dose administered (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104594	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dysuria (n/a - Recovered/Resolved - );Micturition urgency (n/a - Recovered/Resolved - );Urinary tract infection (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104596	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011104601	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Seizure (5min - Recovered/Resolved - Other Medically Important Condition);Speech disorder (5min - Recovered/Resolved - Other Medically Important Condition);Tremor (5min - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011104663	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104666	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DEXAMFETAMINE SULFATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104691	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[PHENYTOIN] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104696	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104697	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])|[IODINE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104706	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	EXFORGE HCT 10 MG/160 MG/12.5 MG FILM-COATED TABLETS [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE, VALSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104714	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	PROTEIN POWDER [NOT AVAILABLE] (C - n/a - n/a - )|[CREATININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104726	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104780	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vaccination site lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011104817	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104818	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104820	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104823	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104828	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011104838	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011104945	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011104945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011105003	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105008	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105009	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105012	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105013	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105020	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105025	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105027	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105030	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105031	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105036	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105038	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105043	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105044	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105045	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105050	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105052	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105056	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105058	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105062	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105063	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105065	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105069	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105073	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105104	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Balance disorder (n/a - Recovered/Resolved - );Dermatitis allergic (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (5wk - Recovered/Resolved - );Muscle spasms (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011105289	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105294	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105296	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105298	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105300	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105301	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105302	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105308	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Meningitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sudden visual loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011105310	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - );Troponin I increased (n/a - Recovered/Resolved - );Troponin T increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011105311	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105313	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105315	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105317	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105326	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105330	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Faecal volume decreased (n/a - Not Recovered/Not Resolved - );Flatulence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105331	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105334	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105513	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105514	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105515	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105516	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011105517	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocardial oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011105521	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105524	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105530	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105537	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105538	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105540	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105544	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011105552	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105661	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105667	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105668	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105670	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105673	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105676	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral ischaemia (0d - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ANIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105682	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105728	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105730	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovered/Resolved - );Movement disorder (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Sleep deficit (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011105747	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105749	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105750	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105759	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105762	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105765	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105790	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (77d - Not Recovered/Not Resolved - );Pain in extremity (77d - Not Recovered/Not Resolved - );Pyrexia (14d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011105799	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105801	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105809	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105811	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105816	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105817	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105818	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105823	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105826	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105830	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105834	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105838	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105842	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105844	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105854	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105858	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105882	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lung hyperinflation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nodule (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011105884	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011105895	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105902	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105905	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - SARS-CoV-2 test positive - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105907	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105908	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105916	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105922	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105933	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105938	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105949	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105950	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105971	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105974	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105998	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011105999	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011105999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011106009	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106037	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106053	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106108	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106120	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106122	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106129	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106131	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106134	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106139	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106143	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106147	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106160	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106162	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011106163	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106167	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106172	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106175	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Stomatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106176	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106186	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106210	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106234	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106260	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106281	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106312	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Administration site pain (n/a - Unknown - );Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106330	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106448	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106451	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106453	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106456	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011106458	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebrovascular accident (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106460	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Initial insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nervous system disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106471	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Local reaction (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106477	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106480	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling jittery (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011106481	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011106492	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Injection site pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106495	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dermatitis acneiform (53d - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Facial discomfort (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pain of skin (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Skin discomfort (n/a - Not Recovered/Not Resolved - );Tendon discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011106502	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106519	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lichen sclerosus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106581	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106585	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106586	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106587	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106589	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106591	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106594	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106599	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106606	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106610	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106611	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011106619	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011106622	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106689	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106830	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal haemorrhage (12d - Recovered/Resolved - Other Medically Important Condition);Renal pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011106884	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106941	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011106999	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Atrial tachycardia (n/a - Recovered/Resolved With Sequelae - Life Threatening);SARS-CoV-2 test negative (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011106999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011107068	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107074	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107075	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107076	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107080	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107081	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107085	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107086	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107088	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107095	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107099	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107107	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107110	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107112	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107114	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107287	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107359	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107369	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107371	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107373	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107381	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107382	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107383	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107386	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Unknown - );Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107387	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107547	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107549	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107550	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107554	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107556	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Other Medically Important Condition);Abdominal pain (n/a - Unknown - Other Medically Important Condition);Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107560	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Unknown - );Malaise (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107561	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107564	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Sumi, T.. Lung squamous cell carcinoma with hemoptysis after vaccination with tozinameran (BNT162b2, Pfizer-BioNTech). Thorac Cancer. 2021;1-4. doi:10.1111/1759-7714.14179 Sumi, T.. Lung squamous cell carcinoma with hemoptysis after vaccination with tozinameran (BNT162b2, Pfizer-BioNTech). Thorac Cancer. 2021;12(22):3072-3075. doi:10.1111/1759-7714.14179	65-85 Years	Not Specified	No	Male	Haemoptysis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Cerebrovascular accident - n/a - [n/a - 100mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011107565	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107566	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107568	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107570	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011107571	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lacunar infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107573	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Rash (87h - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107574	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Cerebral infarction - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107578	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107580	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107581	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107583	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Craniectomy (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011107589	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107592	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Life Threatening);Cerebral haemorrhage (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Life Threatening);Leukaemia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011107593	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011107598	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Stomatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107599	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (45min - Recovered/Resolved - );Hypotension (n/a - Unknown - );Syncope (45min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107603	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107608	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Heart rate irregular (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107611	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107614	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure acute (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (1mo - Recovered/Resolved - Caused/Prolonged Hospitalisation);Left ventricular dysfunction (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lung opacity (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (38d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (38d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory tract infection (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Systemic inflammatory response syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ACOTIAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[ALLERGENS, POLLEN & PLANT EXTRACT, CERNITIN GBX] (C - n/a - n/a - [n/a - 6{DF} - n/a])|[CILOSTAZOL] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[EPERISONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[KETOPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[LOXOPROFEN, LOXOPROFEN SODIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[MECOBALAMIN] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[NAFTOPIDIL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[SUCRALFATE] (C - n/a - n/a - [n/a - 3g - n/a])|[TAK 438] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011107615	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Dehydration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumothorax (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107618	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107619	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107620	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107621	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased activity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107622	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107623	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fear (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107624	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107626	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eosinophil count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107631	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107633	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Jaundice (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Melaena (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107635	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107639	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107640	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gaze palsy (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematemesis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle spasms (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pneumonia aspiration (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AZELNIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AZOSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DAIKENCHUTO, GINGER, GINSENG, ZANTHOXYLUM FRUIT, GINSENG] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[SODIUM FERROUS CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011107643	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Pulmonary toxicity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011107657	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ADENOSINE 5' TRIPHOSPHATE, DISODIUM SALT] (C - n/a - n/a - [n/a - 3g - Oral])|[AMENAMEVIR] (C - n/a - n/a - [n/a - 1200mg - Oral])|[MECOBALAMIN] (C - n/a - n/a - [n/a - 3{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107707	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011107738	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cyst (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107741	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107746	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis allergic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Food allergy (0d - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107754	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107756	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107758	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Lymphoedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107761	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Iritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Joint stiffness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011107768	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107774	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Renal pain (3d - Recovered/Resolved - Other Medically Important Condition);Vomiting (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107776	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107780	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107788	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Haematochezia (n/a - Unknown - Other Medically Important Condition);Haematuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107791	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107800	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LACIDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011107803	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal heart rate abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - n/a - Transplacental])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - Transplacental])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011107806	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107887	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107888	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107891	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107892	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107893	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107899	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107900	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107901	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107909	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107910	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107912	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107916	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107918	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011107940	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemoptysis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011107943	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011107943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108090	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hodgkin's disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108105	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108111	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Rheumatoid arthritis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011108114	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108117	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Respiratory arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011108127	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011108133	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108135	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011108139	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108143	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cystitis noninfective (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Dysuria (n/a - Unknown - );Libido decreased (n/a - Unknown - );Nephritis (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108147	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombocytopenia (91d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	NPLATE [ROMIPLOSTIM] (C - Immune thrombocytopenia - n/a - [337d - n/a - n/a])|REVOLADE [ELTROMBOPAG] (C - Immune thrombocytopenia - n/a - [280d - n/a - Oral - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011108151	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108153	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108154	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011108158	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108160	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Painful respiration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108161	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108164	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis reactive (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[COVID-19 VACCINE] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108165	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allodynia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Ataxia (n/a - Recovering/Resolving - );Brain stem infarction (n/a - Recovering/Resolving - Other Medically Important Condition);Cerebral thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108166	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dermatitis allergic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011108220	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Erythema (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108221	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108224	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Exfoliative rash (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108230	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Unknown - );Muscle twitching (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108232	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Recovering/Resolving - );Injection site induration (8d - Recovered/Resolved - );Injection site swelling (8d - Recovered/Resolved - );Injection site warmth (8d - Recovered/Resolved - );Pruritus (8d - Recovered/Resolved - );Vaccination site reaction (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108245	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye swelling (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MICRONISED SPIRONOLACTONE, POTASSIUM CANRENOATE, SPIRONOLACTONE, SPIRONOLACTONE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108299	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (8d - Not Recovered/Not Resolved - );Myalgia (8d - Not Recovered/Not Resolved - );Nausea (8d - Not Recovered/Not Resolved - );Pyrexia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108300	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (3d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108302	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (4d - Not Recovered/Not Resolved - );Chest pain (4d - Not Recovered/Not Resolved - );Hypoaesthesia (5d - Not Recovered/Not Resolved - );Myalgia (4d - Not Recovered/Not Resolved - );Paraesthesia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108312	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Cough (3d - Recovering/Resolving - );Decreased appetite (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108316	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (12d - Recovering/Resolving - );Dyspnoea (12d - Recovering/Resolving - );Influenza (12d - Recovering/Resolving - );Painful respiration (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108318	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis bullous (n/a - Not Recovered/Not Resolved - );Dry skin (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108319	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (19d - Not Recovered/Not Resolved - );Fatigue (19d - Not Recovered/Not Resolved - );Headache (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108322	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Facial paralysis (3d - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lacrimation increased (1d - Recovered/Resolved - );Loss of consciousness (5d - Recovering/Resolving - );Lymphadenopathy (n/a - Unknown - );Memory impairment (4d - Recovering/Resolving - );Muscle spasms (4d - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pruritus (9d - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Sensorimotor disorder (4d - Recovering/Resolving - );Taste disorder (4d - Recovered/Resolved - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108335	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testis cancer (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011108341	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108343	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108356	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Night sweats (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108373	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011108374	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site swelling (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108375	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108378	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Local reaction (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Vaccination site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108381	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infectious thyroiditis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108382	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Injection site swelling (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108387	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (32d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011108407	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infectious thyroiditis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108410	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108415	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108426	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108427	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (21d - Recovering/Resolving - );Oedema peripheral (21d - Recovering/Resolving - );Swelling (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011108457	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108458	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108459	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Epistaxis (n/a - Unknown - );Hypertension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011108460	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011108506	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108512	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108517	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108520	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108522	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108525	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108527	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108531	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108537	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108539	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108543	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108547	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108548	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108549	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108560	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108841	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108842	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108859	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108861	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108865	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108867	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108869	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108922	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypothermia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Oropharyngeal discomfort (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Palpitations (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108923	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Candida infection (n/a - Unknown - );Chronic obstructive pulmonary disease (6mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disease recurrence (6mo - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011108927	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Pulmonary oedema (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108930	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108932	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (13d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (13d - Recovered/Resolved - Other Medically Important Condition);Lethargy (48d - Recovered/Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011108934	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108935	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108938	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Paralysis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108940	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011108942	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108949	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amenorrhoea (n/a - Unknown - );Dysmenorrhoea (n/a - Unknown - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Unknown - );Menstrual disorder (n/a - Unknown - );Polymenorrhoea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108954	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Costochondritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108964	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Miliaria (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Monoparesis (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Thrombosis (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011108973	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Psoriatic arthropathy (n/a - Recovering/Resolving - Other Medically Important Condition);Skin disorder (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011108974	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Axillary pain (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - );Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - );Stridor (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 6mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011108981	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coma (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disorientation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalitis viral (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AMGEVITA [ADALIMUMAB] (C - Psoriatic arthropathy - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011108985	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Candida infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Expired product administered (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PREDNISONE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011108990	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - );Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - );Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011108990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109017	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109019	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Life Threatening, Other Medically Important Condition);Death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011109036	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 immunisation (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109045	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109048	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109055	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109062	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109071	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109072	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109074	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109075	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109082	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Oedema peripheral (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109083	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hepatitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transaminases increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109084	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109089	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109090	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109103	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109106	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109107	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109111	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109123	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011109124	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109145	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash vesicular (3d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109146	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109147	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109152	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109161	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebellar infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertebral artery dissection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109166	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109171	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109172	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109174	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109188	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109190	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109193	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109201	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109204	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109206	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109210	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Nodule (n/a - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109211	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109233	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109242	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109251	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Recovered/Resolved With Sequelae - Disabling);Sleep disorder (n/a - Recovered/Resolved With Sequelae - Disabling);Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011109253	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109263	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109264	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109272	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109275	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109285	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109286	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109290	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Unknown - );Extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011109297	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109298	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (1wk - Recovered/Resolved - );Electrocardiogram ambulatory abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109306	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109307	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109313	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109336	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109337	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109338	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109345	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109368	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109424	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109479	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109538	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Behcet's syndrome (n/a - Unknown - Disabling, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Costochondritis (n/a - Unknown - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait inability (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Inflammation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Odynophagia (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pulmonary pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - 15mg - n/a])|MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - Autoinflammatory disease - n/a - [221d - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Autoinflammatory disease - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Erythema nodosum - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[PROMETHAZINE HYDROCHLORIDE] (C - Erythema nodosum - n/a - [10d - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[TESTOSTERONE CIPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011109542	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109548	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109568	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109589	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109603	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109607	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109618	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109723	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109730	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tremor (0d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011109731	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Coronavirus infection (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109741	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109744	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial hypoxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109748	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Tongue disorder (n/a - Recovering/Resolving - );Tongue geographic (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011109814	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109908	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109910	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109918	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109924	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109932	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109953	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109961	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109967	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011109969	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109977	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011109978	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011109981	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dysphonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eyelid ptosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle rigidity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011109981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110005	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110007	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemosiderosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Waterhouse-Friderichsen syndrome (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011110010	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110012	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness unilateral (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[CELIPROLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110017	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Truncus coeliacus thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110033	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011110034	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (n/a - Recovering/Resolving - Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110037	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110040	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition);Priapism (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110044	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110045	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110048	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Depression (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110050	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110051	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110052	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110054	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011110056	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110058	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110061	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Melanocytic naevus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Metastatic malignant melanoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110066	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110069	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110122	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [23d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110126	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hilar lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mantle cell lymphoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110128	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110135	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110138	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110139	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Near death experience (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110156	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110159	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (2wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110181	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (3wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110199	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110208	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110212	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Face oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110217	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110219	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110220	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intercostal neuralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110246	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110251	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110257	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Photophobia (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110261	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110266	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110269	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110274	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood thyroid stimulating hormone increased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110295	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dermatitis bullous (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110313	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110315	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1wk - Recovering/Resolving - );Paraesthesia (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110316	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110321	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110322	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pain in jaw (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110353	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - );Sleep disorder due to general medical condition, insomnia type (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110357	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110361	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110370	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vein disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110386	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110391	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110405	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110407	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110420	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110422	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110438	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110439	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110441	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110443	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110471	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110473	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110483	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110487	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110490	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110491	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110494	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Benign prostatic hyperplasia - Unknown - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110495	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110499	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110505	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110508	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110522	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (4wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110530	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110531	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Parosmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110533	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110535	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110541	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Occipital neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110562	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110563	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110566	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110582	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110584	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	HIV peripheral neuropathy (7mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110586	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110595	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110600	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110605	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110611	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110614	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110615	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110617	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110618	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110621	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110622	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110624	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110627	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110633	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110634	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110638	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110640	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110641	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110649	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110652	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011110653	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110656	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110660	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110661	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110671	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110673	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110675	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110677	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110680	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110765	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Purpura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110767	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110784	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	C-reactive protein increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Conjunctival hyperaemia (48h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash maculo-papular (48h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Red blood cell sedimentation rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Serum ferritin increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011110805	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110831	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110835	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (0d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011110837	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (47min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110838	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011110858	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Poor peripheral circulation (n/a - Not Recovered/Not Resolved - );Skin haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110859	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Feeling hot (1d - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110873	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110876	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Diarrhoea (0d - Recovered/Resolved - );Nausea (1d - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110882	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (20d - Not Recovered/Not Resolved - );Nausea (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110884	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110900	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110931	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (47d - Not Recovered/Not Resolved - );Gait disturbance (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011110935	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (n/a - Unknown - );Influenza (n/a - Unknown - );Productive cough (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110940	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (105d - Unknown - );Heart rate decreased (105d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011110942	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110948	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011110991	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011110991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111009	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Urine odour abnormal (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111039	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Somnolence (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111048	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (57d - Not Recovered/Not Resolved - );Rash (57d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111050	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (98d - Not Recovered/Not Resolved - );Paraesthesia (98d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111055	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypotonia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111057	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acne (15d - Recovered/Resolved - );Dermatitis (82d - Recovered/Resolved - );Furuncle (107d - Recovered/Resolved - );Herpes virus infection (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Oral herpes (106d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111065	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011111067	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111068	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111075	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011111078	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111087	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011111091	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111093	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111102	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111108	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111113	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (9d - Recovering/Resolving - );Pyrexia (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111117	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Malaise (2d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111118	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Facial paralysis (31d - Not Recovered/Not Resolved - );Fatigue (31d - Not Recovered/Not Resolved - );Limb discomfort (31d - Not Recovered/Not Resolved - );Paraesthesia (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111120	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111131	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (52d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111134	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - );Lymph node pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111142	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111146	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111148	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (7d - Recovered/Resolved - );Rash (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111156	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111160	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Disturbance in attention (2d - Recovering/Resolving - );Faeces discoloured (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111161	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (33d - Not Recovered/Not Resolved - );Arrhythmia (33d - Not Recovered/Not Resolved - );Malaise (36d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111163	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (12d - Not Recovered/Not Resolved - );Rash (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111170	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Oral herpes (2d - Not Recovered/Not Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111189	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111194	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111209	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111212	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (1d - Recovered/Resolved With Sequelae - );Palpitations (1d - Recovered/Resolved With Sequelae - );Tachycardia (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011111219	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111225	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111249	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pruritus (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111251	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Not Specified	Arthralgia (49d - Not Recovered/Not Resolved - );Limb discomfort (49d - Not Recovered/Not Resolved - );Lymphadenopathy (49d - Not Recovered/Not Resolved - );Malaise (49d - Not Recovered/Not Resolved - );Myalgia (49d - Not Recovered/Not Resolved - );Rash (49d - Not Recovered/Not Resolved - );Syncope (49d - Not Recovered/Not Resolved - );Weight decreased (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111252	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (0d - Recovered/Resolved - );Exercise tolerance decreased (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111253	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111255	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Hypoaesthesia (10d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Lymphadenopathy (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111271	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Facial paralysis (31d - Not Recovered/Not Resolved - );Fatigue (31d - Not Recovered/Not Resolved - );Limb discomfort (31d - Not Recovered/Not Resolved - );Paraesthesia (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111273	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Abnormal faeces (0d - Not Recovered/Not Resolved - );Asthenia (0d - Not Recovered/Not Resolved - );Diarrhoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111275	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovered/Resolved - );Rash pruritic (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111277	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (97d - Not Recovered/Not Resolved - );Back pain (97d - Not Recovered/Not Resolved - );Limb discomfort (97d - Not Recovered/Not Resolved - );Myalgia (97d - Not Recovered/Not Resolved - );Peripheral swelling (97d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111289	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (33d - Not Recovered/Not Resolved - );Palpitations (33d - Not Recovered/Not Resolved - );Sleep disorder (33d - Not Recovered/Not Resolved - );Tachycardia (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111291	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Influenza like illness (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Swelling face (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111293	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (20d - Not Recovered/Not Resolved - );Heart rate increased (15d - Not Recovered/Not Resolved - );Malaise (20d - Not Recovered/Not Resolved - );Palpitations (15d - Not Recovered/Not Resolved - );Tachycardia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111297	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes virus infection (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111298	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111312	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye irritation (70d - Not Recovered/Not Resolved - );Fatigue (70d - Not Recovered/Not Resolved - );Memory impairment (70d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111337	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (50d - Not Recovered/Not Resolved - );Fatigue (50d - Not Recovered/Not Resolved - );Headache (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111340	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Seasonal allergy (n/a - Recovering/Resolving - );Solar dermatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111343	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111354	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011111374	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pain in jaw (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111376	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (61d - Not Recovered/Not Resolved - );Rash (61d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011111383	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111386	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema weeping (5d - Not Recovered/Not Resolved - );Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111389	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (11d - Not Recovered/Not Resolved - );Diarrhoea (11d - Not Recovered/Not Resolved - );Feeling hot (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - );Malaise (11d - Not Recovered/Not Resolved - );Nausea (11d - Not Recovered/Not Resolved - );Neck pain (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111391	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Vaccination site necrosis (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111407	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Pulmonary function test decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111410	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111528	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Pyrexia (n/a - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111553	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111564	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011111597	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111740	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111743	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111744	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111746	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111748	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111758	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011111766	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011111773	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Liver function test abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Liver injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALBUMIN, HUMAN ALBUMIN SOLUTION, HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN, HUMAN SERUM ALBUMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011111775	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111779	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BETULA VERRUCOSA POLLEN] (C - n/a - n/a - [n/a - n/a - Oral])|[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011111839	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011111841	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved With Sequelae - );Vaccination site hypoaesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site joint pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011111853	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011111854	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011111870	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (5d - Recovered/Resolved - Life Threatening);Superficial vein thrombosis (2d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011111906	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011111936	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111951	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (19d - Recovered/Resolved - );Heart rate decreased (19d - Recovered/Resolved - );Heart rate irregular (19d - Recovered/Resolved - );Palpitations (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011111969	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011111969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011112109	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112129	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011112201	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112202	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Productive cough (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011112223	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112248	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pruritus (n/a - Unknown - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011112254	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112269	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112284	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthropathy (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Phlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombophlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011112296	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011112329	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypertension (n/a - Unknown - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site erythema (10d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011112363	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acidosis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Autonomic nervous system imbalance (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (1995min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Orthostatic intolerance (n/a - Unknown - );Presyncope (1995min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (1995min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sluggishness (1995min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (1995min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011112365	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112379	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (10min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112451	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112453	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011112459	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Blood pressure fluctuation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011112476	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112505	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011112510	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112513	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011112523	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Colitis ulcerative (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haematochezia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhagic diathesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Henoch-Schonlein purpura (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - 3000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011112528	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Sensitive skin (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112545	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Recovered/Resolved - Other Medically Important Condition);Cellulitis (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Papule (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - );Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Scratch (n/a - Unknown - Other Medically Important Condition);Skin exfoliation (n/a - Unknown - Other Medically Important Condition);Skin reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112547	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dehydration (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112550	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011112645	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011112668	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112670	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112676	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011112793	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112820	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011112824	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Cold sweat (n/a - Unknown - );Eye discharge (n/a - Unknown - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Neoplasm malignant (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112826	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Unknown - Other Medically Important Condition);Postural orthostatic tachycardia syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112852	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011112877	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112883	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112890	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112912	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Daydreaming (n/a - Unknown - Caused/Prolonged Hospitalisation);Dementia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Unknown - );Hallucination (n/a - Unknown - Caused/Prolonged Hospitalisation);Substance-induced psychotic disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Weight increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011112914	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112926	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112932	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112937	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Anaphylactic reaction (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011112975	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cluster headache (14d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011112989	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011112996	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011112996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113008	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Peripheral artery surgery (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral artery thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113016	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011113017	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113025	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113026	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113035	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113037	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113040	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113053	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113058	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113102	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113117	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113137	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113158	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gaze palsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotonic-hyporesponsive episode (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Unresponsive to stimuli (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113174	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113241	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113277	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113306	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011113357	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113387	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113417	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113419	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011113423	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (1d - Recovered/Resolved - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113427	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113434	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113455	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myelodysplastic syndrome (50d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011113458	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113462	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (4d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113467	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (216d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011113469	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113475	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash maculo-papular (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113543	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113554	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113585	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Incontinence (n/a - Fatal - Results in Death, Other Medically Important Condition);Seizure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	SAMSCA [TOLVAPTAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011113647	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113653	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113654	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113665	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113668	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113671	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113674	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113678	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113679	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tremor (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PIMECROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011113681	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113684	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113691	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (5h - Recovered/Resolved - );Fatigue (24h - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Injection site inflammation (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (24h - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113692	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011113707	Spontaneous	2021-12-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (16h - Recovered/Resolved - );Fatigue (16h - Recovered/Resolved - );Pyrexia (16h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011113708	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113728	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113753	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011113802	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113833	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113837	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113840	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113841	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113845	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113846	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113848	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011113857	Spontaneous	2021-12-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011113857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088915	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088985	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ecchymosis (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011089047	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes ophthalmic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089092	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089107	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Capillary fragility (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Nipple pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089124	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - );Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011089167	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Diplopia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Visual acuity reduced (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	CIALIS 5 MG FILM-COATED TABLETS [TADALAFIL] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[RUPATADINE] (C - n/a - n/a - [n/a - 10mg - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - .4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011089182	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diplopia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Miller Fisher syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011089184	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089186	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011089187	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - Disabling);Trigeminal neuralgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011089220	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral ischaemia (0d - Recovered/Resolved - Other Medically Important Condition);Dysarthria (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089241	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Muscle spasms (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011089269	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011089277	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin reaction (n/a - Not Recovered/Not Resolved - );Thermal burn (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089332	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011089338	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Aphasia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - );Dysaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011089373	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lumbar radiculopathy (n/a - Unknown - Other Medically Important Condition);Testicular pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089404	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[AMYLMETACRESOL, 2,4 DICHLOROBENZYL ALCOHOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089450	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Tension headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089453	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089484	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089503	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011089562	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011089688	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Drug hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089689	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening);Liver function test increased (n/a - Not Recovered/Not Resolved - Life Threatening);Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011089694	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [1518d - 75mg - n/a])|PIOGLITAZONE [PIOGLITAZONE] (C - n/a - n/a - [1621d - 15mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [1d - 40mg - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [706d - n/a - n/a])|[FERROUS SULFATE] (C - n/a - n/a - [1621d - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [1518d - n/a - Respiratory (inhalation)])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [942d - 400ug - n/a])|[PARACETAMOL] (C - n/a - n/a - [1621d - 500mg - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [1268d - 5mL - n/a])|[RAMIPRIL] (C - n/a - n/a - [654d - 1.25mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [1518d - n/a - Respiratory (inhalation)])|[THIAMINE] (C - n/a - n/a - [1591d - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089696	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011089704	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089707	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hypersensitivity (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Product administered at inappropriate site (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011089715	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089726	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089734	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089736	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - Other Medically Important Condition);Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089737	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Palpitations (5d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011089902	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Campylobacter gastroenteritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089904	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011089905	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011089908	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial nerve disorder (n/a - Recovering/Resolving - );Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089909	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011089910	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089914	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089917	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089919	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089920	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089928	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011089931	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011089936	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011089936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090064	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovered/Resolved - );Electrocardiogram (n/a - Unknown - );Injection site pain (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090071	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Bone pain (n/a - Recovering/Resolving - );Haematuria (n/a - Recovering/Resolving - );Melaena (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090078	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (n/a - Unknown - );Chest pain (n/a - Unknown - Other Medically Important Condition);Depressed mood (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Pain (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090083	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090088	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090091	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090094	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090095	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090097	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain oedema (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Ear haemorrhage (n/a - Unknown - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Haematemesis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Vomiting (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011090106	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090109	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure chronic (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Paraparesis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090118	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Seizure (n/a - Unknown - Other Medically Important Condition);Subarachnoid haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090122	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090127	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Motor dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash maculo-papular (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090130	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lacrimation increased (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090133	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090134	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090137	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090147	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Balance disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood potassium decreased (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090160	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Intentional product misuse (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090177	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090192	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090198	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090199	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090200	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090202	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cutaneous vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090208	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090213	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Rectal haemorrhage (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Thrombocytosis - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090220	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090227	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Coronary artery dilatation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sluggishness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090228	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090289	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Tenderness (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011090290	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090297	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090303	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness unilateral (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Optic nerve infarction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011090304	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090305	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090307	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090311	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090312	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pH increased - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011090375	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090583	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090591	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011090710	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090712	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090713	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090715	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090717	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090721	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090899	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090913	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090915	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090917	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090918	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Recovered/Resolved - );Headache (9d - Recovered/Resolved - );Pain in extremity (9d - Recovered/Resolved - );Somnolence (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011090919	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090922	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011090951	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - Hypertension - Unknown - [n/a - 17.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011090973	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Contusion (14d - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011090973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091086	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091091	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091096	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091098	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091102	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091103	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091105	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091107	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011091108	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091111	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091112	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091116	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091119	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011091121	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091125	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091129	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011091130	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091141	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011091177	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Labyrinthitis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091257	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091261	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091262	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091268	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091269	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091271	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091272	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091274	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091277	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091282	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091284	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091292	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091369	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091416	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - );Tinnitus (n/a - Unknown - );Tonsillitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011091466	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091470	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091480	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091481	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091485	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091491	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091494	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091496	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091497	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091615	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Back pain (n/a - Unknown - );Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011091619	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Recovered/Resolved - );Palpitations (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011091709	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091716	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091717	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091718	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091765	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011091853	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericardial effusion (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011091876	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nervous system disorder (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091883	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Appendicitis (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091887	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Contusion (n/a - Unknown - );Eosinophilia (n/a - Unknown - );Petechiae (n/a - Unknown - );Rhinitis (n/a - Unknown - );Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091889	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Anxiety (n/a - Not Recovered/Not Resolved - );Dysuria (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - );Urinary retention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[BUPRENORPHINE] (S - n/a - Unknown - [1d - n/a - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091890	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091893	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nasopharyngitis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonitis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011091901	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Cardiac disorder (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate decreased (n/a - Unknown - );Irregular breathing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091905	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute lymphocytic leukaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091906	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091910	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin T increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091916	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091917	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011091919	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091920	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091927	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091930	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091940	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091950	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091957	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091958	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091967	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011091986	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011091986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092062	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092072	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092073	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death);Renal cyst (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092087	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Paralysis (n/a - Fatal - Results in Death);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092090	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092093	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TAGRISSO [OSIMERTINIB, OSIMERTINIB MESILATE] (C - Lung neoplasm malignant, Malignant ascites - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092096	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arteriosclerosis (n/a - Fatal - Results in Death);Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092107	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - Other Medically Important Condition);Diaphragmatic spasm (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL, TRAMADOL, TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092113	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Death (n/a - Fatal - Results in Death);Fatigue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092115	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092117	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092119	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain lower (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pallor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urinary tract infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092121	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092129	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092132	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neutrophil percentage increased (n/a - Unknown - );Overdose (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092133	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Facial pain (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092152	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092164	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Recovered/Resolved - );Off label use (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092165	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition);Generalised tonic-clonic seizure (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092166	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fibrin D dimer increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092167	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011092176	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092180	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (11d - Recovered/Resolved - Other Medically Important Condition);Fatigue (561h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (633h - Recovered/Resolved - Other Medically Important Condition);Rash (561h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092183	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092186	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092192	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092193	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092202	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Behcet's syndrome (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash macular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092203	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092205	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Unknown - );Hemiparesis (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092206	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure congestive (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eosinophilic myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fluid retention (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyponatraemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Iron deficiency (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Night sweats (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Orchitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pollakiuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Testicular pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vasculitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vitamin D deficiency (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CANAGLIFLOZIN [CANAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092209	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092218	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092221	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PARACETAMOL] (C - Headache, Pyrexia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011092222	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Lethargy (2d - Recovered/Resolved - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[QUETIAPINE, QUETIAPINE FUMARATE] (C - Borderline personality disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092223	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092224	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092225	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011092227	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - );Phlebitis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092229	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Liver function test abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092233	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute pulmonary oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Autoimmune disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Colitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pigmentation disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Septic shock (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092238	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092246	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Scleritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092264	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral artery occlusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092266	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092267	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092270	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - );Haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092278	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011092290	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092292	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (n/a - Not Recovered/Not Resolved - );Hallucination, visual (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Mydriasis (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092293	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Head discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092295	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Overdose (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092303	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092305	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Central pain syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092308	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092310	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092311	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092320	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092323	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011092325	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Palpitations (5wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092328	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL, METHENAMINE] (C - n/a - n/a - [n/a - 200mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[BROMAZEPAM] (C - n/a - n/a - [n/a - 3mg - n/a])|[HYDROCHLOROTHIAZIDE, LISINOPRIL] (C - n/a - n/a - [n/a - 50mg - n/a])|[URAPIDIL, URAPIDIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011092333	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092340	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (31d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nerve injury (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 50ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011092344	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092351	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (135min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092352	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092353	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092359	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle hernia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 300mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092374	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Post inflammatory pigmentation change (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Skin lesion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092379	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paresis (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Sensory loss (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011092380	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092381	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092394	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dermatitis allergic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatic function abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Leukocytosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092402	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - );Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092408	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092409	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092410	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Folliculitis (n/a - Recovering/Resolving - Other Medically Important Condition);Nail pigmentation (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092424	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092425	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011092427	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092431	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Superior sagittal sinus thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Transverse sinus thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092435	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011092437	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092439	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092478	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092485	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (18d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Night sweats (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011092497	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deafness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092524	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Diarrhoea (3d - Recovering/Resolving - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, COLECALCIFEROL, MAGNESIUM] (C - n/a - n/a - )|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092531	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092533	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092536	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011092537	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092661	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (37d - Not Recovered/Not Resolved - );Dizziness (37d - Not Recovered/Not Resolved - );Dyspnoea (37d - Not Recovered/Not Resolved - );Tachycardia (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011092666	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (41d - Not Recovered/Not Resolved - );Inflammatory pain (48d - Not Recovered/Not Resolved - );Myalgia (41d - Not Recovered/Not Resolved - );Paraesthesia (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011092667	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092734	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092770	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (1wk - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011092784	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1wk - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092796	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Not Recovered/Not Resolved - );Bowel movement irregularity (n/a - Not Recovered/Not Resolved - );Defaecation disorder (n/a - Not Recovered/Not Resolved - );Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092832	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hallucination (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011092932	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Febrile convulsion (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011092932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011093009	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011093018	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011093055	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Glossodynia (n/a - Not Recovered/Not Resolved - );Oral pain (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093129	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093131	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093136	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011093141	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093144	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093233	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093440	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (12d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011093799	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vasculitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093900	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093912	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Recovering/Resolving - );Subglottic laryngitis (3d - Recovering/Resolving - );Urticaria (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093920	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093932	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Herpes virus infection (15d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Rash (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093939	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093942	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011093948	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Hyperaesthesia (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Musculoskeletal chest pain (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093955	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Injection site swelling (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093957	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093963	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Disturbance in attention (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093984	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (11d - Not Recovered/Not Resolved - );Arthralgia (18d - Not Recovered/Not Resolved - );Decreased appetite (11d - Not Recovered/Not Resolved - );Disturbance in attention (18d - Not Recovered/Not Resolved - );Dizziness (11d - Not Recovered/Not Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - );Musculoskeletal chest pain (11d - Not Recovered/Not Resolved - );Myalgia (18d - Not Recovered/Not Resolved - );Pain in extremity (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011093986	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombophlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011093993	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Epistaxis (n/a - Unknown - );Hypertension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011093993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011094010	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (20d - Recovering/Resolving - );Coordination abnormal (14d - Recovering/Resolving - );Disorientation (14d - Recovering/Resolving - );Dizziness (20d - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Hypokinesia (20d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Insomnia (19d - Recovering/Resolving - );Limb discomfort (4d - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved With Sequelae - );Paraesthesia (10d - Recovered/Resolved - );Tachycardia (14d - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011094023	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011094120	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094121	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094124	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094127	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094470	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094472	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094505	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	[ALFUZOSIN] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[OLMESARTAN MEDOXOMIL, AMLODIPINE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE] (C - n/a - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011094557	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );Paraesthesia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011094772	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094773	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094774	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094776	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094778	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094779	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094780	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094781	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094782	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094787	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094788	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094790	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094792	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094793	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094796	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094802	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094803	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094813	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011094840	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Unknown - );Injection site induration (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011094857	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Ear pain (n/a - Unknown - );Granulomatosis with polyangiitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Haemoptysis (n/a - Recovered/Resolved - );Hypoacusis (n/a - Unknown - );Mastoiditis (n/a - Unknown - );Middle ear inflammation (n/a - Unknown - );Otorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011094991	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011094992	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011094994	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure systolic increased (n/a - Unknown - );Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gastrointestinal disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - );Meningitis aseptic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011094995	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011094998	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011094999	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011094999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095001	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095002	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (12d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (12d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095007	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eye pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);IIIrd nerve paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neurodegenerative disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sinus pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095010	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095011	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095015	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011095017	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095018	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Contusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gingival bleeding (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095019	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095020	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095022	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095023	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Electrocardiogram PR segment depression (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095026	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011095028	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Asthma (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Asthma-chronic obstructive pulmonary disease overlap syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Emphysema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypokalaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Productive cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Sleep apnoea syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095030	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Anosmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095031	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095034	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095036	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diplopia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095037	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Restless legs syndrome (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095039	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Petechiae (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095040	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095044	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Skin disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095045	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095050	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oral pain (n/a - Recovering/Resolving - );Respiration abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095060	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (6d - Recovered/Resolved - );Myalgia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095070	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Palpitations (4d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095071	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011095073	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash papular (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095074	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095075	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095079	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095084	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (39d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ear swelling (29d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoacusis (29d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sudden hearing loss (29d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tinnitus (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095085	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095089	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenopia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hepatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Liver function test abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095091	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095093	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095095	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095097	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095107	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry eye (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095108	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Discomfort (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095109	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095111	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blister (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095112	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Monoplegia (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095113	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram (n/a - Unknown - );Pain (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095114	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095115	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095118	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095150	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095152	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095153	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (30min - Recovered/Resolved - );Syncope (30min - Recovered/Resolved - Other Medically Important Condition);Vision blurred (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095164	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011095165	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095166	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure congestive (n/a - Fatal - Results in Death, Other Medically Important Condition);Pulmonary oedema (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011095167	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095168	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Overdose (n/a - Recovering/Resolving - );Respiration abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095169	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095171	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dilated cardiomyopathy (n/a - Fatal - Results in Death, Other Medically Important Condition);Myocardial haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Pulmonary thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011095177	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (118h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (118h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (118h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myoglobin blood increased (118h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin increased (118h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095178	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095179	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (110min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095186	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (115d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (2767h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Mumps (115d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Sudden hearing loss (2767h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tinnitus (2767h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Vertigo (115d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Vestibular function test abnormal (115d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095187	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095190	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death, Life Threatening);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011095191	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011095193	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acquired haemophilia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Penile blister (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BIPERIDEN, BIPERIDEN HYDROCHLORIDE] (C - Extrapyramidal disorder - n/a - [n/a - n/a - Oral])|[CHLORPROMAZINE, CHLORPROMAZINE HYDROCHLORIDE] (C - Schizophrenia - n/a - [n/a - n/a - Oral])|[LEVOMEPROMAZINE] (C - Schizophrenia - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RISPERIDONE] (C - Schizophrenia - n/a - [n/a - n/a - Oral])|[TRIAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095195	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095199	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Insomnia (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095200	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (0d - Recovered/Resolved - );Rash (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Urticaria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095202	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095210	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095220	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );Blood potassium decreased (n/a - Unknown - );Blood uric acid increased (n/a - Unknown - );Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095221	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095223	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brugada syndrome (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095226	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amaurosis fugax (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095228	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (25min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095232	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095288	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095293	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095295	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095299	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095303	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095318	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095320	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095329	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095339	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095340	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095341	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095343	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095369	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes zoster meningoencephalitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095372	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011095386	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095389	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Inflammation (n/a - Not Recovered/Not Resolved - Disabling);Physical disability (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011095390	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Brain stem infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diplopia (n/a - Unknown - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza like illness (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011095427	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Head discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095430	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095433	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095436	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2wk - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095440	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095443	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095444	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095445	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Restless legs syndrome (n/a - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095447	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095448	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Unknown - Disabling);Pelvic pain (n/a - Unknown - Disabling);Peripheral coldness (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011095452	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095454	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (24h - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (24h - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (24h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095459	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rhinalgia (n/a - Unknown - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095471	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095472	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095474	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095475	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095476	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095484	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb mass (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095498	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095502	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095504	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095511	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Arthritis reactive (n/a - Recovering/Resolving - Other Medically Important Condition);Arthropathy (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Skin warm (n/a - Recovering/Resolving - Other Medically Important Condition);Weight bearing difficulty (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095513	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011095527	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095529	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095600	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095601	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095605	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095625	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (18d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	JARDIANCE 10 MG FILM-COATED TABLETS [EMPAGLIFLOZIN] (C - n/a - Not applicable - [n/a - 10mg - Oral])|[GLICLAZIDE] (C - n/a - Not applicable - [n/a - 30mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - [n/a - 850mg - Oral])|[NAFTIDROFURYL OXALATE] (C - n/a - Not applicable - [n/a - 100mg - Oral])|[ROSUVASTATIN] (C - n/a - Not applicable - [n/a - 20mg - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095630	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (9d - Not Recovered/Not Resolved - );Fatigue (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095642	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Malaise (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011095719	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (7d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095724	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);COVID-19 (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (19d - Recovered/Resolved - Disabling, Other Medically Important Condition);Memory impairment (n/a - Unknown - Disabling, Other Medically Important Condition);Mental impairment (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011095725	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095729	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Bone pain (n/a - Unknown - );Chills (n/a - Unknown - );Mobility decreased (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095733	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095737	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095742	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095746	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Stress (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095748	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Life Threatening);Cardiac arrest (1d - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);Ventricular fibrillation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (C - n/a - n/a - [1d - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011095750	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095752	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - );Immunisation (n/a - Unknown - );Pain (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095763	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|ZOLEDRONIC ACID [ZOLEDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095764	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extrasystoles (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095769	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095814	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095815	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriatic arthropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095817	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (12h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain in extremity - n/a - [n/a - n/a - n/a])|[VACCINIUM MYRTILLUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095823	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Uveitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095825	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Epilepsy (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Klebsiella test positive (n/a - Unknown - );Peripheral coldness (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095839	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Sensory disturbance (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011095842	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site movement impairment (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095845	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Throat tightness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095846	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095897	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphoria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011095902	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095962	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Sensory level abnormal (2d - Recovered/Resolved - );Skin tightness (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095968	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Unknown - );Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Lung disorder (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011095969	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095973	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chest discomfort (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011095979	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011095992	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood glucose increased (n/a - Unknown - );Glycosylated haemoglobin increased (n/a - Unknown - );Increased insulin requirement (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011095999	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Not Recovered/Not Resolved - );Application site reaction (n/a - Unknown - );Application site swelling (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011095999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096004	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096010	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096015	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096036	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (24h - Recovered/Resolved - );Chills (24h - Recovered/Resolved - );Myalgia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096037	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CARVEDILOL] (C - n/a - n/a - [n/a - 12.5mg - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 4mg - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[LACIDIPINE] (C - n/a - n/a - [n/a - 6mg - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - 1mg - n/a])|[MIRTAZAPINE, MIRTAZAPINE HEMIHYDRATE] (C - n/a - n/a - [n/a - 30mg - n/a])|[MOXONIDINE] (C - n/a - n/a - [n/a - .3mg - n/a])|[PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096122	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096137	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096158	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096196	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096201	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096208	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Testicular pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096218	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Migraine (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096226	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nervous system disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096250	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096254	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096258	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (145h - Recovered/Resolved - );Cough (6d - Recovered/Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Nasal congestion (6d - Recovered/Resolved - );Off label use (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - );Rhinorrhoea (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096272	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosed varicose vein (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096306	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096327	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096329	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096333	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096335	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096340	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096342	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096351	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096353	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096354	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096357	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096358	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096362	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096366	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096369	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011096372	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096380	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cutaneous vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatic failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096385	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypercholesterolaemia (n/a - Recovered/Resolved - Other Medically Important Condition);Platelet count decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Retinal vein occlusion (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096389	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096391	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096396	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Temperature intolerance (n/a - Not Recovered/Not Resolved - );Thyroiditis subacute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	VITAFUSION MULTIVITES [ASCORBIC ACID, BIOTIN, BORON CITRATE, CALCIUM PANTOTHENATE, CHROMIUM PICOLINATE, COLECALCIFEROL, CYANOCOBALAMIN, DL-ALPHA TOCOPHERYL ACETATE, FOLIC ACID, INOSITOL NICOTINATE, MOLYBDENUM CITRATE, PYRIDOXINE HYDROCHLORIDE, RETINOL PALMITATE, SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - Oral])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096397	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bursitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096399	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Cardiovascular disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096400	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Paternal exposure during pregnancy (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Ventricular septal defect (n/a - Not Recovered/Not Resolved - Congenital Anomaly)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10011096405	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011096410	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial pain (n/a - Recovered/Resolved - );Headache (3wk - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - );Neck pain (3wk - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096418	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011096425	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096428	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096436	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096439	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Blindness (n/a - Unknown - Other Medically Important Condition);Blood cholesterol increased (n/a - Unknown - );Deafness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Exposure to contaminated water (n/a - Unknown - );Glucose tolerance impaired (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Hypoacusis (n/a - Unknown - );Seasonal allergy (n/a - Unknown - );Tinnitus (n/a - Unknown - );Vertigo (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096440	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Autism spectrum disorder (n/a - Unknown - Other Medically Important Condition);Poor quality product administered (n/a - Unknown - );Product temperature excursion issue (n/a - Unknown - );Social anxiety disorder (n/a - Unknown - );Therapeutic product effect variable (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096442	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Unknown - );Myasthenia gravis (n/a - Unknown - Other Medically Important Condition);Nasal turbinate hypertrophy (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096445	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Graves' disease (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096449	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin warm (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096451	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096471	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096504	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096522	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096523	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain (n/a - Unknown - );Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tendonitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096525	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096554	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096565	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096603	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096611	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - );Herpes zoster oticus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - Bipolar disorder - n/a - [n/a - n/a - Oral])|LURASIDONE [LURASIDONE] (C - Bipolar disorder - n/a - [n/a - n/a - Oral])|[BROMAZEPAM] (C - Anxiety, Bipolar disorder - n/a - [n/a - n/a - Oral])|[BROMAZEPAM] (C - Bipolar disorder - n/a - [n/a - n/a - Oral])|[LITHIUM CARBONATE] (C - Bipolar disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096620	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3wk - Recovered/Resolved - );Hypoaesthesia (3wk - Recovered/Resolved - Other Medically Important Condition);Muscle twitching (4wk - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - );Paraesthesia (4wk - Recovered/Resolved - Other Medically Important Condition);Pruritus (10wk - Recovered/Resolved - );Skin burning sensation (10wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096621	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096622	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (3d - Recovered/Resolved - Other Medically Important Condition);Anosmia (3d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (3d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (3d - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096623	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096628	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096637	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096644	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096646	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Fatal - Results in Death);Cardiac arrest (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death);Dizziness (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Myocarditis (n/a - Fatal - Results in Death);Pain in extremity (n/a - Fatal - Results in Death);Palpitations (n/a - Fatal - Results in Death);Pericarditis (n/a - Fatal - Results in Death);Thrombosis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011096655	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011096656	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096660	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096662	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (30min - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (30min - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Pericarditis (30min - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096663	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096698	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096707	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096738	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096742	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011096744	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096751	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096753	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096759	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096761	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096770	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096958	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Fatal - Results in Death)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011096964	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096969	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011096980	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096981	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011096982	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096986	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011096988	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011096988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097000	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Other Medically Important Condition);Angina pectoris (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[GARLIC OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARSLEY OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011097005	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097010	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Central serous chorioretinopathy (n/a - Unknown - Other Medically Important Condition);Central vision loss (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Urticaria (n/a - Recovering/Resolving - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011097048	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[INDAPAMIDE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097050	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ISRADIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097056	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097076	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097086	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097091	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097102	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011097110	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097116	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097118	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097119	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Cerebral haematoma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097121	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097139	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - n/a - Dose not changed - [n/a - 75mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - Dose not changed - [n/a - 10mg - Oral])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - Dose not changed - [n/a - 75mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097144	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial flutter (3wk - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (3wk - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097146	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097160	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097173	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097174	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097185	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Toxic skin eruption (2wk - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[METHOTREXATE] (S - Rheumatic disorder - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097189	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	KEYTRUDA [PEMBROLIZUMAB] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011097190	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendonitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [3d - 3{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097192	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097208	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011097211	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097221	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (4wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097224	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (48h - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [257d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011097283	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oligomenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097289	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097292	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097297	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Influenza like illness (30h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097327	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097332	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Subcutaneous])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM, EZETIMIBE, ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097346	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (64h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097351	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097364	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097374	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (7d - Recovering/Resolving - );Lymphadenopathy (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097380	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Psoriasis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097381	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1h - Recovering/Resolving - );Formication (1h - Recovering/Resolving - );Headache (1h - Recovering/Resolving - );Pollakiuria (1h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097392	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097402	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097418	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097419	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097422	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097426	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (1d - Recovered/Resolved - );Influenza like illness (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097430	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097432	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Vaccination site induration (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097433	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097435	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097436	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097437	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (n/a - Recovered/Resolved - );Vaccination site papule (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097441	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Breath odour (n/a - Recovering/Resolving - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097452	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[HYDROXYZINE HYDROCHLORIDE] (C - Anxiety - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097456	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097469	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097473	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097493	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097498	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097499	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097502	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Skin exfoliation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097508	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097513	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097516	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097520	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[KETOTIFEN HYDROGEN FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011097521	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097525	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Phlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097531	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097537	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097545	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097575	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Arthralgia (12d - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (12d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Synovitis (n/a - Unknown - Other Medically Important Condition);Taste disorder (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .2mL - Intramuscular])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097588	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disorientation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate affect (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle rigidity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle spasms (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (30min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097589	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097656	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097661	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chest pain (5min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097667	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disease recurrence (5mo - Recovered/Resolved - );Muscular weakness (5mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097668	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097671	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097679	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - 1{DF} - Intramuscular])	[DULOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097681	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Product preparation error (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097682	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Product preparation error (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097683	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Product preparation error (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097684	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Immunisation reaction (2d - Recovered/Resolved - );Product preparation error (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097685	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097686	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Telangiectasia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )|[GLYCEROL, VASELINE, LIQUID PARAFFIN] (C - n/a - n/a - )|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - )|[PARACETAMOL] (C - n/a - n/a - )|[SIMVASTATIN] (C - n/a - n/a - )|[ZINC GLUCONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097703	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097716	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097722	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pain in extremity (8wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097727	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1h - Recovered/Resolved - );Pain in extremity (1h - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097753	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nail discolouration (116d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	APROVEL [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011097757	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Myositis (13d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Tendonitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACICLOVIR, ACICLOVIR SODIUM] (C - Prophylaxis against transplant rejection - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011097850	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lagophthalmos (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Reduced facial expression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Strabismus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097854	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011097906	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (36h - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seborrhoeic dermatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (36h - Recovered/Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	PROBIOTIC 10 [BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LACTIS, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS BREVIS, LACTOBACILLUS BULGARICUS, LACTOBACILLUS CASEI, LACTOBACILLUS PARACASEI, LACTOBACILLUS PLANTARUM, LACTOBACILLUS RHAMNOSUS, LACTOBACILLUS SALIVARIUS] (C - n/a - n/a - [n/a - n/a - n/a])|[BIFIDOBACTERIUM LACTIS] (C - n/a - Dose not changed - )|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE SULFATE, CHONDROITIN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE, CHONDROITIN] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - Dose not changed - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097932	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097933	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011097944	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011097959	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011097966	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097968	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematochezia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097973	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011097994	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (51d - Not Recovered/Not Resolved - );Cough (51d - Not Recovered/Not Resolved - );Fatigue (51d - Not Recovered/Not Resolved - );Lymphadenopathy (51d - Not Recovered/Not Resolved - );Malaise (51d - Not Recovered/Not Resolved - );Palpitations (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011097994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011098248	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011098545	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Thrombosis (40d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011098758	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098763	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098769	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098772	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098776	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098778	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098779	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098790	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098791	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098794	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098820	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition);Urticaria (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098822	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Feeling hot (n/a - Recovering/Resolving - Disabling);Mobility decreased (n/a - Unknown - Disabling);Muscle spasms (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Tremor (2h - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011098830	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011098831	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Echocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CELECOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098833	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Disabling);Joint range of motion decreased (n/a - Unknown - Disabling);Muscular weakness (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011098837	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011098843	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011098846	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011098850	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Fan, B.. Cerebral Venous Thrombosis post BNT162b2 mRNA SARS-CoV-2 vaccination: A Black Swan Event. American journal of hematolog. 2021;96 (9):E357-E361. doi:10.1002/ajh.26272	18-64 Years	Not Specified	No	Male	Cerebral venous thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011098852	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - );Hypotension (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Rib fracture (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098862	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098863	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Mass (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011098866	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AZELASTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Asthma - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011098867	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098877	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (209d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011098878	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Unknown - );Sinus bradycardia (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098884	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098885	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098890	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011098894	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Depressed mood (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098895	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098898	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hot flush (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Parosmia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Taste disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011098900	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Facial paralysis (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098901	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Extrasystoles (n/a - Unknown - Other Medically Important Condition);Incorrect route of product administration (n/a - Unknown - );Overdose (n/a - Unknown - );Product administered to patient of inappropriate age (n/a - Unknown - );Product preparation error (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL, CALCIUM CITRATE] (C - Prophylaxis - n/a - [n/a - n/a - Oral])|[PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE] (C - n/a - n/a - [1d - n/a - Intramuscular])|[POLIOMYELITIS VACCINE (INACTIVATED)] (C - n/a - n/a - [1d - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098904	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Nausea (n/a - Unknown - );Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011098924	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovering/Resolving - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011098954	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011098954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099002	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099008	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099013	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099022	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099071	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis atopic (n/a - Not Recovered/Not Resolved - );Eczema herpeticum (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes simplex (n/a - Not Recovered/Not Resolved - );Wound infection staphylococcal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099072	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bacterial translocation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Epididymitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hernia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Incarcerated hernia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Orchitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099073	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Fear (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (0d - Recovered/Resolved - Other Medically Important Condition);Hypoxia (2h - Recovered/Resolved - Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099074	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Blood uric acid - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099076	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099090	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099124	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099138	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Life Threatening);Chest pain (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011099144	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - );Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099160	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Platelet disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099195	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain oedema (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral haemorrhage (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiparesis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011099246	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (31d - Not Recovered/Not Resolved - );Limb discomfort (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011099261	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (5d - Recovered/Resolved - );Abnormal faeces (5d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Feeling hot (6d - Recovered/Resolved - );Influenza (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099265	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (26d - Not Recovered/Not Resolved - );Fatigue (26d - Not Recovered/Not Resolved - );Limb discomfort (26d - Not Recovered/Not Resolved - );Myalgia (19d - Not Recovered/Not Resolved - );Oedema peripheral (26d - Not Recovered/Not Resolved - );Peripheral swelling (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011099268	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099275	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Exercise tolerance decreased (20d - Not Recovered/Not Resolved - );Fatigue (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099278	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Food craving (6d - Recovered/Resolved - );Tachycardia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011099283	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099308	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099317	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Postural orthostatic tachycardia syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099328	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PREDNISOLONE] (C - Immune thrombocytopenia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011099329	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099331	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asphyxia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Life Threatening);Cardiac failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Depression (n/a - Not Recovered/Not Resolved - );Hypoxia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary arterial hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011099349	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Antiphospholipid syndrome (n/a - Recovered/Resolved - Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Subarachnoid haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099352	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Obstruction (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099369	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Carpal tunnel syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eustachian tube obstruction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoacusis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral coldness (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Arrhythmia - n/a - [n/a - 5mg - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Prophylaxis - n/a - [n/a - 6mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099380	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099420	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099450	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099566	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099603	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099605	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099629	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Disorientation (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099635	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Fatal - Results in Death);Subarachnoid haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011099641	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arterial occlusive disease (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - );Pain (n/a - Unknown - );Peripheral arterial occlusive disease (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099658	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Overweight (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099678	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099688	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Disabling);Hypertension (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011099690	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Cheng, N.. Cerebral Venous Sinus Thrombosis After Pfizer-BioNTech COVID-19 (BNT162b2) Vaccination. Journal of Clinical Neurology (Korea). 2021;17(4):573-575. doi:10.3988/jcn.2021.17.4.573	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral venous sinus thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099692	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099718	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Depressed level of consciousness (n/a - Fatal - Results in Death);Fatigue (n/a - Not Recovered/Not Resolved - );Hypophagia (n/a - Fatal - Results in Death);Malaise (2d - Recovering/Resolving - );Oxygen saturation decreased (n/a - Fatal - Results in Death);Pyrexia (2d - Recovering/Resolving - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[MICONAZOLE NITRATE] (S - n/a - Dose not changed - [n/a - n/a - n/a])|[NOT AVAILABLE] (S - n/a - Dose not changed - [n/a - n/a - n/a])	KOELZALF / BRAND NAME NOT SPECIFIED [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SHARK-LIVER OIL, SACCHAROMYCETIS VIV, EXTRACT (LIVE YEAST EXTRACT)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011099733	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099737	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099741	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099748	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099751	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099752	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099756	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011099758	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099760	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Migraine (40d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011099763	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Appendicitis (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011099767	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Diarrhoea (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099775	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Paraesthesia (23d - Unknown - );Swelling (23d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011099776	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011099779	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (12d - Recovered/Resolved - );Palpitations (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011099780	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Neurodermatitis (107d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011099784	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (45d - Recovered/Resolved With Sequelae - );Rash (45d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011099785	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099802	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (18d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011099814	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099863	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099865	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Gastrointestinal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011099874	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099888	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099891	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099894	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099897	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099899	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099906	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011099915	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099916	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099925	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099929	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099938	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099942	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011099948	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099963	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011099982	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011099982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100107	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Facial nerve disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011100119	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Behaviour disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Facial discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Facial spasm (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Mental status changes (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Muscle twitching (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Repetitive speech (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Soliloquy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100218	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011100237	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100243	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100249	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Unknown - [1d - 1{DF} - Unknown - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100252	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100256	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011100266	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (43d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - )|[OXCARBAZEPINE] (C - n/a - n/a - )|[QUETIAPINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011100267	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation, Immunisation - Not applicable - [1d - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011100286	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100328	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100393	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Discomfort (n/a - Not Recovered/Not Resolved - );Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100406	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypokinesia (n/a - Recovered/Resolved - );Injection site hypoaesthesia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Unknown - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100467	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100541	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Astigmatism (n/a - Recovering/Resolving - );Craniocerebral injury (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - );Fall (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Respiratory arrest (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 250mg - n/a])|[AZATHIOPRINE, AZATHIOPRINE BP, AZATHIOPRINE PH. EUR.] (C - n/a - n/a - [n/a - 50mg - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - 3000g - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100544	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100641	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fall (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb injury (n/a - Unknown - Other Medically Important Condition);Muscle contusion (n/a - Unknown - Other Medically Important Condition);Rotator cuff syndrome (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100744	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Recovered/Resolved - );Rash macular (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100748	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EDOXABAN [EDOXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011100751	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100756	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (3d - Recovered/Resolved - );Chest pain (6d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100765	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eosinophilia (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100766	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (n/a - Not Recovered/Not Resolved - );Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100767	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Oropharyngeal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100769	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (1d - Recovered/Resolved - );Chills (1d - Unknown - );Night sweats (1d - Recovered/Resolved - );Testicular pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100773	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011100774	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100780	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100782	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Erythema (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100783	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Diarrhoea (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100786	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (39d - Not Recovered/Not Resolved - );Vaccination site pain (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011100788	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100789	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100796	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (0d - Recovering/Resolving - );Myopericarditis (23d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100797	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epididymitis (8d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100798	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Swelling face (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100804	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tinnitus (135d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011100806	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Alopecia (132d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011100812	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011100814	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100817	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (0d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100822	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100836	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011100841	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 10ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100848	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011100851	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Genital herpes (n/a - Unknown - );Neuralgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100852	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100854	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100855	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100856	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011100857	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Osteitis (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100860	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Solar dermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100870	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011100874	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100876	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100877	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100878	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100880	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100883	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100884	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100890	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (3d - Recovered/Resolved - );Thrombocytopenia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100894	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100896	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100901	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (1d - Recovered/Resolved - );Restlessness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100902	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100904	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100908	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100910	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100912	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011100916	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011100928	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100940	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100951	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100970	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Injury (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011100974	Spontaneous	2021-12-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Acute abdomen (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood creatinine abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - );Liver injury (41d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Nephritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011100983	Spontaneous	2021-12-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011100983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077633	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 160mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077638	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077676	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077692	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077718	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Multiple sclerosis relapse (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011077722	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disseminated intravascular coagulation (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Escherichia urinary tract infection (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypophagia (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sepsis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Somnolence (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Subdural haematoma (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077728	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Helplessness (n/a - Unknown - );Hyperventilation (n/a - Not Recovered/Not Resolved - );Initial insomnia (n/a - Unknown - );Malaise (n/a - Unknown - );Neurological symptom (n/a - Unknown - );Suicide attempt (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077733	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011077743	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Loss of personal independence in daily activities (7d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Malaise (n/a - Unknown - Other Medically Important Condition);Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077757	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Condition aggravated (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Ejection fraction decreased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANORO [UMECLIDINIUM BROMIDE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYTOIN, PHENYTOIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011077759	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (2210min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (2210min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (2210min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (2210min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077764	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077776	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077837	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (50d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [1d - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077865	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011077866	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Psoriasis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 87mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077872	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Deafness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peptic ulcer (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[FEXOFENADINE HYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[RALOXIFENE] (C - Osteoporosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011077875	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (3d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011077876	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amnesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077879	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Death (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Retinal tear (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011077884	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077888	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood bicarbonate decreased (n/a - Recovering/Resolving - );Blood glucose increased (n/a - Recovering/Resolving - );Blood pressure diastolic decreased (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Haematocrit decreased (n/a - Recovering/Resolving - );Haemoglobin decreased (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - );Product use issue (n/a - Unknown - );Pulse absent (n/a - Recovering/Resolving - );Red blood cell count decreased (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Troponin T increased (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovered/Resolved - );Visual brightness (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - 5mg - Oral])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 50mg - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 50mg - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 20mg - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - .8mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011077898	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Cardiovascular disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Movement disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Pain (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Pain in jaw (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Paralysis (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUSPIRONE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10011078034	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness unilateral (n/a - Unknown - Other Medically Important Condition);Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Prophylaxis - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078065	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - Unknown - [n/a - n/a - n/a])	[KETOPROFEN, KETOPROFEN LYSINE] (C - Spinal pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078098	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (7d - Recovered/Resolved - Disabling, Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011078178	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (0d - Recovered/Resolved - );Depressed level of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078180	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (0d - Recovered/Resolved - Other Medically Important Condition);Discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Limb discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078183	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Periarthritis (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078206	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphoria (n/a - Recovered/Resolved - );Eye disorder (5s - Recovered/Resolved - );Movement disorder (5s - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078212	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition);Urinary incontinence (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078233	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078237	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hepatitis acute (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078239	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078240	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Lower respiratory tract infection (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition);Product use issue (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Influenza immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011078245	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - );Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078251	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078259	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078264	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Burning sensation (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Fibromyalgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011078293	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Viral infection (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078301	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (12h - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);General physical health deterioration (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (12h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078306	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078311	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078317	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078318	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Chills (2d - Recovered/Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Night sweats (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011078319	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Nausea (n/a - Unknown - );Paralysis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078320	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078321	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078332	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078337	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Recovering/Resolving - );Neck pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078343	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematoma (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078344	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078345	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Pallor (n/a - Not Recovered/Not Resolved - );Post-acute COVID-19 syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078348	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078363	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (32d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Lymphadenitis (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pharyngotonsillitis (n/a - Not Recovered/Not Resolved - );Skin infection (n/a - Not Recovered/Not Resolved - );Swelling face (28d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011078390	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078393	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - n/a - n/a - [n/a - 10mg - Oral])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011078401	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078405	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011078406	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anger (n/a - Recovering/Resolving - Other Medically Important Condition);Brain injury (n/a - Recovering/Resolving - Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Head injury (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Post concussion syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078412	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078417	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078423	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078426	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078432	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ruptured cerebral aneurysm (11d - Recovered/Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011078434	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (7d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - 100mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078438	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chills (n/a - Unknown - );Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Food aversion (n/a - Unknown - );Haematocrit decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - );Leukopenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078440	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Wheezing (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|NUCALA [MEPOLIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFACALCIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ESZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE, PREDNISOLONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[THEOPHYLLINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078466	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011078472	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078474	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	SILDENAFIL [SILDENAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078476	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Lower respiratory tract infection (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Memory impairment (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011078486	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078497	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia aspiration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078503	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (5d - Recovered/Resolved - );Diarrhoea (5d - Recovered/Resolved - );Dizziness (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - );Small fibre neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])|[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078505	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078518	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078519	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Goitre (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078525	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078529	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078534	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078538	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078545	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash macular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078549	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078551	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078554	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRILAT] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078555	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - );Herpes simplex (n/a - Unknown - );Lip pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Muscle twitching (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078565	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078571	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078580	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - );Tenderness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011078586	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078605	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Pleuritic pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078622	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078631	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078638	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078647	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078656	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011078665	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078667	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078676	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078681	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia supraventricular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure fluctuation (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078683	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Tomeoka, F.. A recurrent case of minimal change nephrotic syndrome after COVID-19 vaccination. The 293rd Hokkaido Regional Meeting of the Japanese Society of Internal Medicine. 2021;293rd	65-85 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovered/Resolved - Other Medically Important Condition);Nephrotic syndrome (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078689	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078699	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078716	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Heart rate decreased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011078718	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078729	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078745	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011078785	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Product administration error (n/a - Unknown - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition);Vaccination site bruising (n/a - Unknown - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - Unknown])	APIXABAN [APIXABAN] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - Unknown - [7677d - n/a - Unknown])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Atrial fibrillation - Unknown - [n/a - n/a - Unknown])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - Unknown - [n/a - n/a - Unknown])|[SIMVASTATIN] (C - Cerebrovascular accident - Unknown - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011078817	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011078817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011079016	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079046	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011079103	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (1d - Recovered/Resolved - Other Medically Important Condition);Chills (32h - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (3d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079131	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079136	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079138	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079143	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079145	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079146	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079148	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079149	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079150	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079151	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079186	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Abdominal pain lower (3d - Recovered/Resolved - Other Medically Important Condition);Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Chills (4d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (4d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain of skin (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pH - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079257	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Enteritis infectious (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079267	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011079269	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079280	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure congestive (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Polyuria (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BUSPIRONE, BUSPIRONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN, IBUPROFEN LYSINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011079285	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arterial occlusive disease (26790min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arteriosclerosis (26790min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysarthria (26790min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (26790min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombotic cerebral infarction (26790min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BEVANTOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011079296	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079308	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infarction (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079328	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death, Other Medically Important Condition);Productive cough (n/a - Fatal - Results in Death);Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [15d - n/a - Oral])|[ASCORBIC ACID, RIBOFLAVIN, DEXTRIN, TOCOPHERYL ACETATE, CASEIN, SODIUM SALT] (C - Hypophagia - n/a - [13d - n/a - Oral])|[SENNOSIDE A+B] (C - Constipation - n/a - [15d - n/a - Oral])|[TAK 438] (C - Gastrointestinal disorder - n/a - [15d - n/a - Oral])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Lumbar spinal stenosis - n/a - [15d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011079344	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079345	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079346	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079348	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079349	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079355	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079356	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079358	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079359	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079360	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079362	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079365	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079371	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079425	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079426	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079428	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Monoplegia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079440	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079451	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079454	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dental discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspepsia (2wk - Recovered/Resolved - Other Medically Important Condition);Ear inflammation (7mo - Recovered/Resolved - Other Medically Important Condition);Ear pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Unknown - Other Medically Important Condition);Headache (7mo - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Migraine (7mo - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Nasal inflammation (7mo - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Status epilepticus (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (7mo - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079458	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079460	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079468	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079471	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Photophobia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079473	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Varicella zoster virus infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079479	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079480	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Monoparesis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011079484	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079486	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079544	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079605	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site haematoma (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Thrombosis - n/a - [3d - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011079612	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079632	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079649	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apnoea (3h - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079652	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TOPIRAMATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079656	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (1d - Recovered/Resolved - Other Medically Important Condition);Confusional state (1d - Recovered/Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - );Dry skin (n/a - Unknown - );Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain of skin (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac fibrillation, Supraventricular tachycardia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079680	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mechanical urticaria (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011079734	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079735	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death);Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011079868	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Respiratory failure (n/a - Fatal - Results in Death)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011079869	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011079876	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011079930	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Guttate psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079934	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011079936	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Dehydration (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079942	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Rheumatic disorder - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079944	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079946	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011079947	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011079968	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011079968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011080037	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3mo - Recovered/Resolved - );Bone fissure (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Recovered/Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gingivitis (2wk - Recovered/Resolved - );Headache (n/a - Unknown - );Movement disorder (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tendonitis (n/a - Not Recovered/Not Resolved - );Tenosynovitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080039	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080066	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080067	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acidosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Acute kidney injury (1d - Fatal - Results in Death);Acute respiratory failure (1d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperglycaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral ischaemia (1d - Fatal - Results in Death);Sepsis (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011080070	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080082	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011080087	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011080091	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Kaposi's sarcoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080105	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011080132	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080136	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (4d - Recovered/Resolved - Other Medically Important Condition);Inflammation (7d - Recovered/Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (8d - Recovered/Resolved - Other Medically Important Condition);Painful respiration (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011080150	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011080155	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Migraine with aura (n/a - Unknown - Caused/Prolonged Hospitalisation);Monoparesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011080216	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Hypotonic-hyporesponsive episode (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011080233	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011080249	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080257	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080270	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pain of skin (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011080325	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080328	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080330	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080342	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080343	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080345	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080389	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[HYDROCHLOROTHIAZIDE, LOSARTAN, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080396	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Cold sweat (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Nausea (1d - Recovering/Resolving - );Presyncope (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011080405	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080469	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080473	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial pain (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Diabetes mellitus, Infarction - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 300mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - )|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 25mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 1.25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080477	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080491	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080495	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Neck pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080506	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080513	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Anxiety (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain (2d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vision blurred (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[FLUTICASONE PROPIONATE, SALMETEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - Asthma - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Anxiety, Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011080523	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011080529	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080541	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011080584	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	AERIUS [DESLORATADINE] (C - Chronic sinusitis - n/a - [n/a - n/a - Oral])|AVAMYS [FLUTICASONE FUROATE] (C - Chronic sinusitis - n/a - [n/a - n/a - Nasal])|[ALPHA AMYLASE, ALPHA-AMYLASE (ASPERGILLUS ORYZAE)] (C - Chronic sinusitis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011080601	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080659	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Swelling face (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011080737	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080742	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080747	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080749	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080752	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080754	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011080779	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011080801	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011080817	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hot flush (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011080943	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (8d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - 1{DF} - Unknown])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Unknown - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011080943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011081105	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011081257	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );COVID-19 immunisation (n/a - Unknown - );Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011081307	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune haemolytic anaemia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|VENCLYXTO [VENETOCLAX] (S - Chronic lymphocytic leukaemia - n/a - [n/a - n/a - Oral])|[A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/60/2008, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008-LIKE VIRUS, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, NIB-121), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - Antifungal prophylaxis - n/a - [n/a - n/a - n/a])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011081340	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling abnormal (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011081356	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011081411	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Productive cough (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011081455	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysphoria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011081484	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011081485	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011081488	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac flutter (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011081489	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac flutter (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011081509	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011081909	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Compartment syndrome (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ENOXAPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011081945	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011081945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011082058	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082059	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Urethral haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011082064	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082099	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082110	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Subclavian vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011082116	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011082129	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Unknown - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011082134	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermoid cyst (31d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011082216	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - );Menstrual disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011082219	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (6d - Fatal - Results in Death);Sudden death (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011082232	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011082256	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082260	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011082305	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082309	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082310	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011082312	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011082313	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082340	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired work ability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myasthenia gravis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011082375	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011082519	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082521	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082533	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (3d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ASCORBIC ACID, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082561	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Nausea (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082662	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Orthostatic hypotension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011082975	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011082997	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011082999	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011082999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083002	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083003	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083005	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083008	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083027	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Middle insomnia (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083127	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Lopez, S.. Focal segmental glomerulosclerosis (FSGS) recurrence after mRNA COVID-19 vaccine in a young adult with kidney transplant.. Journal of the American Society of Nephrology. 2021;32:89	18-64 Years	Not Specified	No	Male	Focal segmental glomerulosclerosis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083180	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood brain barrier defect (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Incoherent (n/a - Unknown - );Infection (n/a - Unknown - );Meningitis (n/a - Unknown - Other Medically Important Condition);Motor dysfunction (n/a - Unknown - );Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083183	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Meningitis aseptic (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083185	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[MIRABEGRON] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083197	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083198	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083200	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083206	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Laryngeal stenosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083212	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Viral myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083215	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (1h - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (45min - Recovered/Resolved - );Cold sweat (45min - Recovered/Resolved - );Depressed level of consciousness (45min - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (45min - Recovered/Resolved - Other Medically Important Condition);Seizure (45min - Recovered/Resolved - Other Medically Important Condition);Shock (45min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083232	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - );Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083239	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amnesia (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083242	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083244	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083246	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition);Supraventricular tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083261	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Disease recurrence (0d - Recovered/Resolved - );Feeling abnormal (0d - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083262	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083263	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cold sweat (10min - Recovered/Resolved - );Oxygen saturation decreased (10min - Recovered/Resolved - Other Medically Important Condition);Pallor (10min - Recovered/Resolved - );Presyncope (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083265	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aspartate aminotransferase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase MB increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083267	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aspartate aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood thyroid stimulating hormone increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083272	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - );Fall (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - );Memory impairment (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30min - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011083273	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Matsumura, A.. Immune thrombocytopenia after BNT162b2 mRNA COVID-19 vaccination. The Japanese Journal of Clinical Hematology. 2021;62:1639-1642	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Unknown - );Blood creatinine increased (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );Blood urea increased (n/a - Unknown - );Blood urea nitrogen/creatinine ratio increased (n/a - Unknown - );Gastrointestinal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune thrombocytopenia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphocyte percentage decreased (n/a - Unknown - );Neutrophil percentage increased (n/a - Unknown - );Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Petechiae (n/a - Unknown - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Post procedural haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary alveolar haemorrhage (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Purpura (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALFACALCIDOL] (C - Laryngeal cancer - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CALCIUM LACTATE] (C - Laryngeal cancer - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - Laryngeal cancer - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083326	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hypertension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011083388	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011083391	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011083402	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083403	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083437	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (4d - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BIPERIDEN, BIPERIDEN HYDROCHLORIDE, BIPERIDEN LACTATE] (C - n/a - n/a - [n/a - 2{DF} - Oral])|[RISPERIDONE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011083438	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011083635	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011083641	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Adverse event (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - )|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011083642	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );COVID-19 immunisation (n/a - Unknown - );Cough (n/a - Unknown - );Decreased immune responsiveness (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Respiratory disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CELECOXIB] (C - Arthritis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011083662	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Sinus arrest (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083672	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011083683	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011083693	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011083702	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011083807	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083808	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083813	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083817	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083818	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083819	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083824	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083825	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083829	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083830	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083837	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083842	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083843	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083845	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083846	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083850	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083851	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083854	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083855	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083911	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood glucose increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Glycosylated haemoglobin increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083975	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011083985	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083988	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083995	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac death (n/a - Fatal - Results in Death, Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011083996	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011083997	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011083997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011084007	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site joint movement impairment (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084009	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011084010	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084011	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - );Pallor (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084012	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084013	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084014	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084018	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084020	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084022	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Productive cough (n/a - Unknown - Other Medically Important Condition);Sputum discoloured (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084023	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Unknown - );Fall (n/a - Unknown - );Head injury (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mass (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Unknown - );Night sweats (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011084025	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084026	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084030	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084031	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084035	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084042	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084044	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Flat affect (n/a - Recovering/Resolving - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Recovering/Resolving - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition);Urinary retention (22d - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011084047	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084052	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084055	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site bruising (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084060	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084063	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084065	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Malaise (2d - Recovered/Resolved - );Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011084067	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084069	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Asthenia (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Malaise (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084070	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084073	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084075	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084076	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084083	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084084	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084085	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (3d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thirst (2d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084087	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084088	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (7d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084093	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Heart rate irregular (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084094	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084096	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Fatigue (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death);Thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011084103	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Echocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084104	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );C-reactive protein (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin T increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084105	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Basal ganglia infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084108	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature fluctuation (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hypothermia (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	OZEMPIC [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084110	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011084145	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cerebrovascular accident (n/a - Unknown - );Chills (56d - Recovered/Resolved - );Delirium (n/a - Unknown - );Fall (n/a - Unknown - );Fatigue (56d - Recovering/Resolving - );Headache (56d - Recovered/Resolved - );Malaise (56d - Recovered/Resolved - );Mobility decreased (n/a - Recovering/Resolving - );Myalgia (56d - Recovered/Resolved - );Nausea (56d - Recovered/Resolved - );Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	APIXABAN 2.5MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011084146	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Parkinson's disease (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LIOTHYRONINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011084198	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (2wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011084206	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084217	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084221	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084223	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084224	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084230	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084242	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084243	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084245	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084247	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084249	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084252	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084259	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084384	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011084394	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flushing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084435	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (7d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - )|[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 1.25mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084446	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084564	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011084607	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084609	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084614	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011084619	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084623	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084626	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084627	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011084631	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084633	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084635	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084636	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084640	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084647	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084649	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084652	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011084669	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084677	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011084678	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - Oral])|[GABAPENTIN] (C - n/a - n/a - [n/a - 600mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011084688	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pustular (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011084699	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084701	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084704	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084708	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - Prostatitis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084709	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Back pain (n/a - Unknown - Disabling, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011084717	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084721	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Central serous chorioretinopathy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011084723	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084724	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084732	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011084742	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011084746	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain of skin (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thermal burn (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084748	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular insufficiency (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084751	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - );Restlessness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011084757	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TOLTERODINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084760	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011084761	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram ST-T segment abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084763	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ear discomfort (n/a - Unknown - Other Medically Important Condition);Ear inflammation (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084769	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011084770	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084784	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084794	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart disease congenital (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084796	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (0d - Recovered/Resolved - Other Medically Important Condition);Breast swelling (0d - Recovered/Resolved - );Chest discomfort (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Hypoaesthesia (0d - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - );Sleep disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084832	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Exercise tolerance decreased (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084833	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084834	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Central nervous system viral infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084836	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084837	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Contusion (n/a - Unknown - );Fall (0d - Recovered/Resolved - );Injury (n/a - Unknown - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Wrist fracture (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084839	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084869	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084871	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084873	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[BETAMETHASONE, BETAMETHASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EBASTINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084880	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084883	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084909	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084920	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bacterial sepsis (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory distress (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084947	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial ischaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084973	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (45d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (45d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084975	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1wk - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (1wk - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (1wk - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (1wk - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084984	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084985	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis transverse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011084987	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertensive crisis (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084988	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[RILMENIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011084995	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral artery thrombosis (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011084996	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epiploic appendagitis (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - n/a - [84d - 2{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011084999	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Herpes zoster (1wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011084999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085007	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085015	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening);Cardiac aneurysm (n/a - Not Recovered/Not Resolved - Life Threatening);Pericardial effusion (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [240d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011085018	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085033	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011085049	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pancreatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vasculitis (n/a - Not Recovered/Not Resolved - )	REMICADE [INFLIXIMAB] (S - n/a - Unknown - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085056	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085062	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085078	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085082	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085089	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011085108	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085119	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085125	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thyroiditis subacute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085127	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myelitis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011085135	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085153	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Subdural hygroma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085156	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (48d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085158	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085159	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain abscess (47d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085226	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085227	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085250	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperaesthesia (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Transaminases increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085253	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085264	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085269	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Rash maculo-papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[HUMAN NORMAL IMMUNOGLOBULIN, HUMAN NORMAL IMMUNOGLOBULIN (IV)] (S - n/a - Not applicable - [1d - n/a - n/a])|[LOSARTAN POTASSIUM] (S - Hypertension - Not applicable - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085280	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085283	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085307	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085330	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085349	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085357	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085369	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (20d - Recovered/Resolved - );Dyspnoea (3d - Recovered/Resolved - );Headache (20d - Recovered/Resolved - );Nausea (20d - Recovered/Resolved - );Urticaria (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085371	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint ankylosis (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085391	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[LANSOPRAZOLE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[LITHIUM CARBONATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085409	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085410	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085412	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085416	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085417	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - );Malaise (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085420	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Oral discomfort (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085433	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085434	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085443	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085444	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085451	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	AERIUS 5 MG FILM-COATED TABLET [DESLORATADINE] (C - Antiallergic therapy - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085468	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085479	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085485	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085500	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085503	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085504	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085507	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085559	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085560	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085563	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (14d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085571	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fall (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Quadriplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085572	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Allergy to vaccine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Henoch-Schonlein purpura (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Illness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085580	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Subarachnoid haemorrhage (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011085583	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea haemorrhagic (9d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085614	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085615	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - );Rash erythematous (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085616	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085618	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085619	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085718	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085720	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085729	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085733	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085739	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085740	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085742	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085748	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085750	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pollakiuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011085836	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011085902	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085913	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085921	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085927	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011085934	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011085943	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombophlebitis (8d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011085977	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085984	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085991	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011085998	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011085998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086008	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086010	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086014	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086015	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086065	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tendon rupture (n/a - Unknown - Disabling, Other Medically Important Condition);Tendonitis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	LYRICA [PREGABALIN] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - )|[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - )|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - )|[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011086149	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood glucose decreased (0d - Recovered/Resolved - Other Medically Important Condition);Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Puncture site pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086179	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011086211	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011086221	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aortic valve stenosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	MICARDISPLUS [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - Hypertension - n/a - [10y - 80mg - Oral])|[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - Coagulopathy - n/a - [9y - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [10y - 10mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [9y - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086236	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086244	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleurisy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[HYDROCHLOROTHIAZIDE, LISINOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086245	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086251	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Clumsiness (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086260	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Eye pain (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086262	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086264	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086265	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Gait inability (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011086267	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Malignant melanoma (n/a - Unknown - Other Medically Important Condition);Neoplasm malignant (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086270	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011086288	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Parenteral])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086312	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[NORETHISTERONE ACETATE, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086313	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Angioedema - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086315	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (17d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Stress (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086317	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure diastolic decreased (0d - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Head injury (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (0d - Recovered/Resolved - Other Medically Important Condition);Hyperventilation (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);PO2 increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086329	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - );Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - );Impaired work ability (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Unknown - );Oedema (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin fissures (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086376	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Puncture site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086385	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011086386	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086400	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086451	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011086457	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Eczema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immune system disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011086460	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Depressed mood (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza (150d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (150d - Recovered/Resolved - Other Medically Important Condition);Ocular hyperaemia (27d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Blood pH - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Micturition urgency - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Blood pH - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011086486	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Discomfort (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[VALPROIC ACID] (C - Epilepsy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086609	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Neoplasm skin (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086610	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - 5mg - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure measurement - n/a - [n/a - 25mg - n/a])|[OMEPRAZOLE] (C - Hiatus hernia - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086612	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar artery thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011086628	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blindness unilateral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011086644	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death);Road traffic accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011086645	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086712	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086722	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086725	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086726	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086728	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086735	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1mo - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Somnolence (1mo - Recovered/Resolved - );Visual impairment (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011086804	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acidosis (n/a - Fatal - Results in Death);Pallor (n/a - Unknown - );Shock (n/a - Fatal - Results in Death);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011086813	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011086819	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Body temperature increased (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086820	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Disorientation (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemorrhagic transformation stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mobility decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011086821	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086823	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086824	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - );Drug ineffective (1wk - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Suspected COVID-19 (1wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086835	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011086838	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Accidental overdose (n/a - Unknown - );Bronchial disorder (n/a - Unknown - );Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Crying (n/a - Unknown - );Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Product administered to patient of inappropriate age (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Wrong product administered (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (N - Immunisation - Not applicable - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086883	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086887	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086893	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086898	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086902	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086907	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086912	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011086917	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086925	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086927	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011086946	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiogenic shock (n/a - Fatal - Results in Death);Myocardial infarction (n/a - Fatal - Results in Death);Myocarditis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011086960	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011086960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087013	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hemianopia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011087018	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Arthritis reactive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087025	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011087042	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087049	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087273	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011087275	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087295	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087300	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087320	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087327	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087334	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087419	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (24d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011087465	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087467	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (2d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087517	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087539	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087551	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087553	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087560	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011087582	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087583	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087640	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blindness (44d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cystoid macular oedema (44d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Retinal vascular occlusion (44d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Retinoschisis (44d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011087688	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087709	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087713	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ocular hyperaemia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011087979	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Psychomotor hyperactivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011087989	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011087989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088000	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088092	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	FEBUXOSTAT [FEBUXOSTAT] (C - n/a - Unknown - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011088238	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088241	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088242	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088244	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088245	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088246	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088251	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088302	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088392	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088456	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088457	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088458	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088475	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088478	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088489	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011088655	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling);Urticaria (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011088660	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088673	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Administration site lymphadenopathy (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088681	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011088682	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011088686	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088689	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011088690	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (59d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011088694	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088698	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Axillary pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088710	Spontaneous	2021-12-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Supraventricular extrasystoles (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011088716	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088718	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088727	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Syncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011088729	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema nummular (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[AMOXICILLIN] (S - Otitis media acute - Unknown - [n/a - 1000mg - Oral])|[IBUPROFEN ARGININE] (S - Otitis media acute - Unknown - [n/a - 600mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011088730	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011088739	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crohn's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011088741	Spontaneous	2021-12-27 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Presyncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)] (C - Influenza immunisation - Not applicable - [1d - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011088741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076698	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematemesis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011076712	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011076714	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 30ug - Intramuscular])	ACTOS [PIOGLITAZONE, PIOGLITAZONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 45mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 850mg - Oral])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011076715	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011076738	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076850	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076854	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076856	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076860	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076869	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076926	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076985	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary mass (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076986	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1h - Recovered/Resolved - );Headache (6h - Recovered/Resolved - );Injection site pain (10d - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Nausea (2h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077002	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077004	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077006	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077007	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077008	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077017	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077027	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhinorrhoea (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Visual impairment (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Subcutaneous])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[AZATHIOPRINE, AZATHIOPRINE BP, AZATHIOPRINE PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077048	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077054	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077055	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077061	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077072	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077090	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077152	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077156	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077159	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077181	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077192	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077226	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077235	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077322	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077323	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011077371	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077384	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077410	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bladder disorder (n/a - Unknown - Other Medically Important Condition);Disorientation (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - Immunisation - Not applicable - [n/a - n/a - Intramuscular])|[ACETYLSALICYLIC ACID] (C - n/a - Dose not changed - [n/a - 150mg - Oral])|[CLONAZEPAM] (C - n/a - Dose not changed - [n/a - 1mg - n/a])|[ROPINIROLE, ROPINIROLE HYDROCHLORIDE] (C - Restless legs syndrome - Dose not changed - [n/a - 8mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077446	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077454	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077478	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Oedema peripheral (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077484	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077492	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077495	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (n/a - Unknown - );Rash macular (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077503	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077506	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Musculoskeletal stiffness (3d - Recovered/Resolved - );Neck pain (3d - Recovered/Resolved - );Olfactory nerve disorder (n/a - Unknown - );Oropharyngeal pain (n/a - Recovering/Resolving - );Productive cough (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077521	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077528	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaemia (n/a - Unknown - );Aphthous ulcer (8d - Recovered/Resolved - );Dizziness (8d - Recovered/Resolved - );Influenza like illness (8d - Recovered/Resolved - );Vertigo (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATOMOXETINE HYDROCHLORIDE] (C - Psychomotor hyperactivity - n/a - [n/a - 40mg - Oral])|[BUPRENORPHINE] (C - Pain - n/a - [3y - 35ug - Other])|[DICLOFENAC SODIUM] (C - Arthralgia - n/a - [n/a - 4% - Cutaneous])|[GABAPENTIN] (C - Pain - n/a - [10y - 300mg - Oral])|[MELOXICAM] (C - Arthralgia - n/a - [1y - 15ug - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077532	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077534	Spontaneous	2021-12-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077564	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077566	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation delayed (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077567	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[FLUOXETINE] (C - Depression - n/a - [1541d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011077576	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077578	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077579	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling of eyelid (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011077580	Spontaneous	2021-12-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011077580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074754	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074764	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Palpitations (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011074797	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074872	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011074934	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074962	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dark circles under eyes (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074986	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011075007	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075008	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cachexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011075010	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011075069	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075074	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Fibrinogen degradation products increased (n/a - Recovering/Resolving - Other Medically Important Condition);Gravitational oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Haematoma (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011075289	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[PHENPROCOUMON] (C - n/a - n/a - )|[ROSUVASTATIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011075291	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011075333	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Photophobia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075337	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075401	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075628	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075764	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site erythema (n/a - Recovered/Resolved - );Injection site inflammation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075766	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075787	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3mo - Recovered/Resolved - );Injection site haematoma (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011075790	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011075790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076146	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076154	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076156	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Breast discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076185	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Oedema peripheral (2wk - Unknown - );Pain in extremity (2wk - Unknown - );Retching (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ADVAGRAF [TACROLIMUS] (C - n/a - Unknown - [n/a - 4mg - Oral])|[NADROPARIN CALCIUM] (C - n/a - Unknown - [n/a - .8mL - Subcutaneous])|[PREDNISONE] (C - n/a - Unknown - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076214	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011076241	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076306	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076307	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076308	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076311	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076315	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076324	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076325	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076329	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076330	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076331	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076335	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076366	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076370	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076371	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076375	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076379	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076383	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076384	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076394	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076396	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076400	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076404	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076406	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bundle branch block left (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076408	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthma (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076420	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076421	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076422	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076424	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076431	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076432	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076441	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076442	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076449	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076453	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076516	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076518	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076524	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076529	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076530	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076531	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076532	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076534	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076538	Spontaneous	2021-12-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011076594	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076602	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (4mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076607	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster oticus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011076613	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Chest pain (2d - Recovered/Resolved - Life Threatening);Chills (1d - Recovered/Resolved - );Crohn's disease (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Hyperpyrexia (2d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - Life Threatening);Proctalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011076653	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (50h - Recovered/Resolved - );Pyrexia (50h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011076664	Spontaneous	2021-12-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (7d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011076664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065196	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - );COVID-19 (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065267	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (15h - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Peripheral coldness (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065339	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Neck pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065405	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid oedema (n/a - Not Recovered/Not Resolved - );Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065468	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Clonus (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Head titubation (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011065512	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid oedema (n/a - Not Recovered/Not Resolved - );Periorbital swelling (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065722	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065745	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Gastrointestinal disorder (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011065795	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (8d - Fatal - Results in Death);Pyrexia (8d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011065809	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065816	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011065826	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diastolic hypertension (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Pharyngeal oedema (n/a - Not Recovered/Not Resolved - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011065835	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (113d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011065839	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065866	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal sensation in eye (n/a - Recovering/Resolving - );Lacrimation increased (n/a - Recovering/Resolving - );Sensation of foreign body (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065871	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065894	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal loss of weight (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Conjunctival hyperaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myasthenic syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011065916	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Polymerase chain reaction (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Procalcitonin increased (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin increased (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011065920	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Nervousness (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065922	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065925	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - );Muscle twitching (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065928	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Disabling);Optic nerve infarction (n/a - Not Recovered/Not Resolved - Disabling);Retinal artery thrombosis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011065937	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011065965	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011065996	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Petechiae (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011066001	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011066029	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066081	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Flat affect (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066084	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066086	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (7d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066087	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011066109	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Intraocular pressure increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066116	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Asthma (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	REVINTY ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066117	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011066121	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])|DUPIXENT [DUPILUMAB] (S - Dermatitis atopic - n/a - [n/a - 600mg - Subcutaneous])|[GLATIRAMER, GLATIRAMER ACETATE] (S - Multiple sclerosis - n/a - [n/a - 120mg - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066144	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ENBREL 50 MG [ETANERCEPT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066150	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site induration (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066173	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066189	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066314	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066315	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066317	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diplopia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011066328	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066334	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066354	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066363	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066547	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Vertigo (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066551	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066555	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate irregular (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066573	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066578	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066579	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	C-reactive protein increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammatory marker increased (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thunderclap headache (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011066582	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Pulse absent (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066591	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066737	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Dysphoria (n/a - Recovered/Resolved - );Fall (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066740	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066742	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Influenza - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066745	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011066747	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lip swelling (n/a - Recovering/Resolving - );Oesophageal spasm (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011066771	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011066795	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066797	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066798	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066809	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011066860	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Constipation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011066860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067088	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067090	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Systemic lupus erythematosus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[INDAPAMIDE, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067091	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011067109	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - 2.5mg - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067110	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067119	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Primary headache associated with sexual activity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (S - Influenza immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067131	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Groin pain (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067132	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067133	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (0d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067135	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blood blister (12d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysarthria (n/a - Unknown - Other Medically Important Condition);Dysmenorrhoea (n/a - Unknown - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067137	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Extraocular muscle disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product use issue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Status epilepticus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067138	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067141	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067143	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067145	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (10min - Recovered/Resolved - Life Threatening);Nausea (0d - Recovered/Resolved - Life Threatening);Paraesthesia (10min - Recovered/Resolved - Life Threatening);Tremor (10min - Recovered/Resolved - Life Threatening);Vision blurred (0d - Recovered/Resolved - Life Threatening);Visual impairment (10min - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011067148	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067155	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067160	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ear disorder (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067162	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Coordination abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067177	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tendonitis (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011067216	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067232	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067237	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition);Rash papular (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067570	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067627	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067641	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Cardiovascular disorder (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067655	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067659	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Skin irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLOBETASONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067669	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067671	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial necrosis marker increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067675	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011067678	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067679	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011067682	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling);Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling);Rash macular (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011067697	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (65d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067699	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067705	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gingival pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oral pain (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067708	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067709	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067715	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067717	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (1d - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|ZOSTAVAX [VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED), VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS] (C - Herpes zoster - n/a - [n/a - n/a - n/a])|[ANHYDROUS LEVOTHYROXINE SODIUM] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[RAMIPRIL] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067727	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067728	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Not Specified	Exposure via breast milk (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067730	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood glucose decreased (1d - Recovered/Resolved - Other Medically Important Condition);Dermatitis allergic (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Livedo reticularis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Petechiae (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC DIETHYLAMINE, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Multiple allergies - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE, SODIUM CHLORIDE, GLUCOSE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011067733	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dehydration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067834	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Recovered/Resolved - );Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067862	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067877	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011067902	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011067903	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hot flush (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired work ability (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067911	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011067935	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash maculo-papular (n/a - Recovered/Resolved - );Rash pruritic (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011067935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068011	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011068018	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (90min - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011068019	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011068097	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011068206	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011068209	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Groin pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011068247	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068268	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068289	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011068319	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068383	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068386	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068396	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (2mo - Recovered/Resolved - );Fatigue (2mo - Recovered/Resolved - );Heart rate increased (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011068403	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068415	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Costochondritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011068419	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Joint stiffness (8d - Recovered/Resolved - );Musculoskeletal stiffness (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068420	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011068428	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[APIXABAN] (C - Anticoagulant therapy - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011068429	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068438	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Renal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011068443	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - n/a - )|[ALLOPURINOL] (C - n/a - n/a - )|[GLIMEPIRIDE] (C - n/a - n/a - )|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068449	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LAMOTRIGINE] (C - Affective disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011068454	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Recovered/Resolved - );Lymphadenitis (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068460	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - );Cluster headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011068496	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Balance disorder (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pruritus (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011068519	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011068608	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Injection site lymphadenopathy (n/a - Recovering/Resolving - Disabling);Injection site pain (n/a - Recovering/Resolving - Disabling);Insomnia (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SODIUM VALPROATE, VALPROIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011068808	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pancreatitis acute (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011068810	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymphadenopathy (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011068879	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovered/Resolved - Disabling);Chest pain (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Head discomfort (n/a - Recovered/Resolved - Disabling);Limb discomfort (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011068913	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011068927	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011068927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011069077	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition);Dyspnoea (18d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011069249	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011069325	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Duodenal ulcer haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Faeces discoloured (n/a - Unknown - Caused/Prolonged Hospitalisation);Flatulence (n/a - Unknown - Caused/Prolonged Hospitalisation);Gastric haemorrhage (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011069335	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011069385	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Varicose vein (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011069479	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069480	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069482	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069485	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069585	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Injection site reaction (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Skin disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011069669	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (5d - Recovered/Resolved - Disabling);Fatigue (5d - Recovered/Resolved - Disabling);Headache (5d - Recovered/Resolved - Disabling);Injection site reaction (5d - Recovered/Resolved - Disabling);Malaise (5d - Recovered/Resolved - Disabling);Myalgia (5d - Recovered/Resolved - Disabling);Nausea (5d - Recovered/Resolved - Disabling);Pyrexia (5d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011069704	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069706	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069709	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011069714	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011069714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011070021	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Fatal - Results in Death);Arthralgia (3d - Recovered/Resolved - );COVID-19 (5d - Recovered/Resolved - );Cardiac arrest (n/a - Fatal - Results in Death);Chills (3d - Recovered/Resolved - );Cough (9d - Recovered/Resolved - );Diarrhoea (4d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nasopharyngitis (9d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011070025	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (5d - Recovered/Resolved - );Heart rate increased (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011070049	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Irritability (1d - Recovered/Resolved - );Mood altered (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011070124	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Irritability (1d - Recovered/Resolved - );Mood altered (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011070308	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011070379	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Petechiae (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .2mL - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011070681	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011070718	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011070806	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[FINASTERIDE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])|[PIRACETAM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011070885	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Unknown - );Headache (2d - Unknown - );Pain in extremity (48h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011070925	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovering/Resolving - );Arthralgia (3d - Recovering/Resolving - );Diarrhoea (2d - Recovering/Resolving - );Fatigue (5d - Recovering/Resolving - );Irritability (3d - Recovering/Resolving - );Mood altered (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Vertigo (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - Unknown - [n/a - 4mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011070925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011071279	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anosmia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011071563	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (7d - Recovered/Resolved - Disabling);Fatigue (7d - Recovered/Resolved - Disabling);Headache (7d - Recovered/Resolved - Disabling);Influenza like illness (7d - Recovered/Resolved - Disabling);Injection site reaction (7d - Recovered/Resolved - Disabling);Myalgia (7d - Recovered/Resolved - Disabling);Pyrexia (7d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - [n/a - n/a - n/a])|[ANHYDROUS LEVOTHYROXINE SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011071695	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011071709	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011071750	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Lethargy (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011071928	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011071929	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation reaction (12h - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011071933	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis transverse (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011071936	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011071940	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cholangiocarcinoma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	AERIUS [DESLORATADINE] (S - Asthma - Dose not changed - [n/a - n/a - Oral])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [210d - 3{DF} - Intramuscular])|JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (S - Diabetes mellitus - Drug withdrawn - [n/a - 1000mg - Oral])|[EZETIMIBE] (S - Hypercholesterolaemia - Dose not changed - [n/a - 10mg - Oral])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (S - Asthma - Dose not changed - [n/a - 500ug - Respiratory (inhalation)])|[GLIMEPIRIDE] (S - Diabetes mellitus - Drug withdrawn - [n/a - 3mg - Oral])|[METFORMIN EMBONATE] (S - Diabetes mellitus - Dose not changed - [n/a - 700mg - Oral])|[SIMVASTATIN] (S - Hypercholesterolaemia - Dose not changed - [n/a - 10mg - Oral])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (S - Asthma - Dose not changed - [n/a - 25ug - Respiratory (inhalation)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011071955	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vein occlusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011071957	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011071972	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011071973	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - );Immunisation reaction (2d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011071975	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myeloid leukaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011071979	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .6mL - Intramuscular])|RITUXIMAB [RITUXIMAB] (S - n/a - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - n/a - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011071983	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011071985	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011071991	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral ischaemia (57d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011071994	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (48h - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011071994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072006	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011072007	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (4d - Recovered/Resolved - );Hypertension (4d - Recovered/Resolved - );Polyarthritis (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ATENOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011072033	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072040	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072041	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072043	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vascular purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011072049	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	BRILIQUE 90 MG FILM-COATED TABLETS [TICAGRELOR] (C - Vascular device user - Unknown - [n/a - n/a - n/a])|[ESOMEPRAZOLE MAGNESIUM DIHYDRATE] (C - Prophylaxis - Unknown - [n/a - n/a - n/a])|[EZETIMIBE] (C - Hypercholesterolaemia - Unknown - [n/a - n/a - n/a])|[NEFOPAM, NEFOPAM HYDROCHLORIDE] (C - Back pain - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - Unknown - [n/a - n/a - n/a])|[PERINDOPRIL ARGININE] (C - Prophylaxis - Unknown - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - Hypercholesterolaemia - Unknown - [n/a - n/a - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - Acute myocardial infarction - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072061	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011072065	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug reaction with eosinophilia and systemic symptoms (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haemophagocytic lymphohistiocytosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[IRON SUCROSE] (S - Anaemia postoperative - Drug withdrawn - [3d - 300mg - Intravenous drip])|[LINEZOLID] (S - Bacterial infection - Drug withdrawn - [12d - 1.2g - Oral])|[MOXIFLOXACIN HYDROCHLORIDE] (S - Bacterial infection - Drug withdrawn - [9d - 400mg - Oral])|[PIPERACILLIN, PIPERACILLIN, TAZOBACTAM] (S - Bacterial infection - Drug withdrawn - [22d - 16g - Intravenous drip])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011072070	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011072071	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011072073	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis bullous (20d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072077	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011072080	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011072084	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072093	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072098	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysuria (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072119	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (2d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [321d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072133	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Disease recurrence (n/a - Fatal - Results in Death);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Squamous cell carcinoma (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011072160	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COAPROVEL 300 MG/25 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|PRASUGREL [PRASUGREL] (C - n/a - n/a - [n/a - 10mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072167	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune haemolytic anaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072189	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rheumatic disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011072204	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011072251	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072262	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	[PRAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072265	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072274	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072290	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072293	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (3wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [84d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072300	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072313	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072314	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dehydration (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072315	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Loss of consciousness (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072339	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072344	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072348	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072355	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072358	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Electric shock sensation (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072372	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Varicose vein (6wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072373	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [35d - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072374	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072375	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid oedema (3h - Recovered/Resolved - );Eyelids pruritus (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072379	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site haemorrhage (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072384	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072388	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072428	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (11mo - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072447	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Conjunctival haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072476	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema multiforme (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072495	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072498	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072502	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072525	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072530	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072531	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072534	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072556	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072557	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072559	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072562	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072567	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072571	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072579	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072585	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Influenza like illness (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072596	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Extrasystoles (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011072601	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072603	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Graves' disease (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072620	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072621	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (1d - Recovered/Resolved - );Hypoaesthesia oral (1d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072622	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid oedema (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072627	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011072726	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072731	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072732	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072733	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072735	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072737	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072739	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072740	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072743	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072748	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072749	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072751	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072752	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072797	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072833	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011072856	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal heart rate abnormal (n/a - Unknown - Other Medically Important Condition);Foetal hypokinesia (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072926	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072928	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072929	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072930	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072932	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072933	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072936	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011072943	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011072943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073021	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Psychotic disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PIPAMPERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011073030	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073032	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperpyrexia (4d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073123	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011073136	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073138	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073139	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073140	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073141	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073402	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073414	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073422	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073527	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011073634	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073646	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Breast discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073650	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011073659	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073661	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073726	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073744	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073774	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073789	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011073933	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (4d - Recovered/Resolved - );Arthralgia (2d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011073940	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011073940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011074096	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Change of bowel habit (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|SAXENDA [LIRAGLUTIDE] (S - Overweight - Unknown - [n/a - n/a - n/a])|[LANSOPRAZOLE] (S - Gastrooesophageal reflux disease - Unknown - [n/a - n/a - n/a])|[OMEPRAZOLE] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011074160	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrioventricular dissociation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011074202	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Incomplete course of vaccination (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011074279	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy mediastinal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074283	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Parotitis (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074310	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074316	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074327	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011074366	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074369	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074370	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074373	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011074378	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011074382	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011074387	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine with aura (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074400	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074404	Spontaneous	2021-12-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [1d - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011074428	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074432	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074456	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074506	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074509	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074580	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074582	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011074583	Spontaneous	2021-12-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011074583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051109	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051139	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051221	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051234	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051243	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Epistaxis (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051314	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051315	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051322	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Asthenia (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Vertigo (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - 30ug - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011051353	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood thyroid stimulating hormone decreased (n/a - Not Recovered/Not Resolved - );Goitre (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051356	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051357	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011051362	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051367	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051422	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051443	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Injection site pain (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051468	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051475	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Nuchal rigidity (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051484	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Micturition disorder (n/a - Recovered/Resolved With Sequelae - Disabling);Seminoma (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011051486	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011051497	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dry skin (n/a - Not Recovered/Not Resolved - );Peyronie's disease (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051513	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051516	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Pustule (n/a - Not Recovered/Not Resolved - );Scab (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051520	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051533	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051549	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011051554	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Asthenia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Somnolence (3d - Recovered/Resolved - );Vertigo (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051570	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye irritation (4d - Recovered/Resolved - );Eye swelling (4d - Recovered/Resolved - );Eyelid irritation (4d - Recovered/Resolved - );Hypersensitivity (4d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Pruritus (4d - Recovered/Resolved - );Swelling (4d - Recovered/Resolved - );Swelling face (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051600	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Language disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011051626	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011051697	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arterial occlusive disease (n/a - Not Recovered/Not Resolved - Disabling);Macular oedema (n/a - Not Recovered/Not Resolved - Disabling);Visual field defect (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011051701	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011051703	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Priapism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011051739	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051787	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Flank pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011051799	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (6d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (6d - Recovered/Resolved - Other Medically Important Condition);Myalgia (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	BIKTARVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - HIV infection - n/a - [n/a - 1{DF} - Oral])|REZOLSTA [DARUNAVIR ETHANOLATE, COBICISTAT, DARUNAVIR, COBICISTAT] (C - HIV infection - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051800	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood cholesterol increased (n/a - Not Recovered/Not Resolved - );Blood triglycerides increased (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051805	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011051812	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (7d - Recovered/Resolved - Other Medically Important Condition);Myalgia (7d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (7d - Recovered/Resolved - Other Medically Important Condition);Vomiting (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051821	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Spinal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011051829	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051853	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (7d - Recovered/Resolved - Other Medically Important Condition);Headache (7d - Recovered/Resolved - Other Medically Important Condition);Insomnia (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011051927	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051928	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Recovering/Resolving - );Gingivitis (n/a - Recovering/Resolving - );Stomatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051945	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051969	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011051975	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Temperature intolerance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011051998	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011051998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011052005	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011052121	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052123	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza like illness (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011052124	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Eyelid ptosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052125	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune hepatitis (97d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052128	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal colic (8d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052129	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052132	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal perforation (114d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Intussusception (114d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052134	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Squamous cell carcinoma of skin (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052135	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular function test abnormal (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052136	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052142	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (8d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Squamous cell carcinoma (102d - Unknown - Caused/Prolonged Hospitalisation);Urinary tract infection (224d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052143	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052149	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052150	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dilated cardiomyopathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052152	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Prostatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052154	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	VIth nerve paralysis (25d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052155	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052158	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaemia (158d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (158d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052159	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052161	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (2d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052163	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nephrotic syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052168	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052170	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052173	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal mass (74d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052175	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052177	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Seizure (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052183	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011052186	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011052191	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052195	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052197	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (7d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052203	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052206	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (41d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052207	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052209	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052218	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052219	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (224d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052220	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angle closure glaucoma (72d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052221	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052223	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (60d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052226	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myasthenia gravis (115d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052227	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Ear pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052343	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052455	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052614	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	AMGEVITA [ADALIMUMAB] (C - Crohn's disease, Rheumatoid arthritis - n/a - [n/a - 40mg - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011052618	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	No	Male	Crying (40min - Recovered/Resolved - );Disturbance in attention (40min - Recovered/Resolved - );Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Irregular breathing (40min - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])|[DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED)] (S - Immunisation - Not applicable - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (ADSORBED)] (S - Immunisation - Not applicable - [n/a - n/a - n/a])|[ROTAVIRUS VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052628	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Catarrh (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011052644	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Bone deformity (n/a - Unknown - );Bone loss (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);C-reactive protein increased (n/a - Unknown - );Comminuted fracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Contusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - );Fall (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Haematocrit decreased (n/a - Unknown - );Haemoglobin decreased (n/a - Unknown - );Humerus fracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Joint swelling (n/a - Unknown - );Ligament sprain (n/a - Unknown - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Lymphocyte count decreased (n/a - Unknown - );Motor dysfunction (n/a - Unknown - );Muscle atrophy (n/a - Unknown - );Neutrophil count increased (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Red blood cell count decreased (n/a - Unknown - );Red cell distribution width increased (n/a - Unknown - );Swelling (n/a - Unknown - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - );White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	BUDESONIDE [BUDESONIDE] (C - Asthma - n/a - [n/a - 800ug - Respiratory (inhalation)])|ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[ALLOPURINOL] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[THEOPHYLLINE] (C - Asthma - n/a - [n/a - 300mg - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052648	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry throat (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pharyngeal oedema (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011052653	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052654	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052657	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Fear (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052660	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccinia virus infection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052666	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052678	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052684	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052685	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052690	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011052712	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - Depressed mood - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011052714	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052725	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052726	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052732	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011052734	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (0d - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011052746	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria chronic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052762	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011052765	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011052766	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011052766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053307	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053309	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053315	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053316	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053324	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Feeling abnormal (n/a - Not Recovered/Not Resolved - Life Threatening);Immunisation (n/a - Unknown - Life Threatening);Seizure (2d - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011053330	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053332	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (5d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053340	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011053343	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053354	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053359	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053363	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011053373	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011053376	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypokinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Photophobia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011053380	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011053381	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053384	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053388	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral venous disease (n/a - Unknown - Other Medically Important Condition);Phlebitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [265d - 1{DF} - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053391	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053397	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053406	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - );Influenza (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011053407	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011053408	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011053417	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac murmur (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053429	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053431	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate abnormal (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011053432	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053433	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053435	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Ischaemic limb pain (3d - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053437	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053594	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053595	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart valve operation - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011053598	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Agitation (n/a - Unknown - Other Medically Important Condition);Delirium (1d - Recovered/Resolved - Other Medically Important Condition);Disorientation (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053601	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011053625	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053628	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactoid reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Recovered/Resolved - Other Medically Important Condition);Flushing (n/a - Recovered/Resolved - Other Medically Important Condition);Rash erythematous (n/a - Recovered/Resolved - Other Medically Important Condition);Wheezing (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011053742	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011053750	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011053751	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011053775	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011053921	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rhinitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011053921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054128	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011054129	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011054141	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Disabling);Chills (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LOSARTAN POTASSIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011054172	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054173	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054178	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054179	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054233	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Life Threatening);Aphasia (n/a - Unknown - Life Threatening);Cerebral amyloid angiopathy (n/a - Unknown - Life Threatening);Cerebral disorder (n/a - Unknown - Life Threatening);Cerebral haemorrhage (n/a - Unknown - Life Threatening);Depressed level of consciousness (n/a - Unknown - Life Threatening);Fall (n/a - Unknown - Life Threatening);Fibrin D dimer increased (n/a - Unknown - Life Threatening);Hemiparesis (n/a - Unknown - Life Threatening);Muscular weakness (n/a - Unknown - Life Threatening);Musculoskeletal disorder (n/a - Unknown - Life Threatening);Pulmonary embolism (n/a - Unknown - Life Threatening);Restlessness (n/a - Unknown - Life Threatening);Sleep disorder (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011054332	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	NOT AVAILABLE (C - n/a - n/a - )|TYSABRI [NATALIZUMAB] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011054338	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011054348	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011054350	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - );Rash (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[AMBROXOL HYDROCHLORIDE, TIMOLOL MALEATE, LATANOPROST] (C - n/a - n/a - )|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[ROSUVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011054478	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - );Balance disorder (n/a - Unknown - );Coma (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Gait inability (n/a - Unknown - Disabling);Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Paralysis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Thyroid disorder (n/a - Unknown - );Weight fluctuation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011054498	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid function disorder (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054503	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054534	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054537	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011054565	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Pain (n/a - Unknown - );Peripheral swelling (24h - Unknown - );Pyrexia (48h - Unknown - );Sciatica (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011054578	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Oculomucocutaneous syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054584	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054586	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054589	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054591	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	African trypanosomiasis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Amnesia (2d - Recovered/Resolved - Disabling);Asthenia (n/a - Recovered/Resolved - Disabling);Cardiac flutter (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Disabling);Feeling abnormal (n/a - Recovered/Resolved - Disabling);Headache (0d - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Recovered/Resolved - Disabling);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling);Palpitations (n/a - Recovered/Resolved - Disabling);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Insomnia - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUSPIRONE] (C - Stress - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastric ulcer - n/a - [n/a - n/a - n/a])|[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (C - Gastrointestinal stoma complication - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011054597	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054598	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dysgeusia (3d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054600	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054608	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (28d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054610	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Unknown - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054613	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Vitreous haze (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054627	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054669	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054676	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Basophil count increased (n/a - Unknown - );Chest pain (n/a - Recovering/Resolving - );Cough (76d - Recovered/Resolved - Other Medically Important Condition);Cough variant asthma (1804h - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (76d - Recovered/Resolved - Other Medically Important Condition);Eosinophil count increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neutrophil count decreased (n/a - Unknown - );Productive cough (n/a - Recovered/Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054704	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Oropharyngeal erythema (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pharyngeal swelling (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), A/WISCONSIN/67/2022 (H1N1)PDM09-LIKE STRAIN (A/GEORGIA/12/2022 CVR-167), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011054705	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haemophagocytic lymphohistiocytosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054706	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Carditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CHLORTALIDONE, AZILSARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054711	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054718	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054724	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - Other Medically Important Condition);Dehydration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (24h - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054742	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054743	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054745	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Breast swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054748	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Prinzmetal angina - n/a - [n/a - n/a - n/a])|[NYSTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054750	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Disabling);Influenza (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011054751	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054753	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria chronic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054756	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054765	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstrual disorder (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011054770	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypokinesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011054777	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054785	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Gout (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054789	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeding disorder (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054792	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Nerve injury (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054800	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054809	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054825	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hip surgery (n/a - Recovered/Resolved - Other Medically Important Condition);Lymph node pain (n/a - Recovered/Resolved - );Musculoskeletal pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054832	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054834	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054836	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054838	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cardiac flutter (3d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (5d - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054839	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SENNA ALEXANDRIAN] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054840	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054843	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND HEPATITIS B (RDNA) VACCINE (ADSORBED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011054845	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Haematuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054853	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054861	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011054862	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Gastrointestinal pain (1d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011054865	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - );Oxygen saturation decreased (n/a - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054892	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[VENLAFAXINE HYDROCHLORIDE] (C - Immunisation - n/a - [n/a - 225mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011054985	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Unknown - );Oral discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011054985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055070	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (22d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011055087	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiovascular disorder (1d - Fatal - Results in Death);Diarrhoea (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL SANDOZ 75 MG [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|ENTRESTO 49 MG/51 MG [VALSARTAN, SACUBITRIL] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[ALLOPURINOL] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[MOLSIDOMINE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PANTOPRAZOLE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011055143	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055145	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055147	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055166	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055252	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055304	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011055312	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011055314	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011055316	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ataxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011055317	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011055318	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011055319	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011055381	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055382	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055386	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055389	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055396	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055400	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Blood pressure decreased (n/a - Recovered/Resolved - );Cardiovascular disorder (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055403	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055406	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Eye pain (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - )|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011055407	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (24h - Recovered/Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055408	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055409	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055413	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011055414	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (24h - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (24h - Recovered/Resolved - );Headache (24h - Recovered/Resolved - );Nausea (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055415	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055433	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster oticus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011055462	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Contusion (n/a - Not Recovered/Not Resolved - Disabling);Cough (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Multimorbidity (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011055473	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TELMISARTAN [TELMISARTAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011055494	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (20h - Recovered/Resolved - );Arthralgia (20h - Recovered/Resolved - );Chills (20h - Recovered/Resolved - );Fatigue (20h - Recovered/Resolved - );Headache (20h - Recovered/Resolved - );Myalgia (20h - Recovered/Resolved - );Pyrexia (20h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055527	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Hypertension (2d - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011055579	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055728	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site discomfort (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055753	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Recovering/Resolving - );Glomerular filtration rate decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011055798	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dilated cardiomyopathy (n/a - Recovering/Resolving - Life Threatening);Myocardial fibrosis (n/a - Recovering/Resolving - Life Threatening);Myocarditis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011055847	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Contusion (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Unknown - Disabling);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011055857	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011055873	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055884	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011055900	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Orthostatic hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011055947	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011055948	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011055979	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscle rupture (n/a - Recovered/Resolved With Sequelae - Disabling);Muscle spasms (n/a - Recovered/Resolved With Sequelae - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011055987	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011055987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011056027	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[D ALPHA TOCOFERIL ACETATE, TOCOPHERYL ACETATE] (C - n/a - n/a - [n/a - n/a - Oral])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - Oral])|[LOPERAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - Nasal])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN SODIUM PHOSPHATE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SODIUM CROMOGLICATE] (C - n/a - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056170	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011056190	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011056420	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011056432	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011056538	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011056576	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - n/a - n/a])|[HEPATITIS A VACCINE (INACTIVATED)] (S - Immunisation - Unknown - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011056630	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Bone pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - )|[ROSUVASTATIN] (C - n/a - n/a - )|[THIAMAZOLE] (C - n/a - n/a - )|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - )|[VINPOCETINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011056661	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011056671	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Not Recovered/Not Resolved - );Application site pain (n/a - Not Recovered/Not Resolved - );Application site reaction (n/a - Unknown - );Application site swelling (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011056916	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericardial effusion (13d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011056927	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011056930	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056935	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight bearing difficulty (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011056939	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056944	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056953	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056959	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056960	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011056961	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Inflammation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056963	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011056967	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Noninfective encephalitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011056967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057016	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Cholangitis (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Unknown - );Pain in jaw (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057017	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057023	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057138	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057154	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nasal discomfort (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057198	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Pulmonary oedema (n/a - Recovering/Resolving - Life Threatening);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011057256	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (1d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Myalgia (6d - Recovered/Resolved - );Spinal instability (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011057266	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy mediastinal (n/a - Recovered/Resolved - );Pneumonia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011057290	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Dysgeusia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011057357	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057376	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diabetic ketoacidosis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011057385	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057389	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057399	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057403	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057406	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057409	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057428	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057519	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (8d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011057552	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057554	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057555	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Anaphylactoid reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Throat tightness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057560	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Lethargy (n/a - Recovering/Resolving - Disabling);Palpitations (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011057565	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011057566	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057569	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057571	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chromaturia (n/a - Recovering/Resolving - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Constipation (n/a - Recovering/Resolving - Other Medically Important Condition);Contusion (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dysuria (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling of body temperature change (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pollakiuria (n/a - Recovering/Resolving - Other Medically Important Condition);Purpura (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057572	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Haemorrhagic stroke (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hemiplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Seizure (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011057578	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057582	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypothermia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057585	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057619	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057644	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057656	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Unknown - );Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - );Lethargy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011057661	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057667	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057669	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057671	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057678	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057681	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood potassium increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram change (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);High density lipoprotein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057682	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057690	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057692	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057694	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactoid reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Recovered/Resolved - Other Medically Important Condition);Flushing (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057701	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac arrest (n/a - Unknown - Other Medically Important Condition);Cardiovascular symptom (n/a - Unknown - );Malaise (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057703	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	FYCOMPA [PERAMPANEL] (C - Epilepsy - n/a - [n/a - n/a - n/a])|INOVELON [RUFINAMIDE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - Obstructive airways disorder - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Muscle tightness - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[LEVOCARNITINE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Initial insomnia - n/a - [n/a - n/a - n/a])|[RISPERIDONE] (C - Restlessness - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057704	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (102h - Recovered/Resolved - );Chest pain (102h - Recovered/Resolved - );Myocardial necrosis marker increased (5d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (102h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (102h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057709	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057714	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057718	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057720	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057721	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradykinesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Motor dysfunction (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Tenderness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057756	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011057763	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Lopez, S.. Pernio after COVID-19 Vaccination. The British journal of dermatology. 2021;185(2):445-447. doi:10.1111/bjd.20404	18-64 Years	Not Specified	No	Male	Chillblains (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011057824	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011057884	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057885	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057887	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057888	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057896	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057898	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057945	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - );Polymyalgia rheumatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011057946	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011057946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058023	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058072	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058101	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (22d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058116	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058127	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058133	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058146	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (7s - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058158	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Not Recovered/Not Resolved - );Joint range of motion decreased (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058213	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011058302	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Life Threatening);Eye swelling (n/a - Recovered/Resolved - Life Threatening);Lip swelling (n/a - Recovered/Resolved - Life Threatening);Pharyngeal swelling (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011058311	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058315	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058318	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058319	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Throat tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058322	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aggression (n/a - Not Recovered/Not Resolved - );Bronchitis (n/a - Not Recovered/Not Resolved - );Cough (3wk - Recovered/Resolved - );Crying (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Laryngeal inflammation (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pharyngeal inflammation (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Suicidal ideation (n/a - Not Recovered/Not Resolved - );Tumour marker abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058327	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Application site movement impairment (n/a - Unknown - );Application site pain (n/a - Unknown - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling of body temperature change (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058329	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058354	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Apathy (n/a - Recovering/Resolving - );Crying (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058360	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Blood pressure increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058364	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Temperature intolerance (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058422	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anxiety (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058465	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Unknown - );Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058539	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Rash (n/a - Unknown - );Rash macular (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058560	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Lymph node pain (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rhinorrhoea (n/a - Recovered/Resolved - );Sinus pain (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) DISPERSION FOR INJECTION [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058606	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Injection site lymphadenopathy (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011058612	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058615	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Circulatory collapse (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058616	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058618	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058623	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Unknown - );Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058630	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058631	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058632	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058635	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011058638	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058639	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oral herpes (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058645	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Hepatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058647	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058648	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticarial vasculitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058649	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058650	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058652	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058653	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058654	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058671	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058672	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058673	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058682	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058687	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011058768	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058769	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058770	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058772	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058773	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058775	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058783	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058784	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058789	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058791	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058794	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058805	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058807	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058809	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058810	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058840	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011058841	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Influenza (n/a - Unknown - );Renal pain (n/a - Unknown - );Somnolence (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058846	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Internal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058850	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tendonitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011058851	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058855	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Neoplasm (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058861	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058862	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Arthropathy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058869	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[GOSERELIN, GOSERELIN ACETATE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011058880	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Unknown - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Drug intolerance (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Face oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - );Headache (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Lip oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lip swelling (n/a - Unknown - );Post-acute COVID-19 syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058881	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011058886	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058887	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011058892	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aortic aneurysm (n/a - Unknown - Caused/Prolonged Hospitalisation);Aortic aneurysm rupture (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Inguinal hernia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GINSENG, GLYCYRRHIZA GLABRA, GLYCYRRHIZA] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOGLUTAMIDE, SODIUM GUALENATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOSAPRIDE, MOSAPRIDE CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PEONY FLOWER, GLYCYRRHIZA EXTRACT, SHAKUYAKUKANZOTO] (C - n/a - n/a - [n/a - n/a - n/a])|[SUCRALFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAK 438] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011058896	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Sputum increased (n/a - Not Recovered/Not Resolved - Disabling);Wheezing (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011058897	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (211h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocardial necrosis marker increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Orthopnoea (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rhinorrhoea (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058901	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Visual impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011058945	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011058945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059107	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059108	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	No	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - );Normal newborn (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059129	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059141	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059242	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011059253	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059256	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059257	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059261	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059285	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059287	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059292	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059299	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059301	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059345	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - .3mL - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1min - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059367	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059420	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovered/Resolved - Other Medically Important Condition);Eye discharge (5d - Recovered/Resolved - Other Medically Important Condition);Eye swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (4d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011059423	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart disease congenital (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperacusis (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Photophobia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011059429	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059435	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059436	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059447	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (20d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011059461	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059464	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lethargy (1d - Recovered/Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059466	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Not Recovered/Not Resolved - Disabling);Overweight (n/a - Not Recovered/Not Resolved - Disabling);Skin ulcer (n/a - Not Recovered/Not Resolved - Disabling);Wound (n/a - Not Recovered/Not Resolved - Disabling);Wound abscess (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PRADAXA [DABIGATRAN ETEXILATE, DABIGATRAN ETEXILATE MESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011059467	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059478	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Dry skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Skin discolouration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059482	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Syncope (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011059519	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059522	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059530	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Tendonitis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011059541	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011059542	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011059544	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Alopecia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Body temperature decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011059559	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011059604	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (2d - Recovered/Resolved - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011059777	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011059823	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059825	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059829	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059830	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059831	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059841	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059842	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059845	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059847	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059851	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059858	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059860	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059866	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059871	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059874	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059903	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059904	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Subdural haematoma (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059905	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Oesophageal achalasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059914	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myasthenia gravis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Ischaemic heart disease prophylaxis - Dose not changed - [n/a - 100mg - Oral])|[AZATHIOPRINE] (C - Myasthenia gravis - Dose not changed - [n/a - 100mg - Oral])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - Dose not changed - [n/a - 2.5mg - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - Dose not changed - [n/a - 1700mg - Oral])|[PREDNISONE] (C - Myasthenia gravis - Dose increased - [n/a - 40mg - n/a])|[PYRIDOSTIGMINE BROMIDE] (C - Myasthenia gravis - Dose not changed - [n/a - 240mg - Oral])|[RAMIPRIL] (C - Hypertension - Dose not changed - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059917	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ADVAGRAF [TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])|CELLCEPT [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])|JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AZITHROMYCIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM, MAGNESIUM CARBONATE, MAGNESIUM PIDOLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011059918	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [35d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011059924	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periostitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059926	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Tendon pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALLOPURINOL, METHENAMINE] (C - n/a - n/a - [20y - n/a - Oral])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [20y - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [20y - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059933	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Submandibular gland enlargement (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059937	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Renal artery thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059939	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011059944	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin ulcer (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059961	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011059970	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (78d - Recovered/Resolved - Other Medically Important Condition);Herpes zoster meningitis (78d - Recovered/Resolved - Other Medically Important Condition);Intracranial pressure increased (78d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011059996	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (6wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011059996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060001	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060003	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/FLORIDA/4/2006-LIKE STRAIN, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/SOUTH AUSTRALIA/55/2014 STRAIN, A/SWITZERLAND/9715293/2013 (H3N2) - LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/WISCONSIN/67/2005 (H3N2), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN, B/MALAYSIA/2506/2004 - LIKE STRAIN, B/BEIJING/184/93-LIKE STRAIN (B/YAMANASHI/166/98), A/SYDNEY/5/97 (H3N2)-LIKE STRAIN (A/SYDNEY/5/97 REASS. RESVIR 13), A/BEIJING/262/95 (H1N1) - LIKE STRAIN (A/BEIJING/262/95 REASS. X-127), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NIB-65), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/02/2012, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, IVR-175), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060012	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fibrin D dimer increased (n/a - Recovered/Resolved - Other Medically Important Condition);Oedema peripheral (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060022	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	PREGABALIN [PREGABALIN] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[NICARDIPINE, NICARDIPINE HYDROCHLORIDE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011060024	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (4d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011060029	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011060054	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060073	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060101	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Motor dysfunction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [6d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011060102	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [27d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060111	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060115	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fall (n/a - Recovered/Resolved - );Rib fracture (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060119	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060123	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060136	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Status epilepticus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060140	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [39d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060148	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Nephrotic syndrome (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060151	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [39d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060157	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060158	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Penile vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060163	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060173	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060174	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalitis brain stem (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011060196	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060206	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Musculoskeletal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	MICARDISPLUS 80 MG/12.5 MG TABLETS [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060209	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Synovial cyst (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060218	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALPRAZOLAM] (C - n/a - Not applicable - [n/a - n/a - n/a])|[AMITRIPTYLINE] (C - n/a - Not applicable - [n/a - n/a - n/a])|[BISOPROLOL HEMIFUMARATE] (C - n/a - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060235	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060250	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - );Hyperhidrosis (3d - Recovered/Resolved - );Muscle spasms (3d - Recovered/Resolved - );Puncture site pain (2d - Recovered/Resolved - );Tachycardia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060252	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060291	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060294	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060306	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060308	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060314	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gynaecomastia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|XEPLION [PALIPERIDONE, PALIPERIDONE PALMITATE] (S - Psychotic disorder - Dose not changed - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060320	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060323	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060326	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060328	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Loss of consciousness (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011060331	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011060361	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060366	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060367	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060369	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060370	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - );Folliculitis (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060375	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060383	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060391	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Recovering/Resolving - );Depression (n/a - Recovering/Resolving - );Gastrointestinal motility disorder (n/a - Recovering/Resolving - );Micturition frequency decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060408	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1wk - Recovered/Resolved - );Myalgia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060409	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060410	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060411	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060416	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060452	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[GABAPENTIN] (C - Drug dependence - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060454	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060458	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspepsia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060470	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060471	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060483	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060484	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060485	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060495	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Pollakiuria (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060500	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060501	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011060516	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060528	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [38d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060531	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011060535	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060542	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060552	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060555	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spontaneous haematoma (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060581	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060588	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060595	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011060640	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombosis in device (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011060643	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Vascular pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011060644	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060648	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060652	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011060654	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - Thrombosis - n/a - [n/a - 20mg - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011060656	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060659	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060667	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060670	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060672	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060674	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060678	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060681	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060682	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Dermatitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060695	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Agitation (n/a - Unknown - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - );Headache (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nervousness (n/a - Unknown - );Pyrexia (n/a - Unknown - );Restlessness (n/a - Unknown - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060699	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anorectal discomfort (n/a - Unknown - Other Medically Important Condition);Blood urine present (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dysuria (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Muscle contracture (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Prostatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Urinary tract discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060700	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060703	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060704	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060708	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - );Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060709	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Apathy (10d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (10d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lethargy (10d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (10d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (6d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (10d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011060849	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011060852	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060866	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060868	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060870	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060878	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060880	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011060882	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060893	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060896	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chapped lips (12d - Recovered/Resolved - );Epistaxis (n/a - Unknown - );Feeling cold (n/a - Unknown - );Haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Nasal disorder (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060902	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photosensitivity reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060911	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060912	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Accidental underdose (n/a - Unknown - );Atrioventricular block (n/a - Unknown - Other Medically Important Condition);Product administration error (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060914	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Lip swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - );Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling face (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011060919	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011060920	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lip swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011060921	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Burns third degree (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chromaturia (n/a - Unknown - Other Medically Important Condition);Dysuria (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary retention (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Urine output decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011060922	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060923	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060926	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060934	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Agitation (20min - Recovered/Resolved - );Dyskinesia (20min - Recovered/Resolved - );Head injury (20min - Recovered/Resolved - );Heart rate decreased (20min - Recovered/Resolved - );Hyperhidrosis (20min - Recovered/Resolved - );Syncope (20min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060935	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (0d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rest regimen (48h - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[VALPROATE SEMISODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060948	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060952	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hallucination (3d - Recovered/Resolved - Other Medically Important Condition);Headache (4d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Monoplegia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011060957	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphoedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle swelling (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060958	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Breast tenderness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymph node palpable (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Psoriasis (n/a - Unknown - Other Medically Important Condition);Skin disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011060960	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011060960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061002	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061004	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Portosplenomesenteric venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061011	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011061026	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose reduced - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061039	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erysipelas (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061040	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chillblains (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061045	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061048	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Eyelid function disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Facial paresis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061060	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Monoparesis (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Weight bearing difficulty (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011061127	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061259	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061280	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lung disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011061283	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Viral infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061289	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Hemiplegia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011061321	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061336	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061337	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061340	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061388	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Ocular discomfort (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011061501	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061506	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061507	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061508	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061509	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061514	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061516	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061519	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061520	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061521	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061528	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061534	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061537	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061540	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061578	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061590	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hyperventilation (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - );Oxygen saturation decreased (2d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - );Vaccination site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061596	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061601	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011061602	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061604	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061610	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pustular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061617	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011061618	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Fatal - Results in Death);Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death);Myocardial ischaemia (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011061619	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Pericarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011061626	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061640	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Constipation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Urinary retention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061643	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011061657	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061659	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Unknown - Disabling);Musculoskeletal pain (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling);Vision blurred (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011061674	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011061680	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Bone pain (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011061718	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061734	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Generalised oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatic function abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoalbuminaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urine output decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACOTIAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BACILLUS MESENTERICUS, CLOSTRIDIUM BUTYRICUM, LACTOMIN, LACTOMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061742	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Epistaxis (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasal congestion (n/a - Unknown - Caused/Prolonged Hospitalisation);Ocular hyperaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Polyarthritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash maculo-papular (n/a - Unknown - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011061870	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061876	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061931	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011061987	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061988	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061989	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061992	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011061994	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011061994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062005	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011062019	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062024	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Painful respiration (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062195	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Illusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062216	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062235	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062243	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011062303	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Unknown - );Congenital musculoskeletal disorder of spine (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011062305	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	No	Male	Depressed level of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Exposure via breast milk (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Periorbital oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011062308	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Genital pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062323	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062324	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062328	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062329	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062337	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062338	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062358	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011062385	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Injection site reaction (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011062456	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Complex regional pain syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011062461	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011062463	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062465	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	[ALLIUM SATIVUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM ASCORBATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LECITHIN] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE, OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 60mg - n/a - More in ICSR])|[TOCOPHERYL ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011062469	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Platelet count decreased (106d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Essential thrombocythaemia - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Arteriosclerosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062528	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Carcinoembryonic antigen increased (n/a - Unknown - );Recurrent cancer (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062532	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011062621	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062623	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062627	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062638	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062645	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062662	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062675	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062716	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral artery thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decubitus ulcer (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011062717	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062719	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062724	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062726	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Speech disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011062731	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011062810	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011062852	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011062917	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coronary artery stenosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coronary artery thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011062991	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Shock symptom (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011062991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011063006	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011063009	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiovascular disorder (n/a - Unknown - );Circulatory collapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Unknown - );Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063011	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Rash (n/a - Unknown - Disabling, Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Swelling (n/a - Unknown - Disabling, Other Medically Important Condition);Tenderness (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011063021	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Anger (n/a - Unknown - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Balance disorder (n/a - Unknown - Disabling);Brain fog (n/a - Unknown - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling);Depressed mood (n/a - Unknown - Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Irritability (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Mood altered (n/a - Unknown - Disabling);Mood swings (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Unknown - Disabling);Phonophobia (n/a - Not Recovered/Not Resolved - Disabling);Photophobia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011063022	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MIRABEGRON [MIRABEGRON] (C - Urinary tract disorder - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Urinary tract disorder - n/a - [n/a - n/a - n/a])|[TRIMETHOPRIM] (C - Urinary tract disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011063025	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011063072	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Constipation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063079	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063091	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063092	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063093	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063095	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063098	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063110	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011063128	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063150	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063152	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063160	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063184	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011063194	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063195	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063200	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063220	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063238	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Recovered/Resolved - );Body temperature decreased (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063258	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bedridden (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral artery embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Motor dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 200mg - n/a])|[OMEPRAZOLE, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011063261	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063269	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063274	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063292	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063300	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011063322	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiovascular insufficiency (n/a - Fatal - Results in Death);Respiratory failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011063364	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Epistaxis (n/a - Unknown - );Headache (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063368	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063381	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063386	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063388	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063390	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063392	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063395	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063396	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063405	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063410	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063454	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Optic neuritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011063457	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Cardiac disorder (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011063644	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011063713	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063784	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Disabling);Parosmia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011063847	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011063874	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heat exhaustion (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Lethargy (10d - Recovered/Resolved - Other Medically Important Condition);Nasal mucosal disorder (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011063887	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011063968	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063970	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063973	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011063975	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063978	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Unknown - );Vaccination site inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063994	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuropathy peripheral (91d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011063995	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011063997	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011063997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011064009	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011064011	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	[ALUMINIUM OXIDE, HYDRATED, DIPHTHERIA TOXOID, TETANUS TOXOID, DIPHTHERIA TOXOID, TETANUS TOXOID, ALUMINIUM HYDROXIDE] (C - Immunisation - Drug withdrawn - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064017	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Varicella zoster virus infection (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011064019	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064070	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064099	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064102	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064112	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064122	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast cyst (32d - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011064134	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Nephrolithiasis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011064136	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ataxia (n/a - Unknown - Disabling);Brain stem stroke (n/a - Not Recovered/Not Resolved - Disabling);Diplopia (n/a - Unknown - Disabling);Dizziness (n/a - Unknown - Disabling);Dysarthria (n/a - Unknown - Disabling);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011064149	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064159	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064161	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ataxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiomyopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fear (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nervousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[TRAZODONE HYDROCHLORIDE] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011064297	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011064316	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (18d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (18d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	[COLCHICINE] (C - Arthritis - n/a - [370d - n/a - Oral])|[ECONAZOLE NITRATE, TRIAMCINOLONE ACETONIDE] (C - Eczema infected - n/a - [n/a - n/a - Cutaneous])|[PARACETAMOL] (C - Pain - n/a - [371d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011064328	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Alveolitis (n/a - Not Recovered/Not Resolved - Results in Death, Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Results in Death, Life Threatening);Interstitial lung disease (n/a - Fatal - Results in Death, Life Threatening);Pulmonary congestion (n/a - Not Recovered/Not Resolved - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011064369	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - );Pancreatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011064487	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011064492	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Affective disorder (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064500	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064546	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064555	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064595	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064610	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064636	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064663	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood folate decreased (n/a - Unknown - Other Medically Important Condition);Depression (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immune system disorder (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Vitamin B12 decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LATANOPROST] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011064675	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064796	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064809	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064810	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011064834	Spontaneous	2021-12-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011064854	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Altered state of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Septic shock (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - 10mg - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011064854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011065067	Spontaneous	2021-12-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Hypotension (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011065067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036498	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036518	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036635	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death);Dyspnoea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011036650	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Headache (0d - Recovering/Resolving - );Hypertension (9d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Lymphadenopathy (8d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (9d - Not Recovered/Not Resolved - );Tachycardia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011036704	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036711	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - );Intermittent claudication (n/a - Recovered/Resolved With Sequelae - );Primary stabbing headache (n/a - Recovered/Resolved With Sequelae - );Vertigo (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011036780	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036817	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deformity thorax (n/a - Recovered/Resolved - );Joint stiffness (n/a - Recovered/Resolved - );Lymphoedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036898	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036913	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - );Asthenia (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036915	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - );Asthenia (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036923	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036933	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036934	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036936	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036938	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Muscle contractions involuntary (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036972	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysentery (n/a - Unknown - );Gastritis (n/a - Unknown - );Musculoskeletal chest pain (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036997	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037094	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (C - Influenza immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037096	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .2mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037135	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Dysstasia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011037150	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037155	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Disorientation (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011037160	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037162	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Tachycardia - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037166	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037200	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pallor (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037227	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037230	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011037247	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Eyelid ptosis (n/a - Recovering/Resolving - Other Medically Important Condition);Lacrimation increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037258	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037264	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Clonus (n/a - Recovering/Resolving - Other Medically Important Condition);Epilepsy (n/a - Recovering/Resolving - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037276	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037287	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Artery dissection (n/a - Recovered/Resolved With Sequelae - Life Threatening);Iliac artery occlusion (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011037291	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening);Decreased appetite (n/a - Not Recovered/Not Resolved - Life Threatening);Depression (n/a - Not Recovered/Not Resolved - Life Threatening);Obsessive thoughts (n/a - Not Recovered/Not Resolved - Life Threatening);Suicidal ideation (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011037294	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cluster headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL HYDROCHLORIDE, ATENOLOL PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LOSARTAN, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011037305	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011037308	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037321	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011037350	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037356	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037359	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037369	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037376	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037386	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037389	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037401	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Migraine (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037402	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037405	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Oxygen saturation decreased (n/a - Fatal - Results in Death);SARS-CoV-2 test positive (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011037411	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011037415	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037419	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037422	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037435	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037437	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037439	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037443	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037463	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	LYRICA [PREGABALIN] (C - Neuralgia - n/a - [n/a - 450mg - Oral])|MICARDISPLUS 80 MG/25 MG TABLETS [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - Hypertension - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011037468	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037472	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011037474	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037477	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037484	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011037499	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037520	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar haemorrhage (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011037526	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Application site joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037527	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (64d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperpyrexia (64d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Trigeminal neuralgia (64d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - 100mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 40mg - Oral])|[BISOPROLOL FUMARATE] (C - Sinus tachycardia - n/a - [n/a - 5mg - Oral])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[OMEGA-3-ACID ETHYL ESTERS 90] (C - Hypertriglyceridaemia - n/a - [n/a - 1000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037604	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037712	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037720	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037843	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037868	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037874	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037876	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (8min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037878	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037883	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011037886	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Unknown - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Immune system disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Influenza (n/a - Unknown - Disabling, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Disabling, Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Respiratory arrest (n/a - Unknown - Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Urinary incontinence (n/a - Unknown - Disabling, Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011037891	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Nausea (65min - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Syncope (65min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037894	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037895	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037898	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037917	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Defaecation urgency (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Frequent bowel movements (n/a - Not Recovered/Not Resolved - );Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - );Proctalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037920	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (226h - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (226h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037922	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition);Systemic viral infection (n/a - Unknown - Other Medically Important Condition);Unresponsive to stimuli (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037924	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037925	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Febrile convulsion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011037927	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness unilateral (n/a - Unknown - Other Medically Important Condition);Ear swelling (n/a - Unknown - );Hypoacusis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037931	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037932	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037935	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Ophthalmic herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037940	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037945	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Unknown - Other Medically Important Condition);Foaming at mouth (n/a - Unknown - Other Medically Important Condition);Road traffic accident (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037946	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037947	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tendonitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037952	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Chest X-ray abnormal (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Echocardiogram abnormal (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin I abnormal (n/a - Recovering/Resolving - );Troponin T increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037956	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037964	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonitis (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037970	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037977	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037980	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Dry skin (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Head discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Joint instability (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011037983	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - Other Medically Important Condition);Epistaxis (38d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011037988	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037989	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037990	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037994	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011037996	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011037999	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011037999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038004	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038017	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038019	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038028	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038031	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038038	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired work ability (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038050	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (10min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038054	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038180	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertensive crisis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011038183	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Chills (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Myalgia (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - );Troponin abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038188	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (14d - Recovered/Resolved - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011038190	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038194	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038197	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysgeusia (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Terminal insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038199	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038206	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038211	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038217	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038234	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLONAZEPAM] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038236	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cryptorchism (n/a - Unknown - Disabling);Male genital examination abnormal (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011038243	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038246	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nystagmus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038249	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diabetes mellitus inadequate control (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	INSULIN ASPART [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038252	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038256	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038258	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038260	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011038263	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Sy, M.. Nicolau Syndrome After Glatiramer Acetate Injection in Close Proximity to Administration of SARS-CoV-2 mRNA Vaccine. Neurology neuroimmunology &amp; neuroinflammation. 2021;9(1):1. doi:10.1212/NXI.0000000000001112	18-64 Years	Not Specified	No	Male	Drug interaction (n/a - Recovered/Resolved - Other Medically Important Condition);Embolia cutis medicamentosa (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[GLATIRAMER ACETATE] (I - Multiple sclerosis - Unknown - [5y - 120mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038268	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - Disabling);Gouty tophus (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Joint swelling (n/a - Unknown - Disabling);Musculoskeletal chest pain (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011038546	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Discharge (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Genitourinary symptom (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus bradycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])|[RAMIPRIL] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011038566	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 80mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038567	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (15min - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (22min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038569	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038571	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Epistaxis (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038573	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Tremor (n/a - Recovering/Resolving - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011038574	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038578	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (1d - Recovered/Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (26h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038579	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038580	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038584	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Electrocardiogram ST segment abnormal (n/a - Unknown - );Malaise (n/a - Unknown - );Pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038589	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038592	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011038596	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038600	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac failure congestive (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Left ventricular failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011038601	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038607	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Joint stiffness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - );Throat tightness (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038610	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenopia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flushing (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038617	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011038625	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011038630	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038633	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038636	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Atonic seizures (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ambulatory abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Orthostatic intolerance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somatic symptom disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011038640	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038656	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (1h - Recovered/Resolved - Other Medically Important Condition);Pallor (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011038793	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal infarct (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])|[IOMEPROL] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011038868	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011038959	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011038959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039003	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039220	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Dysgeusia (n/a - Recovering/Resolving - Other Medically Important Condition);Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Phonophobia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039331	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011039332	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011039333	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039338	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (3d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039340	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Eczema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039344	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011039349	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039355	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039361	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039388	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immune system disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011039391	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling);Rash macular (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011039410	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site mass (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	SITAGLIPTIN [SITAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011039413	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039435	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039437	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Disabling);Chest pain (9h - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Influenza like illness (5h - Recovered/Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011039438	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Gastrointestinal disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011039439	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039462	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradyphrenia (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - );Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039463	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VALSARTAN] (C - n/a - n/a - [n/a - 160mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039468	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039487	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011039489	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (78min - Recovered/Resolved - Other Medically Important Condition);Dizziness (78min - Recovered/Resolved - );Limb discomfort (n/a - Recovering/Resolving - );Loss of consciousness (78min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039490	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest pain (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039492	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (110min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039493	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039494	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011039496	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039497	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039500	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039504	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Echocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039507	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039510	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039512	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011039523	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Monocytosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011039524	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011039535	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Macule (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039549	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039638	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039662	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039686	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039766	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039784	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039793	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039889	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (30h - Recovered/Resolved - );Arthralgia (24h - Recovered/Resolved - );Fatigue (30h - Recovered/Resolved - );Headache (48h - Recovered/Resolved - );Myalgia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011039939	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011039939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040060	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Ophthalmic herpes zoster (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011040062	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040063	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	No	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Laryngomalacia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040070	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electric shock sensation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vibratory sense increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040073	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - );Speech disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040077	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040078	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040109	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Disabling);Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Throat irritation (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011040115	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040122	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Immune system disorder (n/a - Unknown - );Overweight (n/a - Unknown - );Rectal haemorrhage (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040129	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Menstruation delayed (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040167	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040176	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040184	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hepatic steatosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040186	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Gastritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Impaired healing (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Skin discolouration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011040190	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash maculo-papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040201	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040216	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (12h - Recovered/Resolved - Other Medically Important Condition);Chills (12h - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040217	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine with aura (n/a - Unknown - Other Medically Important Condition);Migraine without aura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040219	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hiccups (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040240	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040241	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040249	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	PO2 decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040252	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040259	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (7d - Recovered/Resolved - Disabling);Ear pain (n/a - Not Recovered/Not Resolved - Disabling);Ear swelling (n/a - Not Recovered/Not Resolved - Disabling);Hyperacusis (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUPROPION] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011040270	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040272	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040275	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040278	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040281	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040289	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011040294	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040297	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040306	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040310	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011040311	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040312	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Muscle fatigue (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040321	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040333	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040362	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ventricular extrasystoles (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011040364	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Pain (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040366	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Left ventricular failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040393	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040414	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (1d - Fatal - Results in Death, Other Medically Important Condition);Fatigue (1d - Fatal - Results in Death, Other Medically Important Condition);Headache (1d - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011040420	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash erythematous (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040445	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate variability increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040599	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Unknown - );Body temperature increased (1d - Unknown - );Fatigue (2d - Unknown - );Myalgia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040626	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040627	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrioventricular block complete (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blindness unilateral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Personality change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - )|[VALSARTAN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040628	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040632	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mononeuritis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Neuralgic amyotrophy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040677	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040694	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (3d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040698	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011040719	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040725	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral coldness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vestibular neuronitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040763	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Enthesopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040772	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011040778	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011040797	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040819	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tachycardia (6h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011040894	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Body temperature increased (2h - Recovered/Resolved - );Fatigue (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[DICLOFENAC DIETHYLAMINE, DICLOFENAC SODIUM] (C - n/a - Unknown - )|[PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011040915	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011040935	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040936	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040937	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040938	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040940	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040943	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040949	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011040952	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011040952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041183	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site oedema (2d - Recovered/Resolved - );Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011041232	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Asthenia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatic cytolysis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011041282	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041293	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041299	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011041316	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041317	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041318	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041320	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041322	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041323	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041330	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041333	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041335	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (48h - Unknown - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011041336	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011041340	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041343	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041345	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011041381	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Dehydration (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Injection related reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Skin burning sensation (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011041439	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011041472	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Connective tissue inflammation (n/a - Recovering/Resolving - );Myositis (n/a - Recovering/Resolving - );Painful respiration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011041480	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011041484	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Pain in jaw (n/a - Unknown - );Peripheral coldness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	REMICADE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION [INFLIXIMAB] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )|[DOCONEXENT, ICOSAPENT, ESTERS OF UNSATURATED FATTY ACIDS, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[FRUIT] (C - n/a - n/a - )|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )|[ZINC] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011041494	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Epistaxis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - 10mg - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011041623	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (50d - Recovering/Resolving - Other Medically Important Condition);Lymphoma (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011041695	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041700	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041704	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041705	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041711	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041713	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041718	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041719	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041722	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041725	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041729	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041735	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011041771	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Hypoventilation (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011041871	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIMETAZIDINE, TRIMETAZIDINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011041871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011042026	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042031	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Bronchitis (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiac discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011042044	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042077	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011042104	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042118	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042127	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042130	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042133	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042134	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042138	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042139	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042140	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042143	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042182	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Mental disorder (n/a - Not Recovered/Not Resolved - );Panic attack (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042183	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (n/a - Unknown - );Lymphadenectomy (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Unknown - );Papillary thyroid cancer (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thyroidectomy (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011042190	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011042226	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042537	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042542	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042559	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042653	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042657	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042658	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042663	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042671	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042677	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042678	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042680	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011042693	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042750	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Tremor (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011042849	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site erythema (4d - Recovering/Resolving - );Administration site oedema (4d - Recovering/Resolving - );Administration site pain (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042918	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042931	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tinnitus (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011042944	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042957	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042969	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Monoplegia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011042978	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042979	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011042984	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Acute kidney injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haematuria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Petechiae (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011042993	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotension (n/a - Unknown - Disabling);Loss of personal independence in daily activities (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011042995	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011042998	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (151d - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Papilloedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011042998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043031	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043040	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Nervous system disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043057	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex encephalitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043063	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043065	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tension headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043142	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - );Contusion (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043148	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (77d - Unknown - );Headache (2d - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011043189	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammatory marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043202	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043210	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043213	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043223	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Axillary pain (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043225	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (30h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011043229	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Skin disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043230	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043246	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site lymphadenopathy (n/a - Not Recovered/Not Resolved - );Application site reaction (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011043255	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043261	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043263	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043269	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Basilar artery thrombosis (n/a - Fatal - Results in Death);Brain herniation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Central nervous system necrosis (n/a - Fatal - Results in Death);Cerebellar infarction (n/a - Fatal - Results in Death);Coma (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Hypotonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Ischaemic cerebral infarction (n/a - Fatal - Results in Death);Quadriplegia (n/a - Unknown - Caused/Prolonged Hospitalisation);Unresponsive to stimuli (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011043284	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043349	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043454	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043457	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	CSF immunoglobulin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Communication disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalitis autoimmune (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Persecutory delusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043458	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (5d - Recovered/Resolved - );Disease recurrence (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal erythema (n/a - Not Recovered/Not Resolved - );Productive cough (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Upper respiratory tract infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CARBOCISTEINE] (C - Upper respiratory tract inflammation - n/a - [6d - n/a - Oral])|[CEFDITOREN PIVOXIL] (C - Upper respiratory tract inflammation - n/a - [6d - n/a - Oral])|[PARACETAMOL] (C - Upper respiratory tract inflammation - n/a - [6d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043464	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death);Disease recurrence (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	HUMALOG [INSULIN LISPRO] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|[AMLODIPINE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011043531	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043545	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deafness unilateral (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043554	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043555	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (5mo - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011043556	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043557	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043563	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043564	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043566	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043569	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043577	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043603	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal discomfort (0d - Recovered/Resolved - );Abdominal pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Body temperature increased (0d - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Lip oedema (6d - Recovered/Resolved - );Multisystem inflammatory syndrome in children (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (4d - Recovered/Resolved - );Rash (6d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011043631	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043665	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043680	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043685	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043699	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043741	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Feeling of body temperature change (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Lymphadenopathy (2d - Recovered/Resolved - Disabling);Malaise (2d - Recovered/Resolved - Disabling);Myalgia (2d - Recovered/Resolved - Disabling);Pain in extremity (2d - Recovered/Resolved - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011043779	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043814	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pleural mass (n/a - Unknown - Other Medically Important Condition);Pulmonary pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043823	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Overdose (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .6mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043837	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011043845	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043850	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Haemoptysis (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011043897	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Influenza like illness (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011043901	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011043952	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Sudden death (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011043974	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Mechanical urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011043974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044055	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044056	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044061	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044063	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044073	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044076	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044077	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044079	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044082	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - );Eye pain (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044085	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011044090	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044091	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011044187	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Injection site reaction (2d - Recovered/Resolved - Disabling);Malaise (2d - Recovered/Resolved - Disabling);Myalgia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011044292	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044302	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044305	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044306	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Echocardiogram (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044307	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044309	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011044314	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044317	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Generalised tonic-clonic seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Urinary incontinence (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044318	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysstasia (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Headache (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hypersomnia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Vaccination site bruising (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - 3.125mg - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - 25mg - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011044321	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cold sweat (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011044329	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044333	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Panic attack (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sight disability (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011044335	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lethargy (n/a - Unknown - );Palpitations (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044336	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044350	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abnormal dreams (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (3d - Recovered/Resolved - Other Medically Important Condition);Ocular icterus (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Yellow skin (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044352	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044358	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044360	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (3d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044361	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Myelitis transverse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044367	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044368	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044373	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044374	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044377	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - Other Medically Important Condition);Dysphagia (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tongue disorder (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[KETOTIFEN, KETOTIFEN HYDROGEN FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044379	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044381	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044384	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044386	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044411	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044415	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044430	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (4mo - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LOSARTAN POTASSIUM] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044478	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Condition aggravated (1mo - Recovered/Resolved - );Proctitis (1mo - Recovered/Resolved - );Rheumatoid arthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044480	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Photopsia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044483	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - );Platelet count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011044513	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044514	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovering/Resolving - );Back pain (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Hyperhidrosis (1d - Recovering/Resolving - );Pain (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Toothache (2d - Recovering/Resolving - );Tremor (1d - Recovering/Resolving - );Vaccination site movement impairment (2d - Recovering/Resolving - );Vaccination site pain (2d - Recovering/Resolving - );Vaccination site swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [8d - 180mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011044566	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044569	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044570	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044572	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044577	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044582	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044583	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044584	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011044589	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044594	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044597	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044604	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044605	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044607	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044626	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044630	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044631	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044633	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044634	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - );Peripheral nerve lesion (n/a - Unknown - );Vaccination site discomfort (2d - Recovered/Resolved - );Vein disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044641	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - );Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011044680	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011044739	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - Oral])|TRAJENTA [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])|[REPAGLINIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011044950	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XOLAIR [OMALIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011044951	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Muscle spasms (n/a - Recovered/Resolved - );Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011044952	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011044956	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Immunisation (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011044956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045037	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011045057	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045076	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045110	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ENBREL [ETANERCEPT] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045119	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045120	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (n/a - Unknown - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045125	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045126	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045127	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045130	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045139	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045140	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045141	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045147	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045150	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045197	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011045303	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Delusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hallucination, visual (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RIVASTIGMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045341	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045342	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045343	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ENBREL [ETANERCEPT] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011045345	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045349	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Malaise (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011045363	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gouty arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045364	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045367	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ataxia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045368	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045372	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [200d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045373	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045394	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045405	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045409	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011045410	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045414	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Drug withdrawn - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045419	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arteritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ENOXAPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045427	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045429	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|SEVELAMER HYDROCHLORIDE [SEVELAMER HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HEPARIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045436	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (5d - Recovered/Resolved - );Status epilepticus (1d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [214d - .3mL - Intramuscular])	KEPPRA 1000 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011045440	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045448	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011045451	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045452	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amaurosis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045453	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Motor dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045456	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011045457	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011045466	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (3d - Recovered/Resolved - );Hypoacusis (3d - Recovered/Resolved - );Tinnitus (3d - Recovered/Resolved - Other Medically Important Condition);Vertigo (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045467	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (36h - Recovered/Resolved - Other Medically Important Condition);Hot flush (5min - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (36h - Recovered/Resolved - Other Medically Important Condition);Vision blurred (2min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045471	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (20d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (20d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [21d - 2{DF} - Intramuscular])	REPAGLINIDE [REPAGLINIDE] (C - Type 2 diabetes mellitus - Dose not changed - [n/a - 1mg - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - Dose not changed - [n/a - 12.5mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - Dose not changed - [n/a - 1000mg - Oral])|[NICARDIPINE HYDROCHLORIDE] (C - Hypertension - Dose not changed - [n/a - 20mg - Oral])|[RAMIPRIL] (C - Hypertension - Dose not changed - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011045472	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	APROVEL 300 MG TABLETS [IRBESARTAN] (C - Hypertension - Unknown - [n/a - n/a - n/a])|CLOPIDOGREL HYDROGEN SULFATE [CLOPIDOGREL HYDROGEN SULFATE] (C - Peripheral arterial occlusive disease - Unknown - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - Unknown - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - Unknown - [n/a - n/a - n/a])|[RILMENIDINE] (C - Hypertension - Unknown - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - Insomnia - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045483	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045484	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011045486	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045491	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045492	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011045510	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Phlebitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045516	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Heart disease congenital (n/a - Not Recovered/Not Resolved - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [20d - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10011045546	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045556	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011045558	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (1d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Arterial thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011045571	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening);Tremor (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [66d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011045573	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vertigo (8d - Recovered/Resolved - Other Medically Important Condition);Vertigo positional (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045595	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Benign prostatic hyperplasia (n/a - Not Recovered/Not Resolved - );Incontinence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary retention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011045596	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045611	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (4d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (5d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (4d - Recovered/Resolved - );Vomiting (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045641	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2wk - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Rash pruritic (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045645	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045657	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045660	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045661	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry skin (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045663	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045665	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045667	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045673	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045675	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045676	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045678	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045679	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045680	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chillblains (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045692	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045695	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045704	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045713	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045717	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (20s - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045718	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045728	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045729	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045732	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gout (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045738	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011045741	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045751	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045766	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045770	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045838	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011045846	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045855	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045862	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011045904	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045912	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045923	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045951	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045952	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tooth abscess (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045971	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011045976	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045980	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045984	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011045995	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovering/Resolving - );Rash erythematous (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	AVAMYS 27.5 MICROGRAMS/SPRAY NASAL SPRAY SUSPENSION [FLUTICASONE FUROATE] (C - n/a - Not applicable - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011045995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046023	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash macular (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046033	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046041	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011046042	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046050	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046053	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046056	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046062	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Parotitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046065	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046066	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Recovered/Resolved - );Immunisation reaction (6d - Recovered/Resolved - );Photophobia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046071	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046074	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046078	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1min - Recovered/Resolved - );Malaise (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046110	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046129	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011046154	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lung disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046160	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ocular hyperaemia (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046162	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046167	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046169	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046171	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046181	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046186	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Halo vision (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046214	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046216	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Injection site discomfort (2d - Recovered/Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vaccination site pain (3d - Recovered/Resolved - );Vaccination site rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011046222	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046223	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046235	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046251	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046252	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046254	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046255	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046256	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Erectile dysfunction (n/a - Recovering/Resolving - );Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SITAGLIPTIN [SITAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM HYDROBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIPOTASSIUM CLORAZEPATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046259	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046261	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046262	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046263	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Ear discomfort (n/a - Unknown - );Ear pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046267	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046268	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046271	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046274	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046275	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046276	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046291	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046300	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046304	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain of skin (n/a - Unknown - Disabling, Other Medically Important Condition);Renal pain (n/a - Unknown - Disabling, Other Medically Important Condition);Skin discolouration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Skin tightness (n/a - Unknown - Disabling, Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011046305	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046306	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046310	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046321	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Komatsuda, E.. A Case of Erythema Multiform-like Eruption Following Vaccination Against COVID-19. The Japanese Journal of Dermatology. 2021;131(12):2605	65-85 Years	Not Specified	No	Male	Erythema multiforme (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046331	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046342	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011046354	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046356	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046357	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046359	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046370	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Back pain (8d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046373	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046376	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046379	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (15min - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046387	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046388	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011046389	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Autoimmune hepatitis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Hepatic failure (n/a - Unknown - Life Threatening, Other Medically Important Condition);Jaundice (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Renal failure (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011046402	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	SYNJARDY [METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - )|[LATANOPROST, TIMOLOL, TIMOLOL MALEATE, LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046412	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune hepatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Hepatitis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malignant melanoma (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INSULIN GLARGINE [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|INSULIN HUMAN [INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|PEMBROLIZUMAB [PEMBROLIZUMAB] (C - Malignant melanoma - n/a - [291d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046417	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046427	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Echocardiogram normal (n/a - Not Recovered/Not Resolved - );Electrocardiogram normal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046428	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046431	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Chromaturia (n/a - Unknown - Disabling, Other Medically Important Condition);Flank pain (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);White blood cells urine positive (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011046434	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Crohn's disease - n/a - [332d - n/a - n/a])|[ADALIMUMAB] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046435	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046436	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046439	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cold sweat (n/a - Unknown - Other Medically Important Condition);Dysarthria (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046449	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (2d - Recovered/Resolved - Other Medically Important Condition);Hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046451	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND HEPATITIS B (RDNA) VACCINE (ADSORBED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046454	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inflammation (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011046455	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046462	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046464	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046469	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dry throat (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait inability (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Muscle spasms (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011046472	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046474	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011046522	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046532	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046564	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovered/Resolved - );Chills (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046605	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (50d - Recovered/Resolved - );Dyspnoea (59d - Recovering/Resolving - );Fatigue (34d - Recovered/Resolved - );Feeling hot (n/a - Unknown - );Headache (39d - Recovered/Resolved - );Limb discomfort (14d - Recovered/Resolved - );Lymphadenopathy (50d - Recovered/Resolved - );Myalgia (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011046608	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovering/Resolving - );Euphoric mood (0d - Recovering/Resolving - );Fatigue (0d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovering/Resolving - );Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046641	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046761	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046773	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046938	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011046942	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011046947	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011046947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047008	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011047012	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047047	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047069	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Sudden cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011047098	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (3d - Recovered/Resolved - );Extensive swelling of vaccinated limb (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[NEBIVOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047177	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047184	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047205	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema peripheral (6d - Recovered/Resolved - );Peripheral swelling (6d - Recovered/Resolved - );Pruritus (6d - Recovered/Resolved - );Urticaria (6d - Recovered/Resolved - );Vaccination site pruritus (7d - Recovered/Resolved - );Vaccination site swelling (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047261	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047278	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047296	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Gastrointestinal pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047307	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (21h - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047308	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047313	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047315	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047316	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047318	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047319	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047320	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047322	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047323	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Sinusitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047324	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047327	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047328	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047329	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Anxiety (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Flushing (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Insomnia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011047330	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047331	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - );Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047334	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047340	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dehydration (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047341	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047346	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047347	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047349	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047351	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047354	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular symptom (n/a - Unknown - );Fear of death (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011047357	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[HYALURONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047358	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (8min - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Pallor (8min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047359	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Disabling);Anxiety (n/a - Unknown - Disabling);Chest discomfort (n/a - Unknown - Disabling);Disturbance in attention (n/a - Unknown - Disabling);Dizziness (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Unknown - Disabling);Influenza like illness (n/a - Unknown - Disabling);Lethargy (n/a - Unknown - Disabling);Migraine (n/a - Unknown - Disabling);Mood swings (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Oedema peripheral (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling);Presyncope (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling);Rash (n/a - Unknown - Disabling);Swelling (n/a - Unknown - Disabling);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling);Wheezing (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011047360	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Goitre (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Throat tightness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047361	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047365	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047366	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (10min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047367	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047376	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047381	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047388	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047392	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sepsis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047400	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047401	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047404	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chronic sinusitis (n/a - Unknown - );Hypertension (n/a - Unknown - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047405	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047412	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047413	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047414	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abdominal distension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047416	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011047419	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047420	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047430	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047431	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047437	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	SILODOSIN [SILODOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BREXPIPRAZOLE] (C - Depression, Insomnia - n/a - [n/a - n/a - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|[DUTASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[ESTAZOLAM] (C - Depression, Insomnia - n/a - [n/a - n/a - Oral])|[FLUVOXAMINE MALEATE] (C - Depression, Insomnia - n/a - [n/a - n/a - Oral])|[FURSULTIAMINE, FURSULTIAMINE, RIBOFLAVIN] (C - Neuropathy peripheral - n/a - [n/a - n/a - Oral])|[MECOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[REBAMIPIDE] (C - Chronic gastritis - n/a - [n/a - n/a - Oral])|[SUVOREXANT] (C - Depression, Insomnia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047441	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047445	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047446	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011047452	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Cardiac arrest (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Life Threatening);Coronary artery disease (n/a - Recovering/Resolving - Life Threatening);Tachyarrhythmia (n/a - Recovering/Resolving - Life Threatening);Ventricular tachycardia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011047455	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hypoaesthesia oral (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011047462	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047469	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047474	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Catarrh (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Oropharyngeal discomfort (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047477	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - );Peroneal nerve palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory loss (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047478	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Cerebral haemorrhage (n/a - Fatal - Results in Death);Cerebral ventricular rupture (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011047479	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Polymyositis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047483	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047492	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Muscular weakness (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Testicular pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047500	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047504	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011047507	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Microscopic polyangiitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047509	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site bruising (n/a - Unknown - );Vaccination site haemorrhage (n/a - Unknown - );Vaccination site mass (n/a - Unknown - );Vessel puncture site injury (n/a - Unknown - );Wrong technique in product usage process (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011047514	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047520	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047521	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram normal (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047522	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047524	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eyelid ptosis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fungal infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Granulomatosis with polyangiitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunoglobulin G4 related disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Sarcoidosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Tolosa-Hunt syndrome (19d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Trigeminal nerve disorder (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047527	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Hypoaesthesia (3d - Recovered/Resolved - );Muscle twitching (3d - Recovered/Resolved - );Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047550	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047551	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovered/Resolved - );Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047601	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Paresis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Platelet count decreased (n/a - Unknown - );Red blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047603	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Fall (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Foot fracture (n/a - Recovering/Resolving - Other Medically Important Condition);Head injury (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUPROPION] (C - Depression - n/a - [n/a - 450mg - Oral])|[BUSPIRONE] (C - Panic attack - n/a - [n/a - 15mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047608	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeding disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[GUANFACINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Depression - n/a - [n/a - 25mg - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 100mg - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047613	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (33min - Recovered/Resolved - Other Medically Important Condition);Dizziness (33min - Recovered/Resolved - );Nausea (33min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047620	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047626	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30min - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047638	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Kaposi's sarcoma (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047649	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - );Hypoaesthesia eye (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GLIPIZIDE] (C - Diabetes mellitus - n/a - [n/a - 10mg - n/a])|[METFORMIN HYDROCHLORIDE, CANAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 150mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047651	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Feeding disorder (n/a - Not Recovered/Not Resolved - Disabling);Groin pain (n/a - Not Recovered/Not Resolved - Disabling);Oesophageal disorder (n/a - Not Recovered/Not Resolved - Disabling);Tension headache (n/a - Not Recovered/Not Resolved - Disabling);Throat irritation (n/a - Not Recovered/Not Resolved - Disabling);Weight decreased (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011047742	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011047762	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011047765	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011047775	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Life Threatening);Fatigue (n/a - Unknown - Life Threatening);Heart sounds abnormal (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Unknown - Life Threatening);Palpitations (n/a - Unknown - Life Threatening);Pericarditis (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011047776	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Prolapse (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047780	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Unknown - Other Medically Important Condition);Aphasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Gait inability (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Neurological decompensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Psychomotor skills impaired (n/a - Not Recovered/Not Resolved - );Wheelchair user (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011047787	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011047790	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047799	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047806	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Impaired healing (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047836	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047858	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Vitreous detachment (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047864	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nodule (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047866	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047870	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Leukaemia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047874	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047879	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (2d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Irritability (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition);Oral candidiasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (12d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047883	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - );Cognitive disorder (n/a - Unknown - );Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flatulence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hunger (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047890	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Head injury (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047895	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chromaturia (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition);Haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Head discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Head injury (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Scar (n/a - Recovered/Resolved - Other Medically Important Condition);Skin warm (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047899	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blepharospasm (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011047900	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011047909	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047913	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047921	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Disabling);Dysphonia (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Illness (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Lung disorder (n/a - Not Recovered/Not Resolved - Disabling);Mental disorder (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Post-acute COVID-19 syndrome (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011047968	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011047973	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Tinoco, M.. Perimyocarditis Following COVID-19 Vaccination. Clinical Medicine Insights: Cardiology. 2021;15:1-4. doi:10.1177/11795468211056634	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011047979	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling);Movement disorder (n/a - Unknown - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011047984	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011047986	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Product administration error (n/a - Unknown - );Vaccination site haemorrhage (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011047986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048021	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chronic obstructive pulmonary disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048049	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048061	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Ageusia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048064	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Osteoarthritis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011048210	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Immunisation reaction (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048226	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048227	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (555min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048229	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048269	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011048278	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048279	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - Topical])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011048348	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Disabling);Headache (n/a - Recovered/Resolved - Disabling);Presyncope (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011048358	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048363	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vasodilatation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048366	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatic function abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Viral infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011048372	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (6d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011048387	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011048394	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Headache (n/a - Unknown - );Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011048467	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048488	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Albumin globulin ratio decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood albumin decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood immunoglobulin A increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Globulins increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Haematocrit decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemoglobin decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Post herpetic neuralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash vesicular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Red blood cell count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Viral test positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIAZEPAM] (C - Neurosis - n/a - [n/a - n/a - Oral])|[SULPIRIDE] (C - Neurosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011048489	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling);Trigger finger (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011048493	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Oedema peripheral (n/a - Not Recovered/Not Resolved - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011048508	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048532	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (16d - Recovering/Resolving - );Rash (16d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011048537	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myalgia (19d - Not Recovered/Not Resolved - );Myositis (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048542	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (11d - Not Recovered/Not Resolved - );Dyspnoea (11d - Not Recovered/Not Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Malaise (11d - Not Recovered/Not Resolved - );Nausea (11d - Not Recovered/Not Resolved - );Palpitations (11d - Not Recovered/Not Resolved - );Vertigo (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011048543	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (110d - Not Recovered/Not Resolved - );Hypoaesthesia (110d - Not Recovered/Not Resolved - );Muscular weakness (110d - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011048576	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (3d - Recovered/Resolved - );Pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048604	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - );Cerebrospinal fluid leakage (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048615	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspepsia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial injury (n/a - Unknown - Other Medically Important Condition);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011048629	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute sinusitis (19d - Not Recovered/Not Resolved - );Influenza (19d - Not Recovered/Not Resolved - );Pyrexia (19d - Not Recovered/Not Resolved - );Rhinitis (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048630	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (27d - Recovering/Resolving - );Arrhythmia (27d - Recovering/Resolving - );Asthenia (27d - Recovering/Resolving - );Dizziness (27d - Recovering/Resolving - );Musculoskeletal chest pain (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011048726	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (9d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048730	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Miliaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048737	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovering/Resolving - );Headache (14d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Neck pain (32d - Not Recovered/Not Resolved - );Tachycardia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011048802	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048807	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Dehydration (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovered/Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Paranasal sinus discomfort (n/a - Recovering/Resolving - );Polyuria (n/a - Recovering/Resolving - );Productive cough (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Sinus pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011048834	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011048845	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved - );Fall (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048861	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011048889	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048893	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - );Sleep disorder (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048897	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (73d - Not Recovered/Not Resolved - );Fatigue (73d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011048921	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (16d - Not Recovered/Not Resolved - );Diarrhoea (16d - Not Recovered/Not Resolved - );Erythema (16d - Not Recovered/Not Resolved - );Rash macular (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048937	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Polymenorrhoea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011048960	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal loss of weight (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Blood magnesium decreased (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011048960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011049000	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	General physical health deterioration (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Poisoning (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Angiogram - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Angiogram - n/a - [n/a - n/a - n/a])|[MAGNESIUM ASPARTATE DIHYDRATE, MAGNESIUM CITRATE, MAGNESIUM ASPARTATE DIHYDRATE, MAGNESIUM CITRATE ANHYDROUS, MAGNESIUM OXIDE, LIGHT] (C - Angiogram - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Angiogram - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Angiogram - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011049004	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049022	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011049064	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (15min - Recovered/Resolved - );Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - );Blood pressure immeasurable (n/a - Unknown - );Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - );Incontinence (n/a - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Metabolic acidosis (n/a - Recovering/Resolving - );Presyncope (n/a - Recovered/Resolved - );Urinary incontinence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011049087	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (30d - Recovering/Resolving - );Tachycardia (30d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011049091	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049153	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049161	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049169	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049263	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049271	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049273	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049281	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (183d - Recovered/Resolved - );Rash (81d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011049377	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049411	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049412	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049422	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011049425	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011049427	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049483	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhagic stroke (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011049503	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac flutter (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011049573	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049632	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (1470min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011049665	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011049712	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011049736	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049790	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049796	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Crying (n/a - Unknown - Other Medically Important Condition);Depressed mood (n/a - Unknown - Other Medically Important Condition);Depression (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Frustration tolerance decreased (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Mental disorder (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Shoulder injury related to vaccine administration (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Vaccination site movement impairment (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011049835	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011049836	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chronic obstructive pulmonary disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity pneumonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011049869	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049874	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011049878	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	NOT AVAILABLE (C - Dyslipidaemia - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - Hypertension - Dose not changed - [n/a - 20mg - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 100mg - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 20mg - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/MASSACHUSETTS/02/2012, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A] (C - Influenza immunisation - Not applicable - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049901	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (57d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011049917	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - );Tachycardia (3d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011049924	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049931	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049935	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011049954	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash papular (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Unknown - [1d - 1{DF} - Intramuscular - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049990	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011049993	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011049993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050010	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Unknown - );Pyrexia (n/a - Unknown - );Temperature regulation disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050070	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Headache (4d - Recovered/Resolved - );Vision blurred (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050072	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050075	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Chest pain (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050086	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050088	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050104	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050130	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050144	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050146	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050148	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050150	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050152	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011050160	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (63d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011050162	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epididymitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050198	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (0d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dysarthria (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Musculoskeletal disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory depression (0d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO [RIVAROXABAN] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011050205	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011050211	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate decreased (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ENALAPRIL MALEATE] (C - Hypertension - n/a - [72d - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011050255	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Generalised tonic-clonic seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myoclonic epilepsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011050327	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (4d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (4d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011050372	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Albach, F.. Successful BNT162b2 booster vaccinations in a patient with rheumatoid arthritis and initially negative antibody response. Annals of the Rheumatic Diseases. 2021;1-2. doi:10.1136/annrheumdis-2021-220834 Albach, F.. Successful BNT162b2 booster vaccinations in a patient with rheumatoid arthritis and initially negative antibody response. Annals of the Rheumatic Diseases. 2021;80:1361-1362. doi:10.1136/annrheumdis-2021-220834	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - 10mg - n/a - More in ICSR])|UPADACITINIB [UPADACITINIB] (C - Rheumatoid arthritis - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050443	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Albach, F.. Successful BNT162b2 booster vaccinations in a patient with rheumatoid arthritis and initially negative antibody response. Annals of the Rheumatic Diseases. 2021;80:1361-1362. doi:10.1136/annrheumdis-2021-220834	18-64 Years	Not Specified	No	Male	Asthenia (5d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - 10mg - n/a - More in ICSR])|UPADACITINIB [UPADACITINIB] (C - Rheumatoid arthritis - n/a - [n/a - 15mg - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - 100mg - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050447	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050448	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - Disabling);Heart rate (n/a - Recovered/Resolved With Sequelae - Disabling);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling);Tachycardia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011050457	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[COVID-19 VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050459	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Metamorphopsia (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011050470	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Flushing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia oral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash pruritic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Restlessness (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011050512	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Application site swelling (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050525	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Haematemesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immune system disorder (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050529	Spontaneous	2021-12-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050549	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050567	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050588	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050602	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050619	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovered/Resolved - Other Medically Important Condition);Dermatitis contact (n/a - Unknown - );Dysstasia (10d - Recovered/Resolved - );Feeling drunk (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (2d - Recovered/Resolved - );Migraine (n/a - Unknown - );Pyrexia (3wk - Recovered/Resolved - );Skin lesion (n/a - Unknown - );Thrombocytosis (n/a - Unknown - );Vertigo (n/a - Recovered/Resolved - );Vertigo positional (8d - Recovered/Resolved - );Vocal cord paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LYRICA [PREGABALIN] (C - Polyneuropathy, Tinnitus - n/a - [n/a - 450mg - Oral])|TRIUMEQ [ABACAVIR, LAMIVUDINE, DOLUTEGRAVIR] (C - HIV infection - n/a - [n/a - n/a - Oral])|[CHONDROITIN SULFATE] (C - Joint destruction - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011050693	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011050803	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050805	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050816	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050862	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050872	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011050877	Spontaneous	2021-12-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011050877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019483	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019548	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Mydriasis (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Visual impairment (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019580	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019617	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Testicular swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011019622	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011019623	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011019667	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019821	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Laryngeal stenosis (n/a - Recovering/Resolving - Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011019839	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011019843	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Erythema (n/a - Not Recovered/Not Resolved - Disabling);Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011019848	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Recovering/Resolving - Life Threatening);Confusional state (n/a - Recovering/Resolving - Life Threatening);Head discomfort (n/a - Recovering/Resolving - Life Threatening);Hyponatraemia (n/a - Recovering/Resolving - Life Threatening);Nausea (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011019861	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Otitis media (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011019863	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (1d - Recovered/Resolved - );Dyslalia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011019866	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Life Threatening);Bradycardia (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Herpes zoster (n/a - Recovering/Resolving - Life Threatening);Hyperhidrosis (n/a - Recovering/Resolving - Life Threatening);Hypotension (n/a - Recovering/Resolving - Life Threatening);Pallor (n/a - Recovering/Resolving - Life Threatening);Pyrexia (n/a - Recovering/Resolving - Life Threatening);Somnolence (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011019884	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019889	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Flank pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019898	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019903	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibromyalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011019915	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved With Sequelae - Life Threatening);Hypersensitivity (n/a - Recovered/Resolved With Sequelae - Life Threatening);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011019934	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neuromyelitis optica spectrum disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011019945	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019955	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Full blood count abnormal (n/a - Unknown - );White blood cell disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019959	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011019988	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Prostatitis (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019998	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011020068	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening);Spleen ischaemia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011020092	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site discomfort (n/a - Not Recovered/Not Resolved - );Injection site paraesthesia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020094	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020106	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vertigo (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020142	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Telangiectasia (n/a - Recovering/Resolving - );Varicose vein (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	SILODYX 8 MG HARD CAPSULES [SILODOSIN] (C - Neoplasm prostate - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - Dyslipidaemia - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS 90] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020155	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020159	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Rash (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020160	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (175d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011020164	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Fatal - Results in Death);Back pain (n/a - Fatal - Results in Death);Gastrointestinal necrosis (n/a - Fatal - Results in Death);Intestinal infarction (n/a - Fatal - Results in Death);Myocardial infarction (n/a - Fatal - Results in Death);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011020169	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011020247	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020248	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020272	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Flushing (n/a - Unknown - );Oedema (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020278	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020282	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Feeling cold (4d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020292	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - 20[iU] - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - 10[iU] - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020295	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020307	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Venous thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020317	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Respiratory fatigue (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Stress (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020322	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020326	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020336	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020349	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020392	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020396	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020406	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020409	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - Life Threatening);Fatigue (n/a - Recovering/Resolving - Life Threatening);Migraine (n/a - Recovering/Resolving - Life Threatening);Rash macular (n/a - Recovering/Resolving - Life Threatening);Stomatitis (n/a - Recovering/Resolving - Life Threatening);Thrombocytopenia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011020413	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020419	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020428	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoacusis (n/a - Recovered/Resolved With Sequelae - Disabling);Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011020441	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020448	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020451	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020453	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperpyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011020464	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure measurement (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020487	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Thyroiditis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020501	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[DIGOXIN, DIGOXIN PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020508	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Erythema (0d - Recovered/Resolved - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011020513	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020515	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020517	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020523	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020524	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020536	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Bone pain (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020557	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site inflammation (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020561	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020563	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020689	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep terror (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011020840	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020845	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020867	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020868	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Carditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020869	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020871	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020877	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020882	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020888	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020889	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020892	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020893	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020908	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011020914	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020926	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011020937	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020938	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011020948	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011020984	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011020986	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011020986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011021153	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011021167	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011021168	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011021181	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011021187	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (22d - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Loss of consciousness (14d - Recovered/Resolved - Other Medically Important Condition);Seizure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011021190	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011021194	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011021239	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition);Product administration error (0d - Unknown - );Skin reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011021459	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011021734	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (95d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Brain oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Encephalitis autoimmune (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Hallucination (n/a - Unknown - Other Medically Important Condition);Hypokalaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Psychotic disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (95d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Status epilepticus (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Transaminases increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011021884	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1h - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (1h - Recovered/Resolved - Other Medically Important Condition);Sick leave (1h - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011021960	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Disabling);Discomfort (n/a - Unknown - Disabling);Dizziness (n/a - Unknown - Disabling);Injection site pain (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011021963	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011021963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022029	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022033	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022040	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epstein-Barr virus infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Prostatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Splenomegaly (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022099	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022102	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022107	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022109	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022115	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022116	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011022124	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022125	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022127	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011022128	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022131	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infarction (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022132	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022135	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac tamponade (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022158	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022159	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022162	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Magnetic resonance imaging abnormal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022172	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022173	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022174	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cold sweat (n/a - Not Recovered/Not Resolved - );Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear congestion (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022179	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022182	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022185	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Recovered/Resolved - );Initial insomnia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022199	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TESTOSTERONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022203	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022204	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022207	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022212	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022215	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022222	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022227	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022229	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022230	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022237	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022238	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022245	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022246	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022253	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ejection fraction decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema due to cardiac disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - Cardiac disorder - n/a - [n/a - 4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011022254	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Anaphylactic reaction (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood glucose increased (n/a - Unknown - );Blood pressure decreased (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood uric acid increased (n/a - Unknown - );Cold sweat (n/a - Unknown - );Defaecation urgency (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Faeces soft (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);High density lipoprotein decreased (n/a - Unknown - );Low density lipoprotein increased (n/a - Unknown - );Mental impairment (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Pallor (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Somnolence (10h - Recovered/Resolved - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011022263	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (4d - Recovered/Resolved - Other Medically Important Condition);Ear pain (4d - Recovered/Resolved - Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Headache (4d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (4d - Recovered/Resolved - Other Medically Important Condition);Nausea (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022266	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022267	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022268	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022271	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022282	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Immunisation (n/a - Unknown - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022285	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022296	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Illness (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Malaise (n/a - Recovered/Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling);Vomiting (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011022301	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022304	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022305	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022306	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022308	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pancreatitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022310	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022314	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Libido decreased (n/a - Not Recovered/Not Resolved - );Premature ejaculation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011022319	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022322	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022325	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022328	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022357	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022368	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022372	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022528	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (40h - Recovered/Resolved - );Diarrhoea (40h - Recovered/Resolved - );Myalgia (40h - Recovered/Resolved - );Pyrexia (40h - Recovered/Resolved - );Vomiting (40h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Ischaemic heart disease prophylaxis - n/a - [n/a - 1{DF} - Oral])|[ACETYLSALICYLIC ACID] (C - Ischaemic heart disease prophylaxis - n/a - [n/a - 1{DF} - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Ischaemic heart disease prophylaxis - n/a - [n/a - 1{DF} - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Ischaemic heart disease prophylaxis - n/a - [n/a - 1{DF} - Oral])|[RAMIPRIL] (C - Ischaemic heart disease prophylaxis - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022546	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Dermatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Formication (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Spinal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE HYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022548	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022568	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022586	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011022607	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [10s - 1{DF} - Intramuscular - More in ICSR])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022636	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Confusional state (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011022638	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022683	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011022703	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022707	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Unknown - );Lip dry (n/a - Unknown - );Lip ulceration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011022726	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022764	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - 80ug - Intramuscular])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011022765	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COLCHICINE] (C - Gout - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022772	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	KUVAN 100 MG SOLUBLE TABLETS [SAPROPTERIN DIHYDROCHLORIDE] (C - Phenylketonuria - n/a - [n/a - n/a - n/a])|[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022784	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022794	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022796	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022797	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022801	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022813	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022817	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022820	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022823	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Unknown - );Extrasystoles (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022825	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022829	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022838	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022903	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - Disabling);Chills (3d - Recovered/Resolved - Disabling);Decreased appetite (3d - Recovered/Resolved - Disabling);Fatigue (3d - Recovered/Resolved - Disabling);Feeling cold (3d - Recovered/Resolved - Disabling);Headache (3d - Recovered/Resolved - Disabling);Hypersomnia (3d - Recovered/Resolved - Disabling);Injection site reaction (3d - Recovered/Resolved - Disabling);Myalgia (3d - Recovered/Resolved - Disabling);Nausea (3d - Recovered/Resolved - Disabling);Pyrexia (3d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011022918	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022920	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022927	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Head discomfort (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022945	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Body temperature increased (4d - Recovered/Resolved - );Decreased appetite (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling cold (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022953	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011022963	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011022973	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthma (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiovascular disorder (n/a - Unknown - );Choking sensation (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Hypoventilation (n/a - Unknown - Other Medically Important Condition);Hypoxia (n/a - Unknown - Other Medically Important Condition);Hypoxic-ischaemic encephalopathy (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011022974	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomegaly (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nephrolithiasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Sepsis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022975	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011022991	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011022991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011023001	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011023013	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011023020	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Unknown - Other Medically Important Condition);Brain injury (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CYCLOBENZAPRINE] (C - Pain - n/a - [n/a - n/a - Oral])|[PRAZOSIN] (C - Post-traumatic stress disorder - n/a - [n/a - n/a - Oral])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011023023	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011023026	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary thrombosis (185d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011023045	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011023050	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Renal impairment (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011023063	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011023065	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition);Skin reaction (1d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011023074	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DEXAMFETAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011023113	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acquired amegakaryocytic thrombocytopenia (n/a - Unknown - Disabling);Hemiparesis (n/a - Unknown - Disabling);Neurological symptom (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011023119	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (5d - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011023514	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pancreatitis acute (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MICARDIS 80 MG [TELMISARTAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011023525	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diabetes mellitus inadequate control (6d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dysphagia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Speech disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	LANTUS SOLOSTAR [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011023545	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (4mo - Recovered/Resolved - );Malaise (4mo - Recovered/Resolved - );Myocarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011023548	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (7d - Recovered/Resolved - );Swelling face (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011023549	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site inflammation (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011023571	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011023612	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011023628	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011023699	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011023751	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Impaired driving ability (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011023775	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011023775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011024055	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011024097	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011024294	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011024360	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	NOT AVAILABLE [BISOPROLOL, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PITAVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011024631	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	APROVEL [IRBESARTAN] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011024638	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Body temperature increased (24h - Unknown - Other Medically Important Condition);Chills (24h - Unknown - Other Medically Important Condition);Insomnia (24h - Unknown - Other Medically Important Condition);Muscle tightness (24h - Unknown - Other Medically Important Condition);Neck pain (24h - Unknown - Other Medically Important Condition);Pain (24h - Unknown - Other Medically Important Condition);Pain in extremity (24h - Unknown - Other Medically Important Condition);Temperature regulation disorder (24h - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011024675	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Recovered/Resolved - Disabling);Sleep disorder (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011024734	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Chills (n/a - Unknown - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011024806	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - Disabling);Neuralgia (n/a - Recovering/Resolving - Disabling);Radicular pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011024826	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011024897	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mesenteric lymphadenitis (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011024933	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Superficial vein thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombophlebitis migrans (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Varicose vein (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	MABTHERA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION [RITUXIMAB] (C - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - Oral])|[SERTRALINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011024962	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Disabling);Chest discomfort (n/a - Unknown - Disabling);Exercise tolerance decreased (n/a - Unknown - Disabling);Injection site pain (n/a - Unknown - Disabling);Lethargy (n/a - Unknown - Disabling);Mental disorder (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011024990	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011024993	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011024995	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011024996	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011024998	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011024998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025001	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025003	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025006	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025028	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025049	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Encephalitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011025059	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011025062	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Supraventricular extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011025071	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pyrexia (4d - Recovered/Resolved - Life Threatening);Syncope (0d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011025072	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011025108	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011025124	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BETAMETHASONE, BETAMETHASONE VALERATE, BETAMETHASONE VALERATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[KETOCONAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL ANHYDROUS, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011025300	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amputation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Organ failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pneumonitis (32d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site reaction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025301	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025304	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025313	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025314	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025316	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025319	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025320	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025348	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025350	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025365	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025381	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Discomfort (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025384	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - );Rheumatic disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025417	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025419	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025423	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025439	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (166d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025442	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025446	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025448	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011025468	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025472	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025484	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Walking aid user (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011025485	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025486	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025488	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025498	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025503	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025540	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025577	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Disabling);Exercise tolerance decreased (n/a - Recovering/Resolving - Disabling);Myocarditis (n/a - Recovering/Resolving - Disabling);Sleep disorder (n/a - Recovering/Resolving - Disabling);Supraventricular extrasystoles (n/a - Recovering/Resolving - Disabling);Ventricular extrasystoles (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011025623	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025624	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025713	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011025762	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (3d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025777	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011025788	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011025799	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011025909	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025911	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025916	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011025997	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011025997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026020	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (4d - Unknown - Other Medically Important Condition);Fatigue (4d - Unknown - Other Medically Important Condition);Pyrexia (4d - Unknown - Other Medically Important Condition);Tachycardia (4d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026053	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (48h - Recovered/Resolved - );Fatigue (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026291	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026333	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Bedridden (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Constipation (n/a - Recovered/Resolved - );Decubitus ulcer (n/a - Recovered/Resolved - );Dysaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovered/Resolved - );Exercise tolerance decreased (n/a - Recovered/Resolved - );Facial paresis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - );Infection reactivation (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Recovered/Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinary hesitation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ACEMETACIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[BETAMETHASONE DIPROPIONATE, BETAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 40mg - n/a])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - 75mg - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - 1500mg - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - 40mg - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MONOHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[MAGNESIUM CARBONATE, LIGHT, MAGNESIUM OXIDE, LIGHT, MAGNESIUM CARBONATE, MAGNESIUM OXIDE, MAGNESIUM OXIDE, LIGHT, MAGNESIUM CARBONATE] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011026349	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026353	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026357	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026363	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026364	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026380	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026411	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (0d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026443	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[GABAPENTIN] (C - n/a - Dose not changed - [n/a - 900mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026478	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026479	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026480	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026482	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Nasal congestion (n/a - Unknown - );Sputum discoloured (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026499	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026507	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026516	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Arthritis (n/a - Unknown - );Chest pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Poor quality sleep (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011026521	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - );Immunisation (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026561	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site scar (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [58d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011026575	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - );Disorientation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypopnoea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Panic reaction (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026584	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anti-ganglioside antibody positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Constipation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased vibratory sense (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dry mouth (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lumbar radiculopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Reflexes abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Spinal osteoarthritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Urinary retention (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCUSATE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011026585	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026588	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011026589	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011026615	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026623	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011026628	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (10d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (10d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])|VAXZEVRIA SUSPENSION FOR INJECTION COVID-19 VACCINE (CHADOX1-S [RECOMBINANT]) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011026650	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011026651	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026666	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (18h - Recovered/Resolved - );Fatigue (4h - Recovered/Resolved - );Injection site pain (12h - Recovered/Resolved - );Myalgia (18h - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026721	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026743	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026744	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026749	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011026762	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011026767	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026770	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026776	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026782	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026783	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026786	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011026790	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011026803	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026807	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026808	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011026826	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011026826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027017	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - Varicose vein - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - )|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011027041	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027046	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Coma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Resuscitation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011027047	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027048	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027057	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027059	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027061	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027063	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027064	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027066	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breath sounds abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Erectile dysfunction (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027069	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027072	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027073	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Basilar artery thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);General physical condition abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011027074	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027076	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Not Recovered/Not Resolved - );Dyspnoea (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - );Headache (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011027079	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac disorder (205d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027087	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (100d - Recovered/Resolved - Disabling);Fatigue (100d - Recovered/Resolved - Disabling);Menstruation delayed (100d - Recovered/Resolved - Disabling);Myalgia (100d - Recovered/Resolved - Disabling);Uterine pain (100d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TESTOSTERONE DECANOATE, TESTOSTERONE ISOCAPROATE, TESTOSTERONE PHENYLPROPIONATE, TESTOSTERONE PROPIONATE, TESTOSTERONE ISOCAPROATE, TESTOSTERONE PHENYLPROPIONATE, TESTOSTERONE PROPIONATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10011027090	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (37d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Thrombophlebitis (37d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011027096	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027099	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027105	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027106	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swelling (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027107	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027108	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027121	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027127	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011027129	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cyanosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027132	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027137	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027191	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dysgeusia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027207	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027225	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027226	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011027235	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid ptosis (8h - Recovering/Resolving - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027240	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Sensory loss (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027242	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeding disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Giant cell arteritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Joint stiffness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - Hypertonic bladder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027246	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027247	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Furuncle (n/a - Unknown - );Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027255	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011027258	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Peroneal nerve palsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027285	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027291	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027293	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027294	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027295	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027300	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027301	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027302	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027303	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027308	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027312	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027314	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027364	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (5d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027406	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rotator cuff syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027431	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Hepatic enzyme increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027536	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Recovering/Resolving - );Thrombophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011027550	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (20min - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027644	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011027655	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027659	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cluster headache (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027675	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027676	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027678	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027680	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027687	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027688	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027690	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027695	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027698	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027710	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027714	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027717	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027733	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027734	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027751	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Asthenia (n/a - Unknown - );Peripheral vascular disorder (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Seasonal allergy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027754	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011027781	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027783	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027784	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027789	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027792	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	Yes	Male	Eczema eyelids (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027796	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027799	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027801	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[CLOZAPINE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027802	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027812	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027816	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027817	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027819	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (5d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Palpitations (6d - Recovered/Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027820	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027821	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Fatal - Results in Death);Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death);Feeling cold (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Lethargy (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death);Myocardial ischaemia (n/a - Fatal - Results in Death, Other Medically Important Condition);Pain in extremity (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011027823	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027824	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027826	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027827	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027828	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Stress cardiomyopathy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular fibrillation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011027830	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027832	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Burning sensation (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Respiratory disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory tract congestion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Goitre, Hypothyroidism, Thyroid operation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027834	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027836	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027837	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027838	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027839	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027841	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Angina pectoris (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthralgia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cluster headache (17d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Tuberculosis - n/a - [5d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011027843	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027844	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027848	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest X-ray abnormal (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram normal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027850	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027853	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027858	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027860	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027862	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027864	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Pleurisy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027867	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027871	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027873	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027875	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027877	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027881	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011027894	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Gait disturbance (n/a - Recovering/Resolving - );Impaired work ability (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027895	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027896	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027901	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027904	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027907	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Retinal detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011027909	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Platelet count decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027914	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027918	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027923	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027924	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem haemorrhage (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011027925	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027931	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027933	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027936	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011027938	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027943	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027949	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Electrocardiogram normal (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027951	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dizziness postural (n/a - Unknown - );Dyspnoea exertional (n/a - Unknown - );Echocardiogram abnormal (n/a - Unknown - );Fatigue (n/a - Unknown - );Lethargy (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027953	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027954	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Electrocardiogram PR segment depression (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011027956	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bursitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyarthritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Cerebrovascular accident - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011027956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028169	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Activated partial thromboplastin time prolonged (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - );Blood bilirubin increased (n/a - Unknown - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Unknown - Other Medically Important Condition);Body temperature increased (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Hypokalaemia (n/a - Fatal - Results in Death);Hyponatraemia (n/a - Fatal - Results in Death);Lipase decreased (n/a - Unknown - );Pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition);Prothrombin time prolonged (n/a - Unknown - );White blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028194	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Faecaloma (n/a - Recovering/Resolving - Other Medically Important Condition);Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myelitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myelopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Urinary retention (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	EXELON [RIVASTIGMINE] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - Cutaneous])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028195	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Disorientation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028197	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028199	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Miliaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028202	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028207	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperthermia (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immune system disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tonsillitis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028209	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (45d - Unknown - Other Medically Important Condition);Arthralgia (45d - Unknown - Other Medically Important Condition);Chest pain (45d - Unknown - Other Medically Important Condition);Erythema (45d - Unknown - Other Medically Important Condition);Eye irritation (45d - Unknown - Other Medically Important Condition);Gait disturbance (45d - Unknown - Other Medically Important Condition);Headache (45d - Unknown - Other Medically Important Condition);Heart rate decreased (45d - Unknown - Other Medically Important Condition);Limb discomfort (45d - Unknown - Other Medically Important Condition);Lip swelling (45d - Unknown - Other Medically Important Condition);Migraine (45d - Unknown - Other Medically Important Condition);Ocular hyperaemia (45d - Unknown - Other Medically Important Condition);Paraesthesia (45d - Unknown - Other Medically Important Condition);Pharyngeal swelling (45d - Unknown - Other Medically Important Condition);Rash (45d - Unknown - Other Medically Important Condition);Tremor (45d - Unknown - Other Medically Important Condition);Urticaria (45d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028218	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Blood pressure diastolic increased (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Unknown - );Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011028225	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028226	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028243	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye inflammation (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011028273	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028318	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028320	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028327	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028329	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028331	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Crying (n/a - Unknown - );Deformity (n/a - Unknown - Other Medically Important Condition);Eye swelling (n/a - Unknown - Other Medically Important Condition);Impaired work ability (n/a - Unknown - Other Medically Important Condition);Limb mass (n/a - Unknown - );Lip swelling (n/a - Unknown - Other Medically Important Condition);Mouth swelling (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028443	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028444	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028450	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028452	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028453	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028454	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028460	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028465	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028467	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028468	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028472	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028474	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028477	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028485	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028488	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - );Rheumatic disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028520	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune thyroiditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028524	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - n/a - Intramuscular])	[PICLOXYDINE, PICLOXYDINE DIHYDROCHLORIDE] (C - n/a - n/a - )|[PREDNISOLONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028526	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Lung disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028529	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028530	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028531	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028536	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ejection fraction decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028542	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028551	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028559	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028561	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - Dose increased - [n/a - 1{DF} - Oral])|[ROSUVASTATIN] (C - Dyslipidaemia - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028564	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028581	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (19d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (19d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028582	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028585	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyponatraemia (73d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (3wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028590	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028597	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Formication (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028615	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028627	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028630	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[INDAPAMIDE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028632	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028635	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (10d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urticaria (10d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028642	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028645	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myalgia (n/a - Unknown - );Neck pain (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028651	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral sensory neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028652	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - Lung disorder - n/a - [n/a - n/a - n/a])|[MONTELUKAST] (C - Lung disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028655	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Life Threatening);Vaccination failure (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose reduced - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028657	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028660	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Influenza immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (S - Influenza immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028666	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Miller Fisher syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|NIMENRIX MENINGOCOCCAL GROUP A, C, W-135 AND Y CONJUGATE VACCINE [N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID, NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN, NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN, NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN] (S - Immunisation - Not applicable - [n/a - n/a - Subcutaneous])|[ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, ALUMINIUM, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, BORDETELLA PERTUSSIS (INACTIVATED) ADSORBED] (S - Immunisation - Not applicable - [n/a - n/a - Subcutaneous])|[YELLOW FEVER VACCINE (LIVE), YELLOW FEVER VIRUS STRAIN 17D-204 (LIVE, ATTENUATED)] (S - Immunisation - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028671	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Nephrotic syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	APROVEL 300 MG TABLETS [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|LANTUS 100 IU/ML SOLUTION FOR INJECTION IN A CARTRIDGE [INSULIN GLARGINE] (C - Diabetes mellitus management - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus management - n/a - [n/a - n/a - n/a])|PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - Platelet aggregation inhibition - n/a - [n/a - n/a - n/a])|TRESIBA 200 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN [INSULIN DEGLUDEC] (C - Diabetes mellitus management - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Diuretic therapy - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028672	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028676	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	CELLCEPT 500 MG TABLETS [MYCOPHENOLATE MOFETIL] (S - Prophylaxis against transplant rejection - Drug withdrawn - [n/a - 1000mg - Oral])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])|[EVEROLIMUS] (S - Prophylaxis against transplant rejection - Drug withdrawn - [n/a - 3.5mg - Oral])|[PREDNISOLONE] (S - Prophylaxis against transplant rejection - Drug withdrawn - [n/a - 1{DF} - Oral])	REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [EVOLOCUMAB] (C - Hypercholesterolaemia - Not applicable - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Prophylaxis - Not applicable - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Dyslipidaemia - Not applicable - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Hypertension - Not applicable - [n/a - n/a - Oral])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - Not applicable - [n/a - n/a - Oral])|[EZETIMIBE] (C - Prophylaxis - Not applicable - [n/a - n/a - Oral])|[FELODIPINE] (C - Hypertension - Not applicable - [n/a - n/a - Oral])|[FLUINDIONE] (C - Prophylaxis - Not applicable - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - Thyroid disorder - Not applicable - [n/a - n/a - Oral])|[PANTOPRAZOLE] (C - Gastritis prophylaxis - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028680	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028690	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (6wk - Recovered/Resolved - );Headache (6wk - Recovered/Resolved - );Hypertension (6wk - Recovered/Resolved - Other Medically Important Condition);Palpitations (6wk - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028691	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028698	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haemorrhagic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028706	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028708	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011028709	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrioventricular block (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028713	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028773	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Agranulocytosis (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011028776	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028777	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [78d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028778	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thyroiditis subacute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011028780	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011028784	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Lymphadenopathy mediastinal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028788	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011028797	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (S - n/a - Dose not changed - [n/a - 1{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011028864	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028924	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028931	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ROACTEMRA [TOCILIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[CORTISONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028936	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028937	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028950	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028982	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028990	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (1wk - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011028992	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011028997	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palmar erythema (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[AZITHROMYCIN, AZITHROMYCIN DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011028997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029018	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029019	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029049	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029051	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - );Vaccination site inflammation (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029062	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029075	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029081	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oral herpes (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029084	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Petechiae (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029086	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haemangioma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029093	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029101	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011029103	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029104	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029107	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Vaccination site oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	AERIUS 5 MG FILM-COATED TABLET [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029120	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029124	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Hot flush (3d - Recovered/Resolved - );Pruritus (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Rash (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029131	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glycosylated haemoglobin increased (n/a - Not Recovered/Not Resolved - );Hyperglycaemia (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029133	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029139	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Visual acuity reduced (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029141	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Vaccination site erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029153	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Joint ankylosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029156	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029158	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in jaw (n/a - Unknown - );Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029160	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029171	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029172	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029173	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	PRITOR [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[DIGOXIN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[FLUINDIONE] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029182	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (2d - Recovered/Resolved - );Feeling hot (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, RILPIVIRINE] (C - HIV infection - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029184	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029186	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029187	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (60d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011029189	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029196	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[WARFARIN SODIUM] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029198	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029205	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029211	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029217	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conduction disorder (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Sinus node dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029218	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hypersensitivity (5min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029229	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029504	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029560	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029567	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (1wk - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011029568	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029585	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Heart rate increased (1d - Unknown - );Heart rate irregular (1d - Unknown - );Lymphadenopathy (n/a - Recovered/Resolved - );Toothache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011029645	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute kidney injury (8d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Decreased appetite (21d - Recovered/Resolved - );Weight decreased (21d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011029660	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Fear-related avoidance of activities (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011029662	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029669	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Burning sensation (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029676	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Chen, D.. Myopericarditis in a teenager following first mRNA COVID vaccine dose: The role of multi-parametric cardiovascular magnetic resonance.. European Heart Journal - Case Reports. 2021;5(10):10.1093/ehjcr/ytab371. doi:10.1093/ehjcr/ytab371	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029677	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Life Threatening, Disabling);Bedridden (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Cough (n/a - Unknown - Life Threatening, Disabling);Dysphagia (n/a - Unknown - Life Threatening, Disabling);Guillain-Barre syndrome (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Pain in extremity (n/a - Unknown - Life Threatening, Disabling);Pyrexia (n/a - Unknown - Life Threatening, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10011029682	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029695	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029698	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Bradykinesia (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011029699	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029704	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029705	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029706	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029725	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Faeces discoloured (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastric ulcer (n/a - Unknown - Other Medically Important Condition);Gastric ulcer haemorrhage (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029727	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011029739	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029744	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029747	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029751	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pneumothorax (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029754	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Agitation (n/a - Unknown - );Confusional state (n/a - Unknown - );Disorientation (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029756	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029766	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029768	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Gait inability (n/a - Unknown - );Malaise (n/a - Unknown - );Pleural effusion (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029862	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (24h - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lethargy (24h - Recovered/Resolved - Other Medically Important Condition);Pain (24h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029864	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029868	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029869	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011029877	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029879	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Autonomic nervous system imbalance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Exercise tolerance decreased (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Postural orthostatic tachycardia syndrome (n/a - Unknown - Other Medically Important Condition);Product administered at inappropriate site (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intravenous (not otherwise specified)])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011029882	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 80mg - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 300mg - n/a])|[BENZATHINE BENZYLPENICILLIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - .5mg - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - 10mg - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - .4mg - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[MOMETASONE] (C - n/a - n/a - [n/a - 50ug - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - 20mg - n/a])|[PARACETAMOL, CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[TOLYCAINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011029886	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029897	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Libido decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal stiffness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory rate decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011029898	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Delirium (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011029903	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (27d - Recovered/Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011029994	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011029994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030054	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (78d - Recovered/Resolved With Sequelae - );Dyspnoea (78d - Recovered/Resolved With Sequelae - );Exercise tolerance decreased (78d - Recovered/Resolved With Sequelae - );Neuralgia (0d - Recovered/Resolved With Sequelae - );Pain in extremity (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011030062	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (47d - Not Recovered/Not Resolved - );Dyspnoea (47d - Not Recovered/Not Resolved - );Tachycardia (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030067	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (5d - Recovering/Resolving - );Myalgia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030071	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (14d - Recovered/Resolved - );Herpes virus infection (12d - Recovered/Resolved - );Influenza (9d - Recovered/Resolved - );Injection site pain (18d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030084	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030107	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030109	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030112	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (56d - Unknown - );Fatigue (56d - Unknown - );Limb discomfort (56d - Unknown - );Malaise (56d - Unknown - );Myalgia (56d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030119	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030127	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030146	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011030163	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030171	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011030177	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nerve injury (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030180	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030181	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (67d - Unknown - );Sensory disturbance (67d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030216	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030219	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030247	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (52d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011030260	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Listless (n/a - Recovered/Resolved - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030301	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Injection site pain (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030303	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Speech disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030306	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011030350	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (33d - Recovering/Resolving - );Nausea (33d - Recovering/Resolving - );Ocular discomfort (33d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030355	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030362	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Type 2 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030382	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011030383	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030385	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011030393	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammatory bowel disease (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030399	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011030401	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (17d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030404	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Tinnitus (121d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011030408	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030421	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011030423	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011030428	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Impaired work ability (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[GABAPENTIN] (C - Pain - n/a - [n/a - 300mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011030443	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030447	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030455	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye oedema (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030460	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Increased upper airway secretion (71d - Not Recovered/Not Resolved - );Sensation of foreign body (71d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030462	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Macular oedema (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Venous occlusion (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011030467	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - );Hypoaesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030468	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011030470	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030472	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030473	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030479	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011030485	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - );Dizziness postural (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030508	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011030511	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingival oedema (4d - Not Recovered/Not Resolved - );Gingival pain (4d - Not Recovered/Not Resolved - );Oral pain (4d - Not Recovered/Not Resolved - );Toothache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030513	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030523	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011030524	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011030531	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (3d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Proteinuria (3d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011030534	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaphylactic shock (245d - Recovered/Resolved - Other Medically Important Condition);Antiallergic therapy (245d - Recovered/Resolved - );Dysphagia (245d - Recovered/Resolved - );Immunisation (245d - Recovered/Resolved - );Lip swelling (245d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011030545	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030561	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered visual depth perception (n/a - Unknown - );Illiteracy (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Tunnel vision (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030578	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Menstruation delayed (2d - Not Recovered/Not Resolved - );Night sweats (2d - Not Recovered/Not Resolved - );Unevaluable event (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030586	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011030590	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Recovering/Resolving - );Facial pain (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Neuralgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Skin discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030599	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Unknown - );Balance disorder (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);General physical health deterioration (n/a - Unknown - );Heart rate increased (n/a - Recovered/Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - Oral])|[LISDEXAMFETAMINE DIMESYLATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 70mg - n/a])|[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011030610	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011030614	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (75d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030622	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (30d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (30d - Unknown - Other Medically Important Condition);Gynaecological examination (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Menstruation delayed (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011030645	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Unknown - );Nervous system disorder (70d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030652	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030680	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030699	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011030718	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Gastrointestinal pain (n/a - Not Recovered/Not Resolved - );Small airways disease (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030730	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030750	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (76d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030758	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030760	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved With Sequelae - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011030772	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011030774	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030775	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030776	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Rotator cuff syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Spinal instability (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030798	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Not Recovered/Not Resolved - );Renin-angiotensin system inhibition (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Treatment failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030802	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030832	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011030834	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030835	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neurodermatitis (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030837	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspepsia (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Sleep disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030844	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030848	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (115d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030871	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030884	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Eyelid oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030886	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011030894	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Headache (5d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Oedema peripheral (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030913	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Jugular vein distension (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011030917	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (96d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Cough (132d - Recovered/Resolved With Sequelae - );Dizziness (132d - Recovered/Resolved With Sequelae - );Fatigue (133d - Recovered/Resolved With Sequelae - );Feeling hot (132d - Recovered/Resolved With Sequelae - );Oedema (25d - Recovered/Resolved With Sequelae - );Oedema peripheral (25d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011030920	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030921	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030950	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Disturbance in attention (20d - Recovering/Resolving - );Head discomfort (19d - Recovering/Resolving - );Memory impairment (20d - Recovering/Resolving - );Somnolence (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030953	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Mood swings (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030982	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030983	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030989	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011030997	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011030998	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	AMGEVITA [ADALIMUMAB] (C - Crohn's disease - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011030998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011031004	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011031009	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (134d - Recovered/Resolved With Sequelae - );Memory impairment (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011031017	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031039	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031044	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Periorbital swelling (n/a - Not Recovered/Not Resolved - );Pustule (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031051	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (80d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031071	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031072	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031093	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - );Eye inflammation (n/a - Not Recovered/Not Resolved - );Photopsia (n/a - Not Recovered/Not Resolved - );Therapeutic response unexpected (61d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031103	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (17d - Recovered/Resolved With Sequelae - );Vaccination site pain (17d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011031105	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (37d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031113	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031120	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Menstruation irregular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031124	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031130	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (78d - Not Recovered/Not Resolved - );Dyspnoea (78d - Not Recovered/Not Resolved - );Fatigue (78d - Not Recovered/Not Resolved - );Palpitations (78d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031134	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Depressed mood (166d - Not Recovered/Not Resolved - );Disturbance in attention (166d - Not Recovered/Not Resolved - );Exercise tolerance decreased (177d - Not Recovered/Not Resolved - );Memory impairment (166d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031139	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Recovering/Resolving - );Dysuria (4d - Not Recovered/Not Resolved - );Erythema (1d - Not Recovered/Not Resolved - );Hyperhidrosis (4d - Recovering/Resolving - );Inflammatory pain (1d - Not Recovered/Not Resolved - );Injection site erythema (4d - Recovering/Resolving - );Injection site pain (4d - Recovering/Resolving - );Injection site swelling (4d - Recovering/Resolving - );Lymphadenopathy (4d - Recovering/Resolving - );Pain in extremity (4d - Recovering/Resolving - );Pyrexia (4d - Recovering/Resolving - );Somnolence (4d - Recovering/Resolving - );Urine analysis abnormal (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031144	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031166	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031178	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Syncope (5s - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NON SPECIFIED BLOEDDRUKMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031186	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031211	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Body temperature increased (38d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (14d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (13d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031220	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031222	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Diarrhoea (48h - Recovered/Resolved - );Dizziness (48h - Recovered/Resolved - );Fatigue (24h - Recovered/Resolved - );Feeling cold (48h - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NIET GESPECIFICEERD GENEESMIDDEL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031273	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031288	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dry skin (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011031291	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Intracranial mass (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lacrimation increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - n/a - n/a - [n/a - 25mg - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - 2.5mg - n/a])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 5mg - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood cholesterol increased - n/a - [n/a - 40mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 2g - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 5mg - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Urine flow decreased - n/a - [n/a - 400ug - n/a])|[TOLTERODINE] (C - n/a - n/a - [n/a - 4mg - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - Insomnia - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011031293	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031294	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031434	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bedridden (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Eye injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Head injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Subdural haematoma (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [2y - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011031519	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031522	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Chills (n/a - Recovered/Resolved With Sequelae - Disabling);Decreased appetite (n/a - Recovered/Resolved With Sequelae - Disabling);Diarrhoea (n/a - Recovered/Resolved With Sequelae - Disabling);Disorientation (n/a - Recovered/Resolved With Sequelae - Disabling);Feeling abnormal (n/a - Recovered/Resolved With Sequelae - Disabling);Groin pain (n/a - Recovered/Resolved With Sequelae - Disabling);Headache (n/a - Recovered/Resolved With Sequelae - Disabling);Hot flush (n/a - Recovered/Resolved With Sequelae - Disabling);Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Disabling);Nausea (n/a - Recovered/Resolved With Sequelae - Disabling);Pain (n/a - Recovered/Resolved With Sequelae - Disabling);Penile pain (n/a - Recovered/Resolved With Sequelae - Disabling);Photophobia (n/a - Recovered/Resolved With Sequelae - Disabling);Somnolence (n/a - Recovered/Resolved With Sequelae - Disabling);Testicular pain (n/a - Recovered/Resolved With Sequelae - Disabling);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011031524	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011031525	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031530	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031533	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Chest pain (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031538	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031591	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (n/a - Recovered/Resolved With Sequelae - );Nasopharyngitis (n/a - Recovered/Resolved With Sequelae - );Rhinorrhoea (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011031594	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cerebral venous sinus thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Intracranial pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Papilloedema (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011031595	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Intermenstrual bleeding (2d - Unknown - );Migraine with aura (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031604	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Eye pain (4d - Not Recovered/Not Resolved - );Malaise (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031622	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (64d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031625	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011031630	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pancreatitis (30d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011031643	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac discomfort (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031646	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031652	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (59d - Recovered/Resolved With Sequelae - );Parosmia (59d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011031656	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031660	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (50d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031665	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Allergy to arthropod sting (0d - Recovered/Resolved - );Immunisation (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031689	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphonia (40d - Recovered/Resolved With Sequelae - );Injection site erythema (13d - Unknown - );Injection site pain (27d - Not Recovered/Not Resolved - );Injection site swelling (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011031700	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031701	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysstasia (n/a - Not Recovered/Not Resolved - );Hypertension (21d - Recovered/Resolved - );Joint noise (34d - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Palpitations (21d - Recovered/Resolved - );Tinnitus (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031702	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal discomfort (61d - Recovered/Resolved With Sequelae - );Alopecia (61d - Recovered/Resolved With Sequelae - );Arrhythmia (61d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dizziness (61d - Recovered/Resolved With Sequelae - );Dyspnoea (61d - Recovered/Resolved With Sequelae - );Dyspnoea exertional (61d - Recovered/Resolved With Sequelae - );Erectile dysfunction (61d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (61d - Recovered/Resolved With Sequelae - );Malaise (61d - Recovered/Resolved With Sequelae - );Rash (61d - Recovered/Resolved With Sequelae - );Tachycardia (61d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011031716	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (48d - Recovered/Resolved With Sequelae - );Immune system disorder (48d - Recovered/Resolved With Sequelae - );Lymphadenopathy (48d - Not Recovered/Not Resolved - );Pyrexia (48d - Recovered/Resolved With Sequelae - );Respiratory tract infection (48d - Recovered/Resolved With Sequelae - );Tonsillar inflammation (48d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011031718	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (191d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031720	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (16d - Recovered/Resolved - );Nasopharyngitis (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031723	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (50d - Not Recovered/Not Resolved - );Tinnitus (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031748	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (27d - Unknown - );Fatigue (27d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031751	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Not Recovered/Not Resolved - );Back pain (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - );Renal pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031752	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031753	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (2d - Unknown - );Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Unknown - );Mouth haemorrhage (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031758	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (6d - Recovering/Resolving - );Neurodermatitis (6d - Recovering/Resolving - );Pruritus (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031764	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cerebral venous sinus thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Intracranial pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Papilloedema (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011031771	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031772	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031784	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gamma-glutamyltransferase increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031785	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Inappropriate schedule of product administration (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Urinary tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011031792	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Incorrect dose administered (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Rheumatic disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031795	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infection susceptibility increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031801	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031810	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031815	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031836	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031838	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (105d - Unknown - );Menstrual disorder (105d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031849	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovering/Resolving - );Hypersensitivity (1d - Recovering/Resolving - );Swelling face (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031882	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (41d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031892	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031893	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011031919	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031924	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (1d - Recovering/Resolving - );Sneezing (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031925	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle ear inflammation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031942	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011031943	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Recovered/Resolved - Other Medically Important Condition);Burning sensation (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Muscle tightness (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031947	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Apathy (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Respiratory distress (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031951	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031957	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis (5d - Not Recovered/Not Resolved - Other Medically Important Condition);Multiple sclerosis relapse (5d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031959	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Macular oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011031968	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (n/a - Not Recovered/Not Resolved - );Herpes simplex reactivation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011031989	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia oral (n/a - Not Recovered/Not Resolved - );Tongue discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011031989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032008	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood urine present (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032017	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (20d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032023	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (32d - Not Recovered/Not Resolved - );Exercise tolerance decreased (32d - Not Recovered/Not Resolved - );Fatigue (32d - Not Recovered/Not Resolved - );Sleep disorder (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032042	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (44d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032054	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dry mouth (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032065	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo positional (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032067	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032087	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (17d - Not Recovered/Not Resolved - );Headache (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032118	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (119d - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (119d - Not Recovered/Not Resolved - );Visual impairment (119d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032122	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (31d - Not Recovered/Not Resolved - );Diarrhoea (31d - Not Recovered/Not Resolved - );Hypotonia (31d - Not Recovered/Not Resolved - );Malaise (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032134	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011032137	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Pruritus (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032138	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (6d - Not Recovered/Not Resolved - );Parotitis (6d - Not Recovered/Not Resolved - );Xerophthalmia (6d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032148	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032162	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (74d - Recovered/Resolved With Sequelae - );Fatigue (74d - Recovered/Resolved With Sequelae - );Hypotonia (74d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011032175	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032176	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032179	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011032180	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032182	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hilar lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy mediastinal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011032196	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032200	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032202	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (100d - Unknown - );Feeling cold (100d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032212	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032260	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (71d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032266	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Pain in extremity (3d - Recovering/Resolving - );Pain in jaw (3d - Recovering/Resolving - );Renal pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032312	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Micturition urgency (n/a - Not Recovered/Not Resolved - );Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032313	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Oedema (65d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032314	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoacusis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011032357	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chromaturia (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032361	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vasoconstriction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032362	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Menstrual disorder (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032376	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise electrocardiogram abnormal (0d - Unknown - );Immunisation (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032378	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (22d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032391	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032430	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (58d - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure fluctuation (58d - Not Recovered/Not Resolved - );Dizziness (58d - Not Recovered/Not Resolved - );Fatigue (58d - Not Recovered/Not Resolved - );Hot flush (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032434	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Anal haemorrhage (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032476	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032480	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032493	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bone marrow oedema (147d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032497	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032524	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032545	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (36d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032562	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (16d - Not Recovered/Not Resolved - );Neuralgia (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032568	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032574	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032580	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032586	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (30d - Recovered/Resolved - );Food intolerance (77d - Not Recovered/Not Resolved - );Headache (30d - Recovered/Resolved - );Muscle twitching (55d - Not Recovered/Not Resolved - );Myalgia (48d - Not Recovered/Not Resolved - );Paraesthesia (21d - Recovered/Resolved - );Skin burning sensation (70d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032589	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032600	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Peripheral coldness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032602	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immune system disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Tonsillitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011032612	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (10d - Not Recovered/Not Resolved - );Neck pain (10d - Not Recovered/Not Resolved - );Neurological symptom (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032616	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032620	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032627	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032630	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (10d - Recovered/Resolved - );Oligomenorrhoea (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032633	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Unknown - );Weight bearing difficulty (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032640	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (10d - Recovered/Resolved - );Nasopharyngitis (10d - Recovered/Resolved - );Neck pain (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032649	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Angina pectoris (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (2d - Not Recovered/Not Resolved - );Thirst (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032679	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032703	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Schmitt, P.. Acute Myocarditis after COVID-19 vaccination: A case report. Revue de Medecine Interne. 2021;42(11):797-800. doi:10.1016/j.revmed.2021.10.003	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011032742	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032760	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Joint stiffness (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032768	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032782	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032794	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032800	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032802	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032803	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arterial occlusive disease (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011032807	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032809	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011032818	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011032821	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011032835	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia pneumococcal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011032839	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (4d - Not Recovered/Not Resolved - );Diarrhoea (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032840	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011032871	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032876	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (38d - Recovered/Resolved With Sequelae - );Taste disorder (38d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011032896	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute kidney injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - );Tubulointerstitial nephritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032905	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain neoplasm (120d - Not Recovered/Not Resolved - Other Medically Important Condition);Disease progression (120d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011032914	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011032920	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Increased upper airway secretion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011032921	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032937	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032941	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (37d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032943	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032944	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (21d - Not Recovered/Not Resolved - );Paraesthesia (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011032945	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032949	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011032954	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011032981	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011032981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033001	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033012	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sleep disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011033067	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Product administered at inappropriate site (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011033089	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033110	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperaesthesia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033135	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011033146	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (53d - Not Recovered/Not Resolved - );Muscle spasms (53d - Not Recovered/Not Resolved - );Paraesthesia (53d - Not Recovered/Not Resolved - );Temperature regulation disorder (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033164	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (35d - Recovered/Resolved - );Hepatic pain (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033173	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Thrombocytopenia (18d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033180	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (58d - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure fluctuation (58d - Not Recovered/Not Resolved - );Dizziness (58d - Not Recovered/Not Resolved - );Fatigue (58d - Not Recovered/Not Resolved - );Hot flush (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033199	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033204	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033216	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Analgesic therapy (44d - Not Recovered/Not Resolved - );Headache (44d - Not Recovered/Not Resolved - );Immunisation (44d - Not Recovered/Not Resolved - );Muscle strain (44d - Not Recovered/Not Resolved - );Pain in jaw (44d - Not Recovered/Not Resolved - );Toothache (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033227	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Balance disorder (13d - Recovered/Resolved With Sequelae - Disabling);Diplegia (13d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011033229	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Censcak, D.. Guillan-Barre Syndrome after First Vaccination Dose against COVID-19: Case Report.. Acta Medica (Hradec Kralove). 2021;64(3):183-186. doi:10.14712/18059694.2021.31	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensory disturbance (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BUDESONIDE [BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FENOTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[IPRATROPIUM] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011033234	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011033252	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Burning sensation (74d - Not Recovered/Not Resolved - );Dyspnoea (74d - Not Recovered/Not Resolved - );Myalgia (74d - Not Recovered/Not Resolved - );Oedema (74d - Not Recovered/Not Resolved - );Paraesthesia (74d - Not Recovered/Not Resolved - );Skin tightness (74d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033254	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematochezia (59d - Recovered/Resolved - Other Medically Important Condition);Mucous stools (59d - Recovered/Resolved - );Proctitis (59d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011033257	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired healing (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033271	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011033283	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011033284	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033313	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (5d - Not Recovered/Not Resolved - );Immunisation (5d - Not Recovered/Not Resolved - );Tinnitus (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033320	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033354	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Life Threatening);COVID-19 immunisation (n/a - Recovering/Resolving - Life Threatening);Chest pain (1d - Recovered/Resolved - Life Threatening);Chills (0d - Recovered/Resolved - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (3d - Recovered/Resolved - Life Threatening);Malaise (2d - Recovered/Resolved - Life Threatening);Myalgia (4d - Recovered/Resolved - Life Threatening);Pleurisy (2d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011033360	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Oedema peripheral (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011033361	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (26d - Recovering/Resolving - );Herpes zoster (26d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033365	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (3d - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (3d - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (0d - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (3d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011033372	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (74d - Not Recovered/Not Resolved - );Burning sensation (74d - Not Recovered/Not Resolved - );Dyspnoea (74d - Not Recovered/Not Resolved - );Myalgia (74d - Not Recovered/Not Resolved - );Oedema (74d - Not Recovered/Not Resolved - );Paraesthesia (74d - Not Recovered/Not Resolved - );Skin tightness (74d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033374	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Intervertebral disc protrusion (124d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033375	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033399	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Insomnia (1d - Unknown - Caused/Prolonged Hospitalisation);Malaise (1d - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011033407	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033408	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Echocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033419	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033426	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033429	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (60d - Not Recovered/Not Resolved - );Pain in extremity (60d - Not Recovered/Not Resolved - );Pelvic discomfort (60d - Not Recovered/Not Resolved - );Plantar fasciitis (60d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033434	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033437	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Recovering/Resolving - );Initial insomnia (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033452	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (6d - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac discomfort (6d - Not Recovered/Not Resolved - );Pain (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033458	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mucous stools (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033480	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Headache (n/a - Unknown - );Lethargy (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033512	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033514	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033531	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033548	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033552	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (54d - Not Recovered/Not Resolved - );Arrhythmia (58d - Unknown - Other Medically Important Condition);Dysphagia (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033553	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011033557	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (10d - Recovered/Resolved - );Chills (10d - Recovered/Resolved - );Cough (10d - Recovered/Resolved - );Dizziness (10d - Recovered/Resolved - );Influenza (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033567	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (45d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033568	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericardial effusion (53d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (53d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033570	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (11d - Not Recovered/Not Resolved - );Vaccination site reaction (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033603	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Fatal - Results in Death);Lung adenocarcinoma (n/a - Fatal - Results in Death);Metastases to central nervous system (n/a - Fatal - Results in Death);Pulmonary embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011033612	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Groin pain (19d - Recovering/Resolving - );Testicular pain (19d - Recovering/Resolving - );Thrombosis (19d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033615	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstruation delayed (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033620	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033633	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (0d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033639	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033663	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033691	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033697	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle insomnia (13d - Not Recovered/Not Resolved - );Sleep disorder (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033699	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033702	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (57d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011033705	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Unevaluable event (82d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033712	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatitis acute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Liver function test abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033720	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033728	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (22d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033729	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033734	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Polymenorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033736	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (70d - Not Recovered/Not Resolved - );Diplegia (70d - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (70d - Not Recovered/Not Resolved - );Thinking abnormal (70d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033759	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Sluggishness (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033764	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033767	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033778	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033796	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033826	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033833	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011033836	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011033837	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033840	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033864	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011033875	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Taste disorder (61d - Recovered/Resolved - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011033878	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033896	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033906	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033917	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033921	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033934	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (4d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033938	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033942	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033944	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Electrocardiogram PR segment depression (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011033951	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033952	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Flatulence (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011033959	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033981	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033988	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033995	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033998	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011033999	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (46d - Recovered/Resolved With Sequelae - );Sleep disorder (46d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011033999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011034012	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034016	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034029	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sleep disorder (50d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011034035	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034049	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034050	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Performance status decreased (59d - Unknown - );Pyrexia (59d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011034055	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034058	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034073	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034082	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011034102	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034125	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Hypotonia (n/a - Not Recovered/Not Resolved - );Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Sjogren's syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011034127	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (6d - Recovering/Resolving - );Blood pressure increased (6d - Recovering/Resolving - );Muscular weakness (6d - Recovering/Resolving - );Tachycardia (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011034130	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyarteritis nodosa (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034143	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034145	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Action tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Application site reaction (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034146	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034147	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034153	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved With Sequelae - );Limb discomfort (4d - Recovered/Resolved With Sequelae - );Neck pain (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011034155	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Quadriparesis (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034156	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034167	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034174	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034185	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034198	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034203	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011034211	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye haemorrhage (4d - Unknown - Other Medically Important Condition);Hypertension (4d - Unknown - );Muscle twitching (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034222	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast discomfort (81d - Recovered/Resolved With Sequelae - );Chest pain (81d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011034239	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034244	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034248	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (57d - Recovered/Resolved - );Gastric pH decreased (57d - Recovered/Resolved - );Gastrointestinal disorder (57d - Recovered/Resolved - );Herpes virus infection (57d - Recovered/Resolved - );Oropharyngeal discomfort (57d - Recovered/Resolved - );Vomiting (57d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011034253	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	RUNX1 gene mutation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034255	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034262	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034263	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyneuropathy (113d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011034270	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034274	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (38d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011034285	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034288	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (3d - Recovered/Resolved - );Diarrhoea (7d - Recovered/Resolved - );Muscular weakness (8d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034290	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (17d - Not Recovered/Not Resolved - );Headache (21d - Not Recovered/Not Resolved - );Hypoaesthesia (15d - Not Recovered/Not Resolved - );Paraesthesia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011034295	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034297	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (7d - Recovering/Resolving - );Lymphadenopathy (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034310	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034315	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034317	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034327	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034331	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034341	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034350	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034357	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034358	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (2d - Recovered/Resolved - );Cough (29d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Pruritus (2d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011034360	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aggression (n/a - Not Recovered/Not Resolved - );Hallucination (n/a - Not Recovered/Not Resolved - );Hyperacusis (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034375	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034378	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034393	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034397	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034402	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034410	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea at rest (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual acuity reduced (n/a - Not Recovered/Not Resolved - Disabling);Visual field defect (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011034434	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Not Recovered/Not Resolved - );Somnolence (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034445	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034483	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chromaturia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Facial paralysis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Facial paresis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hemiparesis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hemiplegia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypertension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [1d - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011034494	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysarthria (n/a - Unknown - );Encephalitis brain stem (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034500	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034501	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Cerebral ventricle dilatation (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034512	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034513	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034515	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (3d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034517	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea at rest (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034525	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034529	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034544	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034591	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034607	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Magnetic resonance imaging abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034617	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abnormal faeces (15d - Not Recovered/Not Resolved - );Immunisation (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034648	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034651	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Gastrointestinal disorder (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Influenza like illness (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Vomiting (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011034674	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011034678	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Recovering/Resolving - );Immunisation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034689	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (7d - Recovering/Resolving - );Fatigue (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034697	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site hypoaesthesia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034726	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034728	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Antinuclear antibody positive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gamma-glutamyltransferase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Liver injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034734	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034736	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011034743	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Multiple sclerosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myelitis transverse (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011034787	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemoptysis (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034790	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - );Splenomegaly (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034824	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Arthropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthma (n/a - Not Recovered/Not Resolved - );Autoimmune disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - );Blood pressure abnormal (n/a - Not Recovered/Not Resolved - );Cardiac disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Unknown - );Inflammation (n/a - Not Recovered/Not Resolved - );Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Renal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin disorder (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Wheezing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034844	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034854	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034962	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034965	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034966	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034973	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Toxic skin eruption (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LIXIANA 60 MG FILM-COATED TABLETS [EDOXABAN] (C - Prophylaxis - Unknown - [64d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011034977	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011034978	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amnesia (n/a - Unknown - Other Medically Important Condition);Apathy (n/a - Unknown - Other Medically Important Condition);Cognitive disorder (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - n/a - Dose not changed - [n/a - 50mg - Oral])|ULUNAR BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER HARD CAPSULES [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - n/a - Dose not changed - [n/a - 1{DF} - Respiratory (inhalation)])|[FOLIC ACID] (C - n/a - Dose not changed - [n/a - 5mg - Oral])|[MESALAZINE] (C - n/a - Dose not changed - [n/a - 2.4g - Oral])|[MESALAZINE] (C - n/a - Dose not changed - [n/a - 500mg - Rectal])|[TERBUTALINE SULFATE] (C - n/a - Dose not changed - [n/a - 500ug - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011034996	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011034996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011035005	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035022	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035027	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035035	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (6d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Fall (1d - Recovered/Resolved - Other Medically Important Condition);Headache (6d - Recovered/Resolved - Other Medically Important Condition);Odynophagia (6d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Temperature regulation disorder (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011035080	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011035113	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035124	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035139	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[EBASTINE] (C - Rhinitis allergic - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011035168	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035234	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011035322	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Abdominal pain (5d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash erythematous (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035335	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035353	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035355	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035357	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035373	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011035404	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035406	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035448	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALENDRONATE SODIUM, ALENDRONATE SODIUM TRIHYDRATE, ALENDRONIC ACID] (C - Osteoporosis - n/a - [n/a - 70mg - n/a])|[FOLIC ACID] (C - Rheumatoid arthritis - n/a - [n/a - 5mg - n/a])|[METHOTREXATE, METHOTREXATE SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - 15mg - n/a])|[SULFASALAZINE, SULFASALAZINE PH. EUR.] (C - Rheumatoid arthritis - n/a - [n/a - 1000mg - n/a])|[VITAMIN D, CALCIUM] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011035453	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011035458	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pruritus (n/a - Not Recovered/Not Resolved - );Vaccination site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035464	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035468	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035470	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Migraine with aura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035471	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Inflammation - n/a - [n/a - n/a - Oral])|[ANHYDROUS FUSIDIC ACID, FUSIDIC ACID, FUSIDIC ACID HEMIHYDRATE, FUSIDIC ACID PENTAHYDRATE] (C - Eye infection - n/a - [n/a - n/a - Ophthalmic])|[PHENOXYMETHYLPENICILLIN, PHENOXYMETHYLPENICILLIN POTASSIUM] (C - Inflammation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035476	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011035483	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vomiting (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035491	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Breast swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035509	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[HYDROCORTISONE BUTYRATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035529	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035542	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011035551	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011035627	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035639	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035649	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011035681	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035711	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035712	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035722	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dizziness (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Unknown - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035726	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035730	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035738	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035743	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035748	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Echocardiogram normal (n/a - Not Recovered/Not Resolved - );Electrocardiogram normal (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011035756	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035824	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011035946	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011035951	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011035982	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011035997	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011035997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036005	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036014	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036017	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036057	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036058	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036072	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036074	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036076	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036077	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036083	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036084	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036086	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036088	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036093	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036101	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036104	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036122	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036133	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036136	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (53d - Recovered/Resolved With Sequelae - );Fatigue (53d - Recovered/Resolved With Sequelae - );Muscular weakness (53d - Recovered/Resolved With Sequelae - );Visual impairment (53d - Recovered/Resolved With Sequelae - );Weight decreased (53d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011036138	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036150	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute respiratory distress syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Renal failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011036152	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036157	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Unknown - );Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011036159	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036170	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011036175	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036184	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036186	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036192	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Delirium (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011036195	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036200	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036202	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036203	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036225	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site erythema (4d - Not Recovered/Not Resolved - );Injection site swelling (4d - Not Recovered/Not Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036229	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (8d - Not Recovered/Not Resolved - );Influenza like illness (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036242	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036252	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036256	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036257	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (88d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011036259	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036277	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036279	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036286	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036337	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (30d - Not Recovered/Not Resolved - );Eye swelling (39d - Not Recovered/Not Resolved - );Fatigue (39d - Not Recovered/Not Resolved - );Headache (40d - Not Recovered/Not Resolved - );Hyperhidrosis (35d - Not Recovered/Not Resolved - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011036344	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (5d - Recovering/Resolving - );Dizziness (5d - Recovering/Resolving - );Headache (5d - Recovering/Resolving - );Lymphadenopathy (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036346	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (28d - Recovered/Resolved - );Oral herpes (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011036364	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (23d - Not Recovered/Not Resolved - );Paraesthesia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011036382	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (15d - Not Recovered/Not Resolved - );Myalgia (15d - Not Recovered/Not Resolved - );Vaccination site pain (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036384	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Fatigue (3d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036385	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (128d - Recovered/Resolved With Sequelae - );Dyspnoea (128d - Recovered/Resolved With Sequelae - );Hypotonia (128d - Recovered/Resolved With Sequelae - );Tachycardia (128d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011036390	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Recovered/Resolved - );Vaccination site reaction (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036394	Spontaneous	2021-12-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011036404	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011036462	Spontaneous	2021-12-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011036462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004772	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011004789	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (1d - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004791	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004793	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nasal discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004802	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004808	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004819	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004823	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004836	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachyarrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004839	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Conjunctival hyperaemia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Miosis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory failure (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Skin discolouration (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	ABILIFY MAINTENA 400 MG [ARIPIPRAZOLE] (S - Delusion - Drug withdrawn - [n/a - 800mg - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[LITHIUM CARBONATE] (C - n/a - n/a - [n/a - 900mg - Oral])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - n/a - n/a - [n/a - 1500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004847	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004860	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Auditory nerve disorder (n/a - Unknown - Disabling);Ear discomfort (n/a - Unknown - Disabling);Ear disorder (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011004866	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal oedema (n/a - Not Recovered/Not Resolved - Disabling);Retinal vein thrombosis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011004870	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenectomy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004873	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling);Hemiparesis (n/a - Not Recovered/Not Resolved - Disabling);Myocardial infarction (n/a - Not Recovered/Not Resolved - Disabling);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011004878	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tonic clonic movements (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004882	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epilepsy (n/a - Recovered/Resolved With Sequelae - Life Threatening);Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Life Threatening);Mydriasis (n/a - Recovered/Resolved With Sequelae - Life Threatening);Pupil fixed (n/a - Recovered/Resolved With Sequelae - Life Threatening);Respiratory arrest (n/a - Recovered/Resolved With Sequelae - Life Threatening);Tongue biting (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011004883	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004885	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004886	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011004887	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	KEYTRUDA [PEMBROLIZUMAB] (C - Transitional cell carcinoma - n/a - [n/a - 200mg - Intravenous (not otherwise specified)])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004930	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004944	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011005069	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005178	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005189	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005220	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011005221	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Blood urine present (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005224	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005234	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005242	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005246	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised oedema (35d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pulmonary congestion (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[HYDROXYCHLOROQUINE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011005247	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005249	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (20d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011005251	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005252	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005255	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea haemorrhagic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeding disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005259	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011005260	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011005261	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005277	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Neck pain (n/a - Unknown - Disabling, Other Medically Important Condition);Neuralgic amyotrophy (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011005279	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Bone pain (n/a - Unknown - );Chest pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Head discomfort (n/a - Unknown - );Headache (n/a - Unknown - );Heart rate decreased (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Inflammation (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Mental impairment (n/a - Unknown - Other Medically Important Condition);Muscle discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - );Ocular discomfort (n/a - Unknown - );Pulmonary pain (n/a - Unknown - );Visual impairment (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005321	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005326	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Bell's palsy (50d - Unknown - Other Medically Important Condition);Eyelid function disorder (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Speech disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005327	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Diplopia (n/a - Unknown - Other Medically Important Condition);Dry eye (n/a - Unknown - Other Medically Important Condition);Eye pruritus (n/a - Unknown - Other Medically Important Condition);Eye swelling (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - Thyroid disorder - n/a - [n/a - 175mg - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005340	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011005365	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Recovered/Resolved - Other Medically Important Condition);Dysarthria (n/a - Recovered/Resolved - Other Medically Important Condition);Eye disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Tongue paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - Unknown])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Unknown])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - Unknown])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM, POTASSIUM CHLORIDE, POTASSIUM GLYCEROPHOSPHATE, POTASSIUM HYDROGEN CARBONATE, POTASSIUM HYDROGEN TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005376	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005428	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005449	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - );Dyspnoea (n/a - Recovering/Resolving - );Inflammation (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005478	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005482	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005489	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Haemoglobin decreased (n/a - Unknown - );Joint swelling (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	INVOKANA [CANAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|TRAJENTA [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005495	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005501	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Epilepsy (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005558	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeding disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005561	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005563	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature abnormal (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005565	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011005568	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005578	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Productive cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005678	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Penile blister (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CLOMIPRAMINE, CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 37.5mg - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011005815	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Thyroidectomy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005816	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal rigidity (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005842	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005845	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011005846	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005849	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BIOCARE ONE-A-DAY VITAMINS AND MINERALS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE MALEATE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005850	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005853	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011005857	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Plantar fasciitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005858	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Postmenopausal haemorrhage (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005861	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005862	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lip swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005869	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005870	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011005871	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyskinesia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperaesthesia teeth (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pyrexia (10d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011005872	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Disabling);Ear pain (n/a - Recovered/Resolved With Sequelae - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Small intestinal obstruction (n/a - Not Recovered/Not Resolved - Disabling);Tension headache (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011005875	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005878	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005879	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling of body temperature change (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle spasms (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (90min - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005882	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005886	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Photophobia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TIOTROPIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005891	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005893	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005907	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chest discomfort (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OXYBUTYNIN [OXYBUTYNIN, OXYBUTYNIN HYDROCHLORIDE] (C - Urge incontinence - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011005908	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005912	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mental fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005914	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005919	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nerve injury (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sciatica (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005921	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005928	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005933	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Bone pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TESTOSTERONE UNDECANOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005934	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (n/a - Unknown - Other Medically Important Condition);Herpes zoster (6d - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005944	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anal incontinence (n/a - Unknown - Caused/Prolonged Hospitalisation);Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Hallucination (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Unknown - Caused/Prolonged Hospitalisation);Nervous system disorder (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011005947	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial discomfort (n/a - Unknown - Other Medically Important Condition);Facial paresis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of libido (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oral discomfort (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011005970	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005972	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011005975	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Nervousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (19d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011005984	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotonia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005989	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011005992	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Arthropathy (n/a - Unknown - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011005993	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Yawning (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011005993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006021	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006048	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Rotator cuff syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Spinal instability (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006051	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|XELJANZ [TOFACITINIB, TOFACITINIB CITRATE] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006197	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011006215	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006296	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthropathy (n/a - Not Recovered/Not Resolved - );COVID-19 immunisation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011006303	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);COVID-19 immunisation (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006361	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011006370	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Disabling);Dizziness (n/a - Recovered/Resolved - Disabling);Head discomfort (n/a - Recovered/Resolved - Disabling);Impaired work ability (n/a - Recovered/Resolved - Disabling);Palpitations (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011006393	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature fluctuation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - n/a - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006394	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiac discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Impaired work ability (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006422	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (n/a - Unknown - );Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiac failure (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006430	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Sugihara, K.. A case of retinal vein branch occlusion which developed after COVID-19 vaccination. The 41st annual meeting of the Japanese Pharmacological Society. 2021;41st:50	18-64 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006438	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nephritis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006453	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006457	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006460	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006469	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin temperature (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006472	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Glossodynia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Irregular sleep wake rhythm disorder (n/a - Unknown - );Oral pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006493	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood chloride increased (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Sinus tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011006517	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006530	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006534	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006537	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006538	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006539	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006541	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006546	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006550	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011006551	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006553	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006600	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006645	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (1.5h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rhinitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006722	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011006727	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006743	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006745	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006749	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006752	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006755	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011006767	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011006768	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (48h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Supraventricular tachycardia (48h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - n/a - [36y - 1000mg - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [4y - 40mg - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Anticoagulant therapy - n/a - [6y - 75mg - n/a])|[CALCIUM, CALCIUM CARBONATE] (C - Bone disorder - n/a - [4y - 500mg - n/a])|[CARVEDILOL] (C - Cardiac disorder - n/a - [14y - 25mg - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [36y - 200mg - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [3d - 1g - n/a])|[SODIUM VALPROATE] (C - Epilepsy - n/a - [36y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006821	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006822	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (40d - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011006886	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - Life Threatening);Heart rate increased (n/a - Unknown - Life Threatening);Pyrexia (3d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011006918	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011006920	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011006924	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011006968	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperlipidaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Laryngitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011006969	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pulmonary thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011006977	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling face (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ISOTRETINOIN] (C - n/a - n/a - )|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011006977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007013	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphonia (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - );Pain in extremity (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - );Visual impairment (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007025	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007029	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );General physical health deterioration (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007033	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - );Discomfort (n/a - Unknown - );Parosmia (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Unknown - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007051	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007069	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - )|[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Pain - n/a - [n/a - n/a - n/a])|[L-SERINE] (C - n/a - n/a - )|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[PHENYLPROPANOLAMINE HYDROCHLORIDE] (C - Nasal congestion - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007130	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011007142	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Prostatitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007166	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007168	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007180	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Hepatic steatosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007194	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007200	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Tendon pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007201	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007202	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Malaise (n/a - Unknown - );Urinary retention (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[NITROFURANTOIN] (C - n/a - n/a - [n/a - 100mg - n/a])|[PROCHLORPERAZINE] (C - Nausea - n/a - [n/a - 5mg - n/a])|[SENNA ALEXANDRIAN] (C - n/a - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007204	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007205	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007207	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007208	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Epistaxis (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007209	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Lung opacity (n/a - Unknown - Life Threatening, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myocarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pericarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011007214	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007216	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Metamorphopsia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007218	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007225	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness exertional (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dysphagia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Poor quality sleep (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011007236	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypersomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sedation (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007238	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Influenza (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011007241	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Epistaxis (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007242	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired work ability (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007249	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bursitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product administered at inappropriate site (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007254	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Vaccination site cyst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007296	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (6d - Unknown - );Fatigue (6d - Unknown - );Headache (6d - Unknown - );Muscle spasms (6d - Unknown - );Myalgia (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011007309	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INSULIN HUMAN [INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[QUININE] (C - Muscle spasms - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007317	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007327	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Heart valve incompetence (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Rhinitis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular dysfunction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);White blood cell count decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANAKINRA [ANAKINRA] (C - n/a - n/a - [n/a - n/a - n/a])|IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011007330	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007331	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007353	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Body temperature increased (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007392	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011007393	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007394	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007395	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007418	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007438	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007443	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Optic neuritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011007445	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007500	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bacterial prostatitis (n/a - Unknown - );Fungal balanitis (56d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[NEBIVOLOL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011007527	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - );Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PERINDOPRIL TOSILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007531	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Blood creatine phosphokinase abnormal (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007543	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007565	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007568	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007583	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Productive cough (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007603	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007611	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemoptysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007636	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Disabling);Pain (n/a - Unknown - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Palpitations (n/a - Recovering/Resolving - Disabling);Vomiting (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	EDOXABAN [EDOXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE MAGNESIUM DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011007638	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood immunoglobulin M increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Platelet count decreased (n/a - Not Recovered/Not Resolved - );Red blood cell count decreased (n/a - Not Recovered/Not Resolved - );Tonsillar hypertrophy (n/a - Not Recovered/Not Resolved - );White blood cell count decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011007647	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (77d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011007656	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007663	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007664	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Antinuclear antibody increased (n/a - Unknown - Other Medically Important Condition);Hepatocellular injury (105d - Recovered/Resolved - Other Medically Important Condition);Liver disorder (109d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011007699	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (3d - Recovered/Resolved - );Cutaneous vasculitis (12d - Recovered/Resolved - );Dermatitis (12d - Recovered/Resolved - );Extensive swelling of vaccinated limb (12d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Injection site erythema (12d - Recovered/Resolved - );Lip oedema (12d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011007718	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007722	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Skin plaque (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BIKTARVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - HIV infection - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - HIV infection - n/a - [n/a - n/a - Oral])|[VINORELBINE] (C - Kaposi's sarcoma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007777	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007778	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007780	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007786	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007788	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007789	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007790	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007793	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Recovered/Resolved - Other Medically Important Condition);Retinal detachment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011007796	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007800	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007801	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011007927	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3d - Recovering/Resolving - Disabling);Extensive swelling of vaccinated limb (3d - Recovering/Resolving - Disabling);Injection site reaction (3d - Recovering/Resolving - Disabling);Malaise (3d - Recovering/Resolving - Disabling);Nausea (3d - Recovering/Resolving - Disabling);Pyrexia (3d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011007968	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Drug ineffective (1mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011007968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008035	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash vesicular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008124	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008125	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008126	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008129	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008133	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008134	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008135	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008142	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008146	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008150	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008204	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011008347	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (9mo - Recovered/Resolved - Other Medically Important Condition);Gastrointestinal disorder (n/a - Recovered/Resolved - );Immunodeficiency (n/a - Not Recovered/Not Resolved - );Pityriasis rosea (n/a - Unknown - );Pyrexia (9mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008375	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ear pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008397	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (18d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea at rest (18d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea exertional (18d - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (18d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011008429	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011008469	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008492	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008500	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (6d - Recovered/Resolved - );Eye swelling (6d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site erythema (6d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Injection site pruritus (6d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pruritus (6d - Recovered/Resolved - );Urticaria (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ANTIHISTAMINICUM [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008510	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Sensitive skin (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011008551	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (6d - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011008553	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011008622	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008624	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008625	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008626	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008628	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008629	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008630	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008632	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008633	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008638	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008654	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011008666	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Supraventricular extrasystoles (17d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011008677	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008818	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (1d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Thrombocytopenia (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	KARVEZIDE 300 MG/12.5 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - Hypertension - Dose not changed - )|[SIMVASTATIN] (C - Hypercholesterolaemia - Dose not changed - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011008842	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Administration site oedema (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008980	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (4d - Recovered/Resolved - );Hallucination, visual (2d - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Myalgia (4d - Recovered/Resolved - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (3d - Recovered/Resolved - );Restlessness (n/a - Unknown - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Dose not changed - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - n/a - Dose not changed - [n/a - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Dose not changed - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011008982	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site joint movement impairment (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011008982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009113	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011009136	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Dysphagia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Immune-mediated adverse reaction (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Speech disorder (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011009145	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011009150	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009290	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009293	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009305	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Child	Yes	Male	Exposure via breast milk (n/a - Unknown - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009328	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009334	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011009355	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009378	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Exercise tolerance decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011009396	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009520	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009572	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011009577	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[WARFARIN, WARFARIN SODIUM] (C - n/a - Dose not changed - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009616	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovered/Resolved - );Rash macular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009623	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009685	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - )|[CINNARIZINE, PIRACETAM] (C - n/a - n/a - )|[ZOFENOPRIL CALCIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009694	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - )|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )|[MIRTAZAPINE] (C - n/a - n/a - )|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|[SIMVASTATIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011009702	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	PROTEIN POWDER [NOT AVAILABLE] (C - n/a - n/a - )|[ETHYL ACETOACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009721	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );COVID-19 immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	JARDIANCE [EMPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009732	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Contusion (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011009879	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011009901	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009924	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acne (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ANTIHYPERTENSIVUM (BLOEDDRUKVERLAGER) [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|VOEDINGSSUPPLEMENT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009954	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Administration site erythema (4d - Recovered/Resolved - );Administration site oedema (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011009983	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Clostridium difficile infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011009989	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Painful erection (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011009989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011010051	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010278	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Thyroiditis subacute (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011010282	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010290	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010291	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010297	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010299	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010303	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010358	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011010423	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (1d - Recovered/Resolved - );Vaccination site oedema (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011010456	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011010489	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cerebral haemorrhage (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - );Headache (n/a - Unknown - );Intrusive thoughts (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011010518	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (194d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (194d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory disorder (194d - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011010529	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	No	Male	Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011010533	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011010557	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011010561	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Performance status decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011010581	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Recovered/Resolved - );Cardiac discomfort (1h - Recovered/Resolved - );Chest discomfort (1h - Recovered/Resolved - );Diplopia (1h - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011010590	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - );Extensive swelling of vaccinated limb (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011010625	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010669	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010671	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Antibody test abnormal (n/a - Not Recovered/Not Resolved - );Antimitochondrial antibody positive (n/a - Not Recovered/Not Resolved - );Autoimmune cholangitis (n/a - Unknown - Other Medically Important Condition);Blood disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood immunoglobulin E increased (n/a - Unknown - );Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Cytopenia (n/a - Unknown - Other Medically Important Condition);Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dyskinesia (n/a - Unknown - );Electrolyte imbalance (n/a - Unknown - );Eosinophil count increased (n/a - Unknown - );Escherichia urinary tract infection (n/a - Unknown - Other Medically Important Condition);Feeding disorder (n/a - Unknown - );Hepatic function abnormal (n/a - Not Recovered/Not Resolved - );Hypercapnia (n/a - Unknown - );Lacunar infarction (n/a - Unknown - Other Medically Important Condition);Liver disorder (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Other Medically Important Condition);Performance status decreased (n/a - Unknown - );Physical deconditioning (n/a - Unknown - );Purpura (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - );Respiratory disorder (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - );Splenomegaly (n/a - Unknown - );Staphylococcal bacteraemia (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Type I hypersensitivity (n/a - Unknown - Other Medically Important Condition);Type IV hypersensitivity reaction (n/a - Unknown - );Wheezing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[BETAHISTINE MESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[DIMETICONE] (C - n/a - n/a - [n/a - n/a - Oral])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ELOBIXIBAT HYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[IMIDAFENACIN] (C - n/a - n/a - [n/a - n/a - Oral])|[L-ISOLEUCINE, L-LEUCINE, L-VALINE] (C - n/a - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[PHYTOMENADIONE] (C - n/a - n/a - [n/a - n/a - Oral])|[SODIUM CHLORIDE] (C - n/a - n/a - [1d - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011010674	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010677	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010680	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010683	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010687	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010695	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010702	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010707	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011010710	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010726	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (5h - Recovered/Resolved - );Hyperhidrosis (1h - Recovered/Resolved - );Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (5h - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010741	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011010790	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011010924	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loose tooth (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Restlessness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Subdural haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011010998	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011010998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011008	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest discomfort (69d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Lower respiratory tract infection (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011011071	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011074	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011079	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Deafness transitory (2d - Recovered/Resolved - Other Medically Important Condition);Dizziness (2d - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011091	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Lack of spontaneous speech (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011112	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (24h - Recovered/Resolved - Other Medically Important Condition);Angina pectoris (10h - Recovered/Resolved - Other Medically Important Condition);Asthenia (24h - Recovered/Resolved - Other Medically Important Condition);Extrasystoles (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (24h - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (24h - Recovered/Resolved - Other Medically Important Condition);Nausea (24h - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - Vitamin B12 abnormal - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011175	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011221	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011011222	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Paraesthesia (7d - Not Recovered/Not Resolved - );Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011224	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Recovered/Resolved With Sequelae - Life Threatening);Cardiovascular disorder (n/a - Recovered/Resolved With Sequelae - Life Threatening);Ventricular arrhythmia (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011011225	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011011229	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011011233	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (60d - Not Recovered/Not Resolved - );Disturbance in attention (60d - Not Recovered/Not Resolved - );Dizziness (60d - Not Recovered/Not Resolved - );Fatigue (60d - Not Recovered/Not Resolved - );Feeling hot (60d - Not Recovered/Not Resolved - );Hyperhidrosis (60d - Not Recovered/Not Resolved - );Injection site erythema (60d - Not Recovered/Not Resolved - );Paraesthesia (60d - Not Recovered/Not Resolved - );Visual impairment (60d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011011241	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arthralgia (40d - Not Recovered/Not Resolved - );Asthenia (40d - Not Recovered/Not Resolved - );Fatigue (40d - Not Recovered/Not Resolved - );Myalgia (40d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011011246	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011011267	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011269	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (34d - Not Recovered/Not Resolved - );Disturbance in attention (39d - Not Recovered/Not Resolved - );Dizziness (39d - Not Recovered/Not Resolved - );Injection site pain (39d - Not Recovered/Not Resolved - );Myalgia (39d - Not Recovered/Not Resolved - );Nausea (39d - Not Recovered/Not Resolved - );Tachycardia (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011011271	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (63d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011011284	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011290	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011298	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011321	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011327	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011331	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011343	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011354	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011356	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011363	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011365	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011369	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011377	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011378	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011391	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011394	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011401	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011404	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (92d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10011011411	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011417	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death);Nausea (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011011441	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011463	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011480	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011481	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011483	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011487	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011491	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011492	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011510	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011511	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011011516	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011011518	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011520	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Embolism arterial (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Intermittent claudication (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011011523	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (25d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011011526	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011011541	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011011542	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011546	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011550	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011552	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aspiration (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypokalaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011011574	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011576	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (12d - Recovered/Resolved - );Dizziness (9d - Recovered/Resolved - );Herpes zoster (4d - Not Recovered/Not Resolved - );Myalgia (4d - Recovered/Resolved - );Pyrexia (11d - Recovered/Resolved - );Rash (4d - Not Recovered/Not Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011011581	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea haemorrhagic (119d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011596	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gastrointestinal inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011632	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Via, V.. Reactivation of SARS-CoV-2 infection, vaccine failure and off label use: case report, 2021 Via, V.. Possible Reactivation of SARS-CoV-2 in a Patient with Acute Myeloid Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Case Report. SN Comprehensive Clinical Medicine. 2021;3(10):2011-2015. doi:10.1007/s42399-021-01020-0	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011658	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Monoplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011011685	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );SARS-CoV-2 test negative (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011011755	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011771	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block complete (30d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011011774	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - );Hyperpyrexia (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011776	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011797	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011809	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011813	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diastolic hypertension (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011011831	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blister (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Mental fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition);Urinary retention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011834	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Neutrophil count (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011847	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011011851	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Epistaxis (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011860	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011011898	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011901	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011902	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011903	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011011970	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID, PARACETAMOL, ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011011970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011012019	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012021	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (n/a - Unknown - );Cluster headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hospitalisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovered/Resolved - );Loss of personal independence in daily activities (n/a - Unknown - );Pain (n/a - Unknown - );Pain management (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012035	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Impaired work ability (1wk - Recovered/Resolved - );Motor dysfunction (n/a - Unknown - );Nerve compression (n/a - Unknown - );Rotator cuff syndrome (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012063	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Arthritis (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LOSARTAN POTASSIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011012079	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012080	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012086	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012089	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Axillary pain (n/a - Not Recovered/Not Resolved - Disabling);Cheilitis (n/a - Not Recovered/Not Resolved - Disabling);Glossodynia (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Lymph node pain (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Renal pain (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling);Spinal pain (n/a - Not Recovered/Not Resolved - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011012104	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012106	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012112	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012116	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012123	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012125	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012128	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (47d - Recovered/Resolved - Other Medically Important Condition);Blood pressure diastolic increased (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011012143	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012148	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012152	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012154	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness postural (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb discomfort (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012187	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012193	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012202	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Lymphadenitis (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011012210	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012227	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (17d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (17d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011012231	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved With Sequelae - );Gait disturbance (n/a - Recovered/Resolved With Sequelae - );Hypersomnia (n/a - Recovered/Resolved With Sequelae - );Loss of personal independence in daily activities (n/a - Recovered/Resolved With Sequelae - );Muscular weakness (n/a - Recovered/Resolved With Sequelae - Disabling);Vomiting (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011012268	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - );Incorrect route of product administration (n/a - Unknown - );Oral discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012288	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Facial pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012289	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Activated partial thromboplastin time prolonged (n/a - Recovered/Resolved - );Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012290	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012299	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Groin pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012302	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012303	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (9d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012322	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anxiety (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Jaundice acholuric (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011012327	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012330	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012337	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FUROSEMIDE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Heart rate - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Heart rate - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012342	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012345	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash papular (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012346	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012349	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Burning sensation (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012351	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cold urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012354	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Incontinence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Red blood cells urine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012363	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal osteoarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012368	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Coma (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012372	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Glomerulonephritis membranous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - );Proteinuria (n/a - Not Recovered/Not Resolved - );Renal failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cardiac disorder - n/a - [n/a - 75mg - Oral])|[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - 325mg - Oral])|[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - Oral])|[AZELASTINE, AZELASTINE HYDROCHLORIDE] (C - Asthma, Hypersensitivity - n/a - [n/a - .1mg - Nasal])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - 2000[iU] - Oral])|[FISH OIL] (C - n/a - n/a - [n/a - 200mg - Oral])|[FLUTICASONE PROPIONATE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[FLUTICASONE] (C - Asthma - n/a - [n/a - 50mg - Nasal])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 75ug - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 25mg - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 25mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 200mg - Oral])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 25mg - Oral])|[TIZANIDINE] (C - n/a - n/a - [n/a - 4mg - Oral])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012376	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death);COVID-19 pneumonia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011012382	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012419	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012467	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012610	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Meniscus injury (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Psoriatic arthropathy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - 81mg - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Blood pressure measurement - n/a - [n/a - 50mg - n/a])|[OXYCODONE, OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012697	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (40d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10011012699	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012701	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012702	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012703	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Echocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012704	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012707	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012709	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Echocardiogram (n/a - Recovered/Resolved - );Electrocardiogram (n/a - Recovered/Resolved - );Magnetic resonance imaging heart (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012711	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012744	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012753	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012764	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (5wk - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011012784	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011012788	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012794	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011012801	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011012809	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Fatal - Results in Death, Other Medically Important Condition);Chest pain (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Other Medically Important Condition);Myocarditis (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition);Pericarditis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011012811	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011012821	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);COVID-19 (7d - Recovered/Resolved - Other Medically Important Condition);Chest pain (63d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (7d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012822	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012827	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Angioedema (n/a - Unknown - Life Threatening, Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011012841	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Cardiac disorder (n/a - Fatal - Results in Death, Congenital Anomaly);Maternal exposure timing unspecified (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011012850	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012851	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dry skin (n/a - Unknown - );Erythema (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Limb mass (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012853	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (2d - Recovered/Resolved - Other Medically Important Condition);Flank pain (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011012857	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute cardiac event (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cold sweat (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in jaw (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011012860	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deformity thorax (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypersomnia (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Insomnia (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Mass (n/a - Unknown - Disabling, Other Medically Important Condition);Mass excision (n/a - Unknown - Disabling, Other Medically Important Condition);Musculoskeletal discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Musculoskeletal pain (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Penis disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Walking aid user (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011012898	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Acute myocardial infarction, Myocardial ischaemia - n/a - [4796d - 75mg - n/a])|[ATORVASTATIN] (C - Acute myocardial infarction, Myocardial ischaemia - n/a - [n/a - 20mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Acute myocardial infarction, Myocardial ischaemia - n/a - [3759d - 2.5mg - n/a - More in ICSR])|[FERROUS FUMARATE] (C - Anaemia - n/a - [n/a - 420mg - n/a])|[RAMIPRIL] (C - Acute myocardial infarction, Myocardial ischaemia - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011012901	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cardiac infection (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Coronary artery thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011012904	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011012904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013065	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013066	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013070	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013071	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011013073	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011013079	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary sarcoidosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013086	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, INFLUENZA A VIRUS, A/CROATIA/10136RV/2023 (H3N2) LIKE STRAIN X-425A, INACTIVATED] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011013110	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (6wk - Recovered/Resolved - Other Medically Important Condition);Crohn's disease (6wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013115	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (1wk - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013124	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [5d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013126	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013128	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Systemic lupus erythematosus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013132	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eosinophilia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Genital erosion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neutrophilia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oral mucosa erosion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013135	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013137	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013138	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013149	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013161	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (4d - Recovered/Resolved - Other Medically Important Condition);Vomiting (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013164	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013175	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrioventricular block (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013186	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovering/Resolving - );Influenza like illness (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013189	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013192	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute coronary syndrome (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011013193	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013198	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	LANTUS 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - Type 2 diabetes mellitus - n/a - [n/a - 40[iU] - Subcutaneous])|NOVORAPID [INSULIN ASPART] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - 40mg - Oral])|XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - 15mg - Oral])|[AMIODARONE HYDROCHLORIDE] (C - Atrial fibrillation - n/a - [n/a - 200mg - Oral])|[FUROSEMIDE] (C - Chronic kidney disease - n/a - [n/a - 80mg - Oral])|[GLYCERYL TRINITRATE] (C - Angina pectoris - n/a - [n/a - 1{DF} - Transdermal])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 150ug - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN] (C - Thrombosis prophylaxis - n/a - [n/a - 10mg - Oral])|[SPIRONOLACTONE] (C - Chronic kidney disease - n/a - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013201	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013203	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (3d - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (3d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [40d - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013204	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Sudden death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - Arrhythmia - n/a - [n/a - 2{DF} - Oral])|[AMIODARONE HYDROCHLORIDE] (C - Arrhythmia - n/a - [n/a - 200mg - Oral])|[FUROSEMIDE] (C - Arrhythmia - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011013206	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013207	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013215	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haemorrhagic stroke (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011013216	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug reaction with eosinophilia and systemic symptoms (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013219	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute polyneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, MUMPS VIRUS RIT 4385 STRAIN (LIVE, ATTENUATED) DERIVED FROM FROM THE JERYL LYNN PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS, MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS, MUMPS VIRUS RIT 4385 STRAIN, DERIVED FROM JERYL LYNN STRAIN (LIVE, ATTENUATED), MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, MUMPS VIRUS RIT 4385 STRAIN (LIVE, ATTENUATED) DERIVED FROM FROM THE JERYL LYNN PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS, MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS, MUMPS VIRUS RIT 4385 STRAIN, DERIVED FROM JERYL LYNN STRAIN (LIVE, ATTENUATED), MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED), MUMPS VIRUS (LIVE, ATTENUATED), RUBELLA VIRUS (LIVE, ATTENUATED), MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED), MUMPS VIRUS RIT 4385 STRAIN (LIVE, ATTENUATED) DERIVED FROM FROM THE JERYL LYNN PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS, MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS, MUMPS VIRUS RIT 4385 STRAIN, DERIVED FROM JERYL LYNN STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS, MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED), MUMPS VIRUS RIT 4385 STRAIN, DERIVED FROM JERYL LYNN STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED), MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, MUMPS VIRUS RIT 4385 STRAIN (LIVE, ATTENUATED) DERIVED FROM FROM THE JERYL LYNN PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED), MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED), MUMPS VIRUS RIT 4385 STRAIN (LIVE, ATTENUATED) DERIVED FROM FROM THE JERYL LYNN PRODUCED IN CHICK EMBRYO CELLS, RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED), MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED), MUMPS VIRUS RIT 4385 STRAIN, DERIVED FROM JERYL LYNN STRAIN (LIVE, ATTENUATED)] (S - Measles immunisation, Mumps immunisation, Rubella immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[YELLOW FEVER VACCINE (LIVE), YELLOW FEVER VIRUS STRAIN 17D-204 (LIVE, ATTENUATED)] (S - Yellow fever immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013233	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013257	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammatory bowel disease (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013263	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [190d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013278	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Prostatitis (1wk - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013294	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013307	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arterial rupture (n/a - Fatal - Results in Death);Asthenia (n/a - Fatal - Results in Death);Brain oedema (n/a - Fatal - Results in Death);Cardiac hypertrophy (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death);Dizziness (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Eye haemorrhage (n/a - Fatal - Results in Death);Headache (n/a - Fatal - Results in Death);Heart rate decreased (n/a - Fatal - Results in Death);Meningorrhagia (n/a - Fatal - Results in Death);Pulmonary oedema (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Syncope (n/a - Fatal - Results in Death);Vaccination site pain (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011013312	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Myalgia (n/a - Unknown - );Pollakiuria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013318	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013323	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013332	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [185d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013339	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013352	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Localised oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013354	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013362	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013369	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013374	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Formication (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013377	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Axillary pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013378	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eczema (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013396	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013400	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013401	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - );Malaise (1h - Recovered/Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013402	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peritonsillar abscess (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013405	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013406	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013417	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspepsia (n/a - Recovered/Resolved - );Oedema mouth (n/a - Recovered/Resolved - );Pharyngeal oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013421	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013426	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013427	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013429	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013433	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013438	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013441	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperthyroidism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013442	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013445	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (7d - Recovered/Resolved - );Psoriasis (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Platelet aggregation inhibition - Unknown - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013448	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013452	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013454	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Nervousness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013462	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013464	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Dyspnoea exertional (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013468	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013469	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013471	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013474	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013475	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013478	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013479	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013482	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Recovering/Resolving - );Palpitations (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013483	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Haematuria (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013490	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013491	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injected limb mobility decreased (6mo - Not Recovered/Not Resolved - );Monoplegia (6mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013495	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013498	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013505	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperglycaemia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013518	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013519	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (10h - Recovered/Resolved - );Phonophobia (10h - Recovered/Resolved - );Photophobia (10h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013520	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Torticollis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013522	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013533	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013546	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (111d - Not Recovered/Not Resolved - );Wound (111d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011013551	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013632	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013652	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013662	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of personal independence in daily activities (n/a - Unknown - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013695	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013759	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Depression (n/a - Unknown - );Nervousness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013781	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Encephalocele (n/a - Unknown - Other Medically Important Condition);Foetal exposure during pregnancy (n/a - Unknown - );Foetal malformation (n/a - Unknown - Other Medically Important Condition);Hydronephrosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013782	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013788	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013791	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011013793	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013795	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Sato, N.. 2 cases of idiopathic thrombocytopenic purpura (ITP) that developed after COVID-19 vaccine administration. The 673rd Kanto Regional Meeting of the Japanese Society of Internal Medicine. 2021;673rd	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013815	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013826	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013827	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013830	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013836	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013840	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Livedo reticularis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE, LISINOPRIL, HYDROCHLOROTHIAZIDE, LISINOPRIL ANHYDROUS, LISINOPRIL ANHYDROUS, HYDROCHLOROTHIAZIDE EP, LISINOPRIL DIHYDRATE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013841	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Prostatic specific antigen increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013850	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	[PREDNISONE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013852	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eyelid oedema (n/a - Unknown - );Immunisation (n/a - Unknown - );Lip swelling (n/a - Unknown - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013859	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Dizziness (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013872	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	AERIUS 5 MG FILM-COATED TABLET [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013874	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013876	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013880	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013898	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac dysfunction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013901	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Central nervous system lesion (8d - Unknown - Caused/Prolonged Hospitalisation);Myelitis (8d - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013905	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (2d - Recovered/Resolved - );Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (2d - Recovered/Resolved - );Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013906	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Vertigo (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - Erectile dysfunction - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [1d - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011013917	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013921	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011013923	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013931	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhagic stroke (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Off label use (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011013948	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Poor quality sleep (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013952	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011013959	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Acne (65d - Recovered/Resolved - Other Medically Important Condition);Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011013975	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013979	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013980	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - );Left ventricular dilatation (n/a - Unknown - Other Medically Important Condition);Left ventricular dysfunction (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Insulin resistance - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011013992	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011013992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014002	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness unilateral (n/a - Unknown - Other Medically Important Condition);Ear swelling (n/a - Unknown - );Hypoacusis (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014013	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011014026	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014041	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Girbardt, C.. Retinal Vascular Events after mRNA and Adenoviral-Vectored COVID-19 Vaccines-A Case Series. Vaccines. 2021;9 (11):10.3390/vaccines9111349. doi:10.3390/vaccines9111349	18-64 Years	Not Specified	No	Male	Retinal artery occlusion (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Platelet aggregation inhibition - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Lipids abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014048	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014058	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Yoshifuji, A.. COVID-19 vaccine induced interstitial lung disease. Journal of Infection and Chemotherapy. 2022;28:95-98. doi:10.1016/j.jiac.2021.09.010	18-64 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014088	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014122	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hot flush (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014139	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site cellulitis (n/a - Unknown - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014189	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014195	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014207	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Blood pressure increased (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014229	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Injection site induration (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014230	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014237	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Bradykinesia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Neurological symptom (n/a - Unknown - );Personality change (n/a - Not Recovered/Not Resolved - );Slow speech (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014265	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (S - Hypercholesterolaemia - Drug withdrawn - [1mo - 10mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014285	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Motor neurone disease (n/a - Fatal - Results in Death, Other Medically Important Condition);Muscular weakness (n/a - Fatal - Results in Death, Other Medically Important Condition);Peroneal nerve palsy (n/a - Fatal - Results in Death, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011014287	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014292	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014300	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ill-defined disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011014303	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014334	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014445	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014650	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPINEPHRINE, EPINEPHRINE BITARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014653	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site lymphadenopathy (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BETAMETHASONE, BETAMETHASONE VALERATE, BETAMETHASONE VALERATE BP] (C - Skin ulcer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014658	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014690	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014733	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014735	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Aphonia (n/a - Recovering/Resolving - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Respiratory symptom (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Viral pharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014736	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aggression (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anger (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anxiety (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Bacterial infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chromaturia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Delusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Depression (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Distractibility (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Encephalitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Faeces discoloured (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Flushing (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fungal infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hunger (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypersomnia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Irritability (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Mood swings (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Mouth ulceration (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Mutism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Neurotoxicity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Obsessive-compulsive personality disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Retching (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Viral infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - Catatonia - n/a - [n/a - 2.5mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014740	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Swelling face (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014750	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Central vision loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014777	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrioventricular block complete (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011014820	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[METOCLOPRAMIDE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Night sweats - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depressed mood - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014829	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epstein-Barr virus infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014831	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypokinesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011014849	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014875	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014889	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011014909	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011014911	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014929	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Malaise (0d - Recovered/Resolved - );Pallor (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011014957	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011014994	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011014995	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Feeling abnormal (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Mydriasis (0d - Recovered/Resolved - );Posture abnormal (0d - Recovered/Resolved - );Respiratory rate increased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011014995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011015101	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - );Erythema (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Heart rate increased (21d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Palpitations (21d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (14d - Recovered/Resolved - );Vaccination site swelling (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011015138	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appetite disorder (n/a - Unknown - );Cardiac discomfort (12d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Flank pain (7d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vaccination site pain (14d - Recovered/Resolved - );Vaccination site swelling (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011015217	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysphagia (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011015236	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (6d - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011015243	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site bruising (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011015324	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011015361	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[TESTOSTERONE UNDECANOATE] (C - n/a - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011015363	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ALFUZOSIN] (C - n/a - n/a - [n/a - 10mg - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - Oral])|[DORZOLAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ECONAZOLE NITRATE, TRIAMCINOLONE ACETONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 100mg - Oral])|[MICONAZOLE NITRATE, HYDROCORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPYLENE GLYCOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011015387	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	USTEKINUMAB [USTEKINUMAB] (C - Psoriasis - n/a - [n/a - n/a - Parenteral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011015406	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011015430	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Unresponsive to stimuli (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID, BETACAROTENE, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, THIAMINE NITRATE, POTASSIUM CHLORIDE, ZINC OXIDE, CHROMIC CHLORIDE, CUPRIC OXIDE, FERROUS FUMARATE, MAGNESIUM OXIDE, MANGANESE SULFATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, SODIUM MOLYBDATE, CALCIUM HYDROGEN PHOSPHATE, SODIUM SELENATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - 1200mg - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - Nasal])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure abnormal - n/a - [n/a - 20mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Glucose tolerance impaired - n/a - [n/a - 1000mg - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[TIMOLOL, TIMOLOL MALEATE] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011015483	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011015596	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10011015715	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011015715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011016222	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011016231	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011016299	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011016365	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Nakamura, M.. A Case of Japanese Spotted Fever Suspected as Adverse Reaction to COVID-19 Vaccine. The 335th Kyushu Regional Meeting of the Japanese Society of Internal Medicine. 2021;335th	65-85 Years	Not Specified	No	Male	Japanese spotted fever (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011016465	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (n/a - Fatal - Results in Death);Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011016466	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Swelling face (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Urticaria (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011016571	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011016580	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry skin (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling of eyelid (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[ALOE VERA] (S - n/a - Not applicable - [n/a - n/a - n/a])|[TRITICUM AESTIVUM] (S - n/a - Not applicable - [n/a - n/a - n/a])	SILDENAFIL [SILDENAFIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011016583	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somatic symptom disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011016615	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011016703	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011016707	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Unknown - );Sudden hearing loss (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 3{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011016711	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tubulointerstitial nephritis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011016714	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011016723	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angiopathy (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011016726	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011016727	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011016742	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Paralysis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011016746	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011016756	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011016780	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Gastrointestinal haemorrhage (n/a - Fatal - Results in Death);Haematemesis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011016800	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011016808	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anorgasmia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (3h - Recovered/Resolved - Other Medically Important Condition);Dry mouth (3h - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint contracture (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (3h - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (3h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011016979	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Girbardt, C.. Retinal vascular events after mrna and adenoviral-vectored covid-19 vaccines-a case series. Vaccines. 2021;9(11):10.3390/vaccines9111349. doi:10.3390/vaccines9111349	18-64 Years	Not Specified	No	Male	Venous stasis retinopathy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011016979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017136	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[MORPHINE HYDROCHLORIDE] (C - n/a - Dose not changed - )|[OXAZEPAM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011017167	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011017233	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011017266	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017269	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (18h - Recovered/Resolved - );Chills (4h - Recovered/Resolved - );Fatigue (8h - Recovered/Resolved - );Headache (6h - Recovered/Resolved - );Malaise (4h - Recovered/Resolved - );Myalgia (18h - Recovered/Resolved - );Nausea (2h - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017279	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017280	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017356	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017360	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017366	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017387	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017404	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017406	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017433	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALUMINIUM, A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008 - DERIVED STRAIN USED NYMC BX-35] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011017439	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017457	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parapsoriasis (n/a - Recovering/Resolving - );Psoriasis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	NOT AVAILABLE (C - Parapsoriasis - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017462	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017464	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017466	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017491	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017512	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017516	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017526	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site inflammation (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017529	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017552	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017583	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017855	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011017858	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle atrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017870	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017913	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (1d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011017919	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017921	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017933	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011017943	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral haemorrhage (4d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - 1Ci - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011017945	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Syncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011017952	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Febrile convulsion (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011017966	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Unknown - );Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017967	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011017978	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (4d - Recovered/Resolved - Other Medically Important Condition);Urticaria (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011017999	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Unknown - Life Threatening);Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011017999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011018070	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011018074	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018077	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018081	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011018097	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site induration (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011018099	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (67d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011018106	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck mass (2wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018124	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018131	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018137	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Disabling);Feeling abnormal (n/a - Unknown - Disabling);Injection site pain (n/a - Unknown - Disabling);Insomnia (n/a - Unknown - Disabling);Somnolence (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10011018182	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018192	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROMORPHONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018321	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (10min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (10min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 100mg - n/a])|[METOPROLOL SUCCINATE] (C - Hypertension - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018385	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018434	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018439	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018440	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10011018447	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018451	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - );Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011018463	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myasthenia gravis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018464	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hemianopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018465	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pustule (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018468	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018473	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018475	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018480	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018485	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Chronic fatigue syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011018489	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Seizure (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011018491	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011018555	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018707	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Exercise tolerance decreased (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018710	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (8h - Recovered/Resolved - );Injection site pain (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018714	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018720	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Not Recovered/Not Resolved - );Stress (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/DELAWARE/55/2019 CVR-45), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018738	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011018759	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011018760	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018777	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018801	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018810	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4h - Recovered/Resolved - );Nausea (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018814	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018835	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (11d - Recovered/Resolved - );Dizziness (n/a - Unknown - );Headache (5d - Recovered/Resolved - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (4d - Recovered/Resolved - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011018839	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018846	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011018851	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018868	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018892	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011018896	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018983	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011018988	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011018992	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011018992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019002	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019003	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019012	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019014	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019016	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019017	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019019	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019025	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019076	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019091	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019110	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gingivitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Glossitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Onycholysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019151	Spontaneous	2021-12-20 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Back pain (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Haemorrhage subcutaneous (n/a - Recovering/Resolving - Disabling);Tremor (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011019160	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019162	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011019344	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011019351	Spontaneous	2021-12-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011019351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003414	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10011003436	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CHLORPHENAMINE MALEATE] (C - Prophylaxis - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011003448	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011003533	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003538	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003562	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011003602	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Oral herpes (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003653	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003657	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ENBREL 50 MG [ETANERCEPT] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[SULFASALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003659	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (0d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003663	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ACTELSAR HCT 80 MG/12.5 MG TABLETS [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|APROVEL 300 MG FILM-COATED TABLETS [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003669	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003670	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003681	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003682	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003683	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003688	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003690	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003693	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003694	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003739	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003744	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003751	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (1d - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003753	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (4h - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003767	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003779	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003784	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003813	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003815	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003820	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003824	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003830	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (72h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003859	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003878	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003885	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003887	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003898	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003904	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003923	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003956	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pain (700h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pharyngeal inflammation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Somnolence (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tonsillitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VITAMINS NOS] (C - Immune system disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011004021	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenitis (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004030	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004035	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011004042	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004051	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004052	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004059	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004061	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004066	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nasopharyngitis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004070	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004073	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004084	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Application site pain (n/a - Recovered/Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011004093	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004109	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004111	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004121	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004156	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004160	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004173	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011004184	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011004186	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (2d - Recovered/Resolved - );Arthralgia (30h - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004223	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004235	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004244	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Seasonal allergy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004252	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004256	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (24min - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004257	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004260	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - n/a - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004264	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (7d - Recovered/Resolved - );Fatigue (3wk - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (14d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004269	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry skin (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004275	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011004286	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Recovered/Resolved - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004289	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - );Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011004295	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004300	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004301	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004309	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004313	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Not Recovered/Not Resolved - );Application site pain (n/a - Not Recovered/Not Resolved - );Application site swelling (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004315	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004351	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004377	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004402	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004413	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004442	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004447	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004460	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004461	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004465	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004479	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004492	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004496	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004497	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004528	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004537	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004544	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004557	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004563	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004566	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination failure (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011004582	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004595	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004598	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye irritation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Throat irritation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004600	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004608	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004629	Spontaneous	2021-12-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011004682	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011004694	Spontaneous	2021-12-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011004694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000191	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10011000244	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000355	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000408	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Confusional state (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000418	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000424	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000427	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000460	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000466	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000477	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000500	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000503	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000508	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000509	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000513	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Epidural])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000517	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hiccups (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000566	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000598	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000630	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000637	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000646	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000648	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000661	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Retching (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000667	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000668	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash macular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	DULOXETINE HYDROCHLORIDE [DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 60mg - Oral])|LYRICA 75 MG HARD CAPSULES [PREGABALIN] (C - n/a - n/a - [n/a - 75mg - n/a])|[QUETIAPINE] (C - n/a - n/a - [n/a - 400mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000671	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000672	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000675	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000685	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	TRIMBOW 87 MICROGRAMS/5 MICROGRAMS/9 MICROGRAMS PRESSURISED INHALATION, SOLUTION [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - 1{DF} - Respiratory (inhalation)])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000706	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Life Threatening);Chest pain (n/a - Recovering/Resolving - Life Threatening);Choking sensation (n/a - Recovering/Resolving - Life Threatening);Hypotension (n/a - Recovering/Resolving - Life Threatening);Myocarditis (n/a - Recovering/Resolving - Life Threatening);Pyrexia (n/a - Recovering/Resolving - Life Threatening);Syncope (n/a - Recovering/Resolving - Life Threatening);Tachycardia (n/a - Recovering/Resolving - Life Threatening);Throat tightness (n/a - Recovering/Resolving - Life Threatening);Toothache (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011000731	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000732	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000745	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Encephalitis viral (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Cardiovascular event prophylaxis - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000746	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000752	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arterial thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening);Venous thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011000754	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000766	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Muscle strength abnormal (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000767	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	HYRIMOZ [ADALIMUMAB] (C - n/a - n/a - [n/a - 40mg - Cutaneous])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Buccal])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 80mg - Buccal])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - Buccal])|[VALSARTAN] (C - n/a - n/a - [n/a - 320mg - Buccal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000775	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000796	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000804	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000817	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Hypoacusis (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000834	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000839	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tendonitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000851	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Dyspnoea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011000942	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000945	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lip oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[NIMESULIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011000953	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000961	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000963	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000969	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Life Threatening);Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011000976	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000989	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oedema (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000994	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Primary myelofibrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011000995	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pancreatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011001001	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema peripheral (n/a - Unknown - Other Medically Important Condition);Varicose vein (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011001003	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Other Medically Important Condition);Eosinophil count increased (n/a - Recovering/Resolving - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Pancytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Procalcitonin increased (n/a - Recovering/Resolving - Other Medically Important Condition);Psychomotor skills impaired (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011001018	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diplopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemihypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011001020	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011001023	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011001026	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011001044	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001057	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001064	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breath holding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001067	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001069	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (13d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001077	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001088	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001094	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001105	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (148d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10011001134	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (6d - Recovered/Resolved - );Dyspnoea (6d - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Myocarditis (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	[LORATADINE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011001148	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pain (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Product administration error (0d - Unknown - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|GARDASIL 9 [HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, ALUMINIUM, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, BORDETELLA PERTUSSIS (INACTIVATED) ADSORBED] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011001170	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LIXIANA 60 MG FILM-COATED TABLETS [EDOXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001171	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001198	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Tendonitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001216	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001257	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001264	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Male	Crying (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Exposure via breast milk (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001267	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (3h - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (2h - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001275	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Hyperpyrexia (2d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - );Respiratory tract inflammation (n/a - Recovering/Resolving - );Vaccination site lymphadenopathy (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001277	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site warmth (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001287	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001302	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001304	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematoma (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LIXIANA 60 MG FILM-COATED TABLETS [EDOXABAN] (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001325	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001333	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (4d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001335	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (n/a - Recovering/Resolving - );Peyronie's disease (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001338	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2mo - Recovered/Resolved - );Malaise (2mo - Recovered/Resolved - );Pericarditis (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001361	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011001373	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001375	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001388	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pneumothorax (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011001392	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10011001397	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001403	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VENLAFAXINE HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011001428	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011001429	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (13d - Recovered/Resolved - );Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pain in extremity (13d - Recovered/Resolved - );Restless legs syndrome (13d - Recovered/Resolved - );Skin tightness (13d - Recovered/Resolved - );Thrombosis (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011001918	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011001918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011002209	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002210	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site urticaria (n/a - Recovering/Resolving - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002214	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002222	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (13d - Recovered/Resolved - );Occipital neuralgia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002223	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site erythema (n/a - Recovering/Resolving - );Injection site induration (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002229	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002386	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002387	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002388	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002392	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002396	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002404	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002449	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002450	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002451	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002452	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002455	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002460	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002470	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002503	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002511	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002513	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002535	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002544	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002570	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Malaise (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002629	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Circulatory collapse (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002656	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Body temperature fluctuation (3d - Recovered/Resolved - );Bone pain (3d - Recovered/Resolved - );Chest discomfort (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Injection site erythema (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vaccination site lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	DENOSUMAB 60 MG/ML - SOLUTION FOR INJECTION  (C - Osteoporosis - n/a - [2y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002658	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002674	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002685	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002700	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002703	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002704	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002709	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002718	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002735	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002737	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site haematoma (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002744	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011002745	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (3d - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Epistaxis (4d - Recovered/Resolved - );Exercise tolerance decreased (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002749	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002757	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002760	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002761	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002762	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002779	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002782	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002794	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002804	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011002811	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovered/Resolved - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening);Pulmonary infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10011002838	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011002840	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10011002841	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10011002842	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10011002874	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002875	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002878	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002885	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002901	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002925	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002929	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002930	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002931	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002934	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002935	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002944	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002945	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002948	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002953	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002958	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002959	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002964	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002972	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Dizziness postural (n/a - Unknown - );Muscle spasms (1mo - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011002979	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002981	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002987	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002988	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002992	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002993	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002995	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002998	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011002999	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011002999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003007	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003030	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003052	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003059	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003062	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003063	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003068	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003069	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003071	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003086	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003088	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003089	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003090	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003094	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003099	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003107	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guttate psoriasis (2wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003134	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003137	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003142	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003144	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003148	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003158	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003165	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003168	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003189	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003201	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Application site swelling (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003202	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003213	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Renal pain (n/a - Recovered/Resolved - );Sciatica (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10011003217	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003218	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003224	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003229	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003243	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003244	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003254	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003262	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003275	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003279	Spontaneous	2021-12-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Blood pressure increased (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003289	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003290	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003303	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003313	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003317	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003320	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003324	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003335	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003336	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003337	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003343	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003344	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003359	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011003369	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003371	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003373	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003378	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003380	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003381	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003386	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003391	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10011003392	Spontaneous	2021-12-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011003392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010987297	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987355	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to arthropod sting (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987359	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Hypersensitivity (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Swollen tongue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987378	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOCETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987415	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Conjunctivitis (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987416	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987417	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987419	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987420	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987421	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987422	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987424	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987427	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987431	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Nervous system disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987437	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Restlessness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987439	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Genital pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987442	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Decreased appetite (56d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010987445	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987460	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (n/a - Recovered/Resolved - );Extrasystoles (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987461	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Proteinuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987462	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (92d - Recovered/Resolved With Sequelae - );Dizziness (92d - Recovered/Resolved With Sequelae - );Hemiparesis (92d - Recovered/Resolved With Sequelae - );Vomiting (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010987465	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye infection toxoplasmal (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010987473	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987474	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987477	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987481	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987493	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987496	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987499	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987502	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral artery thrombosis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987508	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987510	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - );Diplopia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987512	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987517	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987520	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Unknown - );Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987526	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987528	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987529	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (13d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgia (13d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987531	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987539	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987543	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987545	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Injection site erythema (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987549	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987550	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Disturbance in attention (n/a - Recovered/Resolved - );Exercise tolerance decreased (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987552	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987553	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparesis (15d - Unknown - );Muscle contractions involuntary (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987568	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pancreatic disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987571	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pneumonitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987572	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987573	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adult T-cell lymphoma/leukaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987575	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (121d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987576	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987578	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Polyarthritis (n/a - Unknown - );Pyrexia (n/a - Unknown - );Sjogren's syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987582	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Seizure (0d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987583	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic left ventricular failure (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987585	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987597	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cholecystocholangitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987607	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (0d - Recovered/Resolved - );Cardiovascular disorder (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987609	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987612	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987613	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Depression (42d - Not Recovered/Not Resolved - );Discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Panic disorder (42d - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987617	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987618	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987619	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987620	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Ophthalmoplegia (12d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (12d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987622	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010987623	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987670	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987701	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987702	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash vesicular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010987766	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987841	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis acneiform (n/a - Not Recovered/Not Resolved - );Gingival abscess (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987860	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987912	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987947	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010987948	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE] (C - Cardiac failure - n/a - [n/a - 1.25mg - Oral])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 12.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987965	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening);Weight decreased (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010987971	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987981	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - 10[drp] - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - 7.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987995	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010988004	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening);Troponin I increased (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010988009	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - Other Medically Important Condition);Flushing (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010988010	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sciatic nerve palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010988017	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster meningitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Intracranial pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010988018	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Movement disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|TRULICITY [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988020	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988043	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010988044	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Capillary fragility (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988047	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988062	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010988063	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Aphonia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Hiccups (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988088	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal faeces (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin plaque (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988093	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988115	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (151d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010988120	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (11d - Recovered/Resolved - );Pain (11d - Recovered/Resolved - );Pyrexia (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988121	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Nasopharyngitis (0d - Recovered/Resolved - );Tremor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010988125	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988132	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010988182	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010988243	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988323	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988330	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010988340	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010988342	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010988376	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988378	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (12h - Recovered/Resolved - );Tachycardia (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010988613	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988629	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin abnormal (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010988633	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988635	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010988653	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Adverse event (n/a - Unknown - Life Threatening);Asthenia (n/a - Unknown - Life Threatening);Erythema (n/a - Unknown - Life Threatening);General physical health deterioration (n/a - Unknown - Life Threatening);Malaise (n/a - Unknown - Life Threatening);Myocardial infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010988663	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988670	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - Borderline glaucoma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988671	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Gastrointestinal haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Haematemesis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010988692	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Recovering/Resolving - );Balance disorder (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Listless (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010988753	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988755	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Malaise (5d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010988872	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure fluctuation (n/a - Not Recovered/Not Resolved - );Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METOPROLOL, METOPROLOL TARTRATE] (C - Blood pressure abnormal - n/a - [n/a - 25mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol abnormal - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010988884	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphocytosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988891	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010988897	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Deafness (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010988998	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Head injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lumbar vertebral fracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Superinfection bacterial (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thoracic vertebral fracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[BUPRENORPHINE] (C - n/a - n/a - [n/a - 1{DF} - Transdermal])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 200mg - Oral])|[PARACETAMOL, PARACETAMOL, ASPARTAME] (C - n/a - n/a - [n/a - n/a - Oral])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - n/a - n/a - [n/a - n/a - Oral])|[ZOLPIDEM, ZOLPIDEM HEMITARTRATE, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010988998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010989013	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Cough (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Drug ineffective (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);General physical health deterioration (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Hypotension (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Palliative care (4d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Superinfection bacterial (8d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (14d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - 1{DF} - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - Oral])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - 2{DF} - Respiratory (inhalation)])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 80mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[BUMETANIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[COLCHICINE] (C - Gout - n/a - [n/a - n/a - Oral])|[LACTULOSE, LACTULOSE, LIQUID] (C - n/a - n/a - [n/a - n/a - Oral])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 2.5mg - Respiratory (inhalation)])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[SODIUM PICOSULFATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010989101	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [n/a - n/a - Intramuscular])|[LOSARTAN] (S - Hypertension - Drug withdrawn - [n/a - 100mg - Oral])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - Unknown - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010989323	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthropathy (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Muscle discomfort (3d - Recovered/Resolved - );Nasopharyngitis (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010989324	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CHONDROITIN SULFATE, CHONDROITIN SULFATE SODIUM] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010989336	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010989366	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010989433	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010989442	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Central vision loss (n/a - Not Recovered/Not Resolved - Disabling);Cerebrovascular accident (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Ocular vascular disorder (n/a - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Retinal artery occlusion (n/a - Recovered/Resolved - Disabling);Thrombosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement, Diabetes mellitus - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased, Diabetes mellitus - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - Unknown - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - Unknown - [1d - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - Unknown - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010989684	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Osteoarthritis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010989686	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - Life Threatening, Disabling);Night sweats (n/a - Unknown - Life Threatening, Disabling);Pain (n/a - Unknown - Life Threatening, Disabling);Platelet count decreased (n/a - Unknown - Life Threatening, Disabling);Pyrexia (n/a - Unknown - Life Threatening, Disabling);Rash erythematous (n/a - Unknown - Life Threatening, Disabling);Thrombosis (n/a - Unknown - Life Threatening, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010989689	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Chills (n/a - Unknown - Disabling);Feeling cold (n/a - Unknown - Disabling);Feeling hot (n/a - Unknown - Disabling);Hyperhidrosis (n/a - Unknown - Disabling);Hypothermia (0d - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Limb discomfort (n/a - Unknown - Disabling);Muscular weakness (0d - Recovered/Resolved - Disabling);Neurogenic shock (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling);Product use issue (n/a - Unknown - );Vomiting (0d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PROCHLORPERAZINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010989690	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010989694	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Disabling);Chills (3d - Recovered/Resolved - Disabling);Loss of personal independence in daily activities (3d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TOCOPHEROL [TOCOPHEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010989695	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amyotrophic lateral sclerosis (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Hyperreflexia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Muscle atrophy (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010989699	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Cardiomegaly (n/a - Unknown - );Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Echocardiogram abnormal (n/a - Unknown - );Joint swelling (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Unknown - );Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[MAGNESIUM SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 25mg - n/a])|[OXYCODONE, OXYCODONE HYDROCHLORIDE] (C - Sternotomy - n/a - [n/a - 5mg - Oral])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - Oral])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - 2mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010989712	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carpal tunnel syndrome (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Peripheral nerve injury (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010989714	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (2d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010989718	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Monoplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010989719	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN, IBUPROFEN LYSINE] (C - n/a - n/a - [n/a - 800mg - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010989789	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (3d - Recovered/Resolved - Other Medically Important Condition);Injection site movement impairment (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Skin discolouration (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010989818	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pancreatic carcinoma (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (6d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - Not applicable - )|[OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010989845	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Disabling);Blindness (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Injection site movement impairment (n/a - Recovering/Resolving - Disabling);Injection site reaction (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Musculoskeletal stiffness (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010989916	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010989974	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Polyarthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [1d - n/a - Unknown])|[IXAZOMIB] (S - Plasma cell myeloma - Unknown - [n/a - 4mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010989995	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010989995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990000	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (2d - Recovered/Resolved - );Chest discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010990012	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990023	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nasal discomfort (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990039	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|HUMIRA [ADALIMUMAB] (S - Ankylosing spondylitis - Drug withdrawn - [n/a - 40mg - Subcutaneous])|HUMIRA [ADALIMUMAB] (S - n/a - Drug withdrawn - [n/a - 40mg - Subcutaneous])	[INDAPAMIDE] (C - Essential hypertension - n/a - [n/a - n/a - Oral])|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - Essential hypertension - n/a - [n/a - n/a - Oral])|[THIAMAZOLE] (C - Hyperthyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990055	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4wk - Unknown - Disabling);Back pain (4wk - Unknown - Disabling);Myalgia (4wk - Unknown - Disabling);Renal pain (4wk - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010990081	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site haematoma (n/a - Recovered/Resolved - );Administration site pain (4d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990135	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Heart rate increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010990145	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990147	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990149	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990150	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010990172	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, ZINC, CALCIUM, COPPER, IRON, MAGNESIUM, MANGANESE, PYRIDOXINE HYDROCHLORIDE, RETINOL, ALPHATOCOPHEROL ACETATE, MOLYBDENUM, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, FOLIC ACID, NICOTINAMIDE, PHYTOMENADIONE, RIBOFLAVIN, THIAMINE, PHOSPHOROUS ACID, ZINC, VITAMIN B6, CALCIUM, CHROMIUM, COPPER, IODINE, IRON, MAGNESIUM, MANGANESE, PANTOTHENIC ACID, SELENIUM, RETINOL, ALPHA-TOCOPHEROL, MOLYBDENUM, FLUORINE, VITAMIN B12, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE, ZINC, VITAMIN B6, CALCIUM, COPPER, IRON, MAGNESIUM, MANGANESE, PANTOTHENIC ACID, PHOSPHORUS, RETINOL, ALPHA-TOCOPHEROL, MOLYBDENUM, VITAMIN B12, POTASSIUM ASCORBATE] (C - n/a - n/a - )|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )|[DOCONEXENT, ICOSAPENT, FISH OIL, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - )|[THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, P-AMINOBENZOIC ACID, THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, P-AMINOBENZOIC ACID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010990246	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (2d - Recovered/Resolved - );Erythema (2d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[LORATADINE] (C - Hypersensitivity - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990254	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bedridden (n/a - Recovering/Resolving - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Herpes virus infection (n/a - Recovering/Resolving - Disabling);Immune system disorder (n/a - Recovering/Resolving - Disabling);Nasopharyngitis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010990309	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990317	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010990328	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Oxygen saturation decreased (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010990331	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Seizure (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010990335	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990338	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010990351	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (6d - Recovered/Resolved - Disabling, Other Medically Important Condition);Diarrhoea (5d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010990356	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TESTOSTERONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010990360	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Pollakiuria (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990365	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Duodenal ulcer perforation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010990380	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010990381	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990401	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amyloidosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Giant cell arteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Liver disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010990410	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Oropharyngeal pain (35d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010990430	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990487	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990490	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990495	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990498	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010990502	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990503	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990509	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010990567	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nephritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Proteinuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010990571	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Pulse abnormal (n/a - Recovered/Resolved - );Renal failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010990572	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010990583	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autonomic dysreflexia (n/a - Unknown - Other Medically Important Condition);Blood pressure fluctuation (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Dizziness (n/a - Unknown - );Feeling hot (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Neck pain (n/a - Unknown - );Ophthalmic migraine (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010990612	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram T wave inversion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010990616	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990628	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Recovering/Resolving - Disabling);Arthralgia (n/a - Recovering/Resolving - Disabling);Dermatitis atopic (n/a - Recovering/Resolving - Disabling);Inflammatory marker increased (n/a - Recovering/Resolving - Disabling);Polyarthritis (n/a - Recovering/Resolving - Disabling);Skin disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IRBESARTAN 300 MG [IRBESARTAN] (C - n/a - Unknown - [n/a - 300mg - n/a])|[FENOFIBRATE] (C - n/a - Unknown - [n/a - 267mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010990655	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Bradycardia (1d - Recovered/Resolved - );Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010990686	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Tinnitus (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010990694	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (72h - Recovered/Resolved - );Chest pain (3d - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (72h - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LORATADINE] (C - Hypersensitivity - n/a - [20y - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010990724	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990787	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990788	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010990808	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Formication (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010990905	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010990976	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Hallucination (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010990976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010991002	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Blood glucose abnormal (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991158	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[DESLORATADINE] (C - Hypersensitivity - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991165	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991192	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991201	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991210	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991214	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991231	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991235	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991242	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991245	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991248	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	[DUTASTERIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010991252	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010991255	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010991256	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991264	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Confusional state (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cough (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Hypotonic-hyporesponsive episode (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Psychomotor hyperactivity (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010991274	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991285	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991286	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991287	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991298	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991301	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Pruritus (n/a - Unknown - Disabling);Skin disorder (n/a - Unknown - Disabling);Skin sensitisation (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010991302	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - n/a])|[ERDOSTEINE] (C - n/a - n/a - [n/a - 300mg - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 20mg - n/a])|[THEOPHYLLINE, THEOPHYLLINE ANHYDROUS] (C - n/a - n/a - [n/a - 150mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010991348	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RANEXA [RANOLAZINE] (C - n/a - n/a - [n/a - 750mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - 75mg - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 120mg - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - 10mg - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - 400ug - n/a])|[OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010991406	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991524	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	International normalised ratio increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ADENURIC [FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - n/a])|TRAJENTA [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|TRESIBA [INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010991580	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991595	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991610	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2mo - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (2mo - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[COLECALCIFEROL] (C - Rheumatic disorder - Dose not changed - [n/a - 2000[iU] - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010991618	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991620	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991621	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991622	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991623	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991624	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991625	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991626	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991627	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991630	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991631	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991632	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991636	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991652	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991653	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991654	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991655	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991716	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin discolouration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991750	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (2d - Recovered/Resolved - );Peripheral swelling (2d - Recovered/Resolved - );Thrombosis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010991888	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010991911	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (5h - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Musculoskeletal stiffness (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991915	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agitation (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Drug interaction (n/a - Not Recovered/Not Resolved - );Emotional disorder (n/a - Not Recovered/Not Resolved - );Torticollis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[BOTULINUM TOXIN TYPE A] (S - Torticollis - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991918	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991923	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991931	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991940	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010991950	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Lip swelling (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991953	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Face oedema (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010991972	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Hypersensitivity (n/a - Not Recovered/Not Resolved - Life Threatening);Swelling (n/a - Not Recovered/Not Resolved - Life Threatening);Urticaria (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010991972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010992001	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992018	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster oticus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010992021	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010992028	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Musculoskeletal discomfort (2d - Recovered/Resolved - );Periorbital discomfort (6d - Recovered/Resolved - );Tachycardia (3mo - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010992033	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Application site swelling (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992034	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992038	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992039	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992043	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992055	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010992089	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992109	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992117	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010992125	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Computerised tomogram thorax abnormal (n/a - Not Recovered/Not Resolved - Disabling);Cough (n/a - Recovering/Resolving - Disabling);Fatigue (11d - Recovered/Resolved - Disabling);Hypersensitivity (n/a - Unknown - Disabling);Malaise (11d - Recovered/Resolved - Disabling);Pyrexia (0d - Recovered/Resolved - Disabling);Swollen tongue (n/a - Unknown - Disabling);Vocal cord inflammation (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	BRINTELLIX 20 MG FILM-COATED TABLETS [VORTIOXETINE] (C - n/a - n/a - [n/a - n/a - Oral])|[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010992157	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010992186	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site oedema (2d - Recovering/Resolving - );Administration site pain (3d - Recovering/Resolving - );Fatigue (1wk - Recovering/Resolving - );Headache (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 25ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992253	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (3min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010992316	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992318	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992320	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992322	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992327	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (n/a - Unknown - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992388	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010992391	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Life Threatening);Extrasystoles (n/a - Unknown - Life Threatening);Palpitations (n/a - Unknown - Life Threatening);Sleep disorder (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010992394	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992395	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010992398	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992404	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992471	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992512	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparesis (194d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010992556	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992576	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992587	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992590	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992600	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010992683	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010992701	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010992976	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (0d - Recovered/Resolved - Disabling);Nausea (0d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010992990	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - );Eyelid ptosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010992990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993023	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (35d - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Atrial fibrillation (35d - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Malaise (35d - Recovered/Resolved - Life Threatening);Pancreatitis (35d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010993029	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Unknown - );Pyrexia (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993033	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Rash vesicular (153d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993034	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Rash vesicular (153d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993038	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993044	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death);Seizure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010993047	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010993058	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993064	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coagulopathy (158d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993065	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993079	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993091	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Autoimmune thyroiditis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993095	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute kidney injury (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cardiogenic shock (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Fall (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pulseless electrical activity (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Syncope (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010993099	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Glomerulonephritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993100	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993113	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death);Condition aggravated (n/a - Fatal - Results in Death);Hypertension (n/a - Fatal - Results in Death);Sudden cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010993114	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (11d - Recovering/Resolving - );Oropharyngeal pain (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010993130	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (75d - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993134	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010993139	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010993147	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (26d - Not Recovered/Not Resolved - );Influenza like illness (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010993148	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Granuloma (272d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombosis (272d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vasculitis (272d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993205	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (17d - Not Recovered/Not Resolved - );Chest discomfort (17d - Not Recovered/Not Resolved - );Weight bearing difficulty (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993207	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993214	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993216	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coordination abnormal (12d - Recovered/Resolved With Sequelae - );Myalgia (12d - Recovered/Resolved With Sequelae - );Paraesthesia (12d - Recovered/Resolved With Sequelae - );Sleep disorder (12d - Recovered/Resolved With Sequelae - );Tremor (12d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010993219	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993221	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 immunisation (2d - Unknown - Disabling);Fatigue (2d - Recovering/Resolving - Disabling);Injection site reaction (2d - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010993267	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vasodilatation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993304	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993351	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - Disabling);Ear pain (n/a - Unknown - Disabling);Eye pain (n/a - Unknown - Disabling);Eyelid myokymia (n/a - Unknown - Disabling);Hypoacusis (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Neuralgia (n/a - Unknown - Disabling);Paraesthesia (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling);Tinnitus (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010993377	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (1h - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (1h - Recovered/Resolved - );Cold sweat (1h - Recovered/Resolved - );Defaecation urgency (1h - Recovered/Resolved - );Feeling abnormal (1h - Recovered/Resolved - );Heart rate decreased (1h - Recovered/Resolved - );Nausea (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010993378	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness postural (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Orthostatic hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash erythematous (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993381	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Malaise (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Wound (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993385	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010993391	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010993422	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Disabling);Extensive swelling of vaccinated limb (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010993460	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993477	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site induration (72d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010993481	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ventricular fibrillation (0d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - Not applicable - )|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - Not applicable - )|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - )|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - Not applicable - )|[RAMIPRIL] (C - n/a - Not applicable - )|[TORASEMIDE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010993532	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Nervousness (2d - Recovered/Resolved - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling);Tachycardia (2d - Recovered/Resolved - Disabling);Tremor (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010993540	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (S - Atrial fibrillation - Drug withdrawn - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (S - Benign prostatic hyperplasia - Drug withdrawn - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - Blood cholesterol increased - Drug withdrawn - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993544	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993572	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Lip swelling (n/a - Recovered/Resolved - );Taste disorder (n/a - Recovering/Resolving - );Tongue discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993604	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993639	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Self-destructive behaviour (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010993642	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993643	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993645	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993647	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Dysaesthesia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993655	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993685	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993719	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993752	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (2d - Recovering/Resolving - );Injection site reaction (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pericarditis (2d - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010993774	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - );Skin disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LORAZEPAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993912	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993919	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993926	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Syncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993927	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993931	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993935	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993941	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993946	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993950	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Dysphonia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010993951	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Myelitis transverse (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Nervous system disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Paresis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Sensory loss (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993959	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010993965	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010993989	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Antinuclear antibody increased (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010993989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010994136	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Puncture site reaction (n/a - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovered/Resolved - );Sleep disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994141	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (0d - Recovered/Resolved - Other Medically Important Condition);Malaise (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994177	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994194	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994196	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2h - Recovered/Resolved - Other Medically Important Condition);Dizziness (3h - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (3h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (3h - Recovered/Resolved - Other Medically Important Condition);Tachycardia (3h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994197	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010994203	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994206	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994209	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994214	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994215	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994216	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994222	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dementia (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Parkinson's disease (n/a - Fatal - Results in Death);Urinary tract infection (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010994224	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Unknown - );Body temperature increased (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994229	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to arthropod sting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994250	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994251	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994270	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994278	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010994280	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994281	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cardiovascular function test abnormal - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994284	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010994285	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (4d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994291	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994294	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to arthropod sting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994309	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Breast pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994311	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (48h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994313	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994317	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994323	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994328	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994332	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994339	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (6d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (6d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (6d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (6d - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994343	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994344	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Septic shock (3d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010994347	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994348	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994356	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994360	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine with aura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994363	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Gastrointestinal inflammation (n/a - Unknown - );Haematemesis (n/a - Unknown - Other Medically Important Condition);Haematochezia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994368	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994369	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010994370	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994404	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Photopsia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994437	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994470	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994474	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994475	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994477	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994478	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994479	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994481	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994491	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994493	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994495	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994496	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994497	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994498	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994505	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994506	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994509	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994510	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994511	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994512	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994513	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994517	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994518	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994523	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994525	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994526	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994527	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994528	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994531	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994534	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994536	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994538	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994539	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994545	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994628	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Influenza like illness (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994748	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[INSULIN, INSULIN HUMAN] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994753	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Brain death (n/a - Unknown - Other Medically Important Condition);Cerebral haemorrhage (n/a - Fatal - Results in Death);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010994760	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010994767	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening);Aplastic anaemia (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010994770	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Asthenia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vomiting (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010994773	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994774	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010994775	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994777	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - );Cardiac infection (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Loss of consciousness (1d - Fatal - Results in Death);Muscle twitching (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010994782	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Retinal exudates (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Retinal haemorrhage (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Retinal vein occlusion (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Visual acuity reduced (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010994784	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010994791	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthma (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994793	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994794	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Memory impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994797	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010994798	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994799	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994809	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994810	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994811	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Abdominal pain (n/a - Not Recovered/Not Resolved - Life Threatening);Acute pulmonary oedema (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Bronchospasm (n/a - Not Recovered/Not Resolved - Life Threatening);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Cyanosis (n/a - Not Recovered/Not Resolved - Life Threatening);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - Life Threatening);Hypoxia (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Life Threatening);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening);Respiratory distress (n/a - Unknown - Other Medically Important Condition);Respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening);Troponin T increased (n/a - Not Recovered/Not Resolved - Life Threatening);Wheezing (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010994816	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994825	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary incontinence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994826	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (5d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994941	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL ARGININE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010994990	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010994993	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Temperature intolerance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010994994	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLECAINIDE, FLECAINIDE ACETATE] (C - Atrial flutter - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - Atrial flutter - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010994994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995007	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Joint swelling (n/a - Unknown - Disabling, Other Medically Important Condition);Movement disorder (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (S - Contraception - Unknown - [n/a - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010995009	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995023	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995028	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010995063	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995068	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995071	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Temporomandibular pain and dysfunction syndrome (n/a - Unknown - Other Medically Important Condition);Trismus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995077	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Rash papular (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995080	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010995100	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995104	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash maculo-papular (5d - Recovered/Resolved - );Skin disorder (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995105	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010995108	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lip pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Tongue dry (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995140	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired work ability (1wk - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (8d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1wk - Recovered/Resolved - Other Medically Important Condition);Myositis (1wk - Recovered/Resolved - Other Medically Important Condition);Physical disability (1wk - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995147	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995150	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995152	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995159	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995164	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995166	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995170	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995171	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995176	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995178	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995190	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995191	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995270	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995272	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995276	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (7h - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995280	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995292	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Product preparation error (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sepsis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995293	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995294	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intradermal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995299	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995320	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuropathy (37d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010995328	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995331	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995342	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995346	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995347	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (93d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995350	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995361	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [32d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995368	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Cardiac failure acute (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995375	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010995377	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [27d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010995383	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010995384	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995389	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coronavirus infection (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Myasthenia gravis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010995390	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995393	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site discolouration (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010995398	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pelvic venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995401	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995408	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995412	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995414	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary infarction (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995415	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995424	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [32d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995425	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blindness transient (n/a - Recovered/Resolved - );Cerebellar stroke (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995427	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Allodynia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995434	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010995459	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BROMAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOLSIDOMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995461	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995463	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995477	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010995478	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Accidental overdose (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Incorrect dose administered (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 6{DF} - Intramuscular])	[PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMETICONE, PHLOROGLUCINOL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010995487	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995488	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	PRITORPLUS [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995489	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995490	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995504	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995507	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995513	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995514	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995529	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995538	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995543	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash maculo-papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995557	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995573	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (72h - Recovered/Resolved - );Palpitations (72h - Recovered/Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010995577	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995578	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex reactivation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995580	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|TRESIBA 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN [INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995584	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995585	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995587	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (28d - Recovered/Resolved - );Hypertension (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010995595	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995598	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995605	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010995606	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995609	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995610	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010995612	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995615	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995618	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995621	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (n/a - Recovered/Resolved - );Herpes simplex (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995628	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (7d - Recovered/Resolved - );Dizziness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995634	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995647	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periarthritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995656	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - Myocardial infarction - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - Myocardial infarction - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Myocardial infarction - n/a - [n/a - n/a - Oral])|[SALBUTAMOL SULFATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|[TIOTROPIUM] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995663	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (13h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995669	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995673	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995676	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Restless legs syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995678	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995685	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eructation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - Oral])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010995691	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995692	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995699	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995754	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995760	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995761	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995775	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995778	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010995802	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Retinal operation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995803	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995804	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (1d - Unknown - Other Medically Important Condition);Injection site pain (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (1d - Unknown - Other Medically Important Condition);Off label use (1d - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010995807	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995809	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010995817	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010995817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010996071	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diverticulitis (38d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Peritonitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sepsis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010996119	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - );Seasonal allergy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010996123	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Urticaria (6h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010996125	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010996136	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotonic-hyporesponsive episode (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010996143	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010996260	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010996287	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (90min - Recovered/Resolved - );Cold sweat (90min - Recovered/Resolved - );Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Pyrexia (90min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010996289	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010996301	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010996308	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Body temperature (1d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oral mucosal eruption (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010996326	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010996401	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (24h - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - );Influenza (1wk - Recovered/Resolved - );Influenza like illness (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vision blurred (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010996503	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010996508	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (0d - Fatal - Results in Death);Chest pain (3d - Fatal - Results in Death);Circulatory collapse (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010996510	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010996516	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (52h - Recovered/Resolved - );Body temperature increased (52h - Recovered/Resolved - );Chills (52h - Recovered/Resolved - );Myalgia (52h - Recovered/Resolved - );Nausea (52h - Recovered/Resolved - );Vertigo (52h - Recovered/Resolved - );Vomiting (52h - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010996524	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Life Threatening);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010996529	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cough (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Erythema (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Rash (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010996578	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE] (C - Respiratory symptom - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Respiratory symptom - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010996585	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (98d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010996617	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Epistaxis (2h - Recovered/Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010996757	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Malaise (n/a - Unknown - );Metastatic lymphoma (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Unknown - );Swelling face (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010996996	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010996996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997007	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010997013	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Exposure via breast milk (n/a - Unknown - );Pneumonitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010997101	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pharyngeal swelling (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997110	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997112	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997133	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - 12ug - Respiratory (inhalation)])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010997145	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010997282	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997286	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997296	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997297	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997318	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997319	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatinine increased (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	DARBEPOETIN ALFA [DARBEPOETIN ALFA] (C - Nephrogenic anaemia - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|MICARDIS [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CALCITRIOL] (C - Chronic kidney disease-mineral and bone disorder - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[EVOCALCET] (C - Chronic kidney disease-mineral and bone disorder - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[HEPARIN SODIUM] (C - Dialysis - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[IRON SUCROSE] (C - Iron deficiency anaemia - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997442	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ascites (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Polyserositis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[HUMAN IMMUNOGLOBULIN G, HUMAN NORMAL IMMUNOGLOBULIN] (C - Immunodeficiency - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010997454	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010997522	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997547	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997554	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997561	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010997562	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Feeling hot (3d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (3d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010997573	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood immunoglobulin E increased (n/a - Unknown - );Emotional distress (n/a - Unknown - );Erythema (n/a - Not Recovered/Not Resolved - Disabling);Feeling hot (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Inflammation (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Joint swelling (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Movement disorder (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Neuropathy peripheral (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Peripheral swelling (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Post-traumatic neck syndrome (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010997576	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997591	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010997606	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Localised oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997637	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010997655	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac hypertrophy (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Lymphocytic infiltration (n/a - Fatal - Results in Death);Physical deconditioning (n/a - Unknown - );Pyrexia (n/a - Unknown - );Subarachnoid haemorrhage (n/a - Fatal - Results in Death);Vertebral artery dissection (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010997663	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997667	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood urine present (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010997676	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997683	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Back pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dysstasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Syncope (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010997702	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Carpal tunnel syndrome (n/a - Recovering/Resolving - );Tenosynovitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997729	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010997778	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved With Sequelae - Disabling);Vaccination site paraesthesia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010997851	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997860	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pulpitis dental (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997889	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010997906	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Circulatory collapse (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010997906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998123	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Kidney infection (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010998148	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998159	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Listless (n/a - Not Recovered/Not Resolved - );Mechanical urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998177	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULAGLUTIDE [DULAGLUTIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|PIOGLITAZONE [PIOGLITAZONE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998197	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Neuralgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sensation of foreign body (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[LISDEXAMFETAMINE DIMESYLATE] (C - n/a - n/a - [n/a - 60mg - Oral])|[MONTELUKAST] (C - n/a - n/a - [n/a - 4mg - Oral])|[SERTRALINE] (C - n/a - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010998219	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010998224	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (25d - Recovered/Resolved - );Leukocytosis (25d - Recovered/Resolved - );Red blood cell sedimentation rate increased (25d - Recovered/Resolved - );Thrombocytosis (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	IMBRUVICA 140 MG HARD CAPSULES [IBRUTINIB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010998280	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998358	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Ocular hyperaemia (n/a - Not Recovered/Not Resolved - Disabling);Peripheral coldness (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010998363	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010998420	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998436	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998440	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Hepatic pain (3d - Recovered/Resolved - );Listless (3d - Recovered/Resolved - );Spinal pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998496	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Sensory loss (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010998503	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998573	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Trismus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998620	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010998623	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Ocular discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Ocular hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998633	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010998692	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998706	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998710	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Influenza like illness (1d - Recovered/Resolved - Disabling);Injection site pain (1d - Recovered/Resolved - Disabling);Injection site reaction (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BRINTELLIX 20 MG [VORTIOXETINE] (C - n/a - Unknown - [n/a - 20mg - n/a])|NOT AVAILABLE (C - n/a - Unknown - [n/a - 25mg - n/a])|NOT AVAILABLE (C - n/a - Unknown - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010998792	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010998835	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac arrest (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010998960	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site induration (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010998972	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebral venous sinus thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HYDROCHLORIDE] (C - Gastric mucosal hypertrophy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010998997	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal distension (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Rectal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	CANNABIDIOL [CANNABIDIOL] (C - Neuralgia - n/a - [245d - n/a - Oral])|PROTOPIC [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Lichen sclerosus - n/a - [n/a - n/a - Cutaneous])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|[ALLOPURINOL] (C - Gouty arthritis - n/a - [n/a - n/a - Oral])|[BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE] (C - Diuretic therapy - n/a - [597d - n/a - Oral])|[BISOPROLOL, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [378d - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CLOBETASOL PROPIONATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[COLCHICINE] (C - Arthritis - n/a - [n/a - n/a - Oral])|[DICLOFENAC SODIUM] (C - Arthritis - n/a - [n/a - n/a - Oral])|[DICLOXACILLIN] (C - Infection - n/a - [60d - n/a - Oral])|[DRONABINOL, CANNABIDIOL] (C - Neuralgia - n/a - [273d - n/a - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - Diuretic therapy - n/a - [n/a - n/a - Oral])|[MELATONIN] (C - Insomnia - n/a - [126d - n/a - Oral])|[MICONAZOLE NITRATE, HYDROCORTISONE] (C - Eczema - n/a - [2528d - n/a - Cutaneous])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [249d - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[POTASSIUM CHLORIDE] (C - Mineral supplementation - n/a - [n/a - n/a - Oral])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [736d - n/a - Respiratory (inhalation)])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[SPIRONOLACTONE] (C - Diuretic therapy - n/a - [n/a - n/a - Oral])|[SULFASALAZINE] (C - Arthritis - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Dysuria - n/a - [743d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010998997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010999021	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010999028	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999049	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010999073	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999095	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999106	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999113	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999128	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999131	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Temperature regulation disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999141	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999148	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999167	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown - More in ICSR])	[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999177	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 10ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999178	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999181	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999214	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bone pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999217	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999233	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010999238	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999252	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999263	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010999313	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (15min - Recovered/Resolved - );Injection site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999373	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999375	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999391	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999403	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999407	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999417	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010999418	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	BUMETANIDE [BUMETANIDE] (C - n/a - n/a - )|MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - Renal transplant - n/a - )|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Renal transplant - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[CANDESARTAN] (C - Hypertension - n/a - )|[CARVEDILOL] (C - Hypertension - n/a - )|[COLECALCIFEROL, CALCIUM] (C - Prophylaxis - n/a - )|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - )|[PREDNISOLONE] (C - Renal transplant - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999419	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999421	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Joint swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999427	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999601	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999606	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010999610	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010999740	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010999799	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999809	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Gastrointestinal haemorrhage (n/a - Fatal - Results in Death);Haematemesis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010999828	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010999831	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Syncope (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010999853	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Syncope (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010999890	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010999890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000006	Spontaneous	2021-12-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10011000080	Spontaneous	2021-12-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10011000080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973193	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973202	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010973284	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973315	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973366	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumonitis (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010973372	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral ischaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010973419	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to animal (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973433	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved With Sequelae - );Insomnia (n/a - Recovered/Resolved With Sequelae - );Musculoskeletal pain (n/a - Recovered/Resolved With Sequelae - );Musculoskeletal stiffness (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010973442	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010973455	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973456	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010973471	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Headache (n/a - Unknown - );Petit mal epilepsy (n/a - Unknown - );Respiratory fatigue (n/a - Unknown - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010973486	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973488	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Cholera immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010973490	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973564	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperglycaemia (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	NOVONORM 1 MG TABLETS [REPAGLINIDE] (C - n/a - n/a - [n/a - n/a - n/a])|TOUJEO [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010973625	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cytomegalovirus infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspepsia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hepatomegaly (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Infectious mononucleosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010973655	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010973666	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Oedema peripheral (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericardial effusion (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ventricular extrasystoles (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010973682	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	[OLMESARTAN MEDOXOMIL, AMLODIPINE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973694	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010973701	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombotic stroke (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010973704	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973713	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010973716	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973726	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);VIIth nerve injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010973737	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pustule (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010973746	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973747	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - Cutaneous])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010973754	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Dry eye (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010973766	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010973790	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	ARANESP 60 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [DARBEPOETIN ALFA] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010973916	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010973951	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010973951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010974023	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Colitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysentery (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Epistaxis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gastroenteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010974031	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010974036	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010974045	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urinary tract infection (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974051	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974056	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Unknown - Other Medically Important Condition);Visual field defect (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974076	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974079	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Faeces discoloured (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemoglobin decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010974099	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010974332	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [n/a - n/a - Parenteral])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - 50mg - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010974570	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010974641	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - Unknown - [1d - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE (INACTIVATED)] (S - Immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010974661	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974666	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010974671	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gilbert's syndrome (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - );Viral infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	GASEX [AYURVEDIC PREPARATION NOS, PHYLLANTHUS EMBLICA, PIPER NIGRUM, TERMINALIA BELLIRICA, TERMINALIA CHEBULA, ZINGIBER OFFICINALE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010974705	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyskinesia (n/a - Unknown - );Fall (n/a - Unknown - );Headache (n/a - Unknown - );Hypoaesthesia (37min - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - );Presyncope (37min - Recovered/Resolved - );Seizure (37min - Recovered/Resolved - Other Medically Important Condition);Vaccination site hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974706	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974715	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974716	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974720	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Areflexia (n/a - Unknown - Disabling);Dysphemia (n/a - Recovered/Resolved - Disabling);Eye swelling (n/a - Recovering/Resolving - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Limb discomfort (n/a - Unknown - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Swelling face (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010974725	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974727	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974739	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974757	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Cardiac disorder (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Unknown - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010974758	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Graves' disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperthyroidism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Temperature regulation disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010974774	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974815	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Rash papular (n/a - Recovered/Resolved - Other Medically Important Condition);Skin reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Suffocation feeling (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Throat irritation (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974816	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ERGOCALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010974828	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974847	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974848	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974850	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010974856	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974862	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974865	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974867	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974871	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974873	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974888	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974897	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974898	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010974935	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Poisoning (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Angiogram - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Angiogram - n/a - [n/a - n/a - n/a])|[MAGNESIUM ASPARTATE DIHYDRATE, MAGNESIUM ASPARTATE DIHYDRATE, MAGNESIUM CITRATE] (C - Angiogram - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Angiogram - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Angiogram - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010974935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010975279	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold urticaria (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975286	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired work ability (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975289	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - );Dizziness (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Myalgia (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975294	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975300	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Poor quality sleep (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	SYNJARDY 5 MG/850 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|XULTOPHY 100 UNITS/ML + 3.6 MG/ML SOLUTION FOR INJECTION [LIRAGLUTIDE, INSULIN DEGLUDEC] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010975312	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[MIANSERIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975316	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010975318	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	NOVORAPID 100 U/ML SOLUTION FOR INJECTION IN VIAL. [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975323	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (29d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010975328	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975330	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Pain in extremity (3d - Recovered/Resolved - );Rash pruritic (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	VITAMINBJØRNER JUNGEL [BIOTIN, CYANOCOBALAMINE, FOLIC ACID, NICOTINAMIDE, VITAMIN A, VITAMIN B6, VITAMIN C, VITAMIN E, VITAMINE D3] (C - n/a - n/a - )|[ALPHA-TOCOPHEROL] (C - n/a - n/a - )|[DOCONEXENT] (C - n/a - n/a - )|[ICOSAPENT] (C - n/a - n/a - )|[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - )|[RETINOL] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975334	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature fluctuation (n/a - Unknown - );Head discomfort (n/a - Unknown - );Headache (4d - Recovering/Resolving - );Hyperhidrosis (n/a - Unknown - );Nasopharyngitis (4d - Recovering/Resolving - );Peripheral coldness (n/a - Unknown - );Thirst (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975477	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[GLUCOSAMINE, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE] (C - Osteoarthritis - n/a - [1y - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [2y - n/a - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Prostatic disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010975521	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[COLCHICINE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[COVID-19 VACCINE] (S - Product used for unknown indication - Unknown - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010975541	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anal paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Erythema (n/a - Not Recovered/Not Resolved - Disabling);Feeling hot (n/a - Not Recovered/Not Resolved - Disabling);General physical health deterioration (n/a - Not Recovered/Not Resolved - Disabling);Genital paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Hyperaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Impaired quality of life (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Radiculopathy (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010975756	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Conjunctivitis (41d - Recovered/Resolved - );Ear pain (40d - Recovered/Resolved - );Facial paresis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[AMILORIDE HYDROCHLORIDE, FUROSEMIDE, FUROSEMIDE, ANHYDROUS AMILORIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAXOLOL, BETAXOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010975921	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010975926	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Episcleritis (11d - Recovered/Resolved - );Facial paresis (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ATENOLOL PH. EUR., CHLORTALIDONE PH. EUR., ATENOLOL, CHLORTALIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[DEXPANTHENOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, SOLIFENACIN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010975990	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitiligo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010975990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976007	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976025	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (6h - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Injection site lymphadenopathy (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976098	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976205	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Generalised anxiety disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010976227	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976231	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Breast pain (n/a - Unknown - Other Medically Important Condition);Breast swelling (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976233	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Hiatus hernia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Stress (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tension headache (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[PEPPERMINT OIL] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976241	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976243	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976252	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976255	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrous histiocytoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976258	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Axillary pain (n/a - Unknown - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976261	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (0d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Renal pain (n/a - Unknown - Other Medically Important Condition);Respiratory rate increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976270	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Conjunctival haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976276	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976277	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Platelet count decreased (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976278	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood blister (n/a - Unknown - );Feeling hot (n/a - Recovering/Resolving - );Inflammation (n/a - Recovered/Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976279	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976280	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976283	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Skin discolouration (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CODEINE PHOSPHATE HEMIHYDRATE PHEUR, IBUPROFEN PH. EUR., IBUPROFEN PH. EUR., CODEINE PHOSPHATE PH.EUR., IBUPROFEN, CODEINE PHOSPHATE, IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - Back pain - n/a - [3d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976284	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976289	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976291	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976300	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Freezing phenomenon (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976301	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Kidney infection (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010976308	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976310	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN PH. EUR., IBUPROFEN SODIUM, IBUPROFEN SODIUM DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976318	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976323	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hemiplegic migraine (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010976325	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976326	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Breast pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976327	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Secretion discharge (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976332	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976336	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Tremor (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010976342	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976349	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976354	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976355	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysstasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeding disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976357	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976381	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - .25mg - n/a])|[ESCITALOPRAM] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976427	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976432	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010976468	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Life Threatening);Malaise (n/a - Recovered/Resolved With Sequelae - Life Threatening);Pericarditis (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010976488	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypokinesia (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010976514	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976548	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (4wk - Recovered/Resolved - );Chest pain (4wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976554	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Lung disorder (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976560	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye irritation (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Ocular hyperaemia (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976569	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976575	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976580	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976604	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vaccination site thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976620	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976632	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976637	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976639	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976644	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure congestive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976647	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976655	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Activated partial thromboplastin time prolonged (n/a - Unknown - );Alanine aminotransferase increased (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - );Blood alkaline phosphatase increased (n/a - Unknown - );Blood bilirubin abnormal (n/a - Unknown - );Blood bilirubin increased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - );Gamma-glutamyltransferase increased (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976656	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovered/Resolved - );Extrasystoles (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010976659	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976660	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Articular calcification (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Left ventricular hypertrophy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tendon pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tendonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976685	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hepatic function abnormal (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976696	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovered/Resolved - );Extrasystoles (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010976697	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Recovered/Resolved - );Arthritis (n/a - Unknown - );Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Coma (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - );Intensive care unit acquired weakness (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - );Near death experience (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - );Pancreatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Renal failure (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976709	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976711	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amyotrophic lateral sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976719	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	BRINTELLIX [VORTIOXETINE] (C - n/a - n/a - [n/a - n/a - Oral])|[AZATHIOPRINE, AZATHIOPRINE BP, AZATHIOPRINE PH. EUR.] (C - n/a - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976727	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976740	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - 10mg - Oral])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Tooth abscess - n/a - [10d - n/a - Oral])|[PREDNISONE] (C - n/a - n/a - [n/a - 10mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976746	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976747	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Unknown - Other Medically Important Condition);Interstitial lung disease (n/a - Unknown - Other Medically Important Condition);Organising pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976756	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (5d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010976757	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Nephrolithiasis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010976759	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diphtheria (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination site reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976760	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Convulsions local (526min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (543min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (543min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010976762	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976763	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010976769	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976772	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Mobility decreased (n/a - Unknown - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010976776	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976778	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electroencephalogram abnormal (13d - Recovered/Resolved - );Epilepsy (13d - Recovered/Resolved - Other Medically Important Condition);Headache (13d - Recovered/Resolved - );Loss of consciousness (13d - Recovered/Resolved - Other Medically Important Condition);Malaise (13d - Recovered/Resolved - );Nausea (13d - Recovered/Resolved - );Pyrexia (13d - Recovered/Resolved - );Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976780	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976781	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976784	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sciatic nerve injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976786	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010976790	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976813	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010976814	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Discomfort (n/a - Not Recovered/Not Resolved - Disabling);Erythema (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010976871	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010976927	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010976960	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010976960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010977036	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977042	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PANTOPRAZOLE] (C - n/a - Unknown - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977108	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977119	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - Disabling);Eye pain (n/a - Not Recovered/Not Resolved - Disabling);Facial paralysis (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010977126	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovered/Resolved - );Depression (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hallucination, auditory (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	TREVICTA [PALIPERIDONE, PALIPERIDONE PALMITATE] (C - Mood altered - n/a - [n/a - n/a - n/a])|XELEVIA [SITAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[QUETIAPINE] (C - Mood altered - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977252	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Unknown - );Body temperature increased (n/a - Unknown - );Cardiovascular disorder (n/a - Unknown - );Chills (n/a - Unknown - );Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977287	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Body temperature increased (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977307	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (21d - Recovered/Resolved - Disabling);Respiratory disorder (21d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010977334	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Myalgia (2d - Recovered/Resolved - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	AERIUS [DESLORATADINE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010977403	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (166d - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010977480	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ABILIFY 15 MG TABLETS [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977490	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Loss of consciousness (n/a - Recovering/Resolving - Life Threatening);Malaise (n/a - Recovering/Resolving - Life Threatening);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening);Myoclonus (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010977523	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (12h - Recovered/Resolved - );Headache (12h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977739	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010977765	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (6wk - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010977771	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Renal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010977790	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010977802	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Muscle twitching (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010977972	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010977984	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010977996	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010977996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978010	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978044	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|ZYPREXA [OLANZAPINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978179	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BETAHISTINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978220	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978238	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010978246	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TRULICITY 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978373	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010978457	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Exercise tolerance decreased (30min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (30min - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemianopia (30min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nuchal rigidity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[AMLODIPINE, AMLODIPINE MALEATE] (C - Hypertension - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010978498	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1wk - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Fatigue (1wk - Recovered/Resolved - );Tendon pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978515	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling cold (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (18d - Recovered/Resolved - );Nuchal rigidity (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rhinorrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978589	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010978609	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Monoplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paralysis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010978628	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978646	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Body temperature abnormal (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Night sweats (n/a - Recovered/Resolved - Disabling);Temperature regulation disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010978714	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010978751	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site erythema (3d - Recovered/Resolved - );Administration site oedema (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978783	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978788	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978791	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoparesis (4d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010978792	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010978798	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978802	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978809	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010978813	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010978856	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling);Dysgeusia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010978915	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (6h - Recovered/Resolved - );Headache (6h - Recovered/Resolved - );Myalgia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010978915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979042	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010979060	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Chills (4h - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979106	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979127	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979135	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LISDEXAMFETAMINE DIMESYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979138	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site haematoma (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979302	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Bradycardia (6d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (6d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010979452	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Skin burning sensation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010979481	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Conjunctivitis (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010979570	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Injection site reaction (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010979594	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979639	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpetic radiculopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979652	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979672	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979679	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010979681	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010979682	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979683	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010979722	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Renal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010979727	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysstasia (4wk - Recovering/Resolving - );Haemorrhage (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Muscle atrophy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010979782	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010979803	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979835	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979848	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Recovered/Resolved With Sequelae - Disabling);Migraine (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - Asthma - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Migraine prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010979880	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hypothyroidism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[BETULA VERRUCOSA POLLEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010979882	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Subclavian vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010979982	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Basal cell carcinoma (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Colon cancer (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Extravasation blood (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010979987	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010979987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980010	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980011	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980013	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980018	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980046	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [104d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010980060	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980074	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site oedema (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE, PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - n/a - Unknown - [n/a - n/a - Oral])|[ROSUVASTATIN] (C - n/a - Unknown - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980075	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (20h - Recovered/Resolved - );Vaccination site pain (20h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - Unknown - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980103	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Life Threatening);Pneumonia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010980193	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Feeling cold (2d - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	JAKAVI [RUXOLITINIB, RUXOLITINIB PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980254	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980281	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoaesthesia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980302	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980305	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amaurosis fugax (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Intraocular pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ophthalmic artery thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [22d - n/a - Intramuscular])	MICARDIS [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010980307	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010980315	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	General physical health deterioration (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010980347	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Post-acute COVID-19 syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980348	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - 20mg - n/a])|[DIPOTASSIUM CLORAZEPATE] (C - Depression - n/a - [n/a - 20mg - n/a])|[ETORICOXIB] (C - n/a - n/a - [n/a - 90mg - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL, RAMIPRIL] (C - Hypertension - n/a - [n/a - 2.5mg - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 5mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980364	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Unknown - );Rash (n/a - Unknown - );Skin disorder (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BACLOFEN] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980369	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980385	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fine motor skill dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980417	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980462	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[BACLOFEN] (C - n/a - Unknown - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980513	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Myalgia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010980527	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Night sweats (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980528	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980529	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (5d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (3d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980531	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980537	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rheumatic disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin disorder (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980538	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980541	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980543	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Salivary hypersecretion (0d - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980545	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atypical pneumonia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980550	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980552	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980555	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980565	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980567	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Dyspepsia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980571	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980575	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980577	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980579	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980582	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Blood glucose increased (n/a - Not Recovered/Not Resolved - );Cushingoid (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory disorder (n/a - Not Recovered/Not Resolved - );Tongue discomfort (n/a - Unknown - );Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010980584	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Unknown - );Gastrointestinal disorder (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980586	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - Other Medically Important Condition);Asthenia (0d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Headache (0d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Myalgia (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TOLTERODINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980597	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980604	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980606	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Gastrointestinal disorder (n/a - Unknown - );Muscle twitching (n/a - Unknown - );Nervous system disorder (n/a - Unknown - );Pustule (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980610	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Allergy to chemicals (n/a - Not Recovered/Not Resolved - );Angioedema (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Food allergy (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - );Suffocation feeling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980620	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980658	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980686	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010980692	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010980708	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Cough (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980727	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980744	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PRAVAFENIX 40 MG/160 MG HARD CAPSULES [PRAVASTATIN SODIUM, FENOFIBRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980763	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cardiac murmur (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (4wk - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Sexual dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010980793	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980835	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Genital herpes (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010980911	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010980918	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010980935	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010980966	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010980966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010981016	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block complete (n/a - Unknown - Caused/Prolonged Hospitalisation);Bradycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010981031	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Cardiomegaly (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling);Generalised oedema (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Impaired quality of life (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010981034	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981038	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Embolic cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);SARS-CoV-2 test negative (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010981072	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981081	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010981165	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Burning sensation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Eye pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Neuralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vein disorder (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010981303	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose abnormal (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981376	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981389	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981392	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981393	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981394	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Salivary hypersecretion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981397	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Flushing (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981535	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ascites (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Oedema peripheral (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pollakiuria (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010981554	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981558	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SITAGLIPTIN [SITAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981561	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981563	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981574	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981580	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gaze palsy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);VIth nerve paralysis (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010981587	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericardial effusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981591	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981595	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010981716	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site erythema (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981721	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981722	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981725	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981726	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981732	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981733	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981735	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981737	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981739	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981741	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tooth abscess (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981751	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981755	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981758	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981765	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (40d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010981772	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	International normalised ratio increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[FLUINDIONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981784	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981788	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Diabetic neuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981789	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[CALCIUM FOLINATE, FOLINIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - n/a])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981800	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981806	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981809	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981815	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspepsia (n/a - Recovered/Resolved - );Hypothermia (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981816	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981823	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981826	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981827	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981830	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981836	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (4d - Not Recovered/Not Resolved - );Oropharyngeal pain (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981837	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981842	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATORVASTATIN, EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981874	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010981877	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981904	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vision blurred (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BECLOMETASONE DIPROPIONATE] (C - Antiinflammatory therapy - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981905	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010981910	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Musculoskeletal chest pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Paronychia (n/a - Recovering/Resolving - );Productive cough (n/a - Recovering/Resolving - );Respiratory tract irritation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CRATAEGUS EXTRACT] (C - n/a - n/a - [n/a - 300mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981915	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981916	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981930	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [22d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010981941	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010981985	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010981985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982014	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (1mo - Recovered/Resolved - );Hypertension (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982016	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010982020	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (5mo - Not Recovered/Not Resolved - );Limb discomfort (5mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982022	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982029	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982033	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ecchymosis (2d - Recovering/Resolving - );Hot flush (2d - Recovering/Resolving - );Insomnia (2d - Recovering/Resolving - );Vision blurred (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982035	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982039	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [30d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982041	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (15d - Recovered/Resolved - );Fibrin D dimer increased (15d - Recovered/Resolved - );Malaise (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010982048	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982066	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphonia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])|[A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (S - Influenza immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982070	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010982071	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Night sweats (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Thyroiditis subacute (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982308	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982319	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthropathy (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Burning sensation (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Irritability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])|[PREDNISOLONE] (S - Product used for unknown indication - Unknown - [n/a - 50mg - Unknown])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982332	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982333	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982337	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982338	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	GREPID 75 MG FILM-COATED TABLETS [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|IRBESARTAN 150 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982339	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010982341	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (11h - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982350	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010982358	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Impaired healing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010982372	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010982398	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982403	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (1mo - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982409	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982414	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982415	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982418	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982420	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (2wk - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982421	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982433	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982434	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Keratosis pilaris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982453	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sickle cell anaemia with crisis (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982456	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (3h - Recovered/Resolved - Other Medically Important Condition);Malaise (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982463	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatitis (2d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982471	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982478	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (12h - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (12h - Recovered/Resolved - Other Medically Important Condition);Tachycardia (12h - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982479	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982483	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982486	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (7d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982487	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982488	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982490	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982492	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982494	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Splenomegaly (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982505	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|VILDAGLIPTIN [VILDAGLIPTIN] (C - Type 2 diabetes mellitus - Not applicable - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - Not applicable - [n/a - n/a - n/a])|[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Type 2 diabetes mellitus - Not applicable - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - Not applicable - [n/a - n/a - n/a])|[RUPATADINE] (C - Rhinitis allergic - Not applicable - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Pain - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982544	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (1wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982553	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (3d - Recovered/Resolved - Other Medically Important Condition);Visual acuity reduced (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982559	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982560	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982578	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982585	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982589	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982594	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (18d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [39d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010982595	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982596	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebellar stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - n/a - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982601	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (9d - Recovered/Resolved - );Intestinal obstruction (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982611	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Graves' disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982773	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982776	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Left ventricular enlargement (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982779	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982780	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Vaccination site pain (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010982781	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982783	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982803	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heart rate increased (n/a - Recovering/Resolving - Disabling);Inappropriate schedule of product administration (n/a - Unknown - Disabling);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010982804	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure abnormal (n/a - Unknown - Other Medically Important Condition);Extrasystoles (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (100d - Recovered/Resolved - Other Medically Important Condition);Supraventricular extrasystoles (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Pulmonary embolism - n/a - [n/a - 2.5mg - n/a - More in ICSR])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure abnormal, Heart rate abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982814	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010982822	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Loss of consciousness (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (3d - Unknown - );Pyrexia (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982823	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982830	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heart rate increased (n/a - Recovering/Resolving - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010982831	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hyperhidrosis (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982832	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Obstructive airways disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010982839	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - );Fasciitis (n/a - Unknown - );Prostate infection (n/a - Unknown - Other Medically Important Condition);Prostatitis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010982948	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982980	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010982983	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982987	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sudden hearing loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982988	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010982993	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010982993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983000	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Atrial flutter (32d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Facial paresis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (32d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010983036	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Groin pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes simplex (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983039	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (36d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983044	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (3d - Recovering/Resolving - );Dysgeusia (1d - Recovering/Resolving - );Feeling hot (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983045	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (4d - Recovering/Resolving - );Diarrhoea (2d - Not Recovered/Not Resolved - );Dizziness (8d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Feeling hot (7d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Paraesthesia (6d - Not Recovered/Not Resolved - );Restlessness (4d - Recovering/Resolving - );Somnolence (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983050	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abnormal loss of weight (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);Fatigue (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Petechiae (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010983052	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (87d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983098	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983112	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983113	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983126	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden hearing loss (202d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983128	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983146	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (17d - Recovered/Resolved - );Night sweats (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983155	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Eye pain (7d - Recovering/Resolving - );Headache (7d - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983161	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983164	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea exertional (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - );Hypertensive crisis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983169	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling (n/a - Recovering/Resolving - );Thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983172	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest pain (0d - Recovered/Resolved - );Fatigue (23d - Recovering/Resolving - );Headache (40d - Recovering/Resolving - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983176	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (29d - Not Recovered/Not Resolved - );Influenza like illness (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983199	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (109d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983200	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983201	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (5d - Recovered/Resolved - );Influenza like illness (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983203	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983206	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983216	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983265	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983275	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983279	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983280	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Optic ischaemic neuropathy (1min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983284	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cutaneous vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Petechiae (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983298	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Arrhythmia (1d - Recovering/Resolving - );Fatigue (n/a - Unknown - );Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983299	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Life Threatening);Dyspnoea exertional (n/a - Recovered/Resolved - Life Threatening);Pericardial effusion (n/a - Recovered/Resolved - Life Threatening);Pericarditis (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010983300	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral venous thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983306	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010983315	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983316	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983317	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Injection site pain (7d - Not Recovered/Not Resolved - );Sleep disorder (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983324	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Limb discomfort (63d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983327	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmic storm (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Resuscitation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010983334	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983336	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983344	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983346	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Lymphadenopathy (74d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (74d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983350	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983354	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983362	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010983363	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010983366	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Respiratory distress (105d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983370	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovered/Resolved - );Myalgia (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983378	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983382	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved With Sequelae - );Neck pain (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010983384	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (26d - Not Recovered/Not Resolved - );Photophobia (26d - Not Recovered/Not Resolved - );Somnolence (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983416	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983418	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983419	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Recovered/Resolved - );Constipation (2d - Recovered/Resolved - );Cough (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Loss of libido (14d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983421	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Micturition urgency (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983425	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematoma (122d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010983427	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (12d - Recovering/Resolving - );Dyspnoea exertional (12d - Recovering/Resolving - );Headache (12d - Recovering/Resolving - );Myalgia (12d - Recovering/Resolving - );Palpitations (12d - Recovering/Resolving - );Visual impairment (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983428	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Muscle spasms (5d - Recovering/Resolving - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983443	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Respiratory distress (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983445	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (46d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010983450	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983452	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Mobility decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983458	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983486	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3wk - Recovered/Resolved - Other Medically Important Condition);Dizziness (3wk - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (3wk - Recovered/Resolved - Other Medically Important Condition);Palpitations (3wk - Recovered/Resolved - Other Medically Important Condition);Tachycardia (3wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983513	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug interaction (1d - Recovered/Resolved - );Gastrointestinal haemorrhage (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[HYDROXYCARBAMIDE] (I - Essential thrombocythaemia - Dose not changed - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - 100mg - n/a])|[CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, COLECALCIFEROL CONCENTRATE (OILY FORM)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010983578	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemolytic anaemia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemophagocytic lymphohistiocytosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIPTORELIN, TRIPTORELIN ACETATE] (C - Prostate cancer - n/a - [n/a - 11.25mg - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010983647	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Heart rate increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010983666	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983689	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983715	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983718	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (2h - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010983728	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Pneumonia (30d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983833	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983836	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983840	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983846	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983850	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983857	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983920	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983925	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactoid reaction (n/a - Recovering/Resolving - Life Threatening);Immunisation (n/a - Unknown - Life Threatening);Interchange of vaccine products (n/a - Unknown - Life Threatening);Off label use (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010983927	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983937	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Carpal tunnel syndrome (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Unknown - );Movement disorder (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010983943	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bedridden (n/a - Unknown - Other Medically Important Condition);Body temperature fluctuation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Toothache (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983951	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Other Medically Important Condition);Hemiplegia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983954	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983961	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010983963	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site nodule (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Arthralgia - n/a - [n/a - 10mg - n/a])|[COLESTYRAMINE] (C - n/a - n/a - [n/a - 4g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010983975	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010983975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984025	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010984034	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984036	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Cardiac disorder (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984039	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (n/a - Unknown - Other Medically Important Condition);Gastrointestinal pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Unknown - );Nausea (n/a - Unknown - );Night blindness (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984040	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984045	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Sinonasal obstruction (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984051	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry skin (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984062	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984063	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Anxiety (n/a - Not Recovered/Not Resolved - );Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depression (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984064	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hallucination, visual (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984072	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peritonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pseudomonas infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984079	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984082	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984089	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Kaposi's sarcoma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sciatica (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RALTEGRAVIR [RALTEGRAVIR] (C - HIV test positive - n/a - [n/a - n/a - n/a])|[EMTRICITABINE, TENOFOVIR] (C - HIV test positive - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984099	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Increased tendency to bruise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984105	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Mumps (n/a - Unknown - );Pancreatitis acute (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984121	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010984224	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Haemoptysis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE] (C - n/a - n/a - [n/a - 200{DF} - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010984259	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984261	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984271	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984274	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984279	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984280	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984282	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984293	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984296	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984298	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984300	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984301	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984303	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984311	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984321	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984323	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984326	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984332	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984333	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984342	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984353	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984355	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984356	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984357	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984364	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984366	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984372	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984374	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984452	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984453	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984461	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oedema (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010984466	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010984482	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984517	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010984538	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010984567	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010984582	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010984595	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010984672	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Critical illness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dermatomyositis (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Haemodynamic instability (n/a - Unknown - Caused/Prolonged Hospitalisation);Henoch-Schonlein purpura (n/a - Recovered/Resolved - Other Medically Important Condition);Hepatic function abnormal (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Inflammation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Joint effusion (n/a - Unknown - );Liver injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Purpura (n/a - Unknown - Caused/Prolonged Hospitalisation);Rotator cuff syndrome (n/a - Unknown - );Septic shock (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Serum sickness-like reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - );Testicular pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PREDNISOLONE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010984677	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984682	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984684	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984692	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Horner's syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984730	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );Asthenia (n/a - Not Recovered/Not Resolved - );Chills (8d - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Confusional state (n/a - Unknown - );Cough (8d - Recovered/Resolved - );Decreased appetite (n/a - Recovering/Resolving - );Delusional perception (22d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Hypersomnia (n/a - Recovering/Resolving - );Illness (n/a - Unknown - Other Medically Important Condition);Myalgia (8d - Recovered/Resolved - );Nausea (n/a - Unknown - );Nightmare (n/a - Recovered/Resolved - );Somnolence (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984740	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Diabetes mellitus inadequate control (n/a - Unknown - Other Medically Important Condition);Dizziness (1mo - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984748	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984754	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - Chest pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Chest pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984764	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[HEPATITIS A VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984788	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - );Petit mal epilepsy (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory arrest (n/a - Recovering/Resolving - Life Threatening);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010984916	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984946	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[VALERIAN ROOT EXTRACT, VALERIANAE RADIX DRY EXTRACT, LUPULI STROBULI EXTRACTUM SICCUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010984952	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984958	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984961	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984976	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010984994	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010984994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010985027	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010985063	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Ischaemic stroke (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010985067	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985085	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010985095	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Facial paresis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Ischaemic stroke - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[METRONIDAZOLE BENZOATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010985101	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010985110	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Recovering/Resolving - Disabling);Dizziness (n/a - Recovering/Resolving - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Migraine (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010985129	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985146	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985148	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[TAFAMIDIS MEGLUMINE] (S - n/a - Unknown - [n/a - 61mg - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985164	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Adverse reaction (n/a - Unknown - Other Medically Important Condition);Epilepsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985181	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Organ failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Suspected COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010985186	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombocytopenia (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010985201	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010985232	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985241	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pelvic venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985307	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985319	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Binge drinking (n/a - Unknown - );Breath sounds (n/a - Unknown - );Cachexia (n/a - Unknown - Other Medically Important Condition);Candida infection (n/a - Unknown - );Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Chronic disease (n/a - Unknown - );Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Facial paresis (n/a - Unknown - );Gait inability (n/a - Unknown - );Generalised tonic-clonic seizure (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hepatosplenomegaly (n/a - Unknown - );Hyperparathyroidism (n/a - Unknown - );Oedema peripheral (n/a - Unknown - );Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - );Tenderness (n/a - Unknown - );Vomiting (n/a - Unknown - );Wheezing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985359	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985371	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985405	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985434	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985449	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985452	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985483	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010985507	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985508	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Night sweats (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985516	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985522	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation);Multiple sclerosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985527	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985529	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985532	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985538	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985540	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985542	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985556	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985564	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	INSULATARD [INSULIN HUMAN, INSULIN HUMAN (RDNA), INSULIN HUMAN ISOPHANE (RDNA)] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985577	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985580	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985588	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LIXIANA 60 MG FILM-COATED TABLETS [EDOXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985604	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985614	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985745	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985750	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010985839	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Central nervous system lesion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased activity (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Recovering/Resolving - );Vision blurred (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010985917	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010985991	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral thrombosis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010985992	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Swelling face (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	AVAMYS 27.5 MICROGRAMS/SPRAY NASAL SPRAY SUSPENSION [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010985995	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Body temperature abnormal (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);COVID-19 (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Chest discomfort (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Spinal pain (1d - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010985995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010986044	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Unknown - );Syncope (2h - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (5h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010986074	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986108	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010986109	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986116	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986163	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986165	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])|[METAMIZOLE MAGNESIUM] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986214	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986248	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010986254	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psychotic disorder (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010986284	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986294	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chronic obstructive pulmonary disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chronic sinusitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Drug specific antibody present (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ill-defined disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Product use issue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	DEXAMETHASONE [DEXAMETHASONE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|TOZINAMERAN [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[INFLIXIMAB] (S - Colitis ulcerative - Unknown - [29d - 400mg - Intravenous (not otherwise specified) - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010986304	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sarcoidosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010986315	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[SILDENAFIL, SILDENAFIL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010986324	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986333	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (42d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (42d - Recovered/Resolved - Other Medically Important Condition);Fatigue (42d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010986367	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986373	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986374	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986452	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling of eyelid (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986481	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010986502	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986521	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986530	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986531	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986532	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986540	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986554	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Not Specified	Death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010986585	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986722	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986737	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010986753	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010986847	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anuria (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Fournier's gangrene (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Hepatic enzyme increased (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Hyperkalaemia (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Hypoxia (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Necrotising fasciitis (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Pulseless electrical activity (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Renal failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Scrotal erythema (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Scrotal pain (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Scrotal swelling (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Septic shock (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Ventricular tachycardia (n/a - Unknown - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010986925	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Libido decreased (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010986925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987034	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987047	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010987063	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010987093	Spontaneous	2021-12-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010987197	Spontaneous	2021-12-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1wk - Recovered/Resolved - Disabling);Tremor (1wk - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010987197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010956721	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (0d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956767	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pyrexia (0d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956779	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Nausea (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956796	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010956823	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cytomegalovirus infection (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Streptococcal infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956825	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cutaneous vasculitis (73d - Recovered/Resolved - );Eczema (73d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010956830	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956832	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956842	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure measurement (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010956879	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - );Musculoskeletal chest pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956920	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956966	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Gammopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956970	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956973	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (7d - Recovered/Resolved - Other Medically Important Condition);Cough (7d - Recovered/Resolved - Other Medically Important Condition);Myopericarditis (7d - Recovered/Resolved - Other Medically Important Condition);Pain (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010956975	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombotic microangiopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010956988	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010956990	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	PRADAXA 75 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - Atrial fibrillation - n/a - [n/a - 110mg - Oral])|[SOTALOL, SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 3{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957001	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957006	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Skin abrasion (n/a - Not Recovered/Not Resolved - Disabling);Skin burning sensation (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010957017	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Contusion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957019	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sciatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957027	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957030	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957043	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Face oedema (n/a - Recovered/Resolved - Life Threatening);Localised oedema (n/a - Recovered/Resolved - Life Threatening);Tongue oedema (n/a - Recovered/Resolved - Life Threatening);Urticaria (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010957080	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957086	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysgeusia (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010957139	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957142	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957150	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Discomfort (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957176	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Prostatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957180	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Oral herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957185	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957191	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	KARVEA [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|LEVEMIR [INSULIN DETEMIR] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID FLEXPEN 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957222	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Feeling hot (n/a - Unknown - );Pain (n/a - Unknown - );Palpitations (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010957258	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957345	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LORAZEPAM] (C - Insomnia - n/a - [n/a - 1mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957346	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (7d - Recovered/Resolved - );Pain in extremity (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - n/a - [n/a - 5mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957347	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - n/a - [n/a - 5mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957349	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mechanical urticaria (n/a - Recovering/Resolving - Life Threatening);Urticaria (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010957351	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957373	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Throat tightness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957379	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957381	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957390	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957392	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957395	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957400	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010957412	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster oticus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957414	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fungal skin infection (n/a - Recovered/Resolved - Other Medically Important Condition);Skin reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[MESALAZINE] (C - Colitis microscopic - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957420	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957431	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Post herpetic neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957436	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Disabling);Dysphagia (n/a - Recovering/Resolving - Disabling);Hemihypoaesthesia (n/a - Recovering/Resolving - Disabling);Ischaemic stroke (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JENTADUETO [METFORMIN HYDROCHLORIDE, LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DIPYRIDAMOLE, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010957440	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957441	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Carotid artery dissection (n/a - Not Recovered/Not Resolved - Disabling);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling);Dyslipidaemia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010957448	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010957454	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957462	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Ataxia (n/a - Not Recovered/Not Resolved - Life Threatening);Dysphagia (n/a - Not Recovered/Not Resolved - Life Threatening);Myoclonus (n/a - Not Recovered/Not Resolved - Life Threatening);Paraparesis (n/a - Not Recovered/Not Resolved - Life Threatening);Polyneuropathy (n/a - Not Recovered/Not Resolved - Life Threatening);Restlessness (n/a - Not Recovered/Not Resolved - Life Threatening);Tongue movement disturbance (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|RANEXA 500 MG PROLONGED-RELEASE TABLETS [RANOLAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010957471	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957474	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957483	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010957489	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957492	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematocrit increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957500	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Disabling);Confusional state (n/a - Recovering/Resolving - Disabling);Gait disturbance (n/a - Recovering/Resolving - Disabling);Periorbital swelling (n/a - Recovering/Resolving - Disabling);Proteinuria (n/a - Recovering/Resolving - Disabling);Tachycardia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - 1500mg - n/a])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - n/a - [n/a - 3mg - n/a])|[SOTALOL, SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 80mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010957501	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Tendon disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957509	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957515	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957516	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - Life Threatening);Pain in extremity (n/a - Recovering/Resolving - Life Threatening);Peripheral swelling (n/a - Recovering/Resolving - Life Threatening);Thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010957521	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Respiratory tract oedema (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010957529	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (18d - Recovered/Resolved - Other Medically Important Condition);Dry eye (18d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (18d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957533	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Peripheral paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957543	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957545	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Leukopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957546	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957547	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemoptysis (n/a - Recovered/Resolved With Sequelae - Disabling);Pneumonitis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010957569	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dehydration (2d - Fatal - Results in Death);Dyspnoea (2d - Fatal - Results in Death);Hyperpyrexia (2d - Fatal - Results in Death);Hypertension (2d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010957572	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Dose not changed - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957574	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Limb discomfort (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling);Thirst (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010957575	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	[BISOPROLOL FUMARATE] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957589	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chalazion (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Ear discomfort (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Retching (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010957600	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (70d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957602	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957608	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Middle insomnia (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957622	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diverticulitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[RIFAXIMIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957624	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (16d - Recovered/Resolved - Other Medically Important Condition);Febrile convulsion (16d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957626	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chorioretinopathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010957631	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010957632	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957633	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - Other Medically Important Condition);Small fibre neuropathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957636	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957642	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010957648	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010957925	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Ear infection (n/a - Unknown - Other Medically Important Condition);Hypoacusis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Unknown])|COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010957973	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957977	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957984	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957985	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957986	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957988	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957995	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957997	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Palpitations (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010957998	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010957998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958001	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958003	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958005	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958011	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Faeces discoloured (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Lip swelling (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958014	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010958016	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958017	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958023	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958026	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958033	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Hypokinesia (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin abnormal (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958039	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958040	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958043	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958044	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958045	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958046	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Hypokalaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958047	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Cholecystectomy (n/a - Recovering/Resolving - );Obstructive pancreatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958050	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958053	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Vertebral artery dissection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958054	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958057	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocardial strain imaging abnormal (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis constrictive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958059	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958061	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958062	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958065	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958074	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958076	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958083	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958084	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958087	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958092	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958095	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Echocardiogram abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958099	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958101	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Constipation (n/a - Unknown - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010958187	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Mahajan,S.. Parsonage Turner syndrome after COVID-19 vaccination. Muscle &amp; Nerve. 2021;64(1):E3-E4. doi:10.1002/mus.27255	18-64 Years	Not Specified	No	Male	Neuralgic amyotrophy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958350	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010958354	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958360	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958362	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Haemoptysis (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010958366	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958368	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958371	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (20min - Recovered/Resolved - Other Medically Important Condition);Vaccination site hypoaesthesia (1710min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958379	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958383	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Cough (n/a - Unknown - );Nasopharyngitis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010958384	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BENDROFLUAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958385	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010958390	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature decreased (n/a - Unknown - );Capillary nail refill test abnormal (n/a - Unknown - Other Medically Important Condition);Cold sweat (133min - Recovered/Resolved - );Dizziness (133min - Recovered/Resolved - );Hyperhidrosis (133min - Recovered/Resolved - );Hypotension (133min - Recovered/Resolved - Other Medically Important Condition);Pulse abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958403	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958411	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958412	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958417	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010958419	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Organic erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Penile oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958429	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958430	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958432	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chromaturia (n/a - Unknown - Other Medically Important Condition);Haemolytic anaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Jaundice (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CODEINE SULFATE] (C - Tendon disorder - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Glucose-6-phosphate dehydrogenase deficiency - n/a - [n/a - n/a - n/a])|[ROPINIROLE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958434	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (20min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958436	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958440	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010958442	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958443	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958447	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958462	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958463	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958464	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958465	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958466	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958468	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958472	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958473	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958474	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958478	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958481	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958491	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958494	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958495	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958498	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958501	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958503	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958505	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958508	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958509	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958513	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958514	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	LYUMJEV [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])|TRESIBA [INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010958522	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (15d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (13d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Psoriasis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010958524	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958529	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Subdural haematoma (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958535	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958536	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958538	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Exposure to SARS-CoV-2 (n/a - Unknown - );Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Pain (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010958694	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ascites (n/a - Unknown - Other Medically Important Condition);Chronic obstructive pulmonary disease (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Weight increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[BLACK PEPPER FRUITS] (C - Arthralgia - n/a - )|[BOSWELLIA] (C - Arthralgia - n/a - )|[COLLAGEN TYPE II] (C - Arthralgia - n/a - )|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[HYALURONIC ACID] (C - Arthralgia - n/a - )|[RESVERATROL] (C - Arthralgia - n/a - )|[TURMERIC] (C - Arthralgia - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010958744	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Ill-defined disorder - Not applicable - [1d - n/a - Parenteral])|[COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)] (S - Immunisation - Not applicable - [1d - n/a - Parenteral])|[INFLUENZA QUADRIVALENT VACCINE (RDNA)] (S - Immunisation, Influenza immunisation - Not applicable - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010958744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959213	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959216	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959218	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Magnetic resonance imaging heart (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959220	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ENTECAVIR [ENTECAVIR] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959224	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959225	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Hypotension (n/a - Unknown - );Nausea (n/a - Unknown - );Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959226	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959230	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959232	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Bone pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neck pain (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959234	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Periorbital swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959237	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypopnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959239	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LISINOPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959242	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959244	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959245	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959247	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin T increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959263	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myositis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959264	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959269	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959277	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bronchospasm (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959279	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959280	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959282	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abnormal dreams (n/a - Recovering/Resolving - Disabling);Arthralgia (4d - Recovered/Resolved - Disabling);Diarrhoea (1d - Recovered/Resolved - Disabling);Diplopia (1d - Recovered/Resolved - Disabling);Disturbance in attention (n/a - Unknown - Disabling);Erythema (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Influenza like illness (n/a - Recovering/Resolving - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Lethargy (6d - Recovered/Resolved - Disabling);Neck pain (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Poor quality sleep (n/a - Recovering/Resolving - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling);Rhinorrhoea (4d - Recovered/Resolved - Disabling);Vaccination site pruritus (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[COBAMAMIDE] (C - Neuritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010959283	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959285	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959286	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema multiforme (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959289	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959290	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959299	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AZELASTINE, AZELASTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959301	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Depressed mood (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Suicidal ideation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959305	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959312	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin I increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959390	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959394	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rhinitis (n/a - Not Recovered/Not Resolved - );Sinusitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959396	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Arthritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959399	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959400	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959404	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959412	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Application site swelling (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010959442	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010959487	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	DESLORATADINE [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - n/a - n/a - [4y - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [5y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010959513	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Supraventricular tachycardia (3h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010959581	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[ENALAPRIL MALEATE] (C - n/a - n/a - [10y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010959663	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959664	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959721	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (32d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (32d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010959732	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959738	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959745	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959760	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959765	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oral herpes (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959770	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Hemiplegia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959774	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hallucination (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nightmare (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Parosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959775	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dementia (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010959780	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959784	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Delirium (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (2min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RISDIPLAM [RISDIPLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959788	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959790	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959791	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959792	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arterial occlusive disease (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959794	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspepsia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Furuncle (n/a - Unknown - Other Medically Important Condition);Heart rate abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959797	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959801	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010959803	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Loss of consciousness (2min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959809	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010959814	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959821	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Hallucination (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010959822	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010959883	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (44d - Recovered/Resolved - );Chest discomfort (44d - Recovered/Resolved - );Chest pain (44d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010959956	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959957	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959981	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Lethargy (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959982	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959991	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959994	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Rhinitis (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010959997	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010959997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960002	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960003	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960004	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[ISOPROPYL ALCOHOL] (C - Essential tremor - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960006	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature fluctuation (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960010	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anger (n/a - Recovering/Resolving - Other Medically Important Condition);Crying (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Fear (n/a - Unknown - Other Medically Important Condition);Hallucination (n/a - Unknown - Other Medically Important Condition);Hallucinations, mixed (7d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injury (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BEMFOLA [FOLLITROPIN ALFA, FOLLITROPIN ALFA (GENETICAL RECOMBINATION)] (C - Pyrexia - n/a - [n/a - n/a - n/a])|DULOXETINE HYDROCHLORIDE [DULOXETINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010960014	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960016	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960031	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960034	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Delirium (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960035	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960037	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960040	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960042	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960043	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960120	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inner ear disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960140	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Hypertension (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960198	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960203	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (4mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960205	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960222	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Unknown - );Lymphadenitis (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[RAMIPRIL] (C - n/a - Unknown - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960277	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Illness (n/a - Unknown - );Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960283	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (32min - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Fear (n/a - Unknown - );Loss of consciousness (32min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960292	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Decreased appetite (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010960293	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960294	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal cancer (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010960302	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Furuncle (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960304	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960331	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960332	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960337	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Headache (n/a - Fatal - Results in Death);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010960344	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Trismus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960355	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960357	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nasopharyngitis (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960358	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebellar infarction (n/a - Unknown - Other Medically Important Condition);Subdural haematoma (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960360	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Laryngeal pain (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - Muscle spasms, Myalgia - n/a - [8d - 50mg - Oral])|[TOLPERISONE HYDROCHLORIDE] (C - Muscle spasms - n/a - [8d - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960362	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960374	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960382	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoglycaemia (n/a - Unknown - );Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960384	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cluster headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960386	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960387	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960388	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960393	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal mass (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010960397	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphagia (145d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Guillain-Barre syndrome (71d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (8d - Recovered/Resolved - Life Threatening);Quadriplegia (145d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010960398	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960399	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Acute vestibular syndrome (n/a - Unknown - Disabling, Other Medically Important Condition);Balance disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Disabling, Other Medically Important Condition);Dizziness (n/a - Unknown - Disabling, Other Medically Important Condition);Ear discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Disabling, Other Medically Important Condition);Vertigo (n/a - Unknown - Disabling, Other Medically Important Condition);Vestibular disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010960400	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960404	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (55min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960409	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960419	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960423	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Sepsis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960431	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960441	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Dysgeusia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960449	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960453	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Hypokalaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960458	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysuria (n/a - Not Recovered/Not Resolved - Disabling);Testicular pain (n/a - Not Recovered/Not Resolved - Disabling);Urethral pain (n/a - Not Recovered/Not Resolved - Disabling);Urine odour abnormal (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010960460	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Carpal tunnel syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960468	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Flatulence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960470	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960476	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960479	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960483	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aortic dissection (n/a - Fatal - Results in Death, Other Medically Important Condition);Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - Gastritis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010960486	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Uveitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vogt-Koyanagi-Harada disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960488	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960495	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Carditis (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960499	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (1d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Circulatory collapse (1d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Eye movement disorder (1d - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Haemorrhage (n/a - Unknown - Life Threatening, Disabling);Pallor (0d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Respiration abnormal (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Somnolence (1d - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Tongue biting (n/a - Unknown - Life Threatening, Disabling);Tremor (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Unresponsive to stimuli (n/a - Unknown - Life Threatening, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010960506	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Other Medically Important Condition);Tubulointerstitial nephritis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960509	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960512	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960516	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myoclonic epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960518	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960542	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 47.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960546	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960547	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960552	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	FIASP FLEXTOUCH [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|TOUJEO [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960571	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	HUMALOG [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])|TOUJEO [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 16mg - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960572	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[AVOCADO OIL UNSAPONIFIABLES, SOYBEAN OIL UNSAPONIFIABLES, SOYA OIL, AVOCADO OIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010960588	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	TWYNSTA [AMLODIPINE, TELMISARTAN] (C - Hypertension - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960614	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010960625	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960732	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960735	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960736	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960756	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010960779	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010960793	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (0d - Recovered/Resolved - Other Medically Important Condition);Impaired driving ability (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Respiratory arrest (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010960825	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (2mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[RIZATRIPTAN BENZOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010960959	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - );Hepatosplenomegaly (n/a - Unknown - );Joint swelling (n/a - Recovered/Resolved - );Microcytic anaemia (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - Drug withdrawn - [n/a - 10mg - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010960989	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Disabling);Disturbance in attention (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Oesophageal stenosis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010960989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010961001	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010961030	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961041	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Disabling);Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010961088	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - );Hypotension (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010961093	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961097	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961100	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961102	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961105	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961107	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961116	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Crystal arthropathy (n/a - Not Recovered/Not Resolved - Disabling);Inflammation (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010961150	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PARACETAMOL] (C - n/a - Unknown - [n/a - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961186	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Fatigue (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961194	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010961220	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[AMITRIPTYLINE HYDROCHLORIDE] (C - Herpes zoster - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE, NAPROXEN, NAPROXEN, NAPROXEN, ESOMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - Oral])|[NALOXONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE, NALOXONE, OXYCODONE, OXYCODONE HYDROCHLORIDE, NALOXONE, OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010961230	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site reaction (3h - Recovered/Resolved - Disabling);Pyrexia (3h - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010961248	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Chest pain (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961260	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenitis (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Orchitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010961305	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961311	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Gynaecomastia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961312	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Chills (0d - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961313	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961314	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Angina pectoris (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961366	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961401	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961797	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961807	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal faeces (1d - Recovered/Resolved - );Pallor (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961808	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site inflammation (1d - Recovered/Resolved - );Injection site pain (8h - Recovered/Resolved - );Injection site warmth (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	MELATONIN 1MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961812	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961826	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961830	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961838	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961877	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010961888	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Hyperkinetic heart syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010961892	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961896	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961907	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aggression (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pulmonary pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961918	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961943	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site hyperaesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961945	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epilepsy (n/a - Fatal - Results in Death);Glioblastoma (n/a - Fatal - Results in Death);Hemiplegia (n/a - Fatal - Results in Death);Memory impairment (n/a - Fatal - Results in Death);Visual impairment (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [EVOLOCUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[BARNIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010961968	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961973	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010961975	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (48h - Recovered/Resolved - );Injection site reaction (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010961988	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage intracranial (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhagic stroke (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune thrombocytopenia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Petechiae (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010961991	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Coronary artery dilatation (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram repolarisation abnormality (n/a - Unknown - Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);N-terminal prohormone brain natriuretic peptide increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010961991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010962024	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (48h - Recovered/Resolved - );Injection site reaction (48h - Recovered/Resolved - );Insomnia (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962047	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962058	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962079	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962102	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (24h - Recovered/Resolved - Disabling);Anosmia (24h - Recovered/Resolved - Disabling);COVID-19 immunisation (n/a - Recovered/Resolved - Disabling);Fatigue (2d - Recovering/Resolving - Disabling);Headache (2d - Recovering/Resolving - Disabling);Malaise (2d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010962134	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Asthenia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Delirium (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962225	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) DISPERSION FOR INJECTION [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962229	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962230	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962263	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962328	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962353	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain stem haemorrhage (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010962365	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010962379	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962445	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (7d - Recovered/Resolved - Other Medically Important Condition);Erythema (7d - Recovered/Resolved - Other Medically Important Condition);Fatigue (7d - Recovered/Resolved - Other Medically Important Condition);Limb discomfort (7d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010962615	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962621	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962622	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010962631	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962639	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962644	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962645	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pemphigoid (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010962663	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site haematoma (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962681	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010962782	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962809	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Movement disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962812	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	EXFORGE 5 MG/80 MG [VALSARTAN, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962891	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash macular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010962985	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, INFLUENZA A VIRUS/THAILAND/8/2022 (H3N2)-LIKE STRAIN (A/CALIFORNIA/122/2022, SAN-022), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, INFLUENZA VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) STRAIN (SPLIT, INACTIVATED), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, INFLUENZA A VIRUS/THAILAND/8/2022 (H3N2)-LIKE STRAIN (A/CALIFORNIA/122/2022, SAN-022), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, INFLUENZA VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) STRAIN (SPLIT, INACTIVATED)] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010962985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963145	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010963147	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963151	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Intestinal ischaemia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LINACLOTIDE] (C - Constipation - n/a - [149d - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [149d - n/a - Oral])|[MEMANTINE] (C - Dementia - n/a - [145d - n/a - Oral])|[SODIUM VALPROATE] (C - Irritability - n/a - [149d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010963153	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac tamponade (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema peripheral (64d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (2mo - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (2mo - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010963156	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963165	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (541min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Anaphylactic shock (541min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Hypotension (n/a - Unknown - );Nausea (n/a - Unknown - );Oropharyngeal discomfort (n/a - Unknown - );Shock (n/a - Unknown - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010963180	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure increased (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cyanosis (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pharyngeal stenosis (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Radial pulse abnormal (525min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010963220	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Flushing (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Lichen planus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Noninfective gingivitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin lesion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Stomatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tongue disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tongue geographic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitamin B12 decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vulvovaginal mycotic infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vulvovaginal pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])|[COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963296	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963311	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death);Cardiac failure acute (n/a - Fatal - Results in Death);Chest discomfort (n/a - Fatal - Results in Death)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010963319	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovered/Resolved - Disabling);Chills (1d - Recovering/Resolving - Disabling);Myalgia (1d - Recovering/Resolving - Disabling);Nausea (1d - Recovering/Resolving - Disabling);Pyrexia (1d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010963334	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XARELTO 2.5 MG [RIVAROXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN, EZETIMIBE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010963358	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Unknown - );Fatigue (3d - Unknown - );Myalgia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963390	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovering/Resolving - );Thyroid disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010963393	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963401	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - );Dyspnoea (3mo - Recovered/Resolved - );General physical health deterioration (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010963493	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous sinus thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010963501	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Life Threatening);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening);Hemiplegia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010963505	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963538	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963539	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963547	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963549	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling abnormal (n/a - Not Recovered/Not Resolved - Disabling);Immune system disorder (n/a - Unknown - );Impaired quality of life (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Performance status decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010963553	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963559	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963560	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Walter, A.. A neurologist&apos;s rhombencephalitis after comirnaty vaccination. A change of perspective. Neurological Research and Practice. 2021;3 (1):10.1186/s42466-021-00156-7. doi:10.1186/s42466-021-00156-7	18-64 Years	Not Specified	No	Not Specified	Encephalitis brain stem (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963563	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bone pain (n/a - Unknown - Other Medically Important Condition);Cold-stimulus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Musculoskeletal disorder (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963565	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963573	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Decreased activity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010963576	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963586	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (6mo - Recovered/Resolved - );Myocarditis (169d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FOLIC ACID] (C - Rheumatoid arthritis - n/a - [n/a - 5mg - Oral])|[METHOTREXATE, METHOTREXATE DISODIUM, METHOTREXATE SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - 15mg - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963592	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010963617	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963618	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Productive cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963628	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Exercise tolerance decreased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963631	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963635	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963711	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010963856	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac fibrillation (1mo - Recovered/Resolved - Other Medically Important Condition);Therapeutic product effect decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (I - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])|ENBREL [ETANERCEPT] (I - Ankylosing spondylitis - n/a - [n/a - 50mg - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963865	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Meningitis (19d - Recovered/Resolved With Sequelae - Life Threatening);Pericarditis (19d - Recovered/Resolved With Sequelae - Life Threatening);Septic shock (19d - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010963874	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963875	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010963902	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963925	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1.5d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1.5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963957	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Polymyositis (n/a - Not Recovered/Not Resolved - Disabling);Troponin T increased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	OTEZLA [APREMILAST] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010963961	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010963990	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010963990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964014	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964030	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964039	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964040	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	CORTICOSTEROID [NOT AVAILABLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964059	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous haemorrhage (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964066	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nipple pain (n/a - Not Recovered/Not Resolved - );Nipple swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964169	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Administration site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964221	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010964223	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Male	Cough (6d - Recovered/Resolved - );Diarrhoea (6d - Recovered/Resolved - );Exposure via breast milk (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964224	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010964330	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (48d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964331	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular infarction (6d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964341	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (8d - Recovered/Resolved - );Rash (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964342	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sinus arrest (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964345	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sudden hearing loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964348	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary artery thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964373	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964374	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010964387	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vascular stent occlusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Stent placement - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 80mg - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - 32mg - n/a])|[EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964392	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964417	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964421	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (40d - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (27d - Recovering/Resolving - );Diarrhoea (4d - Recovered/Resolved - );Fatigue (16d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Pain in extremity (14d - Recovered/Resolved - );Tenderness (14d - Recovered/Resolved - );Weight bearing difficulty (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964422	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (86d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964438	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (16d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964440	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Initial insomnia (87d - Recovered/Resolved With Sequelae - );Middle insomnia (87d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010964451	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Suicidal ideation (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964452	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964454	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964464	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - );Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964468	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964475	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiomyopathy (4d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (4d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (7d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Optic nerve injury (60d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vision blurred (60d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010964489	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964490	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964501	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964511	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964513	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964514	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964562	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation (72d - Not Recovered/Not Resolved - );Rash (72d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964577	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (2d - Recovered/Resolved With Sequelae - );Pain in extremity (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010964581	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle insomnia (7d - Unknown - );Paraesthesia (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964586	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964608	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964611	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964616	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crohn's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (3d - Recovered/Resolved - );Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964655	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Diarrhoea (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964657	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (1d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964676	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964677	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (77d - Recovered/Resolved - Other Medically Important Condition);Penile pain (77d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010964689	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Micturition urgency (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964692	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Tinnitus (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964700	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964705	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964710	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964730	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (n/a - Unknown - );Abdominal pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Dyspnoea exertional (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Nausea (n/a - Unknown - );Peripheral coldness (n/a - Unknown - );Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	LYRICA 50 MG [PREGABALIN] (C - n/a - n/a - )|[BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - )|[FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE, FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964742	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (0d - Unknown - Other Medically Important Condition);Injection site pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964744	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (84d - Recovering/Resolving - );Weight decreased (84d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964745	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964754	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010964761	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Fall (4d - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (4d - Not Recovered/Not Resolved - );Muscular weakness (4d - Not Recovered/Not Resolved - );Nervous system disorder (4d - Not Recovered/Not Resolved - );Tremor (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964763	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964771	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Depression (24d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010964774	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Recovered/Resolved - );Petechiae (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964775	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein occlusion (26d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964800	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Diarrhoea (27d - Not Recovered/Not Resolved - );Fatigue (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010964801	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964805	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964810	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Trigeminal neuritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010964826	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964830	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMISULPRIDE] (C - n/a - Not applicable - [n/a - 50mg - n/a])|[LEVOMEPROMAZINE] (C - n/a - Not applicable - [n/a - 5mg - n/a])|[NEBIVOLOL] (C - n/a - Not applicable - )|[SERTRALINE] (C - n/a - Not applicable - [n/a - 25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964835	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010964838	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010964841	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964848	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964852	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010964854	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tenosynovitis (128d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010964860	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964904	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964916	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [31d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964918	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964919	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendon rupture (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964920	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964929	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (S - Mixed anxiety and depressive disorder - Dose not changed - [n/a - n/a - Oral])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010964930	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010964935	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010964939	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Implantable defibrillator insertion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964951	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010964957	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (19d - Recovering/Resolving - );Diarrhoea (19d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964965	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Liver function test abnormal (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010964983	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 2{DF} - Intramuscular])	DUOPLAVIN 75 MG/75 MG FILM-COATED TABLETS [ACETYLSALICYLIC ACID, CLOPIDOGREL] (C - Thrombosis prophylaxis - n/a - [n/a - 1{DF} - Oral])|INSULIN GLARGINE [INSULIN GLARGINE] (C - Type 2 diabetes mellitus - n/a - [n/a - 15[iU] - Subcutaneous])|XIGDUO 5 MG/1,000 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - 2{DF} - Oral])|[ATENOLOL] (C - Hypertension - n/a - [n/a - 50mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - 10mg - Oral])|[EZETIMIBE] (C - Dyslipidaemia - n/a - [n/a - 10mg - Oral])|[GLICLAZIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - 1{DF} - Oral])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964987	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - Not applicable - [n/a - 2{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010964988	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Transient ischaemic attack (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010964988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965003	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux prophylaxis - Unknown - [n/a - 20mg - Oral])|XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Atrial fibrillation - Unknown - [n/a - 20mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Thrombosis prophylaxis - Unknown - [n/a - 40mg - Oral])|[BISOPROLOL, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - Unknown - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - Unknown - [n/a - 8mg - Oral])|[EPLERENONE] (C - Atrial fibrillation - Unknown - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965004	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ENTRESTO 97 MG/103 MG FILM-COATED TABLETS [VALSARTAN, SACUBITRIL] (C - Cardiac failure - n/a - [n/a - 1{DF} - Oral])|[FLUINDIONE] (C - Atrial fibrillation - n/a - [n/a - .5{DF} - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux prophylaxis - n/a - [n/a - 20mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965005	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	CELLCEPT 500 MG TABLETS [MYCOPHENOLATE MOFETIL] (S - Heart transplant - Drug withdrawn - [n/a - 1000mg - Oral])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])|[PREDNISOLONE METASULFOBENZOATE SODIUM] (S - Heart transplant - Dose not changed - [n/a - 5mg - Oral])|[TACROLIMUS, TACROLIMUS MONOHYDRATE] (S - Heart transplant - Dose not changed - [n/a - 2.5mg - Oral])	JANUVIA 100 MG FILM-COATED TABLETS [SITAGLIPTIN] (C - Hyperglycaemia - n/a - [n/a - 100mg - Oral])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 200mg - Oral])|[D,L-LYSINE ACETYLSALICYLATE] (C - Myocardial ischaemia - n/a - [n/a - 75mg - Oral])|[ESCITALOPRAM] (C - Affective disorder - n/a - [n/a - 10mg - Oral])|[FLUVASTATIN SODIUM] (C - Thrombosis prophylaxis - n/a - [n/a - 20mg - Oral])|[FUROSEMIDE] (C - Chronic kidney disease - n/a - [n/a - 40mg - Oral])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 75ug - Oral])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Benign prostatic hyperplasia - n/a - [n/a - 2{DF} - Oral])|[MAGNESIUM CITRATE, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM PIDOLATE, MAGNESIUM LACTATE, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM PIDOLATE, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM LACTATE DIHYDRATE, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM CITRATE ANHYDROUS, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM LACTATE DIHYDRATE] (C - Mineral supplementation - n/a - [n/a - 1{DF} - Oral])|[METFORMIN EMBONATE] (C - Hyperglycaemia - n/a - [n/a - 1400mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - Product used for unknown indication - n/a - [n/a - 40mg - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - .4mg - Oral])|[TESTOSTERONE ENANTATE] (C - Hypogonadism - n/a - [n/a - 250mg - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965006	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965011	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965012	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965016	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010965018	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965019	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovered/Resolved - );Glomerulonephritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Renal failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965023	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphoproliferative disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965026	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ERLEADA [APALUTAMIDE] (C - Prostate cancer - n/a - [n/a - n/a - Oral])|[TRIPTORELIN, TRIPTORELIN ACETATE, TRIPTORELIN PAMOATE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - 75mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965043	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Central serous chorioretinopathy (10d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965045	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Rash macular (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - );Sleep disorder (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965046	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965052	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Varicose vein (75d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010965069	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965071	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Giant cell arteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Orchitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Polymyalgia rheumatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965108	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Multisystem inflammatory syndrome in children (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010965122	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - Disabling);Fatigue (2d - Recovering/Resolving - Disabling);Headache (2d - Recovering/Resolving - Disabling);Myalgia (2d - Recovering/Resolving - Disabling);Nausea (2d - Recovering/Resolving - Disabling);Pyrexia (2d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010965134	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965171	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965205	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thyroiditis subacute (55d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010965208	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (76d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965212	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965213	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965214	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Peripheral coldness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010965224	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965239	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transplant rejection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965244	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pudendal canal syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965252	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Endocarditis (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010965260	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965261	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965266	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erysipelas (8d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965271	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Lymphoedema (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965321	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip swelling (1d - Recovered/Resolved - );Lymphadenopathy (1d - Unknown - );Swelling face (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965388	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (49d - Not Recovered/Not Resolved - );Panic attack (49d - Not Recovered/Not Resolved - );Tremor (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965400	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (0d - Recovered/Resolved - Other Medically Important Condition);Fall (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965401	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Oedema (48d - Not Recovered/Not Resolved - );Vaccination site swelling (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965405	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965406	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (21d - Not Recovered/Not Resolved - );Cardiovascular disorder (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965416	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aggression (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965417	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Gingival pain (n/a - Not Recovered/Not Resolved - );Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperaesthesia teeth (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965425	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965439	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965461	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (38d - Not Recovered/Not Resolved - );Lung disorder (38d - Not Recovered/Not Resolved - );Ocular discomfort (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965474	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Antidepressant therapy (21d - Recovering/Resolving - );Depression (21d - Recovering/Resolving - );Panic attack (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965478	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965495	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965501	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingival recession (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965503	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965504	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (93d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965548	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Hypertension (73d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965551	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (46d - Unknown - );Postmenopausal haemorrhage (46d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965552	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965565	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965566	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965578	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (22d - Unknown - );Eye swelling (21d - Recovered/Resolved - );Hypersensitivity (21d - Recovered/Resolved - );Influenza (22d - Unknown - );Malaise (22d - Unknown - );Ocular hyperaemia (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965582	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010965594	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Sciatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965597	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965607	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (93d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965608	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (16d - Unknown - );Headache (16d - Unknown - );Influenza (2d - Recovered/Resolved - );Nephrotic syndrome (13d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965630	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (182d - Not Recovered/Not Resolved - );Hyperhidrosis (182d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965634	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (35d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965660	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle insomnia (38d - Not Recovered/Not Resolved - );Sleep disorder (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010965679	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Unknown - Other Medically Important Condition);Pain in extremity (1d - Unknown - );Palpitations (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965692	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Cough (1d - Recovering/Resolving - );Dysuria (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965704	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965725	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Glossodynia (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965734	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NON SPECIFIED BLOEDDRUKMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010965736	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Ocular myasthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965738	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010965766	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injected limb mobility decreased (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010965827	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[ANHYDROUS LEVOTHYROXINE SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[FOLIC ACID] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[METHOTREXATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PREDNISOLONE BP] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010965868	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965869	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vasodilatation (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010965876	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965886	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965895	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Deafness traumatic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[PROCHLORPERAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965896	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial septal defect (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Hyperacusis (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Photophobia (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010965898	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Lymphadenitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965904	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Crohn's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Osteoarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965912	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Biopsy breast (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965916	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965917	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal inflammation (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965918	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965920	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010965923	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010965925	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[PROPANTHELINE BROMIDE] (C - Hyperhidrosis - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety, Depression - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965929	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965939	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965945	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965947	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	No	Not Specified	Anti-polyethylene glycol antibody present (n/a - Recovered/Resolved - Other Medically Important Condition);Coagulation factor VIII level decreased (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Drug clearance increased (n/a - Unknown - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965952	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Dementia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Foot fracture (n/a - Unknown - );Gait inability (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Unknown - );Pain (n/a - Unknown - );Plantar fasciitis (n/a - Unknown - );Tendon disorder (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965957	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Localised infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965973	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010965975	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010965988	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965994	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hepatitis B (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010965998	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Superficial vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Thrombophlebitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010965998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010966009	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Reflux laryngitis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010966010	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966015	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966016	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory loss (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966026	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966032	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Localised infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966038	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Tenderness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010966040	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thirst (n/a - Recovered/Resolved - Other Medically Important Condition);Type 2 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966056	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966057	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TICAGRELOR [TICAGRELOR] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[ARTICAINE] (C - n/a - n/a - [1d - n/a - n/a])|[ATORVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966084	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966088	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966094	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966099	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctival haemorrhage (n/a - Unknown - Other Medically Important Condition);Conjunctivitis (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - );Penile haemorrhage (n/a - Unknown - Other Medically Important Condition);Vascular injury (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966102	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966107	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966114	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966115	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966119	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Haemorrhage urinary tract (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010966120	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966126	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site joint movement impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966138	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition);Injection site haemorrhage (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966139	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966148	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966152	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral artery thrombosis (n/a - Recovering/Resolving - Life Threatening);Ischaemic stroke (124d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010966157	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966161	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	LENVIMA [LENVATINIB] (S - n/a - Unknown - [n/a - 20mg - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966163	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature fluctuation (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966168	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epilepsy (4min - Recovered/Resolved - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966185	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ZOFENOPRIL CALCIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966191	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBAMAZEPINE] (C - Trigeminal neuralgia - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Trigeminal neuralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966195	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966199	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966201	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966202	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966219	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966221	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966235	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Irritability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966239	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966240	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966242	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (17d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (13d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966362	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Vaccination failure (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966430	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966433	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966437	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Seizure (40min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010966438	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966440	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Confusional state (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Paralysis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010966449	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966455	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966462	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Disabling);Ear pain (n/a - Unknown - Disabling);Erectile dysfunction (n/a - Unknown - Disabling);Facial pain (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Product use issue (n/a - Unknown - );Sleep disorder due to a general medical condition (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[PREDNISOLONE] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010966472	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[PARACETAMOL, PHOLCODINE, PSEUDOEPHEDRINE, PSEUDOEPHEDRINE HYDROCHLORIDE, PARACETAMOL, PHOLCODINE] (C - Nasopharyngitis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - Gender dysphoria - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010966478	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Exercise tolerance decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966479	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myositis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Psoriasis (n/a - Unknown - Other Medically Important Condition);Psoriatic arthropathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966480	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|INSULIN ASPART [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|INSULIN GLARGINE [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966510	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966512	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (35d - Unknown - );Influenza (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010966517	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (42d - Unknown - );Vulvovaginal mycotic infection (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010966550	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Decreased appetite (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Dysmenorrhoea (n/a - Not Recovered/Not Resolved - );Feeling abnormal (0d - Recovered/Resolved - );Feeling drunk (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (8d - Recovered/Resolved - );Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - );Malaise (0d - Recovered/Resolved - );Menstruation irregular (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Oligomenorrhoea (n/a - Not Recovered/Not Resolved - );Pain in extremity (8d - Recovered/Resolved - );Vaccination site movement impairment (8d - Recovered/Resolved - );Vaccination site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966553	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966554	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epistaxis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Oxygen therapy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010966557	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type 1 diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010966558	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966566	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (11d - Recovering/Resolving - Other Medically Important Condition);Penile vein thrombosis (11d - Recovering/Resolving - Other Medically Important Condition);Peyronie's disease (11d - Recovering/Resolving - );Phlebitis (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966592	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966624	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966643	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Sleep disorder (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966651	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966653	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966666	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (5d - Recovered/Resolved - );Dyspnoea exertional (5d - Recovered/Resolved - );Pain in extremity (5d - Recovered/Resolved - );Performance status decreased (5d - Recovered/Resolved - );Tachycardia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966696	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Atypical pneumonia (7d - Recovering/Resolving - Other Medically Important Condition);Painful respiration (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966700	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966705	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (55d - Not Recovered/Not Resolved - );Venous thrombosis (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966707	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966710	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966718	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral swelling (53d - Recovered/Resolved - );Prothrombin time abnormal (53d - Recovered/Resolved - );Skin discolouration (53d - Recovered/Resolved - );Thrombosis (53d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010966719	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966720	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint range of motion decreased (21d - Recovered/Resolved - );Pain in extremity (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010966726	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966736	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (66d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010966741	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966744	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACEBUTOLOL, ACEBUTOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966746	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966768	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966784	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966786	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966807	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966811	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966824	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966828	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (18d - Recovered/Resolved - );Myalgia (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966830	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966843	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966880	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966881	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966892	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neurodermatitis (84d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010966906	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966908	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966912	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966919	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - );Red blood cell count decreased (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966926	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966945	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966969	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966990	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966993	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010966996	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010966998	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010966998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967002	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967005	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967006	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (76d - Not Recovered/Not Resolved - );Influenza (76d - Not Recovered/Not Resolved - );Renal pain (76d - Not Recovered/Not Resolved - );Spinal pain (76d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967028	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967044	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967050	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967051	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967057	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967063	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	PRASUGREL [PRASUGREL] (C - Infarction - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Infarction - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Infarction - n/a - [n/a - n/a - n/a])|[BISOPROLOL HEMIFUMARATE] (C - Infarction - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Infarction - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Infarction - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967071	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	UROREC [SILODOSIN] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[SOTALOL HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967078	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cytomegalovirus infection reactivation (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967079	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967093	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967099	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epididymitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010967100	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967104	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling face (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010967113	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Joint swelling (n/a - Not Recovered/Not Resolved - );Orthopaedic examination (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967126	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967131	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967136	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967148	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Renal failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - )|[MEFENAMIC ACID] (C - n/a - n/a - )|[SPIRONOLACTONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010967149	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967162	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (54d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967173	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arterial occlusive disease (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010967177	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967183	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967188	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967196	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	OTEZLA [APREMILAST] (C - n/a - Not applicable - [n/a - n/a - n/a])|[OXAZEPAM] (C - n/a - Not applicable - [n/a - 10mg - Oral])|[ZOPICLONE] (C - n/a - Not applicable - [n/a - 7.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967199	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967205	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Peripheral coldness (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967206	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967217	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967225	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967232	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967234	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967235	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])|M-M-RVAXPRO [MEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED), MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS, MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS] (S - Immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])|NIMENRIX [N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID, NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN, NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN, NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN] (S - Immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967243	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967245	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967266	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967270	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967279	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967282	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967284	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	TELMISARTAN ACTAVIS 40 MG TABLETS [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967291	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967295	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cystitis noninfective (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967297	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967319	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967320	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967321	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967340	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [25d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967344	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Mesenteric lymphadenitis (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967345	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967349	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967352	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967354	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967373	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967379	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967383	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967384	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (9d - Recovered/Resolved - );Vertigo (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967387	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967388	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967412	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendon disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967424	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (2d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967437	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoparesis (n/a - Unknown - );Vaccination site hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967457	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967458	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Groin pain (n/a - Unknown - );Testicular pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967471	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967509	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation (80d - Not Recovered/Not Resolved - );Incomplete course of vaccination (80d - Not Recovered/Not Resolved - );Oedema mucosal (80d - Not Recovered/Not Resolved - );Refusal of vaccination (80d - Not Recovered/Not Resolved - );Stomatitis (80d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010967511	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967514	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (0d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010967517	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Unknown - );Lung disorder (n/a - Unknown - );Ocular discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967526	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967532	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (73d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010967551	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Taste disorder (n/a - Not Recovered/Not Resolved - );Tongue discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967562	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967564	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (100d - Not Recovered/Not Resolved - );Rash macular (100d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010967579	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (65d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010967584	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Therapeutic response unexpected (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967588	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967592	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010967599	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010967610	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (60d - Not Recovered/Not Resolved - );Dizziness (60d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010967618	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes ophthalmic (28d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010967657	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (3d - Recovered/Resolved - );Renal pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967664	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (16d - Unknown - );Pruritus (16d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967667	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010967681	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967699	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010967703	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010967712	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010967724	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Conjunctivitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967735	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (6d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967760	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (1d - Recovering/Resolving - Other Medically Important Condition);Ear discomfort (1d - Recovering/Resolving - );Pain in extremity (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967763	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Feeling hot (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Insomnia (7d - Unknown - );Noninfective gingivitis (7d - Not Recovered/Not Resolved - );Pyrexia (7d - Not Recovered/Not Resolved - );Weight decreased (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967766	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Enthesopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967769	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967787	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertensive crisis (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010967792	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inappropriate affect (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967804	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967808	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (14d - Recovered/Resolved - );Neck pain (14d - Recovered/Resolved - );Oropharyngeal pain (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967831	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967885	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967894	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (4wk - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])|[LISINOPRIL DIHYDRATE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967901	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bladder pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967918	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood iron increased (n/a - Unknown - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967922	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Yagi, T.. A case of acute HIV infection diagnosed at onset of persistent pyrexia after novel coronavirus (COVID-19) vaccine injection. The 671st Kanto Regional Meeting of the Japanese Society of Internal Medicine. 2021;671th	18-64 Years	Not Specified	No	Male	Acute HIV infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Unknown - );Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Liver disorder (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010967952	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010967976	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967979	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967981	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010967984	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Benign prostatic hyperplasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bladder injury (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure fluctuation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood urine present (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Body temperature increased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oral herpes (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal impairment (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Upper respiratory tract infection (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary retention (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urine analysis abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALFUZOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010967987	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain oedema (n/a - Unknown - Caused/Prolonged Hospitalisation);Contusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Head injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Psychotic disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010967988	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967989	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010967992	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967994	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asphyxia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Throat tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967995	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010967999	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010967999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968002	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968004	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968008	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968013	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968017	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968018	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968020	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968025	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968026	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968029	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968034	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Acute respiratory distress syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachypnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BUDESONIDE [BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[BUDESONIDE, FORMOTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 2mg - n/a])|[IPRATROPIUM, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE ANHYDROUS, IPRATROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010968038	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968056	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Lung consolidation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968058	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968063	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968069	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (50d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rhabdomyolysis (50d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ABRAXANE [PACLITAXEL, PACLITAXEL ALBUMIN-BOUND] (C - Neoplasm malignant - n/a - [1d - n/a - Intravenous (not otherwise specified)])|[DEXAMETHASONE SODIUM PHOSPHATE] (C - Neoplasm malignant - n/a - [1d - n/a - Intravenous (not otherwise specified)])|[MOXIFLOXACIN HYDROCHLORIDE] (C - Choroidal haemangioma - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968071	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968074	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diabetes mellitus inadequate control (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968075	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968076	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968079	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968081	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968087	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle twitching (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968093	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968096	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pH increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968097	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleurisy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968102	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968103	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968105	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (2d - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, PARACETAMOL] (C - Nasopharyngitis - n/a - [6d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968113	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Pain in jaw (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968114	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thalamic infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968115	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved With Sequelae - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Memory impairment (n/a - Unknown - );Muscle rigidity (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010968117	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968124	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Cognitive disorder (n/a - Unknown - );Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dyslalia (n/a - Recovering/Resolving - Other Medically Important Condition);Encephalitis viral (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Hepatic enzyme increased (n/a - Unknown - );Hepatic function abnormal (n/a - Unknown - );Lymphocyte count increased (n/a - Unknown - );Lymphocyte percentage increased (n/a - Unknown - );Movement disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Speech disorder (n/a - Unknown - );Talipes (n/a - Unknown - Other Medically Important Condition);Urine ketone body present (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968128	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Malaise (n/a - Unknown - );Off label use (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010968129	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968131	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010968134	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Disabling, Other Medically Important Condition);Breast pain (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Neck pain (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010968136	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paralysis (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, EZETIMIBE] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[LINAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[PARACETAMOL, TRAMADOL, TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - Oral])|[TAK 438] (C - Gastric ulcer - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968138	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968139	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eyelid ptosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBOMER] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968140	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968141	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - );Cold sweat (n/a - Unknown - );Headache (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Insomnia (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Lumbar puncture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Meningism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Unknown - );Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968154	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968187	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968239	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968263	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968264	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968282	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968289	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968290	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968298	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968302	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968305	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Unresponsive to stimuli (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010968307	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - );Lower gastrointestinal haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968313	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Erythema multiforme (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968318	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968321	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema peripheral (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968323	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968325	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968326	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968330	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968332	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of personal independence in daily activities (n/a - Unknown - );Mobility decreased (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968336	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (22min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968337	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968338	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Disabling);Heart rate increased (n/a - Recovered/Resolved - Disabling);Heart rate irregular (n/a - Recovered/Resolved - Disabling);Inflammation (n/a - Unknown - Disabling);Loss of consciousness (n/a - Unknown - Disabling, Other Medically Important Condition);Migraine (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010968340	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010968344	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968346	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968352	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968354	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968364	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Polymenorrhoea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968366	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968375	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (3min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968389	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968390	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968392	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010968401	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968410	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL BP, DIPHENHYDRAMINE HYDROCHLORIDE BP, CAFFEINE BP, PHENYLEPHRINE HYDROCHLORIDE BP, CODEINE PHOSPHATE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968417	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Troponin increased (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968418	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968419	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968443	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (36d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010968461	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968468	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968473	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968480	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968512	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968559	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968579	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (n/a - Not Recovered/Not Resolved - );Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - );Menstruation delayed (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968580	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968584	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (52d - Unknown - );Lymphadenopathy (18d - Unknown - );Peripheral swelling (52d - Unknown - );Urticaria (52d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968591	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Petechiae (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968593	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (110d - Not Recovered/Not Resolved - );Rash (110d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968612	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (1d - Recovered/Resolved - );Swelling face (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968613	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea haemorrhagic (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968614	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Swelling face (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968620	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Quality of life decreased (n/a - Recovered/Resolved With Sequelae - );Sudden hearing loss (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010968624	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (9d - Recovered/Resolved With Sequelae - );Fatigue (n/a - Unknown - );Headache (9d - Recovered/Resolved With Sequelae - );Limb discomfort (9d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968628	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heavy menstrual bleeding (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968640	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968653	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968656	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968657	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968689	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (20d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968705	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968718	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - );Pustule (7d - Not Recovered/Not Resolved - );Skin reaction (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968720	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gastrooesophageal reflux disease (31d - Not Recovered/Not Resolved - );Herpes zoster (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968729	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Heart rate increased (0d - Recovered/Resolved - );Illusion (0d - Recovered/Resolved - );Nervousness (0d - Recovered/Resolved - );Paraesthesia oral (0d - Recovered/Resolved - );Restlessness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968731	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (27d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968761	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vascular pain (18d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968773	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968774	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968778	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - );Venous thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968790	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Bronchitis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968803	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968821	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968838	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - );Vaccination site erythema (2d - Not Recovered/Not Resolved - );Vaccination site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968842	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968845	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arterial stent insertion (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968846	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (3d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968859	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (5d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010968864	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Noninfective sialoadenitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968865	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Renal disorder (2d - Recovering/Resolving - );Renal pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968888	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968891	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968897	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968902	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (42d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968904	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal stiffness (30d - Not Recovered/Not Resolved - );Pain (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968905	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Breast pain (32d - Unknown - );Migraine (32d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968907	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968908	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coagulopathy (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968910	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968911	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (11d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Neuralgia (11d - Not Recovered/Not Resolved - );Trigeminal neuralgia (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968919	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertensive crisis (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010968924	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968931	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968937	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968938	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968939	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lichen sclerosus (63d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010968945	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (4d - Not Recovered/Not Resolved - );Pain in extremity (4d - Not Recovered/Not Resolved - );Peripheral swelling (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968952	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Unknown - );Renal pain (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010968958	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chromaturia (2d - Recovered/Resolved - );Clumsiness (4d - Recovered/Resolved - );Illusion (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968961	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010968986	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Bradyphrenia (n/a - Unknown - );Fatigue (n/a - Unknown - );Menstrual disorder (46d - Unknown - );Menstruation delayed (46d - Unknown - );Polymenorrhoea (46d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010968995	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010968995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969012	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969019	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969022	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969027	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Movement disorder (56d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969039	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969041	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969053	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (44d - Unknown - );Condition aggravated (44d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969057	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal pain upper (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969069	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969075	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (16d - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Dry eye (3d - Not Recovered/Not Resolved - );Dry mouth (13d - Not Recovered/Not Resolved - );Dysgeusia (16d - Not Recovered/Not Resolved - );Eye pain (3d - Not Recovered/Not Resolved - );Headache (16d - Not Recovered/Not Resolved - );Hypotonia (n/a - Not Recovered/Not Resolved - );Infectious mononucleosis (n/a - Not Recovered/Not Resolved - );Initial insomnia (1d - Recovered/Resolved - );Limb discomfort (15d - Not Recovered/Not Resolved - );Lymph node pain (15d - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Night sweats (15d - Not Recovered/Not Resolved - );Tongue discomfort (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969090	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Feeling hot (6d - Recovered/Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969092	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Flushing (35d - Not Recovered/Not Resolved - );Pruritus (35d - Not Recovered/Not Resolved - );Skin exfoliation (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969116	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969117	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (12d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969121	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Prostatic specific antigen increased (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969143	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (7d - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969149	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash vesicular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969165	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye irritation (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969185	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (90d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969191	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (40d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010969206	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (62d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969209	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Blood urine present (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969216	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bursitis (26d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969239	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes virus infection (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969242	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (2d - Not Recovered/Not Resolved - );Chest pain (2d - Not Recovered/Not Resolved - );Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969268	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (14d - Not Recovered/Not Resolved - );Feeling cold (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969288	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969298	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (22d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010969307	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (24d - Recovering/Resolving - );Myalgia (24d - Recovering/Resolving - );Retinal detachment (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010969334	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969336	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (2d - Not Recovered/Not Resolved - );Chest pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969341	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (5d - Recovered/Resolved - );Diarrhoea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969342	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (7d - Recovering/Resolving - );Epistaxis (7d - Recovering/Resolving - );Erythema (7d - Recovering/Resolving - );Headache (7d - Recovering/Resolving - );Malaise (7d - Recovering/Resolving - );Swelling (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969348	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glossodynia (59d - Recovering/Resolving - );Immune system disorder (59d - Recovering/Resolving - );Oral fungal infection (59d - Recovering/Resolving - );Tongue coated (59d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969374	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Scleritis (37d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010969381	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pruritus (5d - Recovered/Resolved - );Ocular hyperaemia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969385	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hyperaesthesia (0d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969391	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969399	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969401	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969405	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969406	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969412	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Insomnia (6d - Unknown - );Poor quality sleep (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969425	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Unknown - );Dizziness (3d - Unknown - );Headache (3d - Unknown - );Hypotension (3d - Fatal - Results in Death);Hypothermia (3d - Fatal - Results in Death);Malaise (n/a - Unknown - );Slow response to stimuli (3d - Unknown - );Speech disorder (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010969433	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Encephalitis autoimmune (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - );Hallucination (n/a - Unknown - );Muscle rigidity (n/a - Unknown - );Pyrexia (n/a - Unknown - );Slow speech (n/a - Recovering/Resolving - );Sudden death (n/a - Fatal - Results in Death);Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|OLANZAPINE [OLANZAPINE] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[NADROPARIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010969435	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - Disabling);Cough (2d - Recovering/Resolving - Disabling);Headache (2d - Recovering/Resolving - Disabling);Injection site reaction (2d - Recovering/Resolving - Disabling);Pyrexia (2d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010969529	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969534	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969545	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood test abnormal (n/a - Unknown - );Fatigue (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969549	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain in extremity (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVETIRACETAM] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969554	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition);Fibrosis (n/a - Fatal - Results in Death, Other Medically Important Condition);Hepatic steatosis (n/a - Fatal - Results in Death, Other Medically Important Condition);Hypertension (n/a - Fatal - Results in Death, Other Medically Important Condition);Myocardial fibrosis (n/a - Fatal - Results in Death, Other Medically Important Condition);Myocarditis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010969558	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969559	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (6d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	TRIUMEQ [ABACAVIR, LAMIVUDINE, DOLUTEGRAVIR] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010969578	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal death (n/a - Fatal - Results in Death);Foetal heart rate abnormal (n/a - Fatal - Results in Death);Maternal exposure during pregnancy (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	GESTARELLE G [ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, COPPER GLUCONATE, CYANOCOBALAMIN, DL-ALPHA TOCOPHERYL ACETATE, FERROUS SULFATE, FISH OIL, FOLIC ACID, MAGNESIUM OXIDE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010969588	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Consciousness fluctuating (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010969592	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (14d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Lip pain (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oral herpes (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (24h - Recovered/Resolved - Other Medically Important Condition);Stomatitis (n/a - Recovered/Resolved - Other Medically Important Condition);Sweating fever (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969596	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969600	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969612	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (34h - Recovered/Resolved - );Limb discomfort (34h - Recovered/Resolved - );Pain (34h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - Back pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969619	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969633	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AUBAGIO [TERIFLUNOMIDE] (C - Multiple sclerosis relapse - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969728	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969746	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cranial nerve disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 10mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - 5mg - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[WARFARIN, WARFARIN SODIUM] (C - Atrial fibrillation - n/a - [n/a - 3mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010969752	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010969793	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969796	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969800	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ejaculation failure (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010969802	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969804	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (50d - Recovered/Resolved With Sequelae - );Sudden hearing loss (50d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010969826	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969831	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure systolic decreased (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (0d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010969832	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010969842	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (42d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010969844	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dandruff (0d - Recovering/Resolving - );Rash (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969845	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010969859	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (16d - Not Recovered/Not Resolved - );Cardiovascular disorder (16d - Not Recovered/Not Resolved - );Depression (16d - Not Recovered/Not Resolved - );Fatigue (16d - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Tinnitus (16d - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969861	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969866	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969869	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969870	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969873	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969881	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arrhythmia (90d - Recovering/Resolving - );Asthenia (90d - Recovering/Resolving - );Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - );Cardiomyopathy (n/a - Recovered/Resolved With Sequelae - );Dyspnoea exertional (90d - Recovering/Resolving - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Myalgia (90d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010969899	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bicytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myelodysplastic syndrome (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pancytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010969917	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (11d - Recovered/Resolved - );Abdominal distension (11d - Recovered/Resolved - );Constipation (11d - Recovered/Resolved - );Dizziness (11d - Recovered/Resolved - );Feeling cold (11d - Recovered/Resolved - );Nausea (11d - Recovered/Resolved - );Pain in extremity (11d - Recovered/Resolved - );Vomiting (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969938	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969943	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cognitive disorder (n/a - Recovered/Resolved - );Memory impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969952	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010969974	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain injury (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Ventricular fibrillation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010969984	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Retching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010969986	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure measurement (61d - Recovered/Resolved - );Hyperhidrosis (61d - Recovered/Resolved - );Insomnia (61d - Recovered/Resolved - );Nervousness (61d - Recovered/Resolved - );Restlessness (61d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010969997	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010969997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970001	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970011	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (6d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010970014	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970038	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tubulointerstitial nephritis (124d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970043	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Traumatic haemothorax (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010970058	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Arrhythmia (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970074	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (77d - Recovering/Resolving - );Rash (77d - Recovering/Resolving - );Urticaria (77d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970086	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - );Headache (10d - Not Recovered/Not Resolved - );Hyperhidrosis (10d - Not Recovered/Not Resolved - );Limb discomfort (10d - Not Recovered/Not Resolved - );Malaise (10d - Not Recovered/Not Resolved - );Nausea (10d - Not Recovered/Not Resolved - );Sleep disorder (10d - Not Recovered/Not Resolved - );Tremor (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970104	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970106	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970107	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970109	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rhinitis (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	TOLUCOMBI [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - 20mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[BETAHISTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a - More in ICSR])|[BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - 10mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN, HEPARINOID] (C - n/a - n/a - [n/a - 400mg - n/a])|[METAMIZOLE SODIUM] (C - n/a - n/a - [n/a - 4{DF} - n/a])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 50mg - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970133	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Apathy (38d - Not Recovered/Not Resolved - );Fatigue (38d - Not Recovered/Not Resolved - );Limb discomfort (38d - Not Recovered/Not Resolved - );Myalgia (38d - Not Recovered/Not Resolved - );Somnolence (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970134	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970138	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Hypertension (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970141	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (8d - Recovered/Resolved - );Lymphadenopathy (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970149	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Influenza (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970150	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970169	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Neck pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970172	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970174	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (5d - Not Recovered/Not Resolved - );Dizziness (3d - Recovering/Resolving - );Fatigue (4d - Not Recovered/Not Resolved - );Feeling hot (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Influenza (4d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovering/Resolving - );Lymphadenopathy (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Paraesthesia (2d - Recovered/Resolved - );Visual impairment (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970175	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apathy (77d - Recovering/Resolving - );Cough (75d - Recovering/Resolving - );Decreased appetite (75d - Recovering/Resolving - );Fatigue (77d - Recovering/Resolving - );Malaise (75d - Recovering/Resolving - );Nausea (75d - Recovering/Resolving - );Weight decreased (75d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970178	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Local reaction (2d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970182	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (40d - Recovering/Resolving - );Injection site pain (40d - Recovering/Resolving - );Pain in extremity (40d - Recovering/Resolving - );Vaccination site pain (40d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970195	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Neck pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970199	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970204	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970209	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Recovered/Resolved - );Cough (16d - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Influenza (16d - Recovering/Resolving - );Nasopharyngitis (16d - Recovering/Resolving - );Pain in extremity (16d - Recovering/Resolving - );Paraesthesia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Tachycardia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970223	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970225	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (17d - Not Recovered/Not Resolved - );Pain (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970230	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest discomfort (5d - Recovering/Resolving - );Malaise (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970240	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970245	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970246	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (61d - Unknown - );Limb discomfort (61d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970258	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Hypoaesthesia (0d - Not Recovered/Not Resolved - );Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970260	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Recovering/Resolving - );Influenza like illness (5d - Recovering/Resolving - );Myalgia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970262	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Not Recovered/Not Resolved - );Abnormal faeces (1d - Not Recovered/Not Resolved - );Arrhythmia (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970263	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (1d - Not Recovered/Not Resolved - );Chills (0d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970276	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (68d - Not Recovered/Not Resolved - );Dizziness (68d - Not Recovered/Not Resolved - );Dyspnoea (68d - Not Recovered/Not Resolved - );Nausea (68d - Not Recovered/Not Resolved - );Petechiae (68d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970281	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - );Poor feeding infant (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970283	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970292	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970296	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coordination abnormal (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970300	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970312	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (19d - Not Recovered/Not Resolved - );Herpes zoster (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970323	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970333	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (22d - Recovering/Resolving - );Abdominal pain upper (24d - Recovering/Resolving - );Diarrhoea (22d - Recovering/Resolving - );Dyspepsia (24d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (22d - Recovering/Resolving - );Nausea (24d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970334	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Headache (0d - Recovering/Resolving - );Hypertension (9d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Lymphadenopathy (8d - Recovering/Resolving - );Palpitations (9d - Not Recovered/Not Resolved - );Tachycardia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970336	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Headache (0d - Recovering/Resolving - );Hypertension (9d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Lymphadenopathy (8d - Recovering/Resolving - );Tachycardia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970341	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970344	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Myalgia (40d - Recovered/Resolved With Sequelae - );Pain in extremity (40d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010970348	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970349	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (18d - Not Recovered/Not Resolved - );Headache (18d - Not Recovered/Not Resolved - );Neuralgia (18d - Not Recovered/Not Resolved - );Paraesthesia (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970361	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970362	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970363	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (98d - Not Recovered/Not Resolved - );Tachycardia (98d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970364	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (41d - Recovered/Resolved - );Sleep disorder (63d - Not Recovered/Not Resolved - );Tachycardia (63d - Not Recovered/Not Resolved - );Uveitis (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970377	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970381	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Hot flush (1d - Recovering/Resolving - );Hypoaesthesia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970389	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970391	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970395	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970401	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (5d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - );Urticaria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970415	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970418	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970435	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970440	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Not Recovered/Not Resolved - );Muscle spasms (4d - Unknown - );Muscle spasticity (4d - Unknown - );Myalgia (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970459	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gout (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970472	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (60d - Not Recovered/Not Resolved - );Exercise tolerance decreased (60d - Not Recovered/Not Resolved - );Palpitations (60d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970478	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tinnitus (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010970504	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthropod bite (21d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010970505	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970507	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gout (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970517	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970527	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (55d - Not Recovered/Not Resolved - );Headache (55d - Not Recovered/Not Resolved - );Muscle twitching (55d - Not Recovered/Not Resolved - );Neuralgia (55d - Not Recovered/Not Resolved - );Pyrexia (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970528	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970537	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970542	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (54d - Not Recovered/Not Resolved - );Malaise (54d - Not Recovered/Not Resolved - );Pain in extremity (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970569	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970576	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Oligomenorrhoea (85d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970578	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Smallpox (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010970582	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Thrombosis (1d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970588	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation (0d - Recovered/Resolved - );Muscle spasms (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970597	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010970629	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970630	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (40d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970638	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970657	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970658	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970671	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (51d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010970679	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970681	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970692	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis superficial (n/a - Not Recovered/Not Resolved - );Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970697	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (115d - Not Recovered/Not Resolved - );Musculoskeletal discomfort (115d - Not Recovered/Not Resolved - );Plica syndrome (115d - Not Recovered/Not Resolved - );Skin mass (115d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970703	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Limb discomfort (3d - Recovering/Resolving - );Muscular weakness (0d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Nervous system disorder (0d - Recovered/Resolved - );Paresis (0d - Recovered/Resolved - );Photopsia (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Renal pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970708	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Urticaria (119d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010970714	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - );Menstrual disorder (65d - Recovered/Resolved - Other Medically Important Condition);Postmenopausal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970723	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010970732	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nasal congestion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970777	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970779	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (114d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970780	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Necrotising fasciitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Resuscitation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sepsis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachyarrhythmia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010970783	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye oedema (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970793	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970795	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970803	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Plasmacytoma (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970806	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010970808	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970813	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970815	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970830	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970833	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970843	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovered/Resolved With Sequelae - );Migraine with aura (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010970850	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970859	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (7d - Not Recovered/Not Resolved - );Influenza like illness (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970864	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (44d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970874	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Insomnia (3d - Recovering/Resolving - );Muscle discomfort (5d - Recovering/Resolving - );Swelling (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010970879	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Muscular weakness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010970880	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Not Recovered/Not Resolved - );Muscle spasms (4d - Unknown - );Muscle spasticity (4d - Unknown - );Myalgia (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970885	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010970894	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaria (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Parosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970915	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Leukopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Monocyte count decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Not Recovered/Not Resolved - );Serum ferritin decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970933	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (6d - Recovered/Resolved - );Chills (6d - Recovered/Resolved - );Diarrhoea (6d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Nausea (6d - Recovered/Resolved - );Neurodermatitis (21d - Recovered/Resolved - );Pyrexia (6d - Recovered/Resolved - );Vomiting (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010970975	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac dysfunction (44d - Unknown - Other Medically Important Condition);Exercise tolerance decreased (44d - Unknown - );Fatigue (44d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010970991	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Infection (n/a - Not Recovered/Not Resolved - );Thyroid disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010970991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010971002	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (27d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paresis (27d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Visual impairment (27d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971007	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Arthritis (n/a - Unknown - );Dry eye (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Joint stiffness (n/a - Unknown - );Psoriasis (n/a - Unknown - );Tendonitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010971042	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (11d - Not Recovered/Not Resolved - );Eye pruritus (11d - Not Recovered/Not Resolved - );Hypersensitivity (11d - Not Recovered/Not Resolved - );Lacrimation increased (11d - Not Recovered/Not Resolved - );Oral pruritus (11d - Not Recovered/Not Resolved - );Rhinorrhoea (11d - Not Recovered/Not Resolved - );Sneezing (11d - Not Recovered/Not Resolved - );Taste disorder (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971044	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971061	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971149	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971161	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Guillain-Barre syndrome (2wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraparesis (2wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971165	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Immune system disorder (n/a - Unknown - );Mobility decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 75mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010971181	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (14d - Recovered/Resolved - );Headache (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971197	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Tinnitus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971210	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (39d - Not Recovered/Not Resolved - );Urinary straining (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971214	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971217	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (43d - Recovered/Resolved With Sequelae - );Muscle spasms (43d - Recovered/Resolved With Sequelae - );Muscle twitching (43d - Recovered/Resolved With Sequelae - );Pain in extremity (43d - Recovered/Resolved With Sequelae - );Thrombosis (43d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010971228	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness unilateral (2d - Unknown - Other Medically Important Condition);Dizziness (1d - Unknown - );Hypoaesthesia (2d - Unknown - );Myalgia (n/a - Unknown - );Pain (n/a - Unknown - );Rash (n/a - Unknown - );Tinnitus (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971236	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (19d - Not Recovered/Not Resolved - );Headache (19d - Not Recovered/Not Resolved - );Sinusitis (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971238	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hallucination (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010971243	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (30d - Recovering/Resolving - );Dizziness (30d - Recovering/Resolving - );Headache (30d - Recovering/Resolving - );Neck pain (30d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010971251	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (102d - Not Recovered/Not Resolved - );Myalgia (102d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010971263	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971285	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anticoagulant therapy (n/a - Recovered/Resolved With Sequelae - );Coagulopathy (n/a - Recovered/Resolved With Sequelae - );Thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Venipuncture (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010971288	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Toothache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971289	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971294	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971296	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971302	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (35d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010971304	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (6d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971315	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (81d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971325	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971340	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infection susceptibility increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971345	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010971348	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (11d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971363	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971369	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (6d - Not Recovered/Not Resolved - );Strabismus (3d - Not Recovered/Not Resolved - );Vision blurred (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971370	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971378	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971396	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma exercise induced (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010971399	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (70d - Unknown - );Sudden onset of sleep (70d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010971403	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (n/a - Unknown - );Heart rate decreased (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971407	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971417	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971423	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971431	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle insomnia (7d - Unknown - );Paraesthesia (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971442	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (69d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971470	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - );Hyperhidrosis (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971489	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971499	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010971519	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (12d - Not Recovered/Not Resolved - );Tinnitus (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971525	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971534	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (88d - Not Recovered/Not Resolved - );Dyspnoea (88d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971561	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (18d - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Malaise (14d - Recovered/Resolved - );Muscle spasms (18d - Recovering/Resolving - );Oral discomfort (16d - Recovering/Resolving - );Right atrial hypertrophy (4d - Unknown - );Skin burning sensation (16d - Recovering/Resolving - );Tongue discomfort (16d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971562	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Thrombocytopenia (218d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tinnitus (218d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971568	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971572	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971605	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Ophthalmic vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971620	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010971676	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971692	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971742	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010971769	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Heart rate irregular (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Pulse abnormal (n/a - Unknown - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971831	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971852	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diabetes mellitus (69d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010971868	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (23d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010971878	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (32d - Not Recovered/Not Resolved - );Abdominal distension (32d - Not Recovered/Not Resolved - );Abdominal pain (32d - Not Recovered/Not Resolved - );Defaecation disorder (32d - Not Recovered/Not Resolved - );Dizziness (32d - Not Recovered/Not Resolved - );Eye pain (32d - Not Recovered/Not Resolved - );Headache (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010971900	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Mental disorder (n/a - Unknown - );Nervous system disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971901	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Unknown - );Fatigue (1d - Unknown - );Headache (1d - Unknown - );Heart rate increased (1d - Unknown - );Stress (1d - Unknown - );Vaccination site discomfort (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971903	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971907	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010971925	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971932	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (73d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010971937	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Speech disorder (n/a - Not Recovered/Not Resolved - );Vocal cord paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010971960	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971965	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye irritation (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971980	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010971983	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (4d - Not Recovered/Not Resolved - );Inflammatory bowel disease (4d - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010971998	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010971998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010972005	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (12h - Recovered/Resolved - );Hyperpyrexia (12h - Recovered/Resolved - );Malaise (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972009	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Rheumatic disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972020	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010972036	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (17d - Recovering/Resolving - );Dizziness (17d - Recovering/Resolving - );Headache (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010972038	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (5d - Unknown - );Aphasia (9d - Not Recovered/Not Resolved - );Blepharospasm (40d - Not Recovered/Not Resolved - );Cough (40d - Not Recovered/Not Resolved - );Decreased appetite (24d - Not Recovered/Not Resolved - );Disturbance in attention (9d - Not Recovered/Not Resolved - );Dyspepsia (24d - Not Recovered/Not Resolved - );Dyspnoea (5d - Unknown - );Fatigue (8d - Not Recovered/Not Resolved - );Impaired healing (34d - Not Recovered/Not Resolved - );Influenza (40d - Not Recovered/Not Resolved - );Influenza like illness (40d - Not Recovered/Not Resolved - );Limb discomfort (24d - Not Recovered/Not Resolved - );Malaise (24d - Not Recovered/Not Resolved - );Memory impairment (9d - Not Recovered/Not Resolved - );Oropharyngeal pain (40d - Not Recovered/Not Resolved - );Toothache (1d - Recovered/Resolved - );Weight decreased (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010972068	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972091	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (44d - Recovering/Resolving - );Rhinitis allergic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010972109	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010972126	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010972138	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010972156	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010972186	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972209	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010972225	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Resting tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010972236	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	[INACTIVATED INFLUENZA VIRUS H1N1 HEMAGGLUTININ] (C - Influenza immunisation - Not applicable - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010972249	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010972254	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (4d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972323	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle injury (n/a - Unknown - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010972325	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972338	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Cognitive disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010972351	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Hepatic steatosis (n/a - Unknown - Other Medically Important Condition);Infectious mononucleosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010972362	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ERGOTAMINE TARTRATE, PARACETAMOL, CAFFEINE] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010972364	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972507	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010972603	Spontaneous	2021-12-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972607	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Ectopic atrial rhythm - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010972609	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[HUMAN PAPILLOMAVIRUS VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010972619	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Autoimmune lung disease (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Eating disorder (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Lower respiratory tract infection (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Mental impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Lower respiratory tract infection - n/a - [5d - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010972686	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[EPINEPHRINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010972687	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010972751	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010972843	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENBREL [ETANERCEPT] (C - Psoriatic arthropathy - n/a - [n/a - 50mg - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010972910	Spontaneous	2021-12-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010972910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944590	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphagia (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944594	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Gingival bleeding (n/a - Not Recovered/Not Resolved - );Noninfective gingivitis (n/a - Not Recovered/Not Resolved - );Oral mucosal eruption (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 25ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944603	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944607	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010944639	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944660	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944681	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010944726	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944748	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Pain in extremity (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944753	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear disorder (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944766	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Body temperature fluctuation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944795	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944807	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertensive crisis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010944866	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944891	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944933	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944940	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved With Sequelae - );Pain (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - );Vaccination site movement impairment (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010944943	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Chills (n/a - Recovered/Resolved With Sequelae - );Cough (n/a - Recovered/Resolved With Sequelae - );Dizziness (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Photosensitivity reaction (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010944969	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944995	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperglycaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945028	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[MYCOPHENOLATE SODIUM, MYCOPHENOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945091	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945113	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945122	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - );Oropharyngeal discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945135	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	[ALFACALCIDOL] (C - Vitamin D deficiency - n/a - [n/a - 1ug - Oral])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - Antiviral prophylaxis - n/a - [n/a - n/a - Intramuscular])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945139	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (36d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (36d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010945196	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945243	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Asthma (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945244	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945247	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash maculo-papular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945274	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Dyspnoea (5d - Recovered/Resolved - );Injection site oedema (5d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010945275	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, OLMESARTAN, OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945285	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TRULICITY 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[MYCOPHENOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945288	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945292	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945297	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Face oedema (n/a - Recovering/Resolving - Life Threatening);Laryngeal oedema (n/a - Recovering/Resolving - Life Threatening);Oxygen saturation decreased (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010945308	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945310	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945312	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945313	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945318	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eye pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Idiopathic intracranial hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - Gastritis - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945321	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945324	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transaminases increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE MESILATE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945326	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Delusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle tightness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945329	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hypokinesia (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoxia (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945332	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945340	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle rigidity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945353	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensation of foreign body (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945364	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal vein thrombosis (n/a - Unknown - Other Medically Important Condition);Visual acuity reduced (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945367	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Haematochezia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945370	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945380	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Depression (n/a - Recovering/Resolving - Life Threatening);Onycholysis (n/a - Recovering/Resolving - Life Threatening);Psoriasis (n/a - Recovering/Resolving - Life Threatening);Weight decreased (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	KEYTRUDA [PEMBROLIZUMAB] (C - Lung carcinoma cell type unspecified recurrent - n/a - [n/a - 200mg - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010945383	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vasodilatation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945385	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945387	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945399	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Hypercreatinaemia (n/a - Recovering/Resolving - );Renal impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010945404	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945408	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Unknown - );Migraine (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945414	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945419	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden death (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010945420	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945444	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperpyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010945454	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945464	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945480	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Extensive swelling of vaccinated limb (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010945604	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945613	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945633	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945638	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010945711	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Platelet count decreased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010945831	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Groin pain (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Thrombosis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CORTISONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010945839	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945848	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945871	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Premature baby (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010945922	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Fall (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Limb discomfort (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010945923	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010945924	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010945928	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010945928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010946051	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946055	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946061	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946067	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946070	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010946076	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010946091	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Unknown])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Unknown - [n/a - 1{DF} - Unknown])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [n/a - 1{DF} - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010946108	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946174	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fear (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTROGENS CONJUGATED, ESTRONE SODIUM SULFATE, EQUILIN SULFATE SODIUM] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Hemiplegic migraine - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946244	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hepatic cytolysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Jaundice cholestatic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])|[CELECOXIB] (S - Cervicobrachial syndrome - Drug withdrawn - [6d - n/a - Oral])|[PARACETAMOL, BELLADONNA DRY EXTRACT, CAFFEINE, OPIUM, PARACETAMOL, CAFFEINE, OPIUM, PARACETAMOL, CAFFEINE, OPIUM EXTRACTS, PARACETAMOL, CAFFEINE, OPIUM, PREPARED] (S - Cervicobrachial syndrome - Drug withdrawn - [6d - n/a - Oral])|[PARACETAMOL] (S - Cervicobrachial syndrome - Drug withdrawn - [6d - n/a - Oral])|[SUPROFEN, TRAMADOL HYDROCHLORIDE] (S - Cervicobrachial syndrome - Drug withdrawn - [6d - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010946403	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010946606	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - Aphthous ulcer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946625	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010946659	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extrasystoles (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946692	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Anaemia (n/a - Unknown - Life Threatening);Gastrointestinal haemorrhage (n/a - Unknown - Life Threatening);Hypoprothrombinaemia (n/a - Unknown - Life Threatening)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - )|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - )|[BECLOMETASONE DIPROPIONATE] (C - n/a - Unknown - )|[BUMETANIDE] (C - n/a - n/a - )|[IPRATROPIUM BROMIDE] (C - n/a - Unknown - )|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010946725	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (1d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010946803	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (675min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (675min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (675min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010946806	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - );Pleuritic pain (n/a - Recovered/Resolved - );Product administered to patient of inappropriate age (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946815	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tremor (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946821	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010946843	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling);Post herpetic neuralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010946852	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946878	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - Disabling);Blood creatinine increased (n/a - Recovered/Resolved With Sequelae - Disabling);Decreased appetite (n/a - Recovered/Resolved With Sequelae - Disabling);Fatigue (n/a - Recovered/Resolved With Sequelae - Disabling);Feeling cold (n/a - Recovered/Resolved With Sequelae - Disabling);Glomerular filtration rate decreased (n/a - Recovered/Resolved With Sequelae - Disabling);Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Disabling);Nausea (n/a - Recovered/Resolved With Sequelae - Disabling);Vomiting (n/a - Recovered/Resolved With Sequelae - Disabling);Weight decreased (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [103d - n/a - n/a])	ENBREL [ETANERCEPT] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010946896	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010946901	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946934	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[DALTEPARIN SODIUM] (C - Full blood count abnormal - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010946937	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Liver function test abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart rate irregular - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946939	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (1d - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (4d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (6d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Extrasystoles (n/a - Unknown - Other Medically Important Condition);Fall (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (11d - Recovered/Resolved - Other Medically Important Condition);Heart rate irregular (6d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (10d - Recovered/Resolved - Other Medically Important Condition);Palpitations (11d - Recovered/Resolved - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	[ADAPALENE] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[ISPAGHULA HUSK BP, MEBEVERINE HYDROCHLORIDE, ISPAGHULA HUSK] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946962	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Musculoskeletal chest pain (n/a - Unknown - );Myalgia (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010946967	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMBROXOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE DINITRATE] (C - n/a - n/a - [n/a - n/a - Topical])|[SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010946967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010947021	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling);Exercise tolerance decreased (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Leukopenia (n/a - Recovering/Resolving - Disabling);Neutropenia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010947035	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010947036	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Unknown - Life Threatening);Haematuria (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010947084	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Irritability (1d - Recovered/Resolved - );Mood altered (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947087	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947092	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947127	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Depression (n/a - Recovering/Resolving - );Faeces soft (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947158	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947229	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947252	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - )|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - Unknown - )|[VINCRISTINE, VINCRISTINE SULFATE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010947259	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition);Vaginal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vulvovaginal pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010947305	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disorientation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[CANDESARTAN] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947326	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947384	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (30min - Recovered/Resolved - );Chest pain (30min - Recovered/Resolved - );Muscle spasms (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, CAFFEINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010947410	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947421	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Sleep disorder (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010947485	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010947487	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010947503	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemorrhagic cyst (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Localised oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thyroid cyst (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947529	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010947530	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (14d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (14d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, ALUMINIUM, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, BORDETELLA PERTUSSIS (INACTIVATED) ADSORBED] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947538	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotonic-hyporesponsive episode (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947553	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chills (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Eye pruritus (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Eye swelling (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Lacrimation increased (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Ocular hyperaemia (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pharyngeal swelling (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Skin burning sensation (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010947591	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010947601	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010947610	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abdominal distension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947625	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac discomfort (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PRADAXA 110 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BARNIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010947650	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Cough (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling);Tachycardia (n/a - Unknown - Disabling);Wheezing (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010947805	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947860	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947864	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947894	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010947916	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling);Herpes zoster (n/a - Recovering/Resolving - Disabling);Neuralgic amyotrophy (n/a - Recovering/Resolving - Disabling);Pain (n/a - Recovering/Resolving - Disabling);Post herpetic neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010947928	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thyroiditis subacute (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010947955	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (1d - Recovered/Resolved - Disabling);COVID-19 immunisation (1d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Injection site pain (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL ARGININE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010947960	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (215d - Recovered/Resolved - Other Medically Important Condition);Chest pain (60d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mitral valve incompetence (215d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (60d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010947960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010948079	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Administration site haematoma (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948152	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia induced cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010948161	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Myopericarditis (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pulmonary pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010948190	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Ear discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010948409	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948456	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948461	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010948487	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010948515	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948525	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Spinal pain (7d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010948530	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Giant cell arteritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010948532	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948595	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948628	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Neuralgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [43d - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010948634	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Neck pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948649	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovering/Resolving - );Vaccination failure (10d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948653	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948695	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010948767	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948787	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ear pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Sleep deficit (n/a - Unknown - Other Medically Important Condition);Toothache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948788	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948887	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010948900	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, CAFFEINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010948926	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest X-ray abnormal (n/a - Recovering/Resolving - Life Threatening);Cough (n/a - Recovering/Resolving - Life Threatening);Hypoventilation (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	AMGEVITA [ADALIMUMAB] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010948958	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948962	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Aphthous ulcer (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010948991	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010948998	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010948998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949003	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Gastrointestinal pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949032	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949052	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949081	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Nausea (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ANTI-EMETICUM [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949086	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Stridor (5min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (10s - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010949091	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949101	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949112	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949124	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);CSF protein increased (1292min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalitis (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalopathy (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Magnetic resonance imaging head abnormal (1292min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (1292min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Restlessness (1292min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010949169	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (26d - Recovered/Resolved - );Vaccination failure (26d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010949171	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949195	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949197	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hot flush (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Sensory disturbance (n/a - Unknown - Other Medically Important Condition);Vertigo (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010949198	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coagulation factor VIII level increased (n/a - Not Recovered/Not Resolved - Life Threatening);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	AERIUS [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010949206	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949212	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Unknown - );Arthralgia (n/a - Unknown - );Bacterial sepsis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);C-reactive protein increased (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiovascular insufficiency (n/a - Recovering/Resolving - Life Threatening);Conjunctivitis (n/a - Recovering/Resolving - Life Threatening);Diarrhoea (n/a - Recovering/Resolving - Life Threatening);Fibrin D dimer increased (n/a - Recovering/Resolving - Life Threatening);Hyperlactacidaemia (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Unknown - );Kawasaki's disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multisystem inflammatory syndrome in children (n/a - Recovering/Resolving - Life Threatening);Oedema peripheral (n/a - Recovering/Resolving - Life Threatening);Oropharyngeal erythema (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Petechiae (n/a - Recovering/Resolving - Life Threatening);Pyrexia (n/a - Recovering/Resolving - Life Threatening);Rash (n/a - Recovering/Resolving - Life Threatening);Skin abrasion (n/a - Unknown - );Strawberry tongue (n/a - Recovering/Resolving - Life Threatening);Systemic inflammatory response syndrome (n/a - Recovering/Resolving - Life Threatening);Thrombocytopenia (n/a - Recovering/Resolving - Life Threatening);Vasoplegia syndrome (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010949218	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949220	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949336	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949350	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Parosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Salivary hypersecretion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949363	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949383	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Exercise tolerance decreased (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010949408	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949482	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949501	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Oral herpes (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, ALUMINIUM, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, BORDETELLA PERTUSSIS (INACTIVATED) ADSORBED] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010949507	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Swelling (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949518	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949531	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (10min - Recovered/Resolved - Other Medically Important Condition);Hypotonia (10min - Recovered/Resolved - Other Medically Important Condition);Syncope (10min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949582	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Injection site reaction (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010949586	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949587	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovering/Resolving - );Vaccination failure (10d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949604	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949675	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949696	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Induration (n/a - Recovered/Resolved - );Panniculitis (n/a - Recovered/Resolved - Other Medically Important Condition);Skin mass (n/a - Recovered/Resolved - );Vaccination site induration (n/a - Recovered/Resolved - );Vasculitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 1.875mg - n/a])|[CASSIA] (C - n/a - n/a - [n/a - 1g - n/a])|[ELOBIXIBAT HYDRATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[ETIZOLAM] (C - n/a - n/a - [n/a - .5mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 80mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - 2970mg - n/a])|[MOSAPRIDE, MOSAPRIDE CITRATE] (C - n/a - n/a - [n/a - 45mg - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - 3mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949721	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949749	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949761	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010949765	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949773	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mood swings (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nightmare (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949821	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010949829	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949838	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Disabling);Malaise (n/a - Recovered/Resolved - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010949865	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute kidney injury (n/a - Fatal - Results in Death);Acute myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010949875	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Body temperature increased (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949926	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010949942	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010949964	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010949964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010950031	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pharyngitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010950077	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010950145	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Genital herpes (n/a - Not Recovered/Not Resolved - );Pain of skin (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010950186	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Head injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash rubelliform (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010950204	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950233	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010950325	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (46d - Recovered/Resolved - Life Threatening);Fatigue (29d - Recovered/Resolved - );Thrombocytosis (46d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCARBAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010950382	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (0d - Recovered/Resolved - );Heart rate increased (0d - Recovered/Resolved - );Hypertension (0d - Recovered/Resolved - );Vaccination site pruritus (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010950466	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010950511	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling cold (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Parosmia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010950523	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Headache (7d - Not Recovered/Not Resolved - );Pyrexia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010950524	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950563	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950575	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950577	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950591	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	General physical health deterioration (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Ruptured cerebral aneurysm (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010950625	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - .75mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010950633	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950636	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Application site hypoaesthesia (n/a - Not Recovered/Not Resolved - );Application site movement impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Application site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010950723	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010950785	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovering/Resolving - );Vaccination failure (10d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950852	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010950929	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010950939	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010950962	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (11d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (11d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010950962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951019	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951036	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Breath sounds abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac arrest (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951038	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - );Dizziness (6d - Recovered/Resolved - Other Medically Important Condition);Fatigue (6d - Recovered/Resolved - );Groin pain (n/a - Recovering/Resolving - );Hunger (n/a - Unknown - );Incoherent (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (5d - Recovered/Resolved - );Seizure (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951051	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951054	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis (n/a - Recovering/Resolving - );Colitis ulcerative (n/a - Unknown - Other Medically Important Condition);Frequent bowel movements (n/a - Recovering/Resolving - );Haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Rectal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[GLUCOSAMINE, GLUCOSAMINE SULFATE] (C - Meniscus injury - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951057	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (2d - Recovered/Resolved - Other Medically Important Condition);Extrapyramidal disorder (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Night sweats (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951137	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951140	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Encephalitis bacterial (n/a - Fatal - Results in Death);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Listless (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mastoiditis (n/a - Fatal - Results in Death);Otitis media (n/a - Fatal - Results in Death);Pneumonia pneumococcal (n/a - Fatal - Results in Death);Respiratory failure (n/a - Fatal - Results in Death);Sepsis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - )|[ENALAPRIL MALEATE] (C - n/a - n/a - )|[ROSUVASTATIN CALCIUM] (C - n/a - n/a - )|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010951146	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951152	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951158	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951164	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951168	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951178	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010951194	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alanine aminotransferase increased (n/a - Recovered/Resolved - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Recovered/Resolved - Other Medically Important Condition);Blood creatine phosphokinase MB increased (n/a - Recovered/Resolved - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Recovered/Resolved - Other Medically Important Condition);Blood lactate dehydrogenase increased (n/a - Recovered/Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Recovered/Resolved - Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin T increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951222	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Coronary artery disease (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010951231	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Still's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951280	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951303	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951307	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951317	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Mental fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Mobility decreased (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RANEXA [RANOLAZINE] (C - Microvascular coronary artery disease - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Microvascular coronary artery disease - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Microvascular coronary artery disease - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Microvascular coronary artery disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010951326	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951338	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (2d - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (4d - Recovered/Resolved - Other Medically Important Condition);Sneezing (2d - Recovered/Resolved - Other Medically Important Condition);Toothache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951349	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood iron increased (n/a - Unknown - );Serum ferritin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951352	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dysarthria (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Sensory loss (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010951382	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010951398	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - );Chest pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951408	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - );Pancytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Unknown - );Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BUMETANIDE [BUMETANIDE] (C - Oedema - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])|[ZUCLOPENTHIXOL DECANOATE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951422	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (9d - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (9d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951435	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951534	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertensive heart disease (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Off label use (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010951540	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - Other Medically Important Condition);Diaphragmatic spasm (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL, TRAMADOL, TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951553	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951583	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951587	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951684	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Orthostatic hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951721	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Meningitis herpes (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951722	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951723	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (15d - Recovered/Resolved - Other Medically Important Condition);Tonsillitis (10d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951724	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Drug intolerance (n/a - Recovering/Resolving - Other Medically Important Condition);Food intolerance (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (5d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - Other Medically Important Condition);Rash (0d - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951734	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (4d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951747	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lip swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash macular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951764	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arteriosclerosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|[ETORICOXIB] (S - Pain - Drug withdrawn - [2y - 60mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010951769	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Muscle spasms (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010951801	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010951829	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951839	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye infection (n/a - Unknown - );Eyelid disorder (n/a - Unknown - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - );Visual impairment (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Low density lipoprotein - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951849	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Retching (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - 600mg - n/a])|[COLECALCIFEROL] (C - Prophylaxis - n/a - [n/a - 800[iU] - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LACTULOSE] (C - Constipation - n/a - [n/a - n/a - n/a])|[SODIUM PICOSULFATE] (C - Constipation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951911	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951929	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Umbilical haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951930	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951934	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951936	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951939	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Sudden cardiac death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BICALUTAMIDE] (C - Prostate cancer - n/a - [n/a - n/a - Oral])|[EXTRACT OF EQUISETUM ARVENSE] (C - Prostate cancer - n/a - [n/a - n/a - Oral])|[LEUPRORELIN ACETATE] (C - Prostate cancer - n/a - [n/a - n/a - Subcutaneous])|[NAFTOPIDIL] (C - Prostate cancer - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010951943	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951944	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Anti-neutrophil cytoplasmic antibody positive vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Antineutrophil cytoplasmic antibody positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Glomerulonephritis rapidly progressive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Microscopic polyangiitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Proteinuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951945	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951949	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (25d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (594h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (594h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Systolic dysfunction (594h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin I increased (594h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951953	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oesophageal carcinoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951955	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate decreased (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951960	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951962	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951965	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Myalgia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Pleuritic pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951967	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951969	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951972	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951977	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - );Orthostatic intolerance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Physical deconditioning (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010951978	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010951979	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram normal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951987	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (30min - Recovered/Resolved - Other Medically Important Condition);Nervousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010951988	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - );Eye movement disorder (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Unresponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010951990	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010951990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952003	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Altered state of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);CSF cell count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);CSF glucose increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);CSF protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Demyelination (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperthermia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Joint dislocation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Restlessness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensory disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Shoulder fracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010952006	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952010	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Contusion (n/a - Unknown - );Fall (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Feeling cold (n/a - Unknown - );Headache (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Loss of consciousness (1min - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - );Nausea (29min - Recovered/Resolved - );Pallor (n/a - Unknown - );Presyncope (n/a - Unknown - );Thirst (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952016	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952017	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Foot fracture (n/a - Unknown - );Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle tightness (n/a - Unknown - );Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Plantar fasciitis (n/a - Unknown - );Tendon disorder (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952018	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysphonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperventilation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952151	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952161	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952165	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );SARS-CoV-2 test negative (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[AZITHROMYCIN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE MONOHYDRATE] (S - n/a - Not applicable - [n/a - n/a - n/a])|[PREDNISOLONE] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952212	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (2d - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952213	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Photophobia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sleep paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Vision blurred (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952216	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952220	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Venous thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952225	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METHOTREXATE SODIUM] (C - Psoriatic arthropathy - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952227	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952231	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952233	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Not Specified	Foetal growth restriction (n/a - Unknown - Other Medically Important Condition);Live birth (n/a - Unknown - Other Medically Important Condition);Low birth weight baby (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952234	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (4d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Head discomfort (4d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952333	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Lip swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Night sweats (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Swollen tongue (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952343	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952344	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Eye disorder (n/a - Recovered/Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952345	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Petechiae (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LISINOPRIL, LISINOPRIL DIHYDRATE, HYDROCHLOROTHIAZIDE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952353	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Therapeutic response unexpected (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952358	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952359	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Circulatory collapse (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 400mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ENOXAPARIN SODIUM] (C - n/a - n/a - [n/a - 40mg - Subcutaneous])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - Oral])|[HEPARIN SODIUM, DEXPANTHENOL, ALLANTOIN] (C - n/a - n/a - [n/a - 3{DF} - Topical])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 40mg - Oral])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[TORASEMIDE, TORASEMIDE SODIUM] (C - n/a - n/a - [n/a - 10mg - Oral])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010952372	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - 200mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952383	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Blood test abnormal (n/a - Unknown - );Chest pain (n/a - Unknown - );Cold sweat (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Reflux gastritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952390	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952403	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urine abnormality (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952405	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952406	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952420	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010952427	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Headache (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952428	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952436	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952440	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952441	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952443	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952445	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952450	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952462	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952471	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - );Condition aggravated (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952479	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [21d - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952485	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952489	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952494	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952495	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952505	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952518	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952533	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (7d - Recovering/Resolving - );Vaccination site pain (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952541	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952542	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952545	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952547	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952550	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952552	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye discharge (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nasal congestion (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952555	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952560	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952561	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952571	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Skin striae (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952581	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Otitis externa (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [24d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952587	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952589	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ELIQUIS [APIXABAN] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [ADALIMUMAB] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952592	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952599	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthma (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952600	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952601	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952602	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (4d - Recovered/Resolved - );Influenza like illness (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952603	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash maculo-papular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE, TELMISARTAN] (C - n/a - n/a - )|[TELMISARTAN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952606	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952611	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952613	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952616	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952623	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952626	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952634	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952637	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952638	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952642	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952643	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952644	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952648	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952654	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Dizziness (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952659	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952660	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952662	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952663	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hyporeflexia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952664	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952671	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [31d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952673	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952677	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [58d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952681	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952685	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952698	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010952721	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Eye disorder (15h - Recovered/Resolved - );Eye pain (15h - Recovered/Resolved - );Influenza like illness (15h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952723	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (2d - Recovered/Resolved - );Chest pain (2d - Recovered/Resolved - );Chromaturia (n/a - Recovered/Resolved - );Decreased appetite (2d - Recovered/Resolved - );Extrasystoles (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952725	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952729	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (5d - Recovering/Resolving - );Influenza like illness (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010952742	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952745	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010952758	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Recovered/Resolved - );Anal incontinence (n/a - Recovered/Resolved - );Circulatory collapse (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (C - n/a - n/a - [1d - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952772	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (62d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010952778	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952782	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Chest pain (11d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010952792	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952793	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Foetal exposure during pregnancy (n/a - Unknown - );Hydrocephalus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010952794	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (46d - Fatal - Results in Death);Dementia (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Influenza (n/a - Recovered/Resolved - );Lower respiratory tract infection (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010952796	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952798	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010952803	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010952814	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010952814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953001	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Product administered to patient of inappropriate age (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953006	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953017	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (25d - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin irritation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010953025	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Maldonado, M.. The Pfizer-BNT162b2 mRNA-based vaccine against SARS-CoV-2 may be responsible for awakening the latency of herpes varicella-zoster virus. Brain, Behavior, &amp; Immunity - Health. 2021;18:10.1016/j.bbih.2021.100381. doi:10.1016/j.bbih.2021.100381	65-85 Years	Not Specified	No	Male	Varicella zoster virus infection (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010953032	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Arthritis reactive (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Deep vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - );Intermittent claudication (n/a - Unknown - Caused/Prolonged Hospitalisation);Mobility decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - );Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skin infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Vascular pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Vein disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - 2{DF} - n/a])|LEFLUNOMIDE [LEFLUNOMIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - 300mg - n/a])|[ACETYLSALICYLIC ACID] (C - Hypertension - n/a - [n/a - 100mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - 40mg - n/a])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - 25mg - Oral])|[LOVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 50mg - n/a])|[TAPENTADOL] (C - n/a - n/a - [n/a - 100mg - n/a])|[THIOCTIC ACID] (C - n/a - n/a - [n/a - 600mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953043	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953146	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953185	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Not Specified	Cough (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953191	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inflammation (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010953193	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Ischaemia (n/a - Unknown - Other Medically Important Condition);Limb discomfort (10min - Recovered/Resolved - Other Medically Important Condition);Transient ischaemic attack (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953205	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Connective tissue inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epicondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953208	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Benign prostatic hyperplasia (n/a - Recovering/Resolving - Other Medically Important Condition);Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953212	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - );Musculoskeletal chest pain (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Vaccination site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[DESLORATADINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953225	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953226	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010953227	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010953230	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Viral myocarditis (4wk - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953232	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (5d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACENOCOUMAROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010953247	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein occlusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953249	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mixed liver injury (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953254	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953258	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010953261	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Depressive symptom (n/a - Recovering/Resolving - Other Medically Important Condition);Impaired work ability (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953264	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (14d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953278	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Formication (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953297	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Acute generalised exanthematous pustulosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug reaction with eosinophilia and systemic symptoms (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Multisystem inflammatory syndrome in children (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010953299	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Cerebral haematoma (n/a - Fatal - Results in Death);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|XARELTO [RIVAROXABAN] (S - Atrial fibrillation - Drug withdrawn - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010953309	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953313	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953318	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (168d - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953324	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ADENURIC 80 MG FILM-COATED TABLETS [FEBUXOSTAT] (C - Hyperuricaemia - Not applicable - [n/a - 1{DF} - Oral])|[ACETYLSALICYLIC ACID] (C - Prophylaxis - Not applicable - [n/a - 1{DF} - Oral])|[ALFUZOSIN HYDROCHLORIDE] (C - Urinary tract disorder prophylaxis - Not applicable - [n/a - 1{DF} - Oral])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - Not applicable - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953348	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953354	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pleuropericarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010953359	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyporeflexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	ZYTIGA [ABIRATERONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEUPRORELIN, LEUPRORELIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953369	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010953370	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953379	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amyotrophic lateral sclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953381	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953383	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cholestasis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Eosinophilia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatic cytolysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Systemic inflammatory response syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 2{DF} - Intramuscular])|[EVEROLIMUS] (S - Prophylaxis against transplant rejection - Drug withdrawn - [n/a - 3mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953409	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953420	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953426	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Labile blood pressure (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - )|[MOMETASONE FUROATE ANHYDROUS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953463	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953522	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease progression (n/a - Unknown - );Erythema (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Unknown - );Pruritus (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953524	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Decreased vibratory sense (n/a - Not Recovered/Not Resolved - );Diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Hyporeflexia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - );Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953546	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953549	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	OCREVUS [OCRELIZUMAB] (C - Relapsing-remitting multiple sclerosis - n/a - [n/a - 600mg - Intravenous (not otherwise specified)])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953582	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953599	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010953723	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953760	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953776	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - );Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953780	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Torus fracture (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953790	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010953866	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953930	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Lymph node pain (190d - Recovered/Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Poor quality product administered (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953935	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (3d - Recovered/Resolved - );Diabetic ketoacidosis (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010953950	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010953962	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (10d - Recovered/Resolved - Disabling);Dizziness (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (22d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010953966	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010953976	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010953980	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010953994	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Diarrhoea (2d - Recovering/Resolving - );Fatigue (7d - Recovered/Resolved - );Headache (7d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (4d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (3d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010953996	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (7d - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pulpitis dental (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010953996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954011	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954017	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954022	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954027	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Acute flaccid myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954039	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mobility decreased (115d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954048	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954049	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954051	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Paraesthesia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954052	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954061	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954071	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954092	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Costochondritis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954105	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954115	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954138	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954139	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954150	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (86d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010954159	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954163	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954190	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954203	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (4d - Recovering/Resolving - );Vomiting (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954254	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Panic attack (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954288	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Oropharyngeal pain (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954291	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (19d - Not Recovered/Not Resolved - );Influenza like illness (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Peripheral swelling (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954293	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (6d - Recovered/Resolved - );Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954294	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954296	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954299	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010954303	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954307	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010954310	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Incontinence (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - );Renal failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010954319	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954321	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954324	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010954326	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Multiple sclerosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954335	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Panic attack (516d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954338	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954340	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Language disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954342	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010954343	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954345	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Plantar fasciitis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010954347	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010954353	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010954355	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heart rate increased (18d - Recovering/Resolving - );Palpitations (18d - Recovering/Resolving - );Tachycardia (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954359	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Disturbance in attention (32d - Not Recovered/Not Resolved - );Influenza (13d - Not Recovered/Not Resolved - );Limb discomfort (32d - Not Recovered/Not Resolved - );Myalgia (32d - Not Recovered/Not Resolved - );Vaccination site reaction (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010954361	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Not Recovered/Not Resolved - );Dyspnoea (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Somnolence (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954364	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Influenza (n/a - Unknown - );Vaccination site reaction (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954368	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954377	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954378	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954381	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Feeling hot (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954405	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (45d - Recovering/Resolving - );Nephrolithiasis (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010954408	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954419	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954435	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954444	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954456	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[HUMAN NORMAL IMMUNOGLOBULIN, HUMAN NORMAL IMMUNOGLOBULIN (IV), IMMUNOGLOBULIN G] (C - n/a - n/a - [n/a - 20g - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954484	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010954492	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Feeling cold (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954507	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954562	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954564	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DABIGATRAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010954569	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Coagulation factor increased (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Retinal artery occlusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954633	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954746	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010954748	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010954750	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extrasystoles (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Photopsia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954784	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to vaccine (n/a - Unknown - Life Threatening);Bipolar I disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Diabetes mellitus (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Disability (n/a - Not Recovered/Not Resolved - Life Threatening);Hallucination, auditory (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hallucination, visual (n/a - Unknown - Life Threatening, Other Medically Important Condition);Mania (n/a - Unknown - Life Threatening);Pain (n/a - Unknown - Life Threatening);Panic attack (n/a - Not Recovered/Not Resolved - Life Threatening);Raynaud's phenomenon (n/a - Not Recovered/Not Resolved - Life Threatening);Stroke in evolution (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Vision blurred (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010954873	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954875	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010954886	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	BORTEZOMIB ACCORD [BORTEZOMIB] (S - Plasma cell myeloma - Dose not changed - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|REVLIMID [LENALIDOMIDE] (S - Plasma cell myeloma - Drug withdrawn - [n/a - n/a - n/a])|VELCADE [BORTEZOMIB] (S - Plasma cell myeloma - Unknown - [n/a - n/a - n/a])|[DEXAMETHASONE] (S - Plasma cell myeloma - Dose not changed - [8d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954910	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Burning sensation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tunnel vision (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010954920	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autonomic neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010954940	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010954975	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010954975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010955075	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010955124	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010955138	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death);Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010955144	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010955145	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac death (n/a - Fatal - Results in Death);Hallucination (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010955146	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dermatitis allergic (23d - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pruritus (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010955218	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010955221	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010955230	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Headache (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	[IBUPROFEN] (C - Teething - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010955243	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010955277	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010955405	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myositis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	INVOKANA [CANAGLIFLOZIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PAROXETINE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010955571	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010955668	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010955757	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Cold sweat (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010955764	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010955821	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Epilepsy (2d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[truncated, see ICSR form for full text]	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - )|[VARDENAFIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010955923	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010955948	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010955964	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010955977	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010955977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956014	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956030	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Temperature regulation disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956051	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956059	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956072	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[ATOMOXETINE, ATOMOXETINE HYDROCHLORIDE] (C - Disturbance in attention - n/a - [n/a - n/a - Oral])|[BUDESONIDE] (C - Asthma prophylaxis - n/a - [n/a - n/a - Respiratory (inhalation)])|[KETOCONAZOLE, KETOCONAZOLE PH. EUR.] (C - n/a - n/a - [n/a - n/a - Cutaneous])|[MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956089	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis allergic - n/a - [n/a - n/a - Nasal])|OPATANOL [OLOPATADINE, OLOPATADINE HYDROCHLORIDE] (C - Rhinitis allergic - n/a - [n/a - n/a - Ophthalmic])|[LORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - Oral])|[PHLEUM PRATENSE, PHLEUM PRATENSE (225), PHLEUM PRATENSE POLLEN EXTRACT, TIMOTHY GRASS POLLEN EXTRACT] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956091	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	KETOCONAZOLE [KETOCONAZOLE] (C - Dandruff - n/a - [n/a - n/a - Cutaneous])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Hiatus hernia - n/a - [133d - n/a - Oral])|[OMEPRAZOLE] (C - Peptic ulcer - n/a - [109d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010956101	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956131	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Nausea (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956156	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Headache (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956172	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956174	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010956185	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956198	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956223	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Abdominal pain lower (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	AERIUS [DESLORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - Oral])|AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis allergic - n/a - [n/a - n/a - Nasal])|OPATANOL [OLOPATADINE, OLOPATADINE HYDROCHLORIDE] (C - Rhinitis allergic - n/a - [n/a - n/a - Ophthalmic])|PROTOPIC [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[BUDESONIDE] (C - Asthma prophylaxis - n/a - [n/a - n/a - Respiratory (inhalation)])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Bronchospasm - n/a - [n/a - n/a - Respiratory (inhalation)])|[VITAMIN D, CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956227	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (10h - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (16h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956231	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (99d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010956278	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Joint stiffness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mastication disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Rheumatoid arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[MAGNESIUM OXIDE, MAGNESIUM OXIDE, LIGHT] (C - Constipation - n/a - [n/a - 2000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010956291	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010956293	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Injection site haematoma (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (10d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956373	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010956379	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956388	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010956391	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010956470	Spontaneous	2021-12-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Headache (13d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010956487	Spontaneous	2021-12-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010956487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932452	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932455	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932465	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Skin irritation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010932481	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010932566	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Confusional state (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Arrhythmia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932588	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932592	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Crohn's disease (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SULFASALAZINE] (C - Crohn's disease - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932596	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Amylase decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Aspartate aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Bile acids increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood albumin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood bilirubin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cholestasis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Erectile dysfunction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gamma-glutamyltransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperbilirubinaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Jaundice (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Renal failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Scleral disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932600	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Respiratory disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010932604	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932605	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010932677	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (6d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product administered at inappropriate site (n/a - Unknown - );Vaccination site bruising (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vomiting (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932679	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Congenital hydrocephalus (n/a - Fatal - Results in Death, Congenital Anomaly);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly);Spina bifida (n/a - Fatal - Results in Death, Congenital Anomaly)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010932686	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nervousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010932692	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932693	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010932694	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010932704	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932706	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Unknown - Other Medically Important Condition);Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932707	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932709	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932711	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010932718	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932722	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932892	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENBREL [ETANERCEPT] (C - Rheumatoid arthritis - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932981	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Surgery (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932986	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved - );Joint swelling (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933047	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Bone pain (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010933052	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010933084	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933086	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (148d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ETORICOXIB] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010933156	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Other Medically Important Condition);Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0mo - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [0mo - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010933192	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pancreatitis chronic (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMYLASE, LIPASE, PROTEASE, PANCREALIPASE, PANCREAS POWDER, PANCREAS POWDER FROM PORCINE, PANCREATIN, PANCREATIN BP, PANCRELIPASE AMYLASE, PANCRELIPASE PROTEASE, LIPASE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Pancreatitis - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933197	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010933274	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933276	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933277	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933281	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933300	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epistaxis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haematuria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Multisystem inflammatory syndrome in children (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pharyngeal swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulse abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	FLUENZ TETRA [A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE STRAIN (A/HAWAII/66/2019, MEDI 326775), A/HONG KONG/2671/2019 (H3N2) - LIKE STRAIN (A/HONG KONG/2671/2019, MEDI 325078), B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, MEDI 306444), B/WASHINGTON/02/2019 - LIKE STRAIN (B/WASHINGTON/02/2019, MEDI 323797), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, MEDI 237514), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, MEDI 228029), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/BOLIVIA/559/2013, MEDI 255962), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/NEW CALEDONIA/71/2014, MEDI 263122), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/MICHIGAN/45/2015 (H1N1)PDM09 - LIKE STRAIN (A/SLOVENIA/2903/2015, MEDI 279432), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, MEDI 291690), B/COLORADO/06/2017-LIKE STRAIN (B/COLORADO/06/2017, MEDI 293454), B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, MEDI 306444), A/VICTORIA/2570/2019 (H1N1)PDM09 - LIKE STRAIN (A/VICTORIA/1/2020, MEDI 340505), B/AUSTRIA/1359417/2021 - LIKE STRAIN (B/AUSTRIA/1359417/2021, MEDI 355292), A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/NORWAY/16606/2021, MEDI 355293), B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, MEDI 306444), B/WASHINGTON/02/2019 - LIKE STRAIN (B/WASHINGTON/02/2019, MEDI 323797), A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, MEDI 339018), A/VICTORIA/2570/2019 (H1N1)PDM09 - LIKE STRAIN (A/VICTORIA/1/2020, MEDI 340505)] (S - Influenza immunisation - Not applicable - [1d - n/a - Nasal])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010933311	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933331	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933353	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933385	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SOMATROPIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010933399	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - );Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010933413	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933426	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain in extremity (68h - Recovered/Resolved - Other Medically Important Condition);Upper limb fracture (68h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933440	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Other Medically Important Condition);Cardiogenic shock (n/a - Fatal - Results in Death, Other Medically Important Condition);Fatigue (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Pallor (n/a - Unknown - );Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010933448	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933451	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933452	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010933494	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933496	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933498	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933500	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933588	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933593	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933594	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hangover (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933694	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Mouth ulceration (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Urethritis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933695	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933696	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933698	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933699	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010933867	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arteriosclerosis coronary artery (n/a - Unknown - Life Threatening, Other Medically Important Condition);Cardiac arrest (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Left ventricular dysfunction (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Ventricular dysfunction (n/a - Unknown - Life Threatening, Other Medically Important Condition);Ventricular tachycardia (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010933923	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (9d - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - );Chest pain (9d - Recovering/Resolving - );Headache (9d - Recovering/Resolving - );Myalgia (9d - Recovering/Resolving - );Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010933996	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010933996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010934031	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	ADENURIC [FEBUXOSTAT] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ATORVASTATIN] (C - n/a - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[ESCITALOPRAM] (C - n/a - n/a - )|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - )|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010934048	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chronic cutaneous lupus erythematosus (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - Chronic cutaneous lupus erythematosus - n/a - [n/a - n/a - n/a])|RITUXIMAB [RITUXIMAB] (C - Chronic cutaneous lupus erythematosus - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Chronic cutaneous lupus erythematosus - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - Iron deficiency - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Chronic cutaneous lupus erythematosus - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Chronic cutaneous lupus erythematosus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934087	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934088	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934124	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010934133	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934145	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (5d - Recovered/Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934164	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Impaired work ability (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934182	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Vertigo (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010934183	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010934185	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934191	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934192	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934197	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature decreased (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934222	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (7d - Recovered/Resolved - Other Medically Important Condition);Asthenia (7d - Recovered/Resolved - Other Medically Important Condition);Balance disorder (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (7d - Recovered/Resolved - Other Medically Important Condition);Nausea (7d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934225	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934231	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TESTOSTERONE] (C - Transgender hormonal therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934232	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934244	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tenderness (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934248	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010934253	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934255	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Joint swelling (n/a - Recovered/Resolved With Sequelae - );Oedema (n/a - Recovered/Resolved With Sequelae - Disabling);Sinus disorder (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SILDENAFIL [SILDENAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010934258	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934355	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934375	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934381	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934382	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Asthenia (0d - Recovered/Resolved With Sequelae - );Eczema (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010934385	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010934388	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin T increased (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010934406	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1wk - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934429	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 120mg - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE HYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[METAMIZOLE SODIUM, METAMIZOLE SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - 30[drp] - n/a])|[PROTHIPENDYL HYDROCHLORIDE, PROTHIPENDYL HYDROCHLORIDE MONOHYDRATE] (C - n/a - n/a - [n/a - 80mg - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - 18ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934442	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site erythema (n/a - Unknown - );Administration site oedema (n/a - Unknown - );Administration site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934471	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Anhedonia (n/a - Recovering/Resolving - Other Medically Important Condition);Depressed mood (n/a - Recovering/Resolving - Other Medically Important Condition);Depression (n/a - Recovering/Resolving - Other Medically Important Condition);Fear of death (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Mania (5d - Recovered/Resolved - Other Medically Important Condition);Psychomotor hyperactivity (5d - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LAMOTRIGINE] (C - Bipolar disorder - Unknown - [n/a - 100mg - Oral])|[QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE HEMIFUMARATE] (C - Bipolar disorder - Unknown - [n/a - 100mg - Oral])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Bipolar disorder - Unknown - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934545	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934562	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934566	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - );Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934568	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934571	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934580	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Appetite disorder (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Not Recovered/Not Resolved - );Formication (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition);Skin haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suicidal ideation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934591	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010934600	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934606	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934607	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Supraventricular extrasystoles (n/a - Unknown - Other Medically Important Condition);Ventricular extrasystoles (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934618	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Urticaria (6d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934622	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934626	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934629	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (1d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934631	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934638	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934646	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (4d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010934648	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934652	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (2d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Depression (n/a - Recovering/Resolving - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspepsia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010934740	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934805	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Lymphadenitis (n/a - Recovering/Resolving - );Parotitis (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934807	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934812	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934814	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934821	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934852	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Liver injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - )	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	DEGARELIX [DEGARELIX] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE, OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010934865	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010934881	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemoptysis (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010934888	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010934953	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (40d - Recovered/Resolved With Sequelae - Life Threatening);Hypertension (40d - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010934962	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Photopsia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010934992	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010934995	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Cardiac failure (n/a - Fatal - Results in Death);Eye movement disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010934995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010935002	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935003	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935005	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935041	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935136	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935163	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935183	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site oedema (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935194	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])|[SERTRALINE] (S - Product used for unknown indication - Drug withdrawn - [n/a - 50mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935250	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Renal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935252	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fear (n/a - Recovering/Resolving - );Hypertonic bladder (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - );Muscle tightness (n/a - Recovering/Resolving - );Palpitations (1d - Recovered/Resolved - );Pollakiuria (n/a - Recovering/Resolving - );Tension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935339	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935360	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Unknown - );Rhabdomyolysis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935427	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (19d - Recovered/Resolved - Other Medically Important Condition);Breast tenderness (16d - Recovered/Resolved - Other Medically Important Condition);Chest pain (16d - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Extrasystoles (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (5d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935428	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (7d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935435	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935437	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935443	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935477	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935486	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (11d - Recovered/Resolved - Other Medically Important Condition);Thrombosis (18d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935528	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (185d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935556	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935589	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935628	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935629	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935632	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935633	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935634	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935635	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935636	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935637	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site induration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site movement impairment (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010935640	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010935674	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (75d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935759	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935796	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sciatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)] (S - Immunisation - Not applicable - [n/a - 1{DF} - n/a])	[COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010935836	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Psychotic disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010935841	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aneurysm (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	MIRABEGRON [MIRABEGRON] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010935859	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Ear discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Syncope (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935879	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935888	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FOSINOPRIL SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935904	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (18d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935905	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Recovering/Resolving - Other Medically Important Condition);Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (5d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (5d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935921	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010935930	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - );Respiratory distress (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010935938	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010935945	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010935956	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010935956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010936009	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL, BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL MONOHYDRATE, BETAMETHASONE, CALCIPOTRIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN] (C - n/a - n/a - [n/a - 50mg - Oral])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - n/a - n/a - [n/a - 50ug - Nasal])|[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - 2{DF} - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - 1000mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010936019	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010936117	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Computerised tomogram head abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tonic clonic movements (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [n/a - 1{DF} - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010936178	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (24h - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010936378	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010936433	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nodule (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010936567	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010936587	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010936621	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010936671	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010936676	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010936711	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Heart rate increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010936781	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010936786	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010936796	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010936854	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ENBREL [ETANERCEPT] (C - Ankylosing spondylitis - n/a - [n/a - 50mg - Subcutaneous])|[KETOPROFEN, KETOPROFEN SODIUM] (C - Ankylosing spondylitis - n/a - [n/a - 100mg - Cutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010936854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010937027	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Tinnitus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937030	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937035	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937037	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937039	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937040	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937055	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - Unknown - [n/a - n/a - n/a])|OZEMPIC [SEMAGLUTIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[MICRONISED SPIRONOLACTONE, SPIRONOLACTONE] (C - n/a - Unknown - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937096	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Swelling (n/a - Unknown - )	[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010937119	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937166	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937190	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Retinal vein occlusion (n/a - Recovering/Resolving - );Visual acuity reduced (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937209	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937215	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Unknown - );Deep vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|RIVAROXABAN 15MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937219	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (n/a - Unknown - Life Threatening);Deep vein thrombosis (n/a - Unknown - Life Threatening);Oedema peripheral (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010937274	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010937284	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937285	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937288	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937319	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010937339	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937421	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (43d - Recovered/Resolved With Sequelae - );Injection site hypoaesthesia (43d - Recovered/Resolved With Sequelae - );Paraesthesia (43d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010937423	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - );Headache (81d - Recovered/Resolved With Sequelae - );Influenza like illness (81d - Recovered/Resolved With Sequelae - );Nausea (37d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010937424	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (25d - Recovering/Resolving - );Hypokalaemia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937426	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937428	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Feeling hot (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937429	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937431	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937432	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Micturition urgency (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937433	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937434	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Local reaction (8d - Recovering/Resolving - );Vaccination site reaction (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937449	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (4h - Recovered/Resolved - );Headache (4h - Recovered/Resolved - );Pyrexia (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937454	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937455	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Hypotension (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937461	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (26d - Not Recovered/Not Resolved - );Dyspnoea (26d - Not Recovered/Not Resolved - );Fatigue (26d - Not Recovered/Not Resolved - );Headache (26d - Not Recovered/Not Resolved - );Myalgia (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937466	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (17d - Recovered/Resolved - );Chest pain (17d - Recovered/Resolved - );Diarrhoea (6d - Recovering/Resolving - );Dizziness (15d - Recovered/Resolved - );Fatigue (21d - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Influenza (7d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937467	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Conjunctivitis (4d - Not Recovered/Not Resolved - );Oral herpes (4d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937474	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937476	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010937483	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (36d - Recovered/Resolved With Sequelae - );Rash (36d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010937487	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010937488	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937499	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Not Recovered/Not Resolved - );Circulatory collapse (5d - Not Recovered/Not Resolved - );Dizziness (5d - Not Recovered/Not Resolved - );Feeling hot (5d - Not Recovered/Not Resolved - );Hyperhidrosis (5d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937516	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (3d - Recovered/Resolved With Sequelae - );Myalgia (3d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010937522	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza like illness (42d - Recovering/Resolving - );Nausea (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010937529	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937532	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937568	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Neck pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937601	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Fatal - Results in Death);SARS-CoV-2 test positive (n/a - Fatal - Results in Death);Vaccine breakthrough infection (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010937606	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arterial occlusive disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937621	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (12d - Not Recovered/Not Resolved - );Headache (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937635	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (3d - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Face oedema (3d - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Hypersensitivity (3d - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010937651	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937654	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (0d - Not Recovered/Not Resolved - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937656	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Hiccups (n/a - Unknown - );Influenza (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937660	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010937683	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (18d - Not Recovered/Not Resolved - );Limb discomfort (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937689	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Irritability (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937696	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (14d - Recovered/Resolved - );Muscle spasms (14d - Recovered/Resolved - );Myalgia (14d - Recovered/Resolved - );Paraesthesia (14d - Recovered/Resolved - );Peripheral coldness (14d - Recovered/Resolved - );Vaccination site movement impairment (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937697	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site swelling (2d - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Vaccination site reaction (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937705	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Monoplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937732	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal pain upper (1d - Recovering/Resolving - );Abnormal faeces (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937734	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010937740	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Epistaxis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937743	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - Cardiac failure - n/a - [n/a - 100mg - Oral])|JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 10mg - Oral])|XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - 20mg - Oral])|[AMIODARONE HYDROCHLORIDE] (C - Cardiac failure - n/a - [n/a - 200mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac failure - n/a - [n/a - 10mg - Oral])|[SPIRONOLACTONE] (C - Cardiac failure - n/a - [n/a - 25mg - Oral])|[TORASEMIDE] (C - Cardiac failure - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010937744	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (2d - Recovered/Resolved - );Abnormal faeces (2d - Recovered/Resolved - );Flatulence (2d - Recovered/Resolved - );Gastrointestinal pain (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937748	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Leukaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937750	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010937754	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovering/Resolving - );Dysphagia (2d - Recovering/Resolving - );Dyspnoea (2d - Recovering/Resolving - );Injection site swelling (6d - Recovered/Resolved - );Throat irritation (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937806	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (2d - Recovering/Resolving - );Injection site reaction (2d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937808	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apnoea (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);General physical health deterioration (n/a - Not Recovered/Not Resolved - );Lung neoplasm malignant (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010937809	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937819	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010937828	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010937833	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937834	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937841	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010937842	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apnoea (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);Lung neoplasm malignant (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010937853	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937856	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937861	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937868	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Sleep disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937874	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Swelling face (1d - Recovered/Resolved - );Swelling of eyelid (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937888	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (20d - Not Recovered/Not Resolved - );Exercise tolerance decreased (20d - Not Recovered/Not Resolved - );Hyperhidrosis (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937892	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Heart rate increased (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937900	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (42d - Recovered/Resolved - );Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010937906	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (45d - Not Recovered/Not Resolved - );Blood pressure abnormal (45d - Not Recovered/Not Resolved - );Dizziness (45d - Not Recovered/Not Resolved - );Pain in extremity (45d - Not Recovered/Not Resolved - );Paraesthesia (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937909	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (24d - Recovered/Resolved With Sequelae - );Vaccination site reaction (24d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010937945	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937956	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010937960	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Bone pain (n/a - Not Recovered/Not Resolved - );Conjunctival disorder (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) DISPERSION FOR INJECTION 30 MICROGRAMS/DOSE [TOZINAMERAN] (S - n/a - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010937995	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (6wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010937995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010938003	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[TIAPRIDE] (C - n/a - n/a - [n/a - 200mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938066	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensitisation (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010938184	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Coagulopathy (n/a - Recovering/Resolving - Life Threatening);Fibrin D dimer increased (n/a - Recovering/Resolving - Life Threatening);Pain in extremity (n/a - Recovering/Resolving - Life Threatening);Phlebitis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[EDOXABAN TOSYLATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ENOXAPARIN SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[ISOSORBIDE DINITRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[LAMOTRIGINE] (C - n/a - Unknown - [n/a - 2.5{DF} - n/a])|[RAMIPRIL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010938204	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938221	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparesis (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010938294	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938312	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938480	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Polyneuropathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010938481	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema annulare (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938571	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938629	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extrasystoles (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938631	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALOGLIPTIN BENZOATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[AMLODIPINE BESILATE, ATORVASTATIN CALCIUM, AMLODIPINE, ATORVASTATIN, AMLODIPINE, ATORVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[AZILSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938632	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injection site pain (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938635	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938638	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938639	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hepatic failure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[DROXIDOPA] (C - Orthostatic hypotension - n/a - [n/a - n/a - Oral])|[RABEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938642	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Bone pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Cluster headache (n/a - Recovered/Resolved - Other Medically Important Condition);Eye irritation (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Primary stabbing headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938643	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Obesity (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BENIDIPINE, BENIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 2{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938647	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938650	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (50d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938655	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938657	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938662	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938665	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938668	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938671	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938672	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar infarction (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Coronary artery disease - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - Coronary artery disease - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Coronary artery disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938674	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938679	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cachexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral atrophy (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dehydration (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - );Pallor (n/a - Unknown - );Shock (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938687	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938688	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Recovered/Resolved - Other Medically Important Condition);Disease recurrence (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938689	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BETAMETHASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOBETASONE BUTYRATE, NYSTATIN, OXYTETRACYCLINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938691	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938697	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938701	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Shock (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010938712	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diplopia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye pain (3d - Recovered/Resolved - );Eyelid disorder (n/a - Unknown - Other Medically Important Condition);Eyelid ptosis (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (3d - Recovered/Resolved - );Hypercholesterolaemia (n/a - Unknown - Other Medically Important Condition);Ophthalmoplegia (n/a - Unknown - Other Medically Important Condition);Visual impairment (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010938713	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938719	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema herpeticum (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye pain (n/a - Unknown - );Headache (n/a - Unknown - );Herpes simplex encephalitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938720	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Convulsions local (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938723	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938725	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938727	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938730	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Aspiration (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood alkaline phosphatase increased (n/a - Unknown - );Gastrooesophageal reflux disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Haemoglobin decreased (n/a - Unknown - );Red blood cell count decreased (n/a - Unknown - );Respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Stridor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ANGELICA ROOT, JUJUBE FRUIT, GINGER, GINSENG, ASTRAGALUS, ATRACTYLODES LANCEA ROOT, BUPLEURUM CHINENSE ROOT, GLYCYRRHIZA, CIMICIFUGA RHIZOME DRY EXTRACT, TANGERINE] (C - n/a - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[PIPERACILLIN, TAZOBACTAM] (C - Pneumonia aspiration - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - Oral])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ZINC ACETATE HYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938734	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938737	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938739	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938745	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Subarachnoid haemorrhage (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - Arrhythmia - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010938748	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Colitis ischaemic (n/a - Fatal - Results in Death, Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Gastrointestinal haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure decreased - n/a - [n/a - n/a - Oral])|[ANGELICA ROOT, GLYCYRRHIZA GLABRA, YOKUKANSAN] (C - Sedation - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Blood pressure decreased - n/a - [n/a - n/a - Oral])|[BROTIZOLAM] (C - Sleep disorder therapy - n/a - [n/a - n/a - Oral])|[DOXAZOSIN MESILATE] (C - Blood pressure decreased - n/a - [n/a - n/a - Oral])|[ETIZOLAM] (C - Sedation - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Blood pressure decreased - n/a - [n/a - n/a - Oral])|[RISPERIDONE] (C - Sedation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938752	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938754	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (2d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938756	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938762	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar infarction (n/a - Unknown - Other Medically Important Condition);Cerebral artery embolism (n/a - Unknown - Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938764	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938767	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938769	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938778	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Cerebral venous sinus thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coma scale abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Dyskinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lack of spontaneous speech (n/a - Recovered/Resolved - Other Medically Important Condition);Physical deconditioning (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Stertor (n/a - Recovered/Resolved - Other Medically Important Condition);Thalamus haemorrhage (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - Oral])|[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - n/a - Oral])|[MESALAZINE] (C - n/a - n/a - [n/a - 1200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010938783	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - );Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938789	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Stridor (n/a - Recovered/Resolved - Other Medically Important Condition);Tachypnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - Essential hypertension - n/a - [n/a - 40mg - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 100mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Essential hypertension - n/a - [n/a - 5mg - n/a])|[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - 10mg - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Angina pectoris - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938792	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010938798	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (3030min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938801	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938806	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Product use issue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tonic convulsion (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938807	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Unknown - Other Medically Important Condition);Bone pain (13d - Recovered/Resolved - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (3d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010938872	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (0d - Fatal - Results in Death);Asthenia (n/a - Fatal - Results in Death);Cardiac arrest (0d - Fatal - Results in Death);Cardiac failure acute (0d - Fatal - Results in Death);Malaise (0d - Fatal - Results in Death);Myalgia (n/a - Fatal - Results in Death);Myocardial ischaemia (0d - Fatal - Results in Death)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010938881	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938885	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938895	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938906	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myoclonus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010938940	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - );Depressed mood (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Off label use (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[IVERMECTIN] (S - Scabies - Not applicable - [n/a - n/a - Oral])|[PERMETHRIN] (S - Scabies - n/a - [8d - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938950	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	UROREC 8 MG HARD CAPSULES [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938962	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938963	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010938965	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938970	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938972	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010938975	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site hypersensitivity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938976	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010938994	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010938994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939032	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (23d - Recovered/Resolved - );Dyspnoea (5wk - Recovered/Resolved - );Malaise (23d - Recovered/Resolved - );Myalgia (5wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939042	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939047	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939051	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Migraine (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[SULFASALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939052	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (9d - Recovered/Resolved - );Chest pain (9d - Recovered/Resolved - );Paraesthesia (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939053	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (24h - Recovered/Resolved - );Muscle spasms (24h - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939067	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctival hyperaemia (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939068	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939080	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939081	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939092	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - );Haemorrhoids (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939094	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939097	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	PRADAXA 110 MG [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - )|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939099	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939129	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Angina pectoris (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939137	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939142	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939150	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939155	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (45d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939162	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939163	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Blood pressure increased (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939166	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (5d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Paraesthesia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939182	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939186	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - );Pruritus (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939227	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nasal discomfort (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pharyngitis (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939236	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Motor dysfunction (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939244	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939250	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939257	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939266	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939269	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Lymphadenitis (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site mass (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939271	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939274	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abnormal dreams (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939282	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (22h - Recovered/Resolved - Other Medically Important Condition);Tachycardia (22h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010939284	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Testicular swelling (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010939287	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - );Immunisation (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939289	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dermatitis allergic (4d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mental disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (4d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010939307	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939310	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939317	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939325	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Vaccination site induration (n/a - Recovering/Resolving - );Vaccination site inflammation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939330	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939343	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939368	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939380	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939383	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gynaecomastia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939393	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939397	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939411	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Recovered/Resolved - );Headache (8d - Recovered/Resolved - );Renal colic (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939425	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epicondylitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939427	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939430	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939431	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	UROREC [SILODOSIN] (C - Benign prostatic hyperplasia - Not applicable - [n/a - n/a - n/a])|[DUTASTERIDE] (C - Benign prostatic hyperplasia - Not applicable - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Thyroidectomy - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939433	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - Not applicable - )|ZONEGRAN [ZONISAMIDE] (C - Epilepsy - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939445	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Pallor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939451	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939459	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Aphthous ulcer (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939464	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939485	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939492	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939494	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939495	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939499	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	New daily persistent headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939501	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939515	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939519	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939528	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site joint movement impairment (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939542	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939545	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939548	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939563	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939581	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939582	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939583	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939585	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939586	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939587	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939596	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939598	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939599	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939603	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939605	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Fibrin D dimer increased (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939621	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939623	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939627	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939633	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939642	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939645	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Palatal oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939650	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal stiffness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939652	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Muscle strain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939666	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939667	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - );Genital herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939671	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939676	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939686	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939691	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (10d - Recovered/Resolved - );Vaccination site reaction (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939702	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [63d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939703	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010939705	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939712	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939714	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939720	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Constipation (10d - Recovered/Resolved - );Menstrual disorder (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939722	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939732	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (8h - Recovered/Resolved - );Atrial fibrillation (8h - Recovered/Resolved - );Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010939733	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphthous ulcer (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939734	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939739	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Flat affect (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939740	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939741	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939761	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010939773	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Nephritis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939776	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939780	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Burning sensation (n/a - Recovered/Resolved With Sequelae - );Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved With Sequelae - );Feeling abnormal (n/a - Recovered/Resolved With Sequelae - );Feeling jittery (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - );Palpitations (n/a - Recovered/Resolved With Sequelae - );Pharyngeal swelling (n/a - Unknown - );Throat tightness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tunnel vision (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010939782	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (5d - Recovered/Resolved - );Contusion (n/a - Unknown - );Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Unknown - );Dysarthria (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Unknown - );Fall (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Grunting (n/a - Unknown - );Hypertension (5d - Recovered/Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Unknown - );Oral mucosal blistering (n/a - Unknown - );Oxygen saturation decreased (5d - Recovered/Resolved - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Respiratory distress (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - );Throat tightness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 300mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010939790	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	XELJANZ [TOFACITINIB, TOFACITINIB CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939807	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[DOCONEXENT, ICOSAPENT, FISH OIL, OMEGA-3-ACID ETHYL ESTERS 90] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939825	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939829	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010939831	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pustular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - Hypertriglyceridaemia - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939833	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Constipation (n/a - Not Recovered/Not Resolved - );Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939834	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939838	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Formication (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939841	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939844	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BUPRENORPHINE, BUPRENORPHINE HYDROCHLORIDE] (C - Drug dependence - Not applicable - )|[OXAZEPAM] (C - Anxiety - Not applicable - )|[PAROXETINE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Depression - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939845	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - Hyperglycaemia - Not applicable - )|[RAMIPRIL] (C - Hypertension - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939855	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939892	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Generalised tonic-clonic seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010939900	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (4d - Recovered/Resolved - );Tinnitus (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - Dose not changed - [n/a - 500mg - Oral])|[THIAMAZOLE] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010939913	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Breast swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010939914	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (3h - Recovered/Resolved - Other Medically Important Condition);Cold sweat (3h - Recovered/Resolved - );Feeling hot (3h - Recovered/Resolved - );Nausea (3h - Recovered/Resolved - );Pallor (3h - Recovered/Resolved - );Rash (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939919	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939920	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939938	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010939940	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Venous oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010939990	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[CLONAZEPAM] (C - Obsessive-compulsive disorder - n/a - [n/a - 2mg - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - Dose not changed - [n/a - 5mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Sinus tachycardia - Dose not changed - [n/a - 12.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010939990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010940020	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940064	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemoptysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940174	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940175	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Motor dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940177	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940178	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (10d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940186	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940189	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940197	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940199	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940203	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010940208	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940216	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940220	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hepatic failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940225	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940227	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940230	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Disabling);Paralysis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010940231	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual field defect (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940233	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute pulmonary oedema (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiomyopathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940242	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940252	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Apathy (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Eye disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940253	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[DESLORATADINE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940258	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940266	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940269	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute pulmonary oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940271	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940273	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940279	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010940280	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombotic thrombocytopenic purpura (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940281	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010940296	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Embolism venous (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940312	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Hypotension (n/a - Recovered/Resolved - );Obstructive airways disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940319	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune hypothyroidism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood thyroid stimulating hormone increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940320	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Arthritis (n/a - Recovered/Resolved - );Axonal neuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - );Neuralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940324	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940328	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940357	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Febrile convulsion (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940360	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coeliac artery aneurysm (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940367	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940370	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940371	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940373	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940374	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940376	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940377	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940380	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940382	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940388	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940389	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940390	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940392	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940393	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940410	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940413	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (6mo - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940422	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vitreous detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940444	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic shock (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940454	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940456	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940458	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940464	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940481	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940485	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940490	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940491	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940495	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );SARS-CoV-2 test positive (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940497	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940500	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940504	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010940506	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Local reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940513	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Dyspnoea exertional (3d - Recovered/Resolved - );Immunisation reaction (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SPIKEVAX [ELASOMERAN] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940519	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940521	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940531	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940532	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940534	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Abdominal pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940535	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940537	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Syncope (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940539	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940559	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940570	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940573	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940574	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940582	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940583	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940632	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940637	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940638	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940639	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940640	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940641	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940642	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940648	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940663	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940668	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940671	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940674	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940675	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940676	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940677	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940679	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940682	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940683	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940684	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940686	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940700	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940701	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940705	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940706	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940712	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940713	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940716	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940720	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940722	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940724	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940729	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940731	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940735	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Autoimmune myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brachial plexopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940736	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940741	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940742	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940747	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (3d - Unknown - Other Medically Important Condition);Vaccination failure (3d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940748	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombocytopenia (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940751	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (2wk - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940820	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940826	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940828	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death);Dementia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010940833	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Septic shock (n/a - Fatal - Results in Death);Vasculitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010940847	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - Dose not changed - [n/a - 500mg - Oral])|[THIAMAZOLE] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010940868	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940870	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940875	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TESTOSTERONE [TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940880	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940883	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Orthostatic hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Orthostatic intolerance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940885	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Defect conduction intraventricular (n/a - Unknown - Other Medically Important Condition);Diarrhoea (4d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Physical deconditioning (n/a - Unknown - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940890	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Presyncope (n/a - Unknown - Other Medically Important Condition);Pulse absent (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Unresponsive to stimuli (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940892	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (148h - Recovered/Resolved - Other Medically Important Condition);Milia (2d - Recovered/Resolved - Other Medically Important Condition);Pruritus (148h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940908	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940909	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - );Communication disorder (n/a - Not Recovered/Not Resolved - );Coronary artery dissection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dysarthria (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Unknown - Other Medically Important Condition);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxic-ischaemic encephalopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940911	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Gastroenteritis (n/a - Not Recovered/Not Resolved - );Hemiplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940912	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940917	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940919	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (4d - Recovered/Resolved - Other Medically Important Condition);Aspartate aminotransferase increased (4d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - );Blood creatinine increased (4d - Recovered/Resolved - Other Medically Important Condition);Blood urea increased (4d - Recovered/Resolved - Other Medically Important Condition);Gamma-glutamyltransferase increased (4d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Malaise (4d - Recovered/Resolved - );Muscular weakness (4d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940920	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhagic stroke (0d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010940929	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940930	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (343h - Recovered/Resolved - );Electrocardiogram PR segment depression (15d - Recovered/Resolved - );Electrocardiogram PR segment elevation (15d - Recovered/Resolved - );Pericarditis (343h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (343h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940934	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asphyxia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebral disorder (n/a - Not Recovered/Not Resolved - );Dry throat (n/a - Not Recovered/Not Resolved - );Electric shock sensation (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940935	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	AFINITOR [EVEROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])|SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - 25mg - n/a])|[AZOSEMIDE] (C - n/a - n/a - [n/a - 60mg - n/a])|[BENZALKONIUM CHLORIDE] (C - n/a - n/a - [n/a - 1mg - n/a])|[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - 20mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - n/a - n/a - [n/a - 50ug - n/a])|[LOPERAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1mg - n/a])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[SODIUM CHLORIDE] (C - n/a - n/a - [n/a - 1mg - n/a])|[SODIUM GUALENATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRICHLORMETHIAZIDE] (C - n/a - n/a - [n/a - 1mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010940940	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematemesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Petechiae (n/a - Not Recovered/Not Resolved - );Pleuritic pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010940952	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010940959	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Unknown - );Off label use (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010940959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941066	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941068	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ventricular tachycardia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010941069	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Recovering/Resolving - );Hypersensitivity (n/a - Recovering/Resolving - );Pharyngeal swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941089	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010941092	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941094	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chills (13d - Recovered/Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010941102	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Arthralgia (32d - Recovered/Resolved - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (25d - Recovered/Resolved - );Malaise (n/a - Unknown - );Myalgia (25d - Recovered/Resolved - );Nausea (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010941103	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arthralgia (6mo - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (6mo - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Hypertension (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (6mo - Recovered/Resolved - );Myalgia (6mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010941164	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling of body temperature change (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010941166	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941167	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Obstructive sleep apnoea syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Polycythaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010941170	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial flutter (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010941171	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941178	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941179	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lactic acidosis (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941181	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941184	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Encephalitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Interstitial lung disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010941187	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010941188	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovering/Resolving - Congenital Anomaly, Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	Severe reaction
EU-EC-10010941190	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941192	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941197	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - Other Medically Important Condition);COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dry skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Scrotal erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Scrotal exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Scrotum erosion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin erosion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941199	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Clostridium difficile colitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemophagocytic lymphohistiocytosis (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Still's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tonsillitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Uvulitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ANAKINRA [ANAKINRA] (C - n/a - n/a - [n/a - n/a - n/a])|CICLOSPORIN [CICLOSPORIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - n/a])|[METHOTREXATE SODIUM] (C - n/a - n/a - [n/a - 20mg - n/a])|[METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - 500mg - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 60mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010941203	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941213	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Genital herpes (n/a - Unknown - Other Medically Important Condition);Herpes virus infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941214	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Unknown - );Mental impairment (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MELOXICAM] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941361	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Depression (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Sciatica (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Not Recovered/Not Resolved - Disabling);Spinal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010941431	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dehydration (12h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (12h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (12h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Incontinence (12h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (12h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010941500	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010941507	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941512	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941519	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Chest pain (n/a - Recovering/Resolving - Disabling);Cough (3d - Recovered/Resolved - Disabling);Diarrhoea (3d - Recovered/Resolved - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovered/Resolved With Sequelae - Disabling);Immunisation (n/a - Unknown - Disabling);Myalgia (n/a - Recovered/Resolved With Sequelae - Disabling);Pyrexia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010941531	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010941532	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperproteinaemia (n/a - Unknown - );Muscle injury (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941548	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (0d - Recovered/Resolved - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941557	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - );Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Headache (n/a - Unknown - );Hyperlipidaemia (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - );Sensation of foreign body (n/a - Unknown - );Supraventricular tachycardia (n/a - Unknown - );Tachycardia (n/a - Unknown - );Tension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 100mg - Oral])|[ETIZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - Hypertension - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941563	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Angina pectoris (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941571	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941572	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cervical radiculopathy (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Intervertebral disc degeneration (n/a - Not Recovered/Not Resolved - );Intervertebral disc protrusion (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Musculoskeletal pain (n/a - Not Recovered/Not Resolved - );Nervous system disorder (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941576	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010941619	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Thrombophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010941675	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941677	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941740	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Bronchitis (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010941815	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941877	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010941878	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010941937	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010941994	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (184d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010941994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010942028	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010942048	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Toothache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010942049	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010942053	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010942079	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Recovering/Resolving - Life Threatening);Cardiac ventricular thrombosis (n/a - Recovering/Resolving - Life Threatening);Myocarditis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010942080	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010942128	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (5min - Recovered/Resolved - );Blood pressure increased (5min - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (5min - Recovered/Resolved - Other Medically Important Condition);Cold sweat (5min - Recovered/Resolved - );Dizziness (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942135	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942139	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Epistaxis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypoplastic anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Lethargy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010942149	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Listless (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010942160	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010942189	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942240	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (2mo - Recovered/Resolved - Other Medically Important Condition);Insomnia (2mo - Recovered/Resolved - );Lymphadenitis (2mo - Recovered/Resolved - Other Medically Important Condition);Swelling (2mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942251	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Painful respiration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942266	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Dysstasia (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Near death experience (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Unknown - );Peripheral vein thrombosis (n/a - Unknown - );Rhinorrhoea (n/a - Recovered/Resolved - );Speech disorder (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vein disorder (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010942269	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypothermia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Influenza immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010942296	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pericardial effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010942392	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - Results in Death, Life Threatening);Fatigue (n/a - Unknown - Results in Death, Life Threatening);Fluid intake reduced (n/a - Unknown - Results in Death, Life Threatening);General physical health deterioration (n/a - Unknown - Results in Death, Life Threatening);Hypophagia (n/a - Unknown - Results in Death, Life Threatening);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Life Threatening);Productive cough (n/a - Unknown - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010942426	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010942448	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Furuncle (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942602	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoperfusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertebrobasilar insufficiency (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010942668	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Exposure via breast milk (0d - Recovered/Resolved - Other Medically Important Condition);Somnolence (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942688	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942692	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Drug eruption (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - );Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010942704	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (4d - Recovered/Resolved - );Hypoaesthesia (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Sciatica (n/a - Recovering/Resolving - );Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010942766	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Exposure via breast milk (0d - Recovered/Resolved - Other Medically Important Condition);Somnolence (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942769	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (90d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (90d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010942784	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate decreased (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010942831	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010942859	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - Postictal headache - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010942948	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010942948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943036	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Limb discomfort (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swelling face (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010943171	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - );Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010943419	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943423	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010943425	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943426	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Coordination abnormal (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (3d - Recovered/Resolved - Disabling);Pain in extremity (3d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010943441	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010943455	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	NOT AVAILABLE (C - n/a - Unknown - )|[SOLIFENACIN, SOLIFENACIN SUCCINATE] (C - n/a - Unknown - )|[TAFLUPROST] (C - n/a - Unknown - )|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010943457	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (7d - Recovered/Resolved - );Back pain (2d - Recovered/Resolved - );Dizziness (7d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - );Vaccination site pain (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943481	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute respiratory failure (21d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Antibody-dependent enhancement (21d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Capillary leak syndrome (21d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010943482	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Deafness unilateral (n/a - Recovered/Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010943496	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blepharitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943641	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010943657	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943664	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943667	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Herpes virus infection (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Nasal herpes (n/a - Not Recovered/Not Resolved - );Oral herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943675	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010943678	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010943703	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010943751	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - );Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Immunisation (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010943827	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010943827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010944041	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ischaemic (n/a - Unknown - Other Medically Important Condition);Colitis ulcerative (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Enterocolitis haemorrhagic (n/a - Unknown - Other Medically Important Condition);Faeces discoloured (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010944135	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Catarrh (n/a - Recovered/Resolved - );Disease recurrence (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Rhinorrhoea (n/a - Recovered/Resolved - );Skin swelling (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010944159	Spontaneous	2021-12-13 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Recovered/Resolved With Sequelae - );Swelling (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010944306	Spontaneous	2021-12-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010944306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931412	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931414	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931415	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931424	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931431	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931436	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931446	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931447	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931460	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931462	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (0d - Recovered/Resolved - Other Medically Important Condition);Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010931467	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010931472	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dermatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Impaired fasting glucose (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010931474	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (31d - Recovered/Resolved - Other Medically Important Condition);Hypertensive crisis (31d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010931477	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling);Thrombosis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010931478	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010931482	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010931487	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010931491	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dysphagia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Exfoliative rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010931563	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931744	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931766	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (1d - Recovered/Resolved - );Abdominal pain (1d - Recovered/Resolved - );Flatulence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|USTEKINUMAB [USTEKINUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIFEDIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931799	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931803	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION [RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, STIMULON, MONOPHOSPHORYL LIPID A] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931824	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931842	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931843	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931846	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931860	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931888	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931890	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931892	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931894	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931896	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931912	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931913	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931915	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931918	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931930	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931931	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931939	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Malaise (1wk - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010931950	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931951	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931957	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931965	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931966	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931967	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931970	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931971	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931972	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931973	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931977	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931978	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931984	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932003	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932005	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932016	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain oedema (n/a - Fatal - Results in Death, Other Medically Important Condition);Cerebral haematoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Haemorrhagic stroke (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition);Pulmonary hypertension (n/a - Unknown - Other Medically Important Condition);Subarachnoid haemorrhage (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010932018	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932021	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932024	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932027	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932030	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932033	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932034	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932038	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932039	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932042	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932062	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932074	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932078	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932079	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932083	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (7d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932086	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932090	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932094	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932097	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (59d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932099	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932103	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932106	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010932115	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010932121	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Myocarditis (24d - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010932122	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932136	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932142	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932151	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932154	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932157	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932169	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010932175	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932179	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932183	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932188	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932191	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932195	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932206	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010932213	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010932215	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932224	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010932225	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - 2000mg - Oral])|[CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, COLECALCIFEROL CONCENTRATE (OILY FORM)] (C - n/a - n/a - [n/a - 20000[iU] - Oral])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 5mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 2.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932228	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932231	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932234	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010932237	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010932239	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010932241	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932244	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932245	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932253	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932275	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932287	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932290	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932309	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932313	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932318	Spontaneous	2021-12-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010932328	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010932331	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (18d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Malaise (18d - Recovered/Resolved - );Myalgia (20d - Recovered/Resolved - );Palpitations (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VALERIAN ROOT EXTRACT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010932333	Spontaneous	2021-12-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010932333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928749	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928916	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epilepsy (1min - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	KEPPRA 250 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928964	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010929036	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929075	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929078	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929118	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010929121	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[CALCITRIOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM, CALCIUM CARBONATE, CALCIUM CARBONATE, CALCIUM LACTATE GLUCONATE, CALCIUM GLUBIONATE, CALCIUM GLUBIONATE, CALCIUM LACTOBIONATE, CALCIUM GLUCONATE, CALCIUM GLUCONATE MONOHYDRATE, CALCIUM LACTOBIONATE DIHYDRATE, CALCIUM LACTOBIONATE, CALCIUM GLUCONATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010929125	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	KEPPRA 750 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|OSIMERTINIB [OSIMERTINIB] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010929132	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Odynophagia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929135	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (10d - Recovered/Resolved - Other Medically Important Condition);Bradycardia (10d - Recovered/Resolved - Other Medically Important Condition);Chest pain (10d - Recovered/Resolved - Other Medically Important Condition);Hypotension (10d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (10d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (10d - Recovered/Resolved - Other Medically Important Condition);Seizure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010929138	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010929140	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929144	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash vesicular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929169	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929174	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010929182	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[DELORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929189	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010929190	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Vasculitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010929196	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010929199	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Haematoma (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Loss of consciousness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010929201	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Hypersensitivity (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Skin discolouration (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010929207	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertensive crisis (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010929209	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010929224	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929262	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929280	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929310	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929320	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Influenza like illness (n/a - Recovered/Resolved With Sequelae - );Migraine (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010929371	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929448	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929455	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929474	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929485	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929498	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929499	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929500	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929502	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929557	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929584	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - );Gastritis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929594	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929601	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929604	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929624	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929630	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - );Urticaria contact (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010929643	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929654	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ventricular tachycardia (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929655	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved With Sequelae - Disabling);Headache (n/a - Recovered/Resolved With Sequelae - Disabling);Nausea (n/a - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling);Pyrexia (n/a - Recovered/Resolved With Sequelae - Disabling);Vertigo (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010929678	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Metamorphopsia (n/a - Recovering/Resolving - );Pneumonia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929715	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (29d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010929716	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	LUMIGAN 0.3 MG/ML EYE DROPS, SOLUTION, IN SINGLE-DOSE CONTAINER [BIMATOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SOTALOL, SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010929732	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Gastrointestinal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929735	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertensive crisis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010929759	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Colitis ulcerative (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010929778	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010929780	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 10mg - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 1000mg - Oral])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - 15mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - Oral])|[LORMETAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGALDRATE, MAGALDRATE ANHYDROUS] (C - n/a - n/a - [n/a - 800mg - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - .4mg - Oral])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929781	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929825	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Increased upper airway secretion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929828	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (5d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929836	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (10d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Malaise (0d - Recovered/Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929838	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929843	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929847	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929857	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929861	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929863	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929871	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balanoposthitis (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Gingivitis (5d - Recovered/Resolved - );Headache (45d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (14d - Recovered/Resolved - );Nodule (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010929874	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood glucose increased (2d - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Inflammatory marker increased (2d - Recovered/Resolved - );Malaise (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929875	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010929877	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929878	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929892	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929893	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929922	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pericarditis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929928	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929931	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929937	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Leukopenia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929945	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929955	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929973	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010929979	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (3mo - Recovered/Resolved - );Dyspnoea (3mo - Recovered/Resolved - );Fatigue (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010929994	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Skin discolouration (n/a - Recovering/Resolving - );Skin exfoliation (n/a - Recovering/Resolving - );Skin tightness (n/a - Recovering/Resolving - );Skin wrinkling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010929994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930020	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930022	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010930030	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TELMISARTAN 20 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930033	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (6d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Injection site swelling (6d - Recovered/Resolved - );Tonsillitis (2wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930037	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (9h - Recovered/Resolved - );Headache (9h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010930046	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Congenital musculoskeletal disorder of limbs (n/a - Unknown - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010930049	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Rheumatic disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010930050	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930058	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010930060	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930073	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010930083	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930101	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (1h - Recovered/Resolved - );Heart rate decreased (1h - Recovered/Resolved - );Hyperhidrosis (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010930355	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (30min - Recovered/Resolved - );Dizziness (30min - Recovered/Resolved - );Fatigue (30min - Recovered/Resolved - );Hyperhidrosis (30min - Recovered/Resolved - );Photopsia (30min - Recovered/Resolved - );Puncture site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930551	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Subarachnoid haemorrhage (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010930572	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010930631	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Blood pressure increased (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Mental disorder (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930639	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Burning sensation mucosal (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Puncture site pain (n/a - Not Recovered/Not Resolved - );Retching (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010930652	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930706	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (1h - Recovered/Resolved - );Loss of consciousness (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010930805	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930808	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930810	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010930847	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930848	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930849	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930852	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930854	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930859	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930862	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930864	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930913	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930916	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930918	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930921	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930927	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930958	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930959	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930964	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930966	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930969	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930971	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930992	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010930994	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	Non European Economic Area	Brittain, C.. Recurrent Acute Pancreatitis Following COVID-19 Vaccine-A Case Study. The American Journal of Gastroenterology. 2021;116:S748. doi:10.14309/01.ajg.0000780228.89609.37	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pancreatitis acute (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010930994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010931117	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010931175	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010931180	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chest pain (n/a - Recovering/Resolving - );Chills (3d - Recovered/Resolved - );Dizziness (3h - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (3d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Presyncope (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010931347	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931351	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931352	Spontaneous	2021-12-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Body temperature increased (2d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010931382	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931390	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931391	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931392	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931393	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931394	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931395	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931397	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931398	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931403	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010931404	Spontaneous	2021-12-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010931404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010912471	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Tachyarrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912486	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912492	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912520	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912528	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Diarrhoea (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[BENZALKONIUM CHLORIDE, HYPROMELLOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ENOXAPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912529	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912533	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912538	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912561	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (5d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - );Swelling (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912562	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912582	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912612	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - );Eye disorder (n/a - Not Recovered/Not Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - );Feeding disorder (n/a - Not Recovered/Not Resolved - );Transient ischaemic attack (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912621	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912642	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - );Feeling hot (n/a - Recovered/Resolved With Sequelae - );Hypotension (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010912658	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912675	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site joint swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912695	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912707	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912723	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912738	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Lymph node pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912774	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - );Vasculitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912779	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912804	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (C - Antiviral prophylaxis - n/a - [n/a - .5mL - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912809	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (8d - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - );Rash (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912810	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912859	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912873	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912888	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (5d - Recovered/Resolved - );Conjunctivitis (5d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912923	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912936	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912938	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Confusional state (2d - Recovered/Resolved - );Decreased appetite (2d - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912947	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010912948	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912965	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912974	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010912991	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ataxia (n/a - Recovering/Resolving - Disabling);Cognitive disorder (n/a - Recovering/Resolving - Disabling);Diplopia (n/a - Recovering/Resolving - Disabling);Gait disturbance (n/a - Recovering/Resolving - Disabling);Visual impairment (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010913013	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - );Abdominal pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913034	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial nerve disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010913035	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913051	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hair growth abnormal (n/a - Recovering/Resolving - );Hypokinesia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913072	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dementia Alzheimer's type (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010913084	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);N-terminal prohormone brain natriuretic peptide increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913085	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intradermal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913089	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010913092	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Basal cell carcinoma (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010913094	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening);Pain in extremity (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010913098	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913100	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Life Threatening);Dysphagia (n/a - Recovering/Resolving - Life Threatening);Hypertensive crisis (n/a - Recovering/Resolving - Life Threatening);Myasthenia gravis crisis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[PYRIDOSTIGMINE, PYRIDOSTIGMINE BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010913101	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sciatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010913102	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hyperthyroidism (n/a - Not Recovered/Not Resolved - );Transaminases (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913111	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pruritus (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913120	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Blood testosterone decreased (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Erectile dysfunction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Libido decreased (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010913133	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913139	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010913143	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913149	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune myositis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913225	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myoclonus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Migraine - n/a - [n/a - n/a - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010913404	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Rhinorrhoea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913408	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010913409	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010913534	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913547	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913549	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010913563	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913566	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913567	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913571	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Elfeky, O.. Management of NSAID-Induced Enteropathy. The American Journal of Gastroenterology. 2021;116 (Supp):S1218 Shah, M.. A Rare Case of Superior Mesenteric Vein Thrombosis With Antithrombin III Deficiency and Recent COVID-19 mRNA Vaccination. American Journal of Gastroenterology. 2021;116 (1):S1217-S1218	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - );Abdominal pain lower (n/a - Unknown - );Mesenteric vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Portal vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913586	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010913592	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913612	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913615	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Polyuria (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Visual acuity reduced (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - Depression - n/a - [n/a - n/a - n/a])|MELATONIN [MELATONIN] (C - Nightmare - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Palpitations - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913616	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913618	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Movement disorder (3440min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Osteoarthritis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (3440min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913625	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Fibrin D dimer increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (3d - Unknown - Other Medically Important Condition);Influenza like illness (3d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (3d - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (3d - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913662	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913665	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site papule (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913666	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FENTANYL] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[VALPROIC ACID, SODIUM, VALPROIC ACID, SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALPROIC ACID, VALPROIC ACID, SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010913706	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neutropenia (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|RITUXIMAB [RITUXIMAB] (S - Magnetic resonance imaging - Unknown - [n/a - n/a - Unknown])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - Systemic lupus erythematosus - Unknown - [n/a - n/a - Unknown])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[HYDROXYQUINOLINE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[INFLUENZA VIRUS] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010913750	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Cardiac infection (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913809	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary mass (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) (AN A/CALIFORNIA/7/2009-LIKE VIRUS), A/VICTORIA/361/2011, B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09 – LIKE STRAIN USED (NIB-74) DERIVED FROM A/CHRISTCHURCH/16/2010, INFLUENZA VIRUS VACCINE POLYVALENT] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010913810	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010913821	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010913824	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (3h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913836	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disorientation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate decreased (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010913837	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Traumatic lung injury (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010913899	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010913899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914185	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arrhythmia (3d - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Gallbladder disorder (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved With Sequelae - );Rash (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010914222	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death);Septic shock (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010914257	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	[PERINDOPRIL TERT-BUTYLAMINE, AMLODIPINE, PERINDOPRIL TERT-BUTYLAMINE, AMLODIPINE BESILATE, PERINDOPRIL, AMLODIPINE BESILATE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010914468	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914475	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Henoch-Schonlein purpura (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914503	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914510	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914514	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914528	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Breast mass (n/a - Recovering/Resolving - );Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[DOXAZOSIN MESILATE] (S - n/a - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914531	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - );Infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Labyrinthitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Pelvic discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Pollakiuria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Vestibular neuronitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914532	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry skin (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Skin infection (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914534	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914577	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovering/Resolving - Other Medically Important Condition);Pemphigus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914579	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914586	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gastric cancer (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	[DEXAMETHASONE, DEXAMETHASONE PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE] (C - Decreased appetite - n/a - [n/a - n/a - Oral])|[DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Ascites - n/a - [n/a - n/a - Oral])|[VONOPRAZAN, VONOPRAZAN HYDROGEN FUMARATE] (C - Gastric cancer - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010914600	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (1d - Recovering/Resolving - Disabling);Extrasystoles (1d - Recovering/Resolving - Disabling);Fatigue (1d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - Unknown - [n/a - 30mg - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - 40mg - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[SOTALOL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010914657	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (8h - Recovered/Resolved - Other Medically Important Condition);Nephritis (8h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914692	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Tinnitus (n/a - Unknown - Disabling)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010914697	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (15d - Recovered/Resolved - );Dizziness (15d - Recovered/Resolved - );Fatigue (15d - Recovered/Resolved - );Gastrorrhaphy (15d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010914711	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Madarosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010914747	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914869	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010914923	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010914942	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	LEVEMIR [INSULIN DETEMIR] (C - n/a - Not applicable - )|OLANZAPINE [OLANZAPINE] (C - n/a - Not applicable - [n/a - 10mg - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Not applicable - [n/a - 20mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - Not applicable - [n/a - 10mg - Oral])|[DIGOXIN] (C - n/a - Not applicable - [n/a - .25mg - Oral])|[GLICLAZIDE] (C - n/a - Not applicable - [n/a - 60mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - [n/a - 850mg - Oral])|[NEBIVOLOL] (C - n/a - Not applicable - [n/a - 5mg - Oral])|[SULPIRIDE] (C - n/a - Not applicable - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914950	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Body temperature increased (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010914951	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Unknown - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	JARDIANCE 10 MG [EMPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - 10mg - Oral])|[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [n/a - 75mg - Oral])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 300mg - Oral])|[ATORVASTATIN CALCIUM] (C - Cardiovascular event prophylaxis - n/a - [n/a - 40mg - Oral])|[BISOPROLOL FUMARATE] (C - Cardiac failure - n/a - [n/a - 1.25mg - Oral])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - 1000mg - Oral])|[POTASSIUM CHLORIDE] (C - Hypokalaemia - n/a - [n/a - 10mg - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 1.25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914953	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914956	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Embolism (n/a - Fatal - Results in Death);Haemorrhage subcutaneous (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010914957	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010914963	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NIET GESPECIFICEERD GENEESMIDDEL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|PEMBROLIZUMAB [PEMBROLIZUMAB] (C - Neoplasm malignant - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010914965	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010914968	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleural infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010914969	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (55h - Recovered/Resolved - );Disturbance in attention (55h - Recovered/Resolved - );Dysarthria (55h - Recovered/Resolved - );Feeling abnormal (55h - Recovered/Resolved - );Pain in extremity (55h - Recovered/Resolved - );Vaccination site movement impairment (55h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010914978	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010914978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915010	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Feeling cold (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010915068	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Somnolence (3d - Recovered/Resolved - );Vaccination site pain (5d - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010915148	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Ocular discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010915186	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010915202	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915224	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Intracranial pressure increased (n/a - Unknown - Life Threatening);Optic disc oedema (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010915295	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915306	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac flutter (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915323	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Gastroenteritis viral (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915324	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915327	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (7d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (7d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010915330	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (12d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915336	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (7d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (7d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915337	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915340	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac murmur (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Costochondritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915341	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tension headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915347	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915348	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hot flush (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915364	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915367	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Not Specified	Crying (3d - Recovered/Resolved - );Exposure via breast milk (n/a - Unknown - Caused/Prolonged Hospitalisation);Micturition frequency decreased (3d - Recovered/Resolved - );Nasopharyngitis (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915377	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transmammary])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [5d - 3{DF} - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - n/a - n/a - [7d - 4{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915403	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010915411	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010915422	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010915424	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915426	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Sepsis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010915429	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Other Medically Important Condition);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LYMECYCLINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915454	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	VORTIOXETINE [VORTIOXETINE] (C - n/a - n/a - )|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - )|[SODIUM VALPROATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915458	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010915459	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness postural (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010915562	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug-induced liver injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatic function abnormal (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915592	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Blood pressure systolic decreased (n/a - Unknown - );Bradycardia (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - );Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915621	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperventilation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915629	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alcohol intolerance (n/a - Not Recovered/Not Resolved - );Flushing (n/a - Unknown - );Poisoning (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus congestion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915632	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915638	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915642	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915645	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915647	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemoglobin decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Waldenstrom's macroglobulinaemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010915655	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010915732	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010915765	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid oedema (1d - Recovered/Resolved - Other Medically Important Condition);Lip oedema (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915863	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915864	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915868	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915870	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915871	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915872	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915874	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915881	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010915962	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010915962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916021	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916074	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (5d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (5d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916089	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010916099	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	GLIVEC 400 MG FILM-COATED TABLETS [IMATINIB, IMATINIB MESILATE] (C - n/a - Not applicable - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916110	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916117	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	International normalised ratio fluctuation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916126	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916134	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916149	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Migraine with aura (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916181	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Impaired work ability (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010916187	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916188	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916191	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916199	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916205	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916219	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916225	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916226	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916236	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916324	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010916325	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010916336	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myokymia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nervousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ophthalmic migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	GENVOYA [EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE, COBICISTAT, ELVITEGRAVIR] (C - Secondary immunodeficiency - n/a - [n/a - 510mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916394	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Injection site reaction (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010916413	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (3d - Recovered/Resolved - );Pain in extremity (5d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pollakiuria (1d - Recovered/Resolved - );Puncture site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010916458	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Haematospermia (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010916462	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Depressed level of consciousness (n/a - Fatal - Results in Death);Pneumonia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	PROLIA [DENOSUMAB] (C - Osteoporosis - n/a - [n/a - n/a - Subcutaneous])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Arteriosclerosis - n/a - [n/a - n/a - Oral])|[BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - Transdermal])|[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - Vitamin supplementation - n/a - [n/a - n/a - Oral])|[CYANOCOBALAMIN, THIAMINE DISULFIDE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE] (C - Vitamin supplementation - n/a - [n/a - n/a - Oral])|[CYANOCOBALAMIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE] (C - Vitamin supplementation - n/a - [n/a - n/a - Oral])|[MACROGOL 4000] (C - Constipation - n/a - [n/a - n/a - Oral])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010916487	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916488	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916491	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916492	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916497	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916502	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916504	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916511	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916513	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916528	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916530	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916539	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (97d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (97d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010916586	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010916653	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammatory marker increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED] (S - Influenza immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010916656	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916705	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Meniere's disease (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010916706	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition);Osteoarthritis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010916723	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916784	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Chills (5h - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Panic attack (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010916791	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CETOMACROGOL 1000] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010916872	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Disabling);Chest discomfort (n/a - Recovering/Resolving - Disabling);Dysphonia (n/a - Recovering/Resolving - Disabling);Dyspnoea exertional (n/a - Recovering/Resolving - Disabling);Extrasystoles (n/a - Recovering/Resolving - Disabling);Eye pain (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);General physical health deterioration (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Lacrimation increased (n/a - Recovering/Resolving - Disabling);Oedema peripheral (n/a - Recovering/Resolving - Disabling);Photophobia (n/a - Recovering/Resolving - Disabling);Rhinitis (n/a - Recovering/Resolving - Disabling);SARS-CoV-2 test negative (n/a - Recovering/Resolving - Disabling);Sleep disorder (n/a - Recovering/Resolving - Disabling);Tremor (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010916925	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010916928	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916931	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010916936	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Herpes virus infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Urinary tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010916936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010917027	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010917059	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness unilateral (n/a - Recovered/Resolved With Sequelae - Disabling);Dizziness (n/a - Recovered/Resolved With Sequelae - Disabling);Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010917100	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010917157	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Gastric pH decreased (2d - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	[BRIMONIDINE TARTRATE] (C - n/a - n/a - )|[LATANOPROST, TIMOLOL, TIMOLOL MALEATE, LATANOPROST] (C - n/a - n/a - )|[PERINDOPRIL ARGININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917167	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	UROREC [SILODOSIN] (C - n/a - Dose not changed - [n/a - 8mg - Oral])|[ACENOCOUMAROL] (C - n/a - Dose not changed - [n/a - 3mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - n/a - Dose not changed - [n/a - 5mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - Dose not changed - [n/a - 10mg - Oral])|[CARVEDILOL] (C - n/a - Dose not changed - [n/a - 12.5mg - Oral])|[DIGOXIN] (C - n/a - Dose not changed - [n/a - .25mg - Oral])|[INDAPAMIDE] (C - n/a - Dose not changed - [n/a - 1.5mg - Oral])|[NICERGOLINE] (C - n/a - Dose not changed - [n/a - 30mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917207	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917213	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Giant cell arteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010917486	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Back pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 10mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, SOLIFENACIN SUCCINATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917519	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Headache (2wk - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010917524	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Unknown - );Headache (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - Cerebral infarction - Drug withdrawn - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010917528	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917536	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoparesis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010917590	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917605	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Nausea (n/a - Unknown - );Neck pain (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917652	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010917654	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Feeling cold (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917702	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010917722	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (144d - Recovering/Resolving - );Chest pain (144d - Recovering/Resolving - );Dyspnoea (144d - Recovering/Resolving - );Tachycardia (144d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010917817	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Carditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Mental disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010917817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010918036	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epididymal cyst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epididymitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Prostatic pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Prostatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918047	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema multiforme (7d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918078	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918170	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - );Hot flush (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918171	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Dysphoria (n/a - Unknown - Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918172	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Hypermagnesaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010918173	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918174	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bedridden (n/a - Unknown - );Cerebral artery stenosis (n/a - Unknown - Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Contusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fall (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hydrocephalus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ischaemia (n/a - Unknown - );Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vasospasm (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - Lipids abnormal - n/a - [n/a - n/a - Oral])|[TELMISARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010918181	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010918182	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918184	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Cardiac disorder (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Hypoxic-ischaemic encephalopathy (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010918191	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Macular oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Retinal vein occlusion (n/a - Unknown - Other Medically Important Condition);Subretinal fluid (n/a - Recovering/Resolving - Other Medically Important Condition);Visual acuity reduced (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918195	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918238	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling);Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Mental impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010918252	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Synovitis (14d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918264	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Fatigue (7d - Recovered/Resolved - );Injection site inflammation (7d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Injection site swelling (7d - Recovered/Resolved - );Malaise (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010918266	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918272	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918276	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Injection site pruritus (n/a - Recovering/Resolving - );Injection site rash (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918317	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erysipelas (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Dyspepsia - n/a - [n/a - n/a - Oral])|[WARFARIN SODIUM] (C - Venous thrombosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918366	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin ulcer (n/a - Unknown - Other Medically Important Condition);Vasculitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[DICLOFENAC DIETHYLAMINE, DICLOFENAC SODIUM] (C - Arthralgia - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918370	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysphagia (48h - Recovered/Resolved - );Oesophageal pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918610	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site erythema (3d - Recovered/Resolved - );Administration site oedema (3d - Recovered/Resolved - );Administration site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918885	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918903	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010918940	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918941	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Autism spectrum disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Behaviour disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebral disorder (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Psychomotor hyperactivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918950	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dysgeusia (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal congestion (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010918957	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010918959	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Eyelid irritation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Retinal detachment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vitreous haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010918964	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918966	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Limb discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010918968	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site joint pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010918971	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cheilitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Temperature regulation disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010918971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010919012	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (15h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010919014	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919047	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919050	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Hyperhidrosis (2d - Not Recovered/Not Resolved - );Myalgia (5d - Not Recovered/Not Resolved - );Peripheral vein thrombosis (5d - Not Recovered/Not Resolved - );Thrombosis (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919051	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010919054	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza like illness (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919055	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovering/Resolving - );Fatigue (4d - Recovering/Resolving - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919177	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (10d - Recovering/Resolving - );Daydreaming (10d - Recovering/Resolving - );Decreased appetite (10d - Recovering/Resolving - );Dizziness (10d - Recovering/Resolving - );Fatigue (10d - Recovering/Resolving - );Hot flush (10d - Recovering/Resolving - );Insomnia (10d - Recovering/Resolving - );Limb discomfort (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919187	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (50d - Not Recovered/Not Resolved - );Myalgia (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010919189	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919192	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919313	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919315	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (33d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010919317	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (29d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010919322	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919324	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abnormal faeces (2d - Not Recovered/Not Resolved - );Arthralgia (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919325	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (11d - Not Recovered/Not Resolved - );Loss of consciousness (11d - Not Recovered/Not Resolved - );Malaise (10d - Not Recovered/Not Resolved - );Muscle spasms (11d - Not Recovered/Not Resolved - );Tachycardia (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919326	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919410	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919414	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral ischaemia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010919417	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010919455	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Peripheral swelling (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919560	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Body temperature increased (0d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919564	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010919588	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (17d - Not Recovered/Not Resolved - );Disturbance in attention (17d - Not Recovered/Not Resolved - );Fatigue (17d - Not Recovered/Not Resolved - );Nausea (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919597	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - );Tachycardia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919598	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010919599	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (21d - Recovered/Resolved - );Rash (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919603	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute kidney injury (19d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Cerebral infarction (19d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Cerebrovascular accident (19d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010919725	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (8d - Recovered/Resolved - );Injection site pain (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919728	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010919730	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - );Insomnia (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919732	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain fog (24d - Not Recovered/Not Resolved - );Disturbance in attention (24d - Not Recovered/Not Resolved - );Dizziness (24d - Not Recovered/Not Resolved - );Vision blurred (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010919734	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (0d - Recovered/Resolved - );Cough (0d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919736	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919741	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010919781	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010919831	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (35d - Not Recovered/Not Resolved - );Myalgia (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010919874	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (20d - Not Recovered/Not Resolved - );Injection site pain (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919875	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919883	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (7d - Recovering/Resolving - );Dizziness (7d - Recovering/Resolving - );Fatigue (7d - Recovering/Resolving - );Nausea (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919884	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Allergy to arthropod sting (15d - Unknown - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010919885	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010919885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920005	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (13d - Not Recovered/Not Resolved - );Influenza like illness (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920011	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Lymphadenopathy (42d - Not Recovered/Not Resolved - );Vaccination site pain (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010920012	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920017	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (0d - Not Recovered/Not Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920053	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleurisy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory rate decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010920166	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920168	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (65d - Not Recovered/Not Resolved - );Fatigue (64d - Not Recovered/Not Resolved - );Herpes zoster (4d - Not Recovered/Not Resolved - );Influenza (63d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010920180	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Influenza like illness (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Insomnia (2d - Not Recovered/Not Resolved - );Tachycardia (2d - Not Recovered/Not Resolved - );Vomiting (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010920191	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - );Memory impairment (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[METOPROLOL TARTRATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010920302	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (92d - Not Recovered/Not Resolved - );Limb discomfort (92d - Not Recovered/Not Resolved - );Myalgia (92d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010920305	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sudden hearing loss (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urosepsis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920311	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920317	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (138d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920319	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (62d - Not Recovered/Not Resolved - );Migraine (62d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010920321	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (0d - Unknown - );Malaise (0d - Unknown - );Sensation of foreign body (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010920324	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Haematoma (8d - Recovered/Resolved - );Skin discolouration (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010920385	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eosinophilic oesophagitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oesophageal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920386	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920398	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010920399	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010920403	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Insomnia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920414	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cardiovascular disorder (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920422	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010920425	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920428	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920433	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Recovering/Resolving - );Night sweats (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920442	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial nerve disorder (19d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Paraesthesia (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920947	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	PRADAXA [DABIGATRAN ETEXILATE, DABIGATRAN ETEXILATE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010920973	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Skin mass (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010920975	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010920989	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010920989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921026	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921030	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (6d - Recovered/Resolved - Other Medically Important Condition);Fatigue (7d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (6d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921032	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - Other Medically Important Condition);Angina pectoris (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inflammatory pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Sensation of blood flow (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921033	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypotension (15min - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921041	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921042	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921045	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Scleritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [5d - n/a - n/a])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|ORLISTAT [ORLISTAT] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE SODIUM] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])|[PROMETHAZINE, PROMETHAZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921049	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Retching (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[EPOETIN ALFA] (C - Myelodysplastic syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921058	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Miliaria (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE] (S - n/a - Unknown - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921059	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Dyspraxia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OLANZAPINE [OLANZAPINE] (C - Psychotic disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921088	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010921144	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010921170	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921187	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Nasopharyngitis (n/a - Unknown - Disabling);Paraesthesia (n/a - Unknown - Disabling);Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010921200	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (14d - Recovered/Resolved - );Vasospasm (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010921209	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Arthralgia (5d - Recovered/Resolved - );Chest discomfort (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Malaise (6d - Recovered/Resolved - );Vaccination site pain (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010921234	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Deafness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010921236	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921237	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921238	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Speech disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RANEXA [RANOLAZINE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - Angina pectoris - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921239	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limbal swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921246	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921285	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dysgeusia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921292	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysmenorrhoea (n/a - Unknown - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Menstruation irregular (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921293	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLOBAZAM] (C - Generalised tonic-clonic seizure - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Partial seizures - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921329	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010921395	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921513	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung neoplasm malignant (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Metastases to bone (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Sinus rhythm (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921654	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921658	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Disabling);Contusion (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Recovering/Resolving - Disabling);Drug withdrawal headache (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Irritable bowel syndrome (n/a - Unknown - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Vaccination site bruising (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Fluid retention - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010921676	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Mental impairment (n/a - Unknown - Other Medically Important Condition);Nervousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921684	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921690	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (2d - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921705	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921713	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921716	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine with aura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL ANHYDROUS] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921718	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Disabling);Illness (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling);Pain (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010921724	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Body temperature (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921727	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921731	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921765	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (105d - Not Recovered/Not Resolved - );Intercostal neuralgia (105d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010921768	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (31d - Recovered/Resolved - Disabling);Chest pain (24d - Recovered/Resolved - Disabling);Chills (12d - Recovered/Resolved - Disabling);Diarrhoea (10d - Recovered/Resolved - Disabling);Dizziness (11d - Recovered/Resolved - Disabling);Dyspnoea (41d - Recovered/Resolved - Disabling);Fatigue (31d - Recovered/Resolved - Disabling);Increased tendency to bruise (41d - Recovered/Resolved - Disabling);Lymphadenopathy (11d - Recovered/Resolved - Disabling);Malaise (12d - Recovered/Resolved - Disabling);Mouth haemorrhage (11d - Recovered/Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (41d - Recovered/Resolved - Disabling);Pruritus (41d - Recovered/Resolved - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling);Urticaria (31d - Recovered/Resolved - Disabling);Vaccination site erythema (11d - Recovered/Resolved - Disabling);Vaccination site pain (11d - Recovered/Resolved - Disabling);Vaccination site pruritus (7d - Recovered/Resolved - Disabling);Vaccination site swelling (10d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010921835	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DEXAMFETAMINE SULFATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 10mg - n/a])|[DIAZEPAM] (C - Anxiety, Panic disorder - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921855	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Hypersomnia (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010921868	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Eye irritation (n/a - Recovered/Resolved - Other Medically Important Condition);Eye swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921874	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921877	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bedridden (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Unknown - );Lethargy (3d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (24h - Recovered/Resolved - );Pruritus (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - );Rash erythematous (n/a - Recovering/Resolving - );Urticaria (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - 10mg - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - 10mg - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - Oral])|[FLUTICASONE PROPIONATE] (C - Hypersensitivity - n/a - [n/a - 50ug - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SAMBUCUS NIGRA FLOWER] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921883	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[FINASTERIDE] (S - Alopecia - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921886	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Dorfman, A.. Annals for Hospitalists Inpatient Notes - Myocarditis After Vaccination for SARS-CoV-2.. Annals of Internal Medicine. 2021;174 (11):HO2-HO3. doi:10.7326/M21-3871	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921892	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (0d - Recovered/Resolved - );Shock (0d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (0d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921894	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Brittain, C.. Recurrent acute pancreatitis following COVID-19 vaccine-a case study. American Journal of Gastroenterology. 2021;116 (SUPPL):S748. doi:10.14309/01.ajg.0000780228.89609.37	18-64 Years	Not Specified	No	Male	Pancreatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010921897	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Recovering/Resolving - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921898	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010921901	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921904	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Superficial vein thrombosis (15d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RISEDRONATE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALACICLOVIR HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921912	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Bartlett, V.. Myopericarditis with significant left ventricular dysfunction following COVID-19 vaccination: a case report. American Journal of Case Reports. 2021;22:10.12659/AJCR.934066. doi:10.12659/AJCR.934066	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921924	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye haematoma (n/a - Unknown - Other Medically Important Condition);Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|ELIQUIS [APIXABAN] (S - Anticoagulant therapy - n/a - [n/a - 5mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010921931	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acquired epidermolysis bullosa (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010921979	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010921979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922065	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Epicondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922134	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922208	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COSENTYX [SECUKINUMAB] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - Dizziness - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[KETOPROFEN] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922210	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922219	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Haematochezia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922235	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (116d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010922250	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922252	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922257	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dementia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dermatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Localised infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oxygen saturation abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Sepsis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Heart rate abnormal - n/a - [n/a - 15mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart rate abnormal - n/a - [n/a - 2.5mg - n/a])|[FERROUS SULFATE] (C - Heart rate abnormal - n/a - [n/a - 200mg - n/a])|[FUROSEMIDE] (C - Heart rate abnormal - n/a - [n/a - 20mg - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hyperthyroidism - n/a - [n/a - 20mg - n/a])|[OMEPRAZOLE] (C - Heart rate abnormal - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922262	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Arrhythmia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922263	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922267	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010922269	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ulcerative keratitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922275	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010922277	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death);Drug ineffective (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010922279	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922280	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anhidrosis (n/a - Unknown - Disabling, Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Blood iron (n/a - Unknown - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Depressed mood (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait inability (n/a - Unknown - Disabling, Other Medically Important Condition);Haemoglobin (n/a - Unknown - Disabling, Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Joint warmth (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in jaw (n/a - Unknown - Disabling, Other Medically Important Condition);Platelet count increased (n/a - Unknown - Disabling, Other Medically Important Condition);Rheumatoid arthritis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Somnolence (n/a - Unknown - Disabling, Other Medically Important Condition);Weight decreased (n/a - Unknown - Disabling, Other Medically Important Condition);White blood cell count (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - n/a])|FORXIGA [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[INSULIN HUMAN ISOPHANE, INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [3d - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010922287	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922289	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[AMBENONIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922295	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010922304	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922315	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922317	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922327	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922331	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Legionella infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922343	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922344	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922346	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010922347	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Foetus	Yes	Not Specified	Heart disease congenital (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010922348	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Portal vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922349	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010922358	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010922364	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute pulmonary oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Coronary artery stenosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922382	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922393	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Exercise tolerance decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922402	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Musculoskeletal chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Neck pain (3mo - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (3mo - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922403	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922412	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922425	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922428	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922446	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis acneiform (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922457	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922458	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922462	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922487	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922489	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922497	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Essential tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922502	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cervical radiculopathy (2mo - Recovered/Resolved - );Headache (3wk - Recovered/Resolved - );Malaise (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922503	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922504	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922516	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922518	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922519	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[EBASTINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922520	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922548	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922553	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Injection site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922555	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922560	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922578	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922582	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922585	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Not Recovered/Not Resolved - );Torticollis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922593	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922612	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922618	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[SOLIFENACIN SUCCINATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922621	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922624	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922625	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Influenza like illness (2d - Recovered/Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922626	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922633	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922637	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Face oedema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922640	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922641	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1wk - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922668	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922685	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922695	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922705	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922714	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	DUPIXENT [DUPILUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922716	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922731	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Recovered/Resolved - );Injection site inflammation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Injection site warmth (n/a - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922744	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922747	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Decreased activity (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922751	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010922765	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Insomnia (84h - Recovered/Resolved - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (84h - Recovered/Resolved - Disabling, Other Medically Important Condition);Nausea (84h - Recovered/Resolved - Disabling, Other Medically Important Condition);Night sweats (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (84h - Recovered/Resolved - Disabling, Other Medically Important Condition);Vaccination site pain (84h - Recovered/Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010922766	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922769	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922770	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922772	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922776	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922778	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010922781	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Blood glucose increased (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cluster headache (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pollakiuria (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922782	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bacterial infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cellulitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eczema weeping (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 20mg - n/a])|[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - 800[iU] - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922784	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010922786	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922789	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922790	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Wheelchair user (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010922792	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Secretion discharge (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922840	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Left ventricular dysfunction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010922841	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUINAPRIL, QUINAPRIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922850	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Toma, V.. Myocarditis/pericarditis in association with COVID-19 immunisation: Case reports received by Swissmedic. Vigilance News. 2021;6-8	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922929	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (13d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922933	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922934	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010922940	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922945	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depression (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gallbladder injury (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Liver scan (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial injury (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010922948	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (6d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Incorrect route of product administration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (11d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (11d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922949	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922952	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Excessive cerumen production (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010922953	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010922954	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LYMECYCLINE] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010922956	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);White blood cell count decreased (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])|[MOXONIDINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010922985	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood pressure decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [20d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010922988	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010922997	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010922997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923017	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923034	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923035	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923038	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923039	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923042	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash morbilliform (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923047	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923077	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza like illness (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923088	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923089	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Torticollis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923091	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [91d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923092	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923098	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8h - Recovered/Resolved - );Hyperhidrosis (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923099	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923100	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2wk - Not Recovered/Not Resolved - );Asthenia (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923101	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923107	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923116	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (4wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923120	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923125	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923127	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923131	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923134	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Not Recovered/Not Resolved - );Vaccination site joint pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923137	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (1mo - Recovered/Resolved - );Neuralgia (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923140	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923144	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923173	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (1d - Recovered/Resolved - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923176	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (5d - Recovered/Resolved - );Chest pain (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Insomnia (5d - Recovered/Resolved - );Tachycardia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923181	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Skin oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923188	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923191	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923218	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCORTISONE BUTYRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923221	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923227	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Pancreatitis (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923231	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923246	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MIANSERIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923248	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923261	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923270	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923285	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923286	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - );Immunisation reaction (3d - Recovered/Resolved - );Palpitations (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923290	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923298	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923299	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parkinson's disease (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923301	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923334	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aggression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Agitation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dementia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923358	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923403	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923405	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923408	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923410	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923470	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Mechanical urticaria (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923477	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923479	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010923556	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Limb injury (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923561	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Diarrhoea haemorrhagic (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Haematochezia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010923565	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Joint swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923590	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (15min - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010923595	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - );Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia aspiration (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Respiratory failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Angina pectoris, Transient ischaemic attack - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Angina pectoris, Transient ischaemic attack - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - Prophylaxis against gastrointestinal ulcer - n/a - [n/a - n/a - Oral])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Insomnia, Restlessness - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010923596	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Metastases to central nervous system (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923601	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autonomic nervous system imbalance (n/a - Unknown - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Nervousness (n/a - Unknown - Other Medically Important Condition);Sleep deficit (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923607	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - );Atrioventricular block first degree (n/a - Unknown - );Depression (n/a - Unknown - );Dizziness (n/a - Unknown - );Facial paralysis (25d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Herpes zoster meningitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Microangiopathy (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE, METFORMIN, SITAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Coronary artery disease, Hypertension - n/a - [n/a - n/a - n/a])|[PRAZOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923608	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Myocardial infarction (n/a - Fatal - Results in Death);Respiratory disorder (n/a - Unknown - );Rhinitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010923609	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);CSF cell count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Demyelination (n/a - Unknown - Other Medically Important Condition);Encephalopathy (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Magnetic resonance imaging abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Meningitis bacterial (n/a - Unknown - Other Medically Important Condition);Nervous system disorder (n/a - Unknown - );Nuchal rigidity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - );White matter lesion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[DERMATOPHAGOIDES FARINAE EXTRACT, DERMATOPHAGOIDES PTERONYSSINUS EXTRACT] (C - Mite allergy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923614	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Life Threatening);Inflammation (n/a - Unknown - Life Threatening);Thrombosis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010923615	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[AMLODIPINE BESILATE] (S - Hypertension - Unknown - [n/a - 10mg - n/a])|[NEBIVOLOL] (S - Hypertension - Unknown - [n/a - 10mg - n/a])|[RAMIPRIL] (S - Hypertension - Unknown - [n/a - 10mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923618	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923621	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Encephalitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalitis bacterial (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Meningoencephalitis viral (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923623	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (1d - Recovered/Resolved - );Immunisation (n/a - Unknown - );Lymph node pain (3d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Nasopharyngitis (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Sensitive skin (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923624	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nerve injury (n/a - Unknown - Disabling);Tinnitus (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010923634	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Disease recurrence (225h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myoclonus (225h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Stress (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CELECOXIB [CELECOXIB] (C - n/a - n/a - [n/a - 4{DF} - Oral])|[ACETYLSALICYLIC ACID] (C - Cerebral infarction - n/a - [n/a - n/a - Oral])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[IMIDAFENACIN] (C - Hypertonic bladder - n/a - [n/a - 2{DF} - Oral])|[KETOPROFEN] (C - n/a - n/a - [n/a - n/a - Cutaneous])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[NAFTOPIDIL] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[REBAMIPIDE] (C - n/a - n/a - [n/a - 2{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923637	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (3d - Recovered/Resolved - Other Medically Important Condition);Chest pain (10d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923640	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Fatal - Results in Death, Other Medically Important Condition);Foetal heart rate abnormal (n/a - Fatal - Results in Death, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[ANHYDROUS METHYLDOPA, METHYLDOPA, METHYLDOPA SESQUIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010923641	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysphoria (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010923660	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Polymenorrhoea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010923662	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pruritus (n/a - Recovered/Resolved With Sequelae - );Urticaria (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010923663	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myopericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SILDENAFIL CITRATE [SILDENAFIL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010923664	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|DRONEDARONE [DRONEDARONE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923666	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010923669	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Scab (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Autoimmune thyroiditis - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923677	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010923678	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923683	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010923785	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923789	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Tongue erythema (n/a - Recovered/Resolved - );Tongue oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010923828	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010923843	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010923845	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bundle branch block right (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923861	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatomyositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysphagia (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010923883	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);General physical health deterioration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010923884	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010923884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010924918	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Disabling);Skin disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010924918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010925723	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood cholesterol increased (n/a - Unknown - );Blood triglycerides increased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Carpal tunnel syndrome (n/a - Not Recovered/Not Resolved - );Cervicobrachial syndrome (n/a - Unknown - );Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Low density lipoprotein increased (n/a - Unknown - );Nerve injury (n/a - Unknown - );Neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Tendonitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MIRTAZAPINE] (C - Depression - n/a - [n/a - 45mg - Oral])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010925725	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Fall (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010925728	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Acute vestibular syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ear disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (15d - Recovered/Resolved - Disabling, Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010925742	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Functional gastrointestinal disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010925748	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925750	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye pain (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Strabismus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SOTALOL, SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925751	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL SODIUM] (C - Gout - n/a - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010925752	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Discomfort (3d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hypokinesia (6d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Myalgia (6d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925754	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925756	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sarcoidosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010925761	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925762	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LINAGLIPTIN [LINAGLIPTIN] (C - Aortic anastomosis - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Aortic anastomosis - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - Aortic anastomosis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[RAMIPRIL] (C - Aortic anastomosis - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Aortic anastomosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925771	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis contact (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|GARDASIL 9 [HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010925859	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010925859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010926099	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis reactive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010926100	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010926115	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pharyngeal lesion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Tonsillar ulcer (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SILDENAFIL [SILDENAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMOXICILLIN SODIUM, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010926118	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010926120	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010926123	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010926124	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010926187	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010926745	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010926752	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling abnormal (n/a - Unknown - );Vaccination site haemorrhage (n/a - Unknown - );Vascular pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010926819	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - );Eye swelling (n/a - Not Recovered/Not Resolved - );Ocular hyperaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010926845	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010926992	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010926992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927057	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010927083	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010927159	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010927187	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (5wk - Recovered/Resolved - );Nausea (5wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927213	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927215	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927242	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927247	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927250	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927320	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927334	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927343	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927361	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Eczema infantile (n/a - Recovering/Resolving - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927364	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Joint lock (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint noise (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927366	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010927505	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest X-ray abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chronic kidney disease (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Exposure to SARS-CoV-2 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ultrasound Doppler normal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [n/a - 1{DF} - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010927528	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927551	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927555	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Not Recovered/Not Resolved - Disabling);Computerised tomogram (n/a - Not Recovered/Not Resolved - Disabling);Confusional state (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Not Recovered/Not Resolved - Disabling);Laboratory test (n/a - Not Recovered/Not Resolved - Disabling);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling);Seizure (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Status epilepticus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - n/a - [n/a - 1{DF} - Unknown])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010927614	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010927619	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927639	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);General physical health deterioration (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (3d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010927669	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010927677	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010927790	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bacterial infection (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010927846	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010927953	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac ventricular thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	EUCREAS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|FORXIGA [DAPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010927964	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010927966	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Coronary artery thrombosis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulse abnormal (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010927966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010928009	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral thrombosis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010928010	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes simplex reactivation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928100	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928121	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (8d - Recovered/Resolved With Sequelae - Life Threatening);Fatigue (n/a - Unknown - Other Medically Important Condition);Thinking abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010928130	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (34d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010928131	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928162	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928166	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928167	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Erythema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928195	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928348	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010928389	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Ocular discomfort (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010928405	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Results in Death);Cerebral haemorrhage (3d - Fatal - Results in Death);Chest pain (n/a - Not Recovered/Not Resolved - Results in Death);Circulatory collapse (n/a - Not Recovered/Not Resolved - Results in Death);Headache (n/a - Not Recovered/Not Resolved - Results in Death);Neck pain (n/a - Not Recovered/Not Resolved - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010928406	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928418	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928500	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928520	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928559	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Heart rate decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010928612	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010928634	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010928705	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Not Specified	Abdominal pain (n/a - Recovering/Resolving - );Exposure via breast milk (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928770	Spontaneous	2021-12-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymph node pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Puncture site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010928832	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010928833	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928836	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Altered state of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Osteomyelitis bacterial (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010928838	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010928849	Spontaneous	2021-12-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010928849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899366	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctivitis allergic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/60/2008, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008-LIKE VIRUS, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, NIB-121), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Antiviral prophylaxis - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899419	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Unknown - );Headache (n/a - Unknown - );Hypertensive crisis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899442	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899445	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (43d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	EMTRICITABINE 200MG TABLET, EFAVIRENZ 600MG TABLET, TENOFOVIR DISOPROXIL 245MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|REZOLSTA 800 MG/150 MG FILM-COATED TABLETS [DARUNAVIR, COBICISTAT] (C - n/a - n/a - [n/a - n/a - n/a])|TIVICAY 50 MG FILM-COATED TABLETS [DOLUTEGRAVIR] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, DEXPANTHENOL, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010899448	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM CARBONATE HEAVY, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899622	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899629	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899630	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899632	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899636	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899640	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Carditis (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - );Costochondritis (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pneumonitis (n/a - Recovering/Resolving - );Red blood cell sedimentation rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899641	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899644	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899646	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899651	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899652	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899655	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899656	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899662	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899668	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899670	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899671	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899678	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899679	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haemorrhage subcutaneous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899680	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Fluid retention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inferior vena cava dilatation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Proteinuria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899681	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899682	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Electrocardiogram abnormal (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - );Troponin increased (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899683	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - );Premature baby (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010899684	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899685	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899686	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899690	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899692	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899694	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Decreased appetite (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Diarrhoea (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Hot flush (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010899701	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperhidrosis (1h - Recovered/Resolved - );Syncope (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899706	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure congestive (5241min - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperuricaemia (n/a - Unknown - );Rectal haemorrhage (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])|ELIQUIS [APIXABAN] (S - Cerebrovascular accident prophylaxis - Dose reduced - [n/a - 2.5mg - Oral - More in ICSR])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - Cardiac failure congestive - Unknown - [170d - n/a - Oral])|SAMSCA [TOLVAPTAN] (C - Cardiac failure congestive - Unknown - [418d - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Cardiac failure congestive - Unknown - [54mo - n/a - Oral])|[CASSIA, SENNA GLYCOSIDES STANDARDIZED 60%, SENNOSIDES CALCIUM SALTS] (C - Constipation - Unknown - [210d - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - Unknown - [540d - n/a - Oral])|[TAK 438] (C - Gastric ulcer - Unknown - [1233d - n/a - Oral])|[URSODEOXYCHOLIC ACID] (C - Cholelithiasis - Unknown - [542d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010899716	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899949	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899950	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram PR segment depression (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899952	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899956	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899957	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899959	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Endocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899965	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899971	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guttate psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CETOSTEARYL ALCOHOL] (C - n/a - n/a - [n/a - 500g - n/a])|[CLOBETASONE] (C - n/a - n/a - [n/a - 100g - n/a])|[CLOTRIMAZOLE] (C - n/a - n/a - [n/a - 30g - n/a])|[LIQUID PARAFFIN] (C - n/a - n/a - [n/a - 500g - n/a])|[PARAFFIN WHITE SOFT] (C - n/a - n/a - [n/a - 500g - n/a])|[PHENOXYETHANOL] (C - n/a - n/a - [n/a - 500g - n/a])|[POLYSORBATE 60] (C - n/a - n/a - [n/a - 500g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899972	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyskinesia (n/a - Unknown - );Fatigue (n/a - Unknown - );Gaze palsy (n/a - Unknown - Other Medically Important Condition);Palpitations (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010899978	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899984	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899990	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899994	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010899997	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900011	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900016	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900027	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900031	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900032	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (10min - Recovered/Resolved - );Hyperhidrosis (10min - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (10min - Recovered/Resolved - Other Medically Important Condition);Vomiting (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HYDROXYCARBAMIDE [HYDROXYCARBAMIDE] (C - Myelofibrosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900061	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900064	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900065	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin disorder (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900066	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900067	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900068	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Balance disorder (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Confusional state (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Memory impairment (n/a - Recovering/Resolving - );Photophobia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900069	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900070	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eating disorder (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900124	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900133	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900137	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Faeces discoloured (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haematemesis (11021min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900152	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900158	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900268	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arterial disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BETAHISTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900269	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Cardiovascular disorder (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010900270	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Periorbital swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900312	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chills (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (2d - Recovering/Resolving - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010900324	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010900330	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010900351	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - )|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900352	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Atrial fibrillation - n/a - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900425	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900433	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoparesis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010900435	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900436	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haematemesis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900445	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|FORTISIP [CARBOHYDRATES NOS, FATS NOS, MINERALS NOS, PROTEIN, VITAMINS NOS] (C - n/a - n/a - [n/a - 1{DF} - n/a])|HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - 1{DF} - Intramuscular])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - 4{DF} - Respiratory (inhalation)])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 1{DF} - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[FERROUS SULFATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FLUDROCORTISONE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[GLYCERYL TRINITRATE] (C - Chest pain - n/a - [n/a - 1{DF} - n/a])|[ISPAGHULA HUSK] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LACTULOSE] (C - n/a - n/a - [10d - 10mL - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - 1{DF} - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[MIDODRINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PEPPERMINT OIL] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Dyspepsia - n/a - [n/a - 20mL - n/a])|[PROMETHAZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 1{DF} - Respiratory (inhalation)])|[SENNA ALEXANDRIAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900580	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900585	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);White blood cell count abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900592	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900598	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cerebral artery embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemoglobinaemia (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010900600	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (0d - Recovered/Resolved - );Hypotension (n/a - Unknown - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900601	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (45min - Recovered/Resolved - );Syncope (45min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900604	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GABAPENTIN] (C - Nerve injury - n/a - [n/a - n/a - n/a])|[MORPHINE, MORPHINE POLY(STYRENE-CO-DIVINYLBENZENE) SULFONATE, MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE, MORPHINE SULFATE PH. EUR.] (C - Back pain - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Abdominal discomfort - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900606	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (4h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900611	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900664	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Other Medically Important Condition);Delirium (n/a - Recovering/Resolving - Other Medically Important Condition);Dysstasia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900671	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angiopathy (n/a - Unknown - );Contusion (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Night sweats (n/a - Unknown - );Vasculitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900672	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010900673	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SILDENAFIL [SILDENAFIL] (C - Erectile dysfunction - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Anastomotic ulcer - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900682	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CINNARIZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLARITHROMYCIN] (C - n/a - n/a - [7d - 1{DF} - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - n/a - n/a - [7d - 4{DF} - n/a])|[FLURBIPROFEN, FLURBIPROFEN PH. EUR.] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[IBUPROFEN, IBUPROFEN PH. EUR.] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900956	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (20min - Recovered/Resolved - Other Medically Important Condition);Dizziness (20min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900958	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900970	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (2d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900973	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900976	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - Back disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010900979	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010900980	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (50min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010900998	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular tachycardia (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - Depression - Not applicable - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010900998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010901017	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901067	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901068	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901072	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901075	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901244	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010901254	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010901261	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010901279	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010901305	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Disturbance in attention (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain of skin (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901310	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901313	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901315	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901317	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901318	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901319	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901440	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adrenal adenoma (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [85d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010901471	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010901574	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Unknown - );Cough (n/a - Unknown - );Headache (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Rhinitis (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010901577	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901580	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901583	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901589	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901591	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901592	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901594	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901684	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening);Platelet count decreased (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010901751	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010901837	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (86d - Recovered/Resolved - );Periarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010901866	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Malaise (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010901887	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|PIOGLITAZONE [PIOGLITAZONE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrioventricular block - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901895	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901896	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysmenorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901899	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - Other Medically Important Condition);Head discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901904	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901905	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (40min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901907	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901908	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010901911	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901915	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (204min - Recovered/Resolved - Other Medically Important Condition);Diplopia (204min - Recovered/Resolved - Other Medically Important Condition);Urticaria (204min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901917	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901920	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901926	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Demyelination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901927	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[JUJUBE, PAEONIA LACTIFLORA ROOT EXTRACT, EPHEDRA, GINGER, PUERARIA, GLYCYRRHIZA, CINNAMON BARK] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010901937	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901939	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - Other Medically Important Condition);Swelling face (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - 7.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901941	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901952	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lichen planus (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901955	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901962	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site joint erythema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901965	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Multiple sclerosis (n/a - Recovering/Resolving - Disabling);Muscle spasticity (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (3d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BACLOFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - Pain - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010901966	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (48h - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Panic reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901968	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fluid retention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010901970	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (17d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (17d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901973	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pH increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901974	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (3h - Recovered/Resolved - Other Medically Important Condition);Bundle branch block right (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (3h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL ZENTIVA [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901978	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epididymitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Genital herpes (n/a - Unknown - );Inflammatory bowel disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901986	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - );Ultrasound scan abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010901987	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010901991	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010901991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902004	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902005	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved - );Interstitial lung disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902008	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902014	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Transient ischaemic attack (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902020	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (4d - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902025	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Flank pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Groin pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902037	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain of skin (7d - Recovered/Resolved - );Sleep disorder (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010902039	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010902048	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (1d - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902056	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010902066	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902067	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Unknown - Other Medically Important Condition);Vaccination site paraesthesia (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902071	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902072	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902080	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010902092	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902093	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902094	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902095	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902097	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902129	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Essential hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Unknown - );Secondary hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902366	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chromaturia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902410	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010902432	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902508	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902510	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - 135{DF} - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[MICONAZOLE NITRATE, HYDROCORTISONE] (C - n/a - n/a - [7d - 2{DF} - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PEPPERMINT OIL] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[QUININE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902513	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Optic neuritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902518	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902519	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902521	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Abdominal distension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphocyte count abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mass (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902526	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902528	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ocular discomfort (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Sensory loss (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010902560	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Disturbance in attention (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Injection site reaction (1d - Recovered/Resolved - Disabling);Pain in extremity (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010902650	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral thrombosis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010902653	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cutaneous T-cell lymphoma (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition);Hodgkin's disease (n/a - Recovered/Resolved - Other Medically Important Condition);Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902657	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902659	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint stiffness (n/a - Recovered/Resolved - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902660	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Headache (n/a - Recovered/Resolved With Sequelae - Disabling);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010902662	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902665	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	GLIBENCLAMIDE [GLIBENCLAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902667	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902672	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010902676	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902695	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902708	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010902764	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010902872	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphonia (0d - Recovered/Resolved - Life Threatening);Lymphadenopathy (0d - Recovered/Resolved - Life Threatening);Pyrexia (0d - Recovered/Resolved - Life Threatening);Tongue oedema (0d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010902876	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Monoplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902925	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Brain natriuretic peptide abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bundle branch block left (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Wheezing (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - n/a - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Abdominal discomfort - n/a - [n/a - 40ug - n/a])|IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - 300mg - n/a])|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypothyroidism - n/a - [n/a - 50ug - n/a])|[ATORVASTATIN] (C - Atherosclerosis prophylaxis - n/a - [n/a - 10mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - Not applicable - [n/a - 2.5mg - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 400mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010902957	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010902957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903249	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010903261	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903268	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Pityriasis (n/a - Recovering/Resolving - Other Medically Important Condition);Pityriasis rosea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010903271	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (2d - Recovered/Resolved - Other Medically Important Condition);Gastritis (1d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903273	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (6d - Recovered/Resolved - Other Medically Important Condition);Cough (2d - Recovered/Resolved - Other Medically Important Condition);Migraine (8d - Recovered/Resolved - Other Medically Important Condition);Myalgia (7d - Recovered/Resolved - Other Medically Important Condition);Nausea (5d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (9d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903276	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903279	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903283	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BIKTARVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - Clinical trial participant - n/a - [n/a - n/a - n/a])|DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|ENTRESTO [SACUBITRIL VALSARTAN SODIUM HYDRATE, VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - n/a])|PRASUGREL [PRASUGREL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010903286	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Venipuncture - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Mouth breathing - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010903423	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010903429	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010903430	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010903597	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903598	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903807	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RANEXA [RANOLAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROCHLORPERAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Cardiac failure congestive - n/a - [n/a - n/a - n/a])|[THIAMINE NITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010903926	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (33d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010903931	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (59d - Not Recovered/Not Resolved - );Myalgia (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010903936	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (3d - Unknown - );Hypersensitivity (3d - Unknown - );Palpitations (3d - Unknown - );Tachycardia (3d - Unknown - );Tremor (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010903939	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiomyopathy (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocarditis (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010903953	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (3d - Not Recovered/Not Resolved - );Injection site erythema (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010903969	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010903971	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010903974	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010903990	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (7d - Not Recovered/Not Resolved - );Fatigue (7d - Not Recovered/Not Resolved - );Nausea (7d - Not Recovered/Not Resolved - );Night sweats (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010903992	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - );Cardiovascular disorder (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010903992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904003	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904005	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling abnormal (0d - Recovered/Resolved - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904007	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dry mouth (0d - Recovering/Resolving - );Dysphagia (0d - Recovering/Resolving - );Dysphonia (0d - Recovering/Resolving - );Dyspnoea (0d - Recovering/Resolving - );Sensation of foreign body (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904026	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (5d - Not Recovered/Not Resolved - );Disturbance in attention (5d - Not Recovered/Not Resolved - );Fatigue (5d - Not Recovered/Not Resolved - );Influenza (5d - Not Recovered/Not Resolved - );Night sweats (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904028	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Nasopharyngitis (3d - Not Recovered/Not Resolved - );Paranasal sinus discomfort (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904051	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Vaccination site movement impairment (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904055	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (118d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010904068	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Limb discomfort (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904069	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (36d - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010904077	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperuricaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010904085	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (69d - Not Recovered/Not Resolved - );Fatigue (69d - Not Recovered/Not Resolved - );Rash (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010904091	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (23d - Unknown - );Fatigue (23d - Unknown - );Injection site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010904095	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (37d - Not Recovered/Not Resolved - );Chest pain (37d - Not Recovered/Not Resolved - );Fatigue (36d - Not Recovered/Not Resolved - );Nervousness (36d - Not Recovered/Not Resolved - );Performance status decreased (36d - Not Recovered/Not Resolved - );Tachycardia (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904098	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010904100	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (42d - Recovering/Resolving - );Tachycardia (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904115	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904117	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (8d - Recovering/Resolving - );Fatigue (8d - Recovering/Resolving - );Somnolence (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904123	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Somnolence (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904125	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010904129	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovering/Resolving - );Haematochezia (2d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904152	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Haematochezia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (S - n/a - n/a - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010904165	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904238	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hereditary fructose intolerance (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904240	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Influenza (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904245	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010904248	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904251	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Testicular swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - Oral])|[IPRATROPIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - Oral])|[MOLSIDOMINE] (C - n/a - n/a - [n/a - n/a - Oral])|[NITRENDIPINE] (C - n/a - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010904268	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010904371	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904378	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904401	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovering/Resolving - );Chills (12h - Recovering/Resolving - );Headache (4d - Not Recovered/Not Resolved - );Insomnia (12h - Recovering/Resolving - );Lymphadenopathy (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904553	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (30s - Recovered/Resolved - Other Medically Important Condition);Malaise (30s - Recovered/Resolved - Other Medically Important Condition);Myoclonus (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010904636	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Unknown - );Ear pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Periorbital swelling (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904687	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904690	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Respiratory distress (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010904710	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904723	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Hypotension (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904727	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904747	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010904818	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Blood pressure decreased (n/a - Unknown - Disabling);Chills (n/a - Unknown - Disabling);Decreased appetite (n/a - Unknown - Disabling);Delirium febrile (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010904826	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904827	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904833	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904846	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (3d - Recovered/Resolved - );Arthralgia (3d - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010904856	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904878	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904880	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010904896	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010904896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905051	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905225	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute pulmonary oedema (n/a - Not Recovered/Not Resolved - Life Threatening);Brain death (n/a - Not Recovered/Not Resolved - Life Threatening);Cardio-respiratory arrest (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	NOT AVAILABLE (C - n/a - n/a - [n/a - 1{DF} - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010905237	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905244	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905250	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905253	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905268	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905275	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905279	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905282	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905283	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905299	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905352	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Erysipelas (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fear of death (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia oral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010905551	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905629	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905631	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site mass (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	METFORMIN HYDROCHLORIDE, VILDAGLIPTIN [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACARBOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MECOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[NICERGOLINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905642	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rheumatoid arthritis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ORENCIA [ABATACEPT] (C - n/a - n/a - [n/a - n/a - n/a])|[CELECOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905648	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Energy increased (n/a - Unknown - );Nasal congestion (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905655	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death);Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Fatal - Results in Death);Ventricular fibrillation (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010905656	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Henoch-Schonlein purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (2d - Recovered/Resolved - );Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (2d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010905659	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905668	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905669	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905675	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905677	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), A/SOUTH AUSTRALIA/55/2014 STRAIN, B/PHUKET/3073/2013-LIKE STRAIN, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2) - LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, IVR-175), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, IVR-175), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - n/a - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010905681	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Neoplasm (n/a - Unknown - Other Medically Important Condition);Neoplasm malignant (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010905683	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (230min - Recovered/Resolved - );Epilepsy (230min - Recovered/Resolved - Other Medically Important Condition);Gaze palsy (230min - Recovered/Resolved - Other Medically Important Condition);Myotonia (207min - Recovered/Resolved - );Seizure (230min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010905700	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Internal haemorrhage (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Platelet count decreased (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[TENELIGLIPTIN HYDROBROMIDE HYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010905703	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Macular oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Retinal vein occlusion (n/a - Recovering/Resolving - Other Medically Important Condition);Subretinal fluid (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual acuity reduced (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010905707	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010905708	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - );Pain (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905710	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death);Muscle rigidity (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010905721	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Asthenia (n/a - Recovering/Resolving - Disabling);Back pain (n/a - Recovering/Resolving - Disabling);Chest pain (n/a - Recovering/Resolving - Disabling);Clumsiness (n/a - Recovering/Resolving - Disabling);Dizziness (n/a - Recovering/Resolving - Disabling);Dyspnoea exertional (n/a - Recovering/Resolving - Disabling);Extrasystoles (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);General physical health deterioration (n/a - Recovering/Resolving - Disabling);Hyperaesthesia (n/a - Recovering/Resolving - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Impaired work ability (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Muscular weakness (n/a - Recovering/Resolving - Disabling);Musculoskeletal stiffness (n/a - Recovering/Resolving - Disabling);Neck pain (n/a - Recovering/Resolving - Disabling);Night sweats (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Palpitations (n/a - Recovering/Resolving - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Vaccination site hypoaesthesia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010905731	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis reactive (n/a - Recovering/Resolving - );Inflammatory marker increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[PANTOPRAZOLE SODIUM] (C - Gastritis - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905739	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010905740	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905745	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905749	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905765	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Body temperature increased (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905850	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905861	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905871	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905893	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010905915	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Unknown - );Fatigue (4d - Unknown - );Myalgia (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010905926	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])|SPIKEVAX COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010905926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906260	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Disabling);Petechiae (n/a - Not Recovered/Not Resolved - Disabling);Vasodilatation (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010906265	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906272	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BUMETANIDE [BUMETANIDE] (C - Fluid retention - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - Fluid retention - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906275	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling);Brain fog (n/a - Recovering/Resolving - Disabling);Decreased appetite (n/a - Recovering/Resolving - Disabling);Dizziness (37d - Recovered/Resolved - Disabling);Eye pain (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Unknown - Disabling);Heart rate (29d - Recovered/Resolved - Disabling);Influenza like illness (28d - Recovered/Resolved - Disabling);Movement disorder (n/a - Unknown - Disabling);Nausea (6d - Recovered/Resolved - Disabling);Oropharyngeal pain (n/a - Recovered/Resolved - Disabling);Poor quality sleep (n/a - Recovering/Resolving - Disabling);Pyrexia (48d - Recovered/Resolved - Disabling);Sinusitis (n/a - Recovering/Resolving - Disabling);Upper-airway cough syndrome (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010906280	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (2d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906282	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Chamling, B.. Occurrence of acute infarct-like myocarditis following COVID-19  vaccination: just an accidental co-incidence or rather  vaccination-associated autoimmune myocarditis. Clinical Research in Cardiology. 2021;110(11):1850-1854. doi:10.1007/s00392-021-01916-w	18-64 Years	Not Specified	No	Male	Autoimmune myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906285	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Disabling);Facial paralysis (n/a - Unknown - Disabling);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunoglobulins (n/a - Not Recovered/Not Resolved - Disabling);Paraplegia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010906286	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dry throat (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Extrasystoles (n/a - Unknown - Disabling, Other Medically Important Condition);Hypopnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Product use issue (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Rash macular (n/a - Unknown - Disabling, Other Medically Important Condition);Respiratory disorder (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010906289	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Hanna, J.. Minimal Change Disease After First Dose of Pfizer-BioNTech COVID-19 Vaccine: A Case Report and Review of Minimal Change Disease Related to COVID-19 Vaccine. Canadian Journal of Kidney Health and Disease. 2021;8:10.1177/20543581211058271. doi:10.1177/20543581211058271	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Other Medically Important Condition);Glomerulonephritis minimal lesion (n/a - Unknown - Other Medically Important Condition);Nephrotic syndrome (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906291	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906297	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Ehrlich, P.. Biopsy-proven lymphocytic myocarditis following first mRNA COVID-19 vaccination in a 40-year-old male: case report. Clinical Research in Cardiology. 2021;110(11):1855-1859. doi:10.1007/s00392-021-01936-6	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906308	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906311	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (18d - Recovered/Resolved - Other Medically Important Condition);Chest pain (17d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (21d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906312	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906314	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906315	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cataract (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flat affect (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906319	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Chamling, B.. Occurrence of acute infarct-like myocarditis following COVID-19 vaccination: just an accidental co-incidence or rather vaccination-associated autoimmune myocarditis?. Clinical Research in Cardiology. 2021;110(11):1850-1854. doi:10.1007/s00392-021-01916-w	18-64 Years	Not Specified	No	Male	Autoimmune myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906322	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Axillary pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Heart rate increased (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Lymph node pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010906323	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906402	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 immunisation (0d - Fatal - Results in Death);Sudden death (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010906440	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Pedersen, R.. Negative SARS-CoV-2 antibodies, T-cell response and virus neutralization following full vaccination in a renal transplant recipient: a call for vigilance. Clinical Microbiology and Infection. 2021;27(9):1371-1373. doi:10.1016/j.cmi.2021.05.042	18-64 Years	Not Specified	No	Male	Local reaction (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DARBEPOETIN ALFA [DARBEPOETIN ALFA] (C - n/a - n/a - [n/a - n/a - n/a])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Renal transplant - n/a - [n/a - 3mg - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[MYCOPHENOLIC ACID] (C - Renal transplant - n/a - [n/a - 360mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010906451	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Basal ganglia haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paresis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906453	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Retinal artery occlusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906492	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010906498	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovered/Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906526	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906530	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Myocarditis (2mo - Recovered/Resolved - );Poor quality sleep (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	VOEDINGSSUPPLEMENT [NOT AVAILABLE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906532	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906544	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906547	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Irritability (n/a - Not Recovered/Not Resolved - );Primary stabbing headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906554	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (1wk - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (9d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010906556	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Inflammatory marker increased (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906697	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Atrioventricular block complete (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac pacemaker insertion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Confusional state (n/a - Unknown - );Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - );Headache (1d - Recovering/Resolving - );Heart rate decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hospitalisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - );Panic reaction (n/a - Unknown - );Peripheral swelling (n/a - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ABILIFY [ARIPIPRAZOLE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010906843	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010906844	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010906865	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (22d - Unknown - );Tendon sheath disorder (22d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010906870	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (89d - Not Recovered/Not Resolved - );Tinnitus (91d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010906872	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (25d - Recovered/Resolved - );Dizziness (25d - Recovered/Resolved - );Headache (25d - Recovered/Resolved - );Limb discomfort (25d - Recovered/Resolved - );Nausea (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010906873	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (87d - Not Recovered/Not Resolved - );Atrial fibrillation (87d - Not Recovered/Not Resolved - );Dyspnoea (87d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906886	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (13d - Recovering/Resolving - );Myalgia (13d - Recovering/Resolving - );Pain (n/a - Unknown - );Syncope (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906887	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (1d - Recovering/Resolving - );Chest pain (1d - Recovering/Resolving - );Injection site erythema (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Sense of oppression (1d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906891	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906900	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (61min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906904	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906905	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Peripheral vascular disorder (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010906913	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blindness transient (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906915	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906924	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (87d - Not Recovered/Not Resolved - );Atrial fibrillation (87d - Not Recovered/Not Resolved - );Dyspnoea (87d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010906925	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906926	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010906934	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906944	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906947	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Petechiae (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Liver transplant - n/a - [n/a - n/a - n/a])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Liver transplant - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Seizure - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906948	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906949	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Presyncope (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906952	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906955	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis reactive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Chronic inflammatory demyelinating polyradiculoneuropathy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906957	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INFLIXIMAB [INFLIXIMAB] (C - Crohn's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010906959	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry skin (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906967	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hypertensive crisis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010906968	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Extrasystoles - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Blood uric acid - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Extrasystoles - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906974	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906975	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906981	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010906990	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (129h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010906991	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Hiccups (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Rash (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010906997	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Taste disorder (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010906997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010907010	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907012	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907024	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (25d - Recovered/Resolved - );Weight bearing difficulty (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907028	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907031	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (3d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907033	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907052	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (16d - Not Recovered/Not Resolved - );Fatigue (16d - Not Recovered/Not Resolved - );Headache (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907058	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (16d - Not Recovered/Not Resolved - );Fatigue (16d - Not Recovered/Not Resolved - );Headache (16d - Not Recovered/Not Resolved - );Hypertension (16d - Not Recovered/Not Resolved - );Influenza (16d - Not Recovered/Not Resolved - );Nasopharyngitis (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907063	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907066	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alopecia areata (55d - Unknown - );Arrhythmia (55d - Unknown - );Immune system disorder (55d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907091	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spinal cord infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907094	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (61d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010907096	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site erythema (9d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Vaccination site haematoma (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907098	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907100	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010907101	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907102	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Hot flush (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907124	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (27d - Recovered/Resolved - );Nasopharyngitis (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010907126	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907127	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Unknown - );Nausea (3d - Unknown - );Pyrexia (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907130	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Feeling hot (31d - Not Recovered/Not Resolved - );Hot flush (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010907134	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (6d - Not Recovered/Not Resolved - );Dizziness (6d - Not Recovered/Not Resolved - );Nausea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907141	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (0d - Recovering/Resolving - );Diarrhoea (0d - Recovering/Resolving - );Dyspnoea (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907145	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907171	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Hyperaesthesia (2d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Malaise (2d - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907172	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907186	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010907187	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (77d - Recovered/Resolved With Sequelae - );Arrhythmia (77d - Recovered/Resolved With Sequelae - );Cognitive disorder (77d - Recovered/Resolved With Sequelae - );Cough (77d - Recovered/Resolved With Sequelae - );Depressed level of consciousness (77d - Recovered/Resolved With Sequelae - );Dyspnoea (77d - Recovered/Resolved With Sequelae - );Exercise tolerance decreased (77d - Recovered/Resolved With Sequelae - );Fatigue (77d - Recovered/Resolved With Sequelae - );Headache (77d - Recovered/Resolved With Sequelae - );Language disorder (77d - Recovered/Resolved With Sequelae - );Malaise (77d - Recovered/Resolved With Sequelae - );Rash (32d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010907199	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907205	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907235	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907236	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dysphonia (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Snoring (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010907240	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907242	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aplastic anaemia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Life Threatening);Thrombosis (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010907243	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907247	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907253	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Furuncle (n/a - Unknown - );Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Platelet count increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907254	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907259	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Communication disorder (n/a - Unknown - );Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Walking disability (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907260	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - );Asthenia (n/a - Unknown - );Cataract (n/a - Unknown - Other Medically Important Condition);Choking (n/a - Unknown - Other Medically Important Condition);Conjunctivitis (n/a - Unknown - );Diplopia (n/a - Unknown - );Dysphonia (n/a - Unknown - );Eating disorder (n/a - Unknown - );Eyelid ptosis (n/a - Unknown - );Hordeolum (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Influenza (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lacrimation increased (n/a - Unknown - );Myasthenia gravis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907272	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Fall (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - );Hypotension (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash macular (n/a - Unknown - );Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907274	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907278	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907282	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907289	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Blood disorder (n/a - Not Recovered/Not Resolved - );Cardiac disorder (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fall (n/a - Unknown - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Listless (n/a - Not Recovered/Not Resolved - );Lung disorder (n/a - Not Recovered/Not Resolved - );Near death experience (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907423	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010907427	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907438	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Narcolepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907442	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907451	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907453	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute myeloid leukaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907465	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907476	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907481	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes ophthalmic (n/a - Recovering/Resolving - Other Medically Important Condition);Rosacea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907492	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907500	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907501	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907507	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Head injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907508	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	International normalised ratio increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])|[ACENOCOUMAROL] (S - Product used for unknown indication - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907511	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907512	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907514	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (66d - Recovered/Resolved - );Decreased appetite (66d - Recovered/Resolved - );Tachycardia (66d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907525	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907527	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907534	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Mesenteric vein thrombosis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Portal vein thrombosis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010907538	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Proteinuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	ELIQUIS [APIXABAN] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ALFUZOSIN HYDROCHLORIDE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|[ZOPICLONE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907545	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tonic clonic movements (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907548	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907550	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907552	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - Factor V Leiden mutation - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907559	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907564	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vitreous detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907570	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010907575	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac tamponade (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907576	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Portal vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907577	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907578	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907604	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907610	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Demyelinating polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907611	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907612	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyarthritis (10d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907629	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [43d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907651	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (15d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907653	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Immunisation reaction (1d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907756	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Maternal exposure during pregnancy (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Nail aplasia (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010907757	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle strength abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Peroneal nerve palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907874	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dystonia (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907892	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (25d - Recovered/Resolved - );Movement disorder (n/a - Recovered/Resolved - );Neuropathy peripheral (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010907895	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010907904	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - );Hypersomnia (n/a - Recovering/Resolving - );Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLESTYRAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010907923	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907927	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907949	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Acute respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENOBARBITAL] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010907954	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010907955	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907957	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo positional (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907960	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907971	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907979	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907983	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010907989	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010907989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908020	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908021	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Immunisation reaction (3d - Recovered/Resolved - );Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908038	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908039	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Menstrual disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908041	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908044	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908055	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chillblains (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908083	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovering/Resolving - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908084	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908097	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908098	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908102	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908106	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908107	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908119	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure fluctuation (n/a - Recovering/Resolving - );Heart rate abnormal (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908125	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908138	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash macular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908144	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1wk - Recovering/Resolving - );Weight decreased (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908154	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908156	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Palpitations (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908183	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908188	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908189	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (1d - Recovered/Resolved - );Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908195	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908199	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908201	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908203	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908204	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908205	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908207	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908210	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908211	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908213	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908225	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908262	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010908263	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908264	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electric shock sensation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908266	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (48h - Recovered/Resolved - );Dizziness (48h - Recovered/Resolved - );Immunisation (n/a - Recovered/Resolved - );Off label use (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908336	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908340	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908346	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908347	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908350	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908351	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tongue oedema (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908352	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908353	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908355	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Feeling of body temperature change (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908359	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908369	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908373	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908387	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908395	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908397	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspepsia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908411	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908412	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (n/a - Recovered/Resolved - );Night sweats (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908419	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2d - Recovered/Resolved - );Menstrual disorder (3d - Not Recovered/Not Resolved - );Rash pruritic (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LEVOCETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908429	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908432	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908450	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908451	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	BRINTELLIX 20 MG FILM-COATED TABLETS [VORTIOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908457	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908464	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Condition aggravated (n/a - Recovered/Resolved With Sequelae - );Dyspnoea exertional (6d - Recovered/Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Tracheitis (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010908469	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908483	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (30min - Recovered/Resolved - );Palpitations (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908486	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908505	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908510	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Epigastric discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908513	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site inflammation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908519	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908524	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908525	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908536	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908537	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010908545	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908554	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908557	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Night sweats (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Sluggishness (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010908560	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908571	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Polymyalgia rheumatica - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908572	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908582	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908584	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Dizziness postural (0d - Recovered/Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (8d - Recovered/Resolved With Sequelae - Disabling);Nasopharyngitis (1d - Recovered/Resolved - Disabling);Tinnitus (0d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010908585	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908587	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010908588	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908592	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EDOXABAN [EDOXABAN] (C - Deep vein thrombosis - n/a - [n/a - n/a - n/a])|ENZALUTAMIDE [ENZALUTAMIDE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|PEMBROLIZUMAB [PEMBROLIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - 75mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[GOSERELIN, GOSERELIN ACETATE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Fatigue - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908599	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908606	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (2d - Recovered/Resolved - Other Medically Important Condition);Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Dehydration (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (2d - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (2d - Recovered/Resolved - Other Medically Important Condition);Tension headache (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908608	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Habit cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Listless (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908618	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Duodenogastric reflux - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908619	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysstasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908622	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (18h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (18h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010908740	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Fernandes, E. Acute Pericarditis and Comirnaty vaccine: coincidence or causality?. Medicina Interna - Congressos Nacionais. 2021;28:336	65-85 Years	Not Specified	No	Male	Acquired ATTR amyloidosis (n/a - Unknown - );Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010908746	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Mateus-Pinheiro, A. Neurologic complications of SARS-CoV-2 immunization: a series of three cases. Portuguese Journal of Internal Medicine. 2021;28:57	18-64 Years	Not Specified	No	Male	Central nervous system lesion (n/a - Recovered/Resolved - Other Medically Important Condition);Hemihypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Monoparesis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010908832	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (39d - Not Recovered/Not Resolved - );Hypertension (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908833	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Unknown - );Pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908839	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Not Recovered/Not Resolved - );Urticaria (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908840	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Unknown - );Fatigue (0d - Unknown - );Headache (0d - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908872	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (42d - Unknown - );Influenza like illness (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908877	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (2d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908887	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (21d - Recovering/Resolving - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tachycardia (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010908906	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010908959	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010908959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909048	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909064	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Reduced facial expression (n/a - Unknown - Other Medically Important Condition);Speech disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010909068	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL [UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010909072	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010909074	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (10d - Recovered/Resolved - );Melaena (10d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909273	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010909285	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (1h - Recovered/Resolved - );Somnolence (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010909425	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Unknown - );Inflammation (n/a - Recovered/Resolved - Other Medically Important Condition);Muscle disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909428	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (6d - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909436	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Miqdad, M.. Acute Myocarditis Following the Administration of the Second BNT162b2 COVID-19 Vaccine Dose. Cureus. 2021;13(10):e18880. doi:10.7759/cureus.18880	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010909488	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site induration (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010909558	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Disabling);Back pain (n/a - Unknown - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Renal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010909559	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010909561	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MICARDIS [TELMISARTAN] (C - n/a - n/a - [15d - n/a - n/a])|TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [15d - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [15d - n/a - n/a])|[AZELNIDIPINE] (C - n/a - n/a - [15d - n/a - n/a])|[BETAHISTINE MESILATE] (C - n/a - n/a - [15d - n/a - n/a])|[BUPLEURUM FALCATUM ROOT] (C - n/a - n/a - [15d - n/a - n/a])|[BYAKKOKANINJINTO, GLYCYRRHIZA GLABRA] (C - n/a - n/a - [15d - n/a - n/a])|[CITRUS FRUIT] (C - n/a - n/a - [15d - n/a - n/a])|[DAISAIKOTO, RHUBARB, GINGER] (C - n/a - n/a - [15d - n/a - n/a])|[ETHYL LOFLAZEPATE] (C - n/a - n/a - [15d - n/a - n/a])|[FEBUXOSTAT] (C - n/a - n/a - [15d - n/a - n/a])|[GINSENG, GLYCYRRHIZA GLABRA, RYOKEIJUTSUKANTO] (C - n/a - n/a - [15d - n/a - n/a])|[GINSENG, GLYCYRRHIZA GLABRA] (C - n/a - n/a - [15d - n/a - n/a])|[PAEONIA LACTIFLORA ROOT] (C - n/a - n/a - [15d - n/a - n/a])|[PEMAFIBRATE] (C - n/a - n/a - [15d - n/a - n/a])|[PINELLIA TERNATA ROOT] (C - n/a - n/a - [15d - n/a - n/a])|[RHEUM PALMATUM ROOT] (C - n/a - n/a - [15d - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [15d - n/a - n/a])|[SCUTELLARIA BAICALENSIS ROOT] (C - n/a - n/a - [15d - n/a - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - n/a - n/a - [15d - n/a - n/a])|[ZINGIBER OFFICINALE RHIZOME] (C - n/a - n/a - [15d - n/a - n/a])|[ZIZIPHUS JUJUBA SEED] (C - n/a - n/a - [15d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010909562	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - n/a - [1d - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909563	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Typhoid fever (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909574	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired work ability (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909575	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909580	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (46h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909585	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909586	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Lung disorder (n/a - Unknown - );Pulmonary mass (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, OLMESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909591	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Disabling, Other Medically Important Condition);Illness (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010909594	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Bone density abnormal - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010909597	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (12h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [302d - 75mg - Oral])|[ROSUVASTATIN] (C - n/a - n/a - [302d - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909599	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Diplegia (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SOLIFENACIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010909605	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ENALAPRIL MALEATE, NITRENDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909608	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cervical radiculopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuritis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909610	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010909611	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ENALAPRIL MALEATE, NITRENDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010909615	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909616	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909845	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909846	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pityriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pityriasis rosea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010909856	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909857	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling of despair (n/a - Recovered/Resolved - Other Medically Important Condition);Gingival bleeding (2d - Recovered/Resolved - Other Medically Important Condition);Haemorrhage (2d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010909865	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Duncan-Lowey, J.. Coronavirus Disease 2019 in a Patient with a Systemic Autoinflammatory Syndrome due to an NLRC4 Inflammasomopathy. Open Forum Infectious Diseases. 2021;8(8):10.1093/ofid/ofab362. doi:10.1093/ofid/ofab362	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ANAKINRA [ANAKINRA] (C - Haemophagocytic lymphohistiocytosis - n/a - [n/a - 100mg - n/a - More in ICSR])|[PREDNISONE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010909865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010910047	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Cardiac disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010910246	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash macular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010910248	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010910256	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Dysstasia (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of control of legs (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Sitting disability (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|TESTOSTERONE [TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010910328	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Life Threatening, Other Medically Important Condition);Platelet count decreased (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Purpura (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Carotid artery stenosis - n/a - [n/a - n/a - n/a])|[ELTROMBOPAG] (C - Immune thrombocytopenia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010910340	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysstasia (n/a - Unknown - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENBREL [ETANERCEPT] (C - Rheumatoid arthritis - n/a - [n/a - n/a - Unknown])|ENBREL [ETANERCEPT] (C - n/a - n/a - [n/a - 50mg - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010910390	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vein occlusion (n/a - Recovering/Resolving - Other Medically Important Condition);Visual acuity reduced (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PRADAXA 150 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010910401	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (10d - Recovered/Resolved - );Chest pain (10d - Recovered/Resolved - );Chills (10d - Recovered/Resolved - );Fatigue (10d - Recovered/Resolved - );Headache (10d - Recovered/Resolved - );Malaise (10d - Recovered/Resolved - );Myalgia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HYDROCHLOROTHIAZIDE 25MG TABLET, ALISKIREN 150MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TELMISARTAN 80 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910407	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010910422	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910461	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Murakawa, K.. A Case of Alveolar Hemorrhage That Was Suspected to Be an Adverse Reaction to SARS-CoV-2 Vaccine. The 125th Chugoku Regional Meeting of the Japanese Society of Internal Medicine. 2021;125th	65-85 Years	Not Specified	No	Male	Cardiomegaly (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - );Lung disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung opacity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary alveolar haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010910480	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Influenza like illness (2d - Recovered/Resolved - );Puncture site pain (9d - Recovered/Resolved - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910481	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Nervous system disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010910524	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010910536	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ear pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[AZATHIOPRINE, AZATHIOPRINE SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910604	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010910629	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910633	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010910680	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910724	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema multiforme (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010910766	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010910774	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010910835	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperaesthesia (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Sensory disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010910871	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010910899	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010910943	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010910943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010911036	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - );Internal haemorrhage (n/a - Unknown - Other Medically Important Condition);Red blood cell count decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010911055	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010911081	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Autoimmune encephalopathy (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hallucination (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hip fracture (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myoclonus (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Renal failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010911085	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[AZATHIOPRINE, AZATHIOPRINE SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911086	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[AZATHIOPRINE, AZATHIOPRINE SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911099	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Not Recovered/Not Resolved - Disabling);Fatigue (1d - Not Recovered/Not Resolved - Disabling);Headache (1d - Not Recovered/Not Resolved - Disabling);Malaise (1d - Not Recovered/Not Resolved - Disabling);Vertigo (1d - Not Recovered/Not Resolved - Disabling);Vision blurred (1d - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010911100	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Photopsia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911105	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death, Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure congestive (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory acidosis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010911114	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ear pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle tightness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010911127	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Disabling);Abnormal faeces (n/a - Unknown - );Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Unknown - );Basophil count increased (n/a - Unknown - );Blood uric acid increased (n/a - Unknown - );Candida infection (n/a - Unknown - );Confusional state (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Unknown - Disabling);Depression (n/a - Not Recovered/Not Resolved - );Eosinophil count increased (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - );Food intolerance (n/a - Not Recovered/Not Resolved - );Fungal infection (n/a - Not Recovered/Not Resolved - );Gastrointestinal inflammation (n/a - Unknown - );Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Disabling);Hypersensitivity (n/a - Unknown - );Inflammation (n/a - Unknown - );Pain (n/a - Unknown - );Serum ferritin increased (n/a - Recovering/Resolving - );Sleep disorder (n/a - Unknown - );Thermal burn (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - );Urine abnormality (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Unknown - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010911132	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911138	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911143	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site lymphadenopathy (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911170	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911342	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Platelet count decreased (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010911408	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (6d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911435	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dermatitis allergic (n/a - Unknown - Other Medically Important Condition);Photophobia (n/a - Unknown - Other Medically Important Condition);Pyrexia (14d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010911443	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911471	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911539	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition);Ophthalmic herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular - More in ICSR])	MERCAPTOPURINE [MERCAPTOPURINE] (C - n/a - Unknown - )|[CARVEDILOL] (C - n/a - Unknown - )|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Unknown - )|[FUROSEMIDE] (C - n/a - Unknown - )|[SPIRONOLACTONE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010911567	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911614	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010911649	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Dyspnoea (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site reaction (3d - Recovered/Resolved - );Insomnia (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010911738	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911784	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010911794	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiration abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010911820	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Swelling (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911854	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (6d - Recovered/Resolved - );Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (7d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010911873	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010911918	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Muscle spasms (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010911929	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010911929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912074	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Hyperventilation (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010912094	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010912157	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain lower (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010912182	Spontaneous	2021-12-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010912403	Spontaneous	2021-12-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010912403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887045	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887064	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Cognitive disorder (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Speech disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887076	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discharge (0d - Recovered/Resolved - );Muscle rigidity (0d - Recovered/Resolved - );Tremor (0d - Recovered/Resolved - );Trismus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887078	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYGEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887095	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887126	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887127	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Haemorrhoids thrombosed (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887136	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887156	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site oedema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887183	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887215	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Asthenia (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010887217	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887224	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discharge (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887238	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887330	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure systolic increased (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Lip swelling (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887332	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic lymphocytic leukaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887381	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887408	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887422	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|[PRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Parkinson's disease - n/a - [n/a - 2.1mg - Oral])|[SELEGILINE] (C - Parkinson's disease - n/a - [n/a - 2.5mg - Oral])|[THIAMINE] (C - Parkinson's disease - n/a - [n/a - 100mg - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887426	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887429	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887436	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010887449	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pollakiuria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887450	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887463	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - );Skin swelling (n/a - Unknown - );Skin warm (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887473	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887479	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010887507	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Testicular pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887513	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010887543	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887581	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887584	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	GLYXAMBI 10 MG/5 MG FILM-COATED TABLETS [LINAGLIPTIN, EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 10mg - Oral])|[ACETYLSALICYLIC ACID] (C - Myocardial ischaemia - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN] (C - Diabetes mellitus - n/a - [n/a - 20mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 2000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887621	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887629	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887631	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887646	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887654	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887662	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887665	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887668	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Uveitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010887685	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (7d - Recovered/Resolved - );Disturbance in attention (7d - Recovered/Resolved - );Dyspnoea (7d - Recovered/Resolved - );Feeling hot (7d - Recovered/Resolved - );Irritability (7d - Recovered/Resolved - );Somnolence (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010887694	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010887699	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Axillary pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887705	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887708	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887715	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887716	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Hyperpyrexia (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887719	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Burning sensation (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887720	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Recovering/Resolving - );Face oedema (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887739	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887740	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[NOT AVAILABLE] (S - Hypercholesterolaemia - Dose not changed - [n/a - n/a - n/a])	BUMETANIDE - TABLET  (C - n/a - Not applicable - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Not applicable - [n/a - n/a - n/a])|NOVORAPID 100 E/ML, OPLOSSING VOOR INJECTIE IN FLACON. [INSULIN ASPART] (C - n/a - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887838	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram T wave inversion (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - );Mitral valve prolapse (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887839	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887840	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Echocardiogram abnormal (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887842	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010887843	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887850	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ABASAGLAR [INSULIN GLARGINE] (C - n/a - n/a - [n/a - 3mL - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010887854	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Pleural effusion (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887937	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Malaise (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010887939	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887940	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887941	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram T wave inversion (n/a - Recovered/Resolved - Other Medically Important Condition);Left ventricular dysfunction (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887947	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010887952	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Recovering/Resolving - );Orthostatic hypotension (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887954	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887956	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[COCAINE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887958	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010887960	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010887960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888071	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Computerised tomogram abnormal (n/a - Not Recovered/Not Resolved - );Echocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888073	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888075	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888078	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888084	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888086	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888090	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Back pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888091	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888160	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypokinesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888162	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888163	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888165	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888172	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888173	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888174	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888175	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovered/Resolved - );Rectal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888177	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888227	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888229	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Cough (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Fatigue (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888238	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888239	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888247	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus tachycardia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888251	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888254	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperglycaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888255	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888258	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888261	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888267	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888268	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888269	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888270	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888272	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Nausea (n/a - Unknown - );Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888299	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888306	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888307	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888310	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Hyperventilation (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - );Pleuritic pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888312	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Orthopnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888313	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888315	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888317	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Unknown - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Painful respiration (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888318	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Aphonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Concussion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Contusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888323	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888324	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888326	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888327	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888330	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888331	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pharyngitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888332	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888335	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888336	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888338	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - );Pain in jaw (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888340	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888439	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888445	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888446	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888448	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888452	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888455	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888457	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888461	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888462	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888468	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Left ventricular dysfunction (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888471	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammatory bowel disease (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888472	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888477	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888478	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Uveitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888482	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Fall (n/a - Recovering/Resolving - );Head injury (n/a - Recovering/Resolving - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888484	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888485	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888487	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888491	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888492	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888495	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Influenza (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888498	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lip swelling (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888500	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010888504	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888510	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888511	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888512	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysmenorrhoea (n/a - Unknown - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Unknown - Other Medically Important Condition);Menstrual disorder (n/a - Unknown - Other Medically Important Condition);Polymenorrhoea (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888513	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Other Medically Important Condition);Concomitant disease aggravated (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888515	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pallor (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888521	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888524	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Ear discomfort (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888528	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888540	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888543	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle twitching (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Sensory loss (n/a - Unknown - Other Medically Important Condition);Varicose vein (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888544	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888545	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888558	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888559	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888566	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888568	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888569	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiration abnormal (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888570	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of personal independence in daily activities (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888572	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888574	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888579	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888580	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888581	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888582	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888584	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Mental impairment (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888585	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Sinus bradycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888587	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888589	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888591	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888592	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Mobility decreased (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Unknown - Disabling);Oedema (n/a - Recovered/Resolved - Disabling);Oedema peripheral (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pelvic girdle pain (n/a - Unknown - Disabling);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vasculitic rash (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010888599	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888602	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (16d - Recovered/Resolved - Other Medically Important Condition);Chest pain (8d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (16d - Recovered/Resolved - Other Medically Important Condition);Pericardial effusion (8d - Recovered/Resolved - Other Medically Important Condition);Respiratory arrest (16d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888603	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888604	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888605	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888608	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888610	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888611	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888612	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888613	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888616	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888617	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888619	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888620	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888622	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888624	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888625	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888628	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888629	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arteriosclerosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Subarachnoid haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombotic cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888631	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Motor dysfunction (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888634	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888635	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchial wall thickening (n/a - Unknown - Caused/Prolonged Hospitalisation);Bronchitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hepatic enzyme increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung infiltration (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nasal congestion (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888649	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010888655	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Internal haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010888791	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sarcoidosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010888959	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010888959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010889133	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nodal rhythm (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010889143	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lung disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010889145	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Impaired work ability (4d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010889151	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2.5mo - Recovered/Resolved - );Pain in extremity (2.5mo - Recovered/Resolved With Sequelae - );Trigger finger (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010889225	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010889311	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Parotid gland enlargement (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010889345	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010889384	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (10min - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010889429	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010889585	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010889594	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Initial insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010889600	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010889625	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Body temperature increased (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010889899	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010889942	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspepsia (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening);Urinary incontinence (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010889989	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoxia (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Organ failure (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Skin reaction (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Thrombocytopenia (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010889989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010890011	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	INSULATARD 100 IU/ML SUSPENSION FOR INJECTION IN A VIAL [INSULIN HUMAN ISOPHANE (RDNA)] (C - n/a - n/a - [n/a - n/a - n/a])|INSUMAN RAPID SOLOSTAR 100 IU/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010890042	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890114	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Unknown - Disabling);Bone pain (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Unknown - Disabling);Lymphadenopathy (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010890139	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Monoplegia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010890221	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010890389	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010890438	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (51d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sarcoid-like reaction (51d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010890439	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Eye pain (n/a - Recovering/Resolving - );Ocular discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890450	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890454	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Gastroenteritis (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890607	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010890638	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Body temperature increased (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash vesicular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PHENOXYMETHYLPENICILLIN BENZATHINE] (C - Erysipelas - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010890833	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (4d - Recovered/Resolved - );Oedema peripheral (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE] (C - Hypertension - Dose not changed - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890835	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Contusion (1d - Recovering/Resolving - );Cough (2d - Recovering/Resolving - );Fatigue (4d - Unknown - );Feeling hot (4d - Unknown - );Headache (1d - Recovered/Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (4d - Unknown - );Insomnia (4d - Unknown - );Lymph node pain (5d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Unknown - );Oropharyngeal pain (2d - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (2d - Recovering/Resolving - );Vaccination site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010890836	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890837	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (5wk - Not Recovered/Not Resolved - Other Medically Important Condition);Alopecia areata (5wk - Not Recovered/Not Resolved - Other Medically Important Condition);Photosensitivity reaction (2mo - Recovering/Resolving - Other Medically Important Condition);Skin discolouration (2mo - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010890838	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890842	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Central serous chorioretinopathy (n/a - Unknown - Other Medically Important Condition);Choroidal neovascularisation (n/a - Unknown - Other Medically Important Condition);Cystoid macular oedema (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypermetropia (n/a - Unknown - Other Medically Important Condition);Macular degeneration (n/a - Unknown - Other Medically Important Condition);Ocular discomfort (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010890848	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010890855	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (5d - Unknown - );Asthenia (5d - Unknown - );Chills (5d - Unknown - );Diarrhoea (4d - Unknown - );Fatigue (5d - Unknown - );Headache (5d - Unknown - );Lymphadenopathy (11d - Unknown - );Myalgia (5d - Unknown - );Nausea (5d - Unknown - );Pyrexia (5d - Unknown - );Vaccination site pain (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010890858	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anal abscess (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (15min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (48d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (10min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010890865	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010890873	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - Life Threatening);Heart rate increased (n/a - Recovered/Resolved - Life Threatening);Palpitations (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE, PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - Hypertension - Dose not changed - [11mo - n/a - Oral])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - Dose not changed - [11mo - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010890879	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010890883	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bacterial infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010890967	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site reaction (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010890967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891009	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891126	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atelectasis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Atrial flutter (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure systolic decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Exercise tolerance decreased (n/a - Recovering/Resolving - );Inflammatory marker increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Night sweats (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleuritic pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LYRICA 50 MG HARD CAPSULES [PREGABALIN] (C - n/a - n/a - [n/a - 50mg - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - 5mg - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891140	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrioventricular block complete (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	BYDUREON [EXENATIDE] (C - n/a - n/a - [n/a - 2mg - Subcutaneous])|XIGDUO [METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FENOFIBRATE] (C - n/a - n/a - [n/a - 250mg - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - 60mg - n/a])|[HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010891162	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891164	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Food allergy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891174	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Uveitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010891190	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891231	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - Not applicable - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - n/a - Not applicable - [n/a - 10[drp] - Oral])|[FENOFIBRATE] (C - n/a - Not applicable - [n/a - 200mg - Oral])|[NEBIVOLOL HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - 5mg - Oral])|[ROSUVASTATIN] (C - n/a - Not applicable - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891268	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AZITHROMYCIN, AZITHROMYCIN DIHYDRATE] (C - n/a - n/a - [n/a - 500mg - n/a])|[LACIDIPINE] (C - n/a - n/a - [n/a - 4mg - n/a])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 8mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891334	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010891338	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling);Blood urine (n/a - Not Recovered/Not Resolved - Disabling);Dysuria (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010891343	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	LYRICA 25 MG [PREGABALIN] (C - n/a - n/a - [n/a - 25mg - n/a])|VIMPAT 150 MG [LACOSAMIDE] (C - n/a - n/a - [n/a - 150mg - n/a])|[ACENOCOUMAROL] (C - Aortic valve replacement - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891376	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891431	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Hot flush (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891434	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891455	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (1d - Recovering/Resolving - );Abnormal faeces (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891465	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010891472	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Erectile dysfunction (53d - Recovering/Resolving - );Influenza (53d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010891474	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death);Hypotonia (n/a - Fatal - Results in Death);Nasopharyngitis (n/a - Fatal - Results in Death);Nausea (n/a - Fatal - Results in Death);Oropharyngeal pain (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010891475	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (0d - Recovered/Resolved - );Asthenia (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891490	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (21d - Recovered/Resolved - );Tachycardia (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891491	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Unknown - );Insomnia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891492	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891499	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891501	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891511	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Influenza (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891515	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891516	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891518	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891520	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (15d - Not Recovered/Not Resolved - );Limb discomfort (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891521	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891524	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891528	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (6d - Recovering/Resolving - );Limb discomfort (6d - Recovering/Resolving - );Vein disorder (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891533	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010891542	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891543	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891545	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891547	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891552	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010891554	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Obstruction (n/a - Recovered/Resolved - );Oxygen saturation decreased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891555	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891557	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010891559	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891579	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891581	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (18d - Not Recovered/Not Resolved - );Heart rate increased (18d - Not Recovered/Not Resolved - );Influenza like illness (18d - Not Recovered/Not Resolved - );Pyrexia (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891590	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bronchitis (13d - Not Recovered/Not Resolved - );Cough (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891594	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Muscular weakness (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891599	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Vomiting (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891602	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Sleep disorder (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891604	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (99d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891606	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891615	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891618	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - 400mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010891652	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891656	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (15d - Not Recovered/Not Resolved - );Limb discomfort (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891657	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Vomiting (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891664	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal degeneration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal ischaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual field defect (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010891801	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tonic convulsion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010891822	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Vaccination site erythema (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891829	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010891847	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Acute sinusitis (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Conjunctival hyperaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Conjunctivitis (n/a - Recovering/Resolving - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Sinusitis (n/a - Recovering/Resolving - Other Medically Important Condition);Toothache (n/a - Recovering/Resolving - Other Medically Important Condition)	[PROPOFOL] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - Acute sinusitis - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Dysmenorrhoea - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - Acute sinusitis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010891875	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891886	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891888	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010891894	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891903	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891923	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[NAPROXEN SODIUM] (C - n/a - n/a - [n/a - 550mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010891986	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010891986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892000	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sepsis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [1d - 1{DF} - Parenteral])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Prophylaxis - Not applicable - [n/a - 1{DF} - Parenteral])	IRINOTECAN [IRINOTECAN, IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE TRIHYDRATE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])|[CALCIUM FOLINATE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])|[FLUOROURACIL] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892012	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2s - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892109	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892204	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892208	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892225	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892226	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892231	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892305	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (4d - Recovered/Resolved - );Arthralgia (2d - Recovered/Resolved - );Body temperature increased (3d - Recovered/Resolved - );Chills (8h - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892378	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Axillary pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892379	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adrenocortical insufficiency acute (n/a - Unknown - );Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pleurisy (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010892447	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892461	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892462	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892487	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892490	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892499	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Increased insulin requirement (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	INSULATARD FLEXPEN [INSULIN HUMAN, INSULIN HUMAN (RDNA), INSULIN HUMAN ISOPHANE (RDNA)] (C - Type 2 diabetes mellitus - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[DUTASTERIDE] (C - n/a - n/a - )|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - )|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - )|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010892512	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Gait disturbance (n/a - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892521	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892529	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892533	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892536	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Pain in extremity (1mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892543	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010892549	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insulin resistance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	NOVORAPID 100 U/ML SOLUTION FOR INJECTION IN A VIAL [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892611	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heart rate increased (n/a - Recovering/Resolving - Life Threatening);Pneumonia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010892617	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010892626	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) - SUSPENSION FOR INJECTION  (C - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892690	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Rash pruritic (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010892737	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892738	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892739	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892740	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892742	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010892743	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Electrocardiogram T wave amplitude increased (n/a - Recovered/Resolved - Other Medically Important Condition);Lung infiltration (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892744	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ejection fraction decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (13830min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin I increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892747	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Fatal - Results in Death);Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010892748	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Lung infiltration (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Sinus tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892753	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892754	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892755	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892757	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Tachypnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892759	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Life Threatening);Chest pain (n/a - Unknown - Life Threatening);Dizziness (n/a - Unknown - Life Threatening);Myocarditis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010892763	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892764	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892768	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic intramural haematoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892769	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Faecal occult blood positive (n/a - Recovered/Resolved - );Haematochezia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892784	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892786	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892788	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral coldness (n/a - Recovering/Resolving - Other Medically Important Condition);Tachypnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892789	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892791	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892792	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892794	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Choking (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892796	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892800	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Radiculopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Viral myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892805	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haemoptysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - );Renal injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010892814	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892818	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892822	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892841	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892842	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892844	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892855	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892857	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892868	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892869	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892875	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892879	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Panniculitis (n/a - Recovered/Resolved - );Tonsillitis streptococcal (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010892913	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892914	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892915	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892917	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892920	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])|[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (S - Immunisation - Not applicable - [1d - .5mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892926	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892928	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram QT prolonged (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram T wave inversion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892934	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892937	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - );Cough (n/a - Unknown - );Hypotension (n/a - Unknown - );Pyrexia (n/a - Unknown - );Septic shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892939	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892941	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892944	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892946	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892951	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892956	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892959	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892962	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Accidental overdose (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product preparation error (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892967	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892968	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lower respiratory tract infection (29d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010892969	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram abnormal (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892972	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892973	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Left ventricular hypertrophy (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892976	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892977	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892985	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blindness transient (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - );Cough (n/a - Unknown - );Fall (n/a - Unknown - );Fatigue (n/a - Unknown - );Hallucination, visual (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - );Vertigo (n/a - Unknown - );Vision blurred (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892987	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892989	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Hallucination (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Nasopharyngitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010892993	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010892995	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010892995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893001	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893002	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );International normalised ratio increased (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893003	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893004	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893007	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893008	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Chest pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893009	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893010	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - );Swelling face (n/a - Recovered/Resolved - );Swollen tongue (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893022	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893023	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893031	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893032	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893043	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893045	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Immunisation (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893048	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893050	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893055	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893057	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Vertebral artery dissection (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893064	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893071	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Peripheral arterial occlusive disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010893074	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893079	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urticarial vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893081	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893086	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893088	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893089	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893092	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893094	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893095	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aggression (n/a - Unknown - );Depressed mood (n/a - Unknown - );Hypervigilance (n/a - Unknown - );Somnolence (n/a - Unknown - );Suicidal ideation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893096	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893099	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition);Viral pharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893101	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Type I hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893104	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (80min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893106	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893107	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Muscle spasticity (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FAMPRIDINE [FAMPRIDINE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - Blood iron decreased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893113	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Atrioventricular block (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893123	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893124	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893125	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram T wave peaked (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lung infiltration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893129	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BROTIZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE MALEATE, DIHYDROCODEINE PHOSPHATE, METHYLEPHEDRINE HYDROCHLORIDE-DL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[JUJUBE FRUIT, GINSENG, GLYCYRRHIZA GLABRA, MAGNOLIA BARK, BUPLEURUM CHINENSE ROOT, PERILLA FRUTESCENS, PINELLIA TERNATA ROOT, SCUTELLARIA BAICALENSIS ROOT, PORIAE COCOS SCLEROTIUM] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[LOXOPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PEONY FLOWER, GLYCYRRHIZA EXTRACT, SHAKUYAKUKANZOTO] (C - n/a - n/a - [n/a - n/a - n/a])|[PITAVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])|[REBAMIPIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THEOPHYLLINE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[TULOBUTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893178	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893188	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893191	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893251	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Coronary artery disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893252	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Unknown - );Migraine with aura (n/a - Unknown - );Visual field defect (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893255	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893257	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893288	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893325	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness exertional (67d - Recovered/Resolved - );Palpitations (67d - Recovered/Resolved - );Pericarditis (67d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010893331	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (5h - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Skin infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombophlebitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010893365	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893382	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (5d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010893391	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vein disorder (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010893398	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Connective tissue disease-associated interstitial lung disease (n/a - Recovered/Resolved With Sequelae - Disabling);Interstitial lung disease (n/a - Recovered/Resolved With Sequelae - Disabling);Rheumatoid arthritis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Tachycardia - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE] (C - Antidepressant therapy - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - Antidepressant therapy - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010893456	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893460	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cardiac aneurysm (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cardiac disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Inflammation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010893462	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893464	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893465	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Unknown - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893467	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FENOFIBRATE, FENOFIBRATE (NANONISED), FENOFIBRATE MICRONISED] (C - n/a - n/a - [n/a - n/a - n/a])|[LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893473	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893474	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893476	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893482	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893483	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893484	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893488	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893493	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation delayed (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893495	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893498	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Ear pain (1d - Recovered/Resolved - Other Medically Important Condition);Facial pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Toothache (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMC X-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Prophylaxis - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893512	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893514	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893524	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893528	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893529	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893530	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893531	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - );Diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Neck pain (n/a - Unknown - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893532	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893533	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Orthopnoea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893539	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicectomy (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Appendicitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Intentional self-injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893544	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Sinus tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893547	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - );Chills (n/a - Unknown - );Depressed mood (n/a - Unknown - );Dizziness (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893553	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893558	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Blood disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Cerebral haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Coagulopathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Subdural haematoma (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893559	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Seizure (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010893566	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893567	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Lung infiltration (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893568	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatic cyst (n/a - Unknown - );Neuralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal cyst (n/a - Unknown - );Rhabdomyolysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893570	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893573	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893574	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893577	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Coagulopathy (n/a - Unknown - );Heavy menstrual bleeding (n/a - Recovering/Resolving - );Menstrual disorder (n/a - Unknown - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893590	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893602	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACEMETACIN] (C - Abdominal pain - n/a - [n/a - n/a - Oral])|[METHSCOPOLAMINE] (C - Abdominal pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010893606	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893615	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893637	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893639	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893670	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893714	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Radiculitis brachial (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010893739	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010893743	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Anosmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Unknown - );Diplopia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - );Hypoacusis (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sick leave (n/a - Unknown - );Visual impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[PARACETAMOL, PARACETAMOL, ASPARTAME] (C - Pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893822	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pallor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893823	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893824	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Fatal - Results in Death);Dehydration (n/a - Fatal - Results in Death);Oropharyngeal discomfort (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pharyngitis (n/a - Unknown - );Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010893825	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Axillary pain (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved With Sequelae - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010893827	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893830	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893833	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893834	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tinnitus (n/a - Unknown - Caused/Prolonged Hospitalisation);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893841	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893846	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893847	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovered/Resolved - );Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010893882	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Axonal and demyelinating polyneuropathy (n/a - Recovering/Resolving - );Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893888	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (21d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Calculus bladder (15d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Palliative care (3d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Tachypnoea (3d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010893894	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (72d - Unknown - );Hyperhidrosis (72d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010893905	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010893923	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010893955	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (77d - Unknown - );Hyperhidrosis (77d - Unknown - );Night sweats (77d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010893974	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010893974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894065	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Aphasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894069	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894071	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894080	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Cardiac arrest (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Death (n/a - Fatal - Results in Death, Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Discomfort (n/a - Unknown - );Fall (n/a - Unknown - );Fatigue (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Incontinence (n/a - Unknown - );Myalgia (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Respiratory arrest (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 2.5mg - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[TENELIGLIPTIN HYDROBROMIDE HYDRATE, CANAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 1mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894084	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010894097	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Immunisation (n/a - Unknown - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894103	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Unknown - Caused/Prolonged Hospitalisation);Cellulitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894115	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ANASTROZOLE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[CABERGOLINE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[QUETIAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TESTOSTERONE DECANOATE, TESTOSTERONE ISOCAPROATE, TESTOSTERONE PHENYLPROPIONATE, TESTOSTERONE PROPIONATE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010894120	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894121	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Costochondritis (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC, DICLOFENAC DIETHYLAMINE, DICLOFENAC EPOLAMINE, DICLOFENAC POTASSIUM, DICLOFENAC RESINATE, DICLOFENAC SODIUM, DICLOFENAC SODIUM PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894122	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010894129	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Ventricular extrasystoles (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894132	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Eye pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Flank pain (n/a - Unknown - );Headache (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894147	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894153	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute pulmonary oedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894156	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - 50mg - Oral])|[EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])|[LUSEOGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894157	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894159	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - );Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Recovering/Resolving - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894162	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Faeces soft (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasal obstruction (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894166	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Factitious disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Immune system disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Neuropathy peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Viral infection (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894174	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894185	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Gastrooesophageal reflux disease (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Unknown - );Nasal inflammation (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894189	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epidural haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skull fracture (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Subarachnoid haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894192	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Other Medically Important Condition);Cardiac failure (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Myocardial ischaemia (n/a - Unknown - Other Medically Important Condition);Oedema peripheral (n/a - Unknown - Other Medically Important Condition);Urine output decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894193	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Myelitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuromyelitis optica spectrum disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894198	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (6d - Recovered/Resolved - );Dyspnoea (6d - Recovered/Resolved - );Electrocardiogram ST segment elevation (4d - Recovered/Resolved - Other Medically Important Condition);Myocardial necrosis marker increased (4d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (4d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894202	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894204	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Apnoea (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Palpitations (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894207	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894211	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arteriosclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperlipidaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[DIFENIDOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[DIPYRIDAMOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[PACLITAXEL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894213	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (34d - Recovered/Resolved - Other Medically Important Condition);Hypotension (34d - Recovered/Resolved - Other Medically Important Condition);Pallor (34d - Recovered/Resolved - Other Medically Important Condition);Syncope (34d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894214	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (86h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (71h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal pain (71h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (71h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (71h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894218	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lung infiltration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mouth ulceration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894220	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894221	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Life Threatening);Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010894222	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894230	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Embolism venous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Hyperaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Post thrombotic syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894282	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bundle branch block right (6d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiomyopathy (n/a - Unknown - Other Medically Important Condition);Chest discomfort (8d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Chest pain (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (8d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (8d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Malaise (26h - Recovered/Resolved With Sequelae - );Myalgia (9d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocardial fibrosis (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocardial oedema (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (9d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral coldness (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (194h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894292	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Unknown - Other Medically Important Condition);Deafness neurosensory (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894296	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Cyanosis (n/a - Not Recovered/Not Resolved - Life Threatening);Hypertrophic cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Oliguria (n/a - Not Recovered/Not Resolved - Life Threatening);Pain in extremity (n/a - Not Recovered/Not Resolved - );Respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010894298	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abulia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894300	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Intestinal obstruction (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - n/a - n/a - [53d - n/a - n/a - More in ICSR])|OLANZAPINE [OLANZAPINE] (C - n/a - n/a - [7d - 2{DF} - n/a])|[BROTIZOLAM] (C - n/a - n/a - [60d - 1{DF} - n/a])|[CARBAZOCHROME SODIUM SULFONATE] (C - n/a - n/a - [1d - 2{DF} - n/a - More in ICSR])|[CEFOZOPRAN, CEFOZOPRAN HYDROCHLORIDE] (C - n/a - n/a - [1d - 1g - Intravenous drip - More in ICSR])|[DEXAMETHASONE, DEXAMETHASONE PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [3d - .25{DF} - Intravenous drip - More in ICSR])|[DIAZEPAM] (C - n/a - n/a - [27d - 1{DF} - n/a])|[FAMOTIDINE, OMEPRAZOLE] (C - n/a - n/a - [15d - 1{DF} - Intravenous drip])|[FLUNITRAZEPAM] (C - n/a - n/a - [60d - 1{DF} - n/a])|[HALOPERIDOL, HALOPERIDOL BP] (C - n/a - n/a - [27d - 1{DF} - n/a])|[L-ISOLEUCINE, L-LEUCINE] (C - n/a - n/a - [11d - 2000mL - n/a - More in ICSR])|[LEVOMEPROMAZINE MALEATE] (C - n/a - n/a - [53d - 3{DF} - n/a - More in ICSR])|[MAGNESIUM OXIDE] (C - n/a - n/a - [60d - 2g - n/a])|[NIFEDIPINE] (C - n/a - n/a - [60d - 1{DF} - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [60d - 4{DF} - n/a])|[SENNOSIDE A] (C - n/a - n/a - [60d - 3{DF} - n/a])|[SODIUM VALPROATE] (C - n/a - n/a - [60d - 3{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894304	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894310	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894315	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Wheezing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ABILIFY [ARIPIPRAZOLE] (C - Schizophrenia - n/a - [1757d - 400mg - Intramuscular])|[BROTIZOLAM] (C - Insomnia - n/a - [n/a - .25mg - Oral])|[MIDODRINE HYDROCHLORIDE] (C - Hypotension - n/a - [n/a - 4mg - Oral])|[SENNOSIDE A+B] (C - Constipation - n/a - [n/a - 12mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894316	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pneumomediastinum (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894319	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894321	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894330	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea paroxysmal nocturnal (n/a - Unknown - Caused/Prolonged Hospitalisation);Generalised oedema (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Orthopnoea (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urine output decreased (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894342	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse drug reaction (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894349	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram abnormal (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin I increased (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894354	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Basal ganglia haemorrhage (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Brain compression (n/a - Fatal - Results in Death, Other Medically Important Condition);Glossoptosis (n/a - Unknown - );Haemorrhage intracranial (n/a - Fatal - Results in Death, Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Respiratory depression (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Carotid artery stent insertion - n/a - [n/a - n/a - Oral])|[ALFACALCIDOL] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CARBOCISTEINE] (C - Productive cough - n/a - [n/a - n/a - Oral])|[DISOPYRAMIDE, DISOPYRAMIDE PHOSPHATE] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[FLUDROCORTISONE ACETATE] (C - Cerebral salt-wasting syndrome - n/a - [n/a - n/a - Oral])|[LEMBOREXANT] (C - Insomnia - n/a - [n/a - n/a - Oral])|[LEVETIRACETAM] (C - Seizure - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[POLAPREZINC] (C - Mineral supplementation - n/a - [n/a - n/a - Oral])|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - Oral])|[SODIUM VALPROATE] (C - Seizure - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894357	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Endocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung infiltration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Staphylococcal infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894359	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Oropharyngeal discomfort (n/a - Unknown - );Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894360	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Schizophrenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894369	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Toxic skin eruption (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894373	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894379	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010894385	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Malaise (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894387	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894388	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Myopericarditis (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010894389	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894391	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Overdose (n/a - Unknown - );Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Ulcer (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894393	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Lung infiltration (n/a - Unknown - Other Medically Important Condition);Sinus rhythm (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894397	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894418	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010894424	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Vitreous detachment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894428	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894433	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894434	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894438	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894449	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894454	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894455	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894456	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894457	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894474	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894479	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Hemiparaesthesia (n/a - Not Recovered/Not Resolved - );Peripheral venous disease (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894491	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RUPATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894499	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6h - Recovered/Resolved - );Nausea (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894500	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - );Skin swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894504	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894505	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovering/Resolving - );Headache (7d - Recovering/Resolving - );Vomiting (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894507	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894510	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Immunisation reaction (7d - Recovered/Resolved - );Insomnia (6d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894511	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894518	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894519	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894520	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Loss of libido (n/a - Recovering/Resolving - );Musculoskeletal chest pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894528	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894530	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894531	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site rash (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894532	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894534	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894537	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Rhinorrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	[CYAMEMAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANCREAS POWDER, PANCREAS POWDER FROM PORCINE, PANCREATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894539	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894541	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894542	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894545	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (1d - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894546	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894551	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894554	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894561	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894568	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894569	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [41d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894572	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894574	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Asthma (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894580	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disturbance in attention (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894582	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Oedema (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894587	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894588	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894590	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vitiligo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894598	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894610	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894611	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894620	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gout (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894621	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894623	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	APROVEL [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894624	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894626	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894629	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in jaw (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894635	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894637	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894638	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894642	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894643	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894645	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894646	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894654	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894659	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894663	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894666	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894669	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894682	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894683	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin I increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894686	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894689	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894692	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894696	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894699	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894700	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894704	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894709	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Productive cough (n/a - Recovering/Resolving - );Sciatica (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894713	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894714	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Recovered/Resolved - );Purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894717	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Condition aggravated (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894724	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894725	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Recovered/Resolved - );Tachycardia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894731	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894732	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894733	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894747	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894748	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disease recurrence (n/a - Recovering/Resolving - );Rash morbilliform (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [37d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894750	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (30d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Rash vesicular (n/a - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010894762	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894763	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (15d - Recovered/Resolved - );Immunisation reaction (15d - Recovered/Resolved - );Lethargy (15d - Recovered/Resolved - );Oropharyngeal pain (15d - Recovered/Resolved - );Rhinitis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894781	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Flank pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894797	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ENTRESTO 24 MG/26 MG FILM-COATED TABLETS [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - n/a])|HARTMEDICATIE [NOT AVAILABLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [EVOLOCUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 2.5 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894798	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Subclavian vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894811	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894813	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894816	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894817	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894818	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Unknown - Caused/Prolonged Hospitalisation);Gastrointestinal inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894819	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscle contracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894825	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dehydration (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894826	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894832	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894834	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894837	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894841	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894842	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Embolism venous (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894846	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cold sweat (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010894855	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894867	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894871	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory tract infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894875	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010894880	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hepatic haemorrhage (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010894881	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Endocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Staphylococcal infection (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894886	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894887	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Extraocular muscle disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nystagmus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894888	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening);Hydrocephalus (n/a - Not Recovered/Not Resolved - Life Threatening);Myoclonus (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010894889	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894891	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Tenderness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894895	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Conjunctivitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dry eye (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ketoacidosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894896	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling);Flatulence (n/a - Not Recovered/Not Resolved - Disabling);Myopericarditis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010894897	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Gastrointestinal necrosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Intestinal obstruction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peritonitis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010894899	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894901	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (3397min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894902	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010894904	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Feeling cold (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894906	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894907	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010894908	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Breast swelling (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894909	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894911	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010894912	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure congestive (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 2.5mg - n/a - More in ICSR])|ENTRESTO [VALSARTAN, SACUBITRIL] (C - Cardiac failure congestive - n/a - [170d - n/a - Oral])|SAMSCA [TOLVAPTAN] (C - Cardiac failure congestive - n/a - [418d - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Cardiac failure congestive - n/a - [54mo - n/a - Oral])|[CASSIA, SENNA GLYCOSIDES STANDARDIZED 60%, SENNOSIDES CALCIUM SALTS] (C - Constipation - n/a - [210d - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [334d - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [540d - n/a - Oral])|[TAK 438] (C - Gastric ulcer - n/a - [1233d - n/a - Oral])|[URSODEOXYCHOLIC ACID] (C - Cholelithiasis - n/a - [542d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010894912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010895015	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895018	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895019	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895025	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspepsia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Exfoliative rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nasal congestion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895045	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895048	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Haematochezia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (5d - Recovered/Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010895053	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895056	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haematoma (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895061	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895065	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Myocardial strain imaging (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Pulmonary infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895066	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895068	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895069	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010895076	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895080	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895083	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenopia (n/a - Not Recovered/Not Resolved - Disabling);Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling abnormal (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Optic neuritis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[CHLORPHENAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN, IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010895084	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Apathy (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BACLOFEN] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895094	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895097	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895104	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleuropericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895108	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypokinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Left ventricular dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Splenomegaly (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895122	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea exertional (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895125	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895128	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895141	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - 25mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895143	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Unknown - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Unknown - Disabling);Vision blurred (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010895151	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Disorientation (n/a - Unknown - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010895156	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895162	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895173	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895296	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895319	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Visual analogue scale (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895320	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895327	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRABEGRON] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895334	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895336	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sputum abnormal (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895344	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895345	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypertension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tonic convulsion (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010895346	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895347	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895353	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895355	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - );Gait inability (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895359	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895361	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895364	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895369	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895375	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Ejection fraction decreased (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895377	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895380	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895381	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895384	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895387	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Depression (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010895391	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895394	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cauda equina syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Lumbar puncture (n/a - Recovering/Resolving - Other Medically Important Condition);Myelitis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895396	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895397	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895405	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895407	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895417	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Presyncope (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895422	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895423	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypophagia (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895428	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895433	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Myocardial fibrosis (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010895465	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Monoplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010895468	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Antiphospholipid syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895469	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895477	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895484	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895485	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (15min - Recovered/Resolved - );Syncope (15min - Recovered/Resolved - Other Medically Important Condition);Vision blurred (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895488	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895494	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune hepatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperthyroidism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895495	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895496	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymph node pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895497	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895498	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895499	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895501	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895502	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895505	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895506	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895518	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lip oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Skin burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895520	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895521	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895522	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895524	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895525	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895527	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895531	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Nasal congestion (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895532	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895534	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895535	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895539	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895543	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Feeding disorder (n/a - Not Recovered/Not Resolved - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - );Hepatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - );Odynophagia (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Right atrial enlargement (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895545	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Encephalitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Meningitis aseptic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895547	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895548	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895550	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895553	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895558	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus bradycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895562	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895563	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895571	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895572	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895574	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895575	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Atypical pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bronchitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac failure congestive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypervolaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rales (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895597	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Myopericarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895598	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895601	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Sinus bradycardia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LACTULOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895606	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895612	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895613	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895616	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895617	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatosplenomegaly (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypocalcaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle tightness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895620	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895624	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895625	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895626	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Sinus tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895628	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895629	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895632	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895636	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895643	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895649	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895653	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895654	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Endocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895656	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895661	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895662	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895667	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895670	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895672	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysuria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Rash pruritic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary retention (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[BUPRENORPHINE] (S - Drug withdrawal maintenance therapy - Dose not changed - [n/a - 24mg - Subcutaneous - More in ICSR])	BUPRENORPHINE [BUPRENORPHINE] (C - Drug withdrawal maintenance therapy - n/a - [n/a - 2mg - Sublingual])|LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895673	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895674	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895679	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Myocardial injury (n/a - Recovered/Resolved - Other Medically Important Condition);Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895684	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895685	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Burning sensation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895686	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895687	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rhinovirus infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus bradycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895688	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Impaired quality of life (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895692	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895695	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895696	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895698	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895703	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895711	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (21d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010895720	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - );Pleuritic pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895724	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895726	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - Other Medically Important Condition);Eye irritation (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle swelling (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OMEPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895751	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895753	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895774	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895803	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Malaise (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010895804	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895864	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895868	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895871	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis chronic (n/a - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895874	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010895887	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895891	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895896	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895898	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Petit mal epilepsy (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895908	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895913	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovered/Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895918	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895919	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895927	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ventricular extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895937	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895947	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Dysarthria (1d - Recovered/Resolved - Other Medically Important Condition);Dystonia (1d - Recovered/Resolved - );Formication (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895948	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	CLOPIDOGREL BESILATE [CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895959	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010895960	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010895966	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895967	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895974	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010895980	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895982	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895984	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010895986	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895994	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Glossopharyngeal neuralgia (2mo - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010895996	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010895996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896000	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896014	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896017	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (8d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896020	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896022	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal colic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896027	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Tonic convulsion (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896029	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Testicular disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896033	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Visual acuity reduced (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896037	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010896039	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary infarction (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896041	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896045	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896053	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010896063	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Asthenia (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896075	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896077	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010896083	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896084	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Relapsing-remitting multiple sclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896086	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896088	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (5d - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - );Leukopenia (66d - Recovered/Resolved - Other Medically Important Condition);Thrombocytopenia (66d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896090	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896131	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Retinal haemorrhage (n/a - Not Recovered/Not Resolved - Disabling);Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010896132	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Adenovirus reactivation (n/a - Recovered/Resolved - Disabling);Keratitis viral (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [189d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010896138	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactoid reaction (1d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010896145	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[IRBESARTAN] (C - Hypertension - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896155	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896159	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896181	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896193	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parkinsonian rest tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896195	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896197	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896213	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (137d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896214	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896217	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896246	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010896247	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896248	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010896249	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010896260	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Shock (n/a - Fatal - Results in Death);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010896261	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertensive crisis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896266	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896267	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010896268	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896272	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (7d - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896280	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])|[PARACETAMOL] (S - Pain - Drug withdrawn - [n/a - n/a - Oral])	SITAGLIPTIN [SITAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUINAPRIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896283	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896286	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ecchymosis (10d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896290	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral paralysis (21d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[TRANDOLAPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896292	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010896305	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896308	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (119d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896312	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Keratitis (86d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|OZEMPIC [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ANETHOLE TRITHIONE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, FERROUS SULFATE, FERROUS SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[AZELASTINE, AZELASTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), CALCIUM, CHOLECALCIFEROL CONCENTRATE, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[KETOTIFEN, KETOTIFEN HYDROGEN FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL 4000] (C - n/a - n/a - [n/a - n/a - n/a])|[MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMETICONE, PHLOROGLUCINOL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM CROMOGLICATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010896325	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896336	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Adult	No	Male	Cerebellar stroke (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - )|FEBUXOSTAT [FEBUXOSTAT] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - )|[LACTITOL, LACTITOL MONOHYDRATE] (C - n/a - n/a - )|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )|[OXYCODONE, OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - )|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010896343	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896344	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896357	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (4d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896364	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary bulla (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiration abnormal (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896365	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010896366	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiration abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896385	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010896386	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896390	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896391	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896419	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896429	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896432	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (42d - Not Recovered/Not Resolved - );Rash (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010896461	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hallucination, olfactory (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896464	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896480	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896491	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - Disabling);Headache (1d - Recovering/Resolving - Disabling);Malaise (1d - Recovering/Resolving - Disabling);Pyrexia (1d - Recovering/Resolving - Disabling);Rhinorrhoea (1d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010896525	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896668	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896691	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hyposmia (n/a - Not Recovered/Not Resolved - );Nasal discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896696	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896707	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896719	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010896730	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hallucination (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896751	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896755	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896756	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysstasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypophagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rhabdomyolysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896790	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diplopia (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896857	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hypertension (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896862	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896867	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Blindness transient (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (0d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010896878	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Pemphigus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - 1[drp] - n/a])|[MOMETASONE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[RISEDRONATE SODIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896918	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896936	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovered/Resolved - );Heart rate increased (n/a - Unknown - );Malaise (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010896942	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010896956	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Blood uric acid (n/a - Unknown - );Lymph node pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010896957	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pemphigus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Mouth ulceration - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORDIAZEPOXIDE] (C - Folliculitis - n/a - [n/a - 5mg - n/a])|[DIAZEPAM] (C - Folliculitis - n/a - [n/a - 2mg - n/a])|[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Folliculitis - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - Folliculitis - n/a - [n/a - n/a - n/a])|[FLUCONAZOLE] (C - Folliculitis - n/a - [14d - 2mg - n/a])|[OXETACAINE] (C - Mouth ulceration - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896958	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatic steatosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Unresponsive to stimuli (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[AZILSARTAN] (C - n/a - n/a - [n/a - 40mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896960	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896963	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	REMSIMA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION [INFLIXIMAB] (C - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[METFORMIN] (C - n/a - n/a - [n/a - 500mg - Oral])|[METHOTREXATE] (C - n/a - n/a - [n/a - 15mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010896993	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010896993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010897017	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Orthopnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010897019	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspepsia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010897023	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	C-reactive protein increased (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);N-terminal prohormone brain natriuretic peptide increased (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Systemic lupus erythematosus (159h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897124	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - 16mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897150	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (S - Depression - Dose not changed - [n/a - 1{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897211	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010897216	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Night sweats (n/a - Unknown - Caused/Prolonged Hospitalisation);Prinzmetal angina (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897220	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Gastritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897222	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia oral (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897319	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amenorrhoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897336	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897338	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (1d - Recovered/Resolved - Other Medically Important Condition);Chest pain (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal chest pain (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Speech disorder (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897359	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[AMMONIUM GLYCYRRHIZATE, GLYCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AZELASTINE HYDROCHLORIDE, AZITHROMYCIN, AZITHROMYCIN DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLEMASTINE, CLEMASTINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEQUITAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLOPATADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Low density lipoprotein increased - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897364	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypokinesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Shoulder injury related to vaccine administration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897369	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Erythema (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010897373	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Disabling);Impaired work ability (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010897377	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897378	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897379	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897380	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897390	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010897441	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897445	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia totalis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897463	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injected limb mobility decreased (5mo - Not Recovered/Not Resolved - Disabling);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling);Skin discolouration (n/a - Recovered/Resolved - Disabling);Vaccination site swelling (5mo - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010897491	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897495	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Hemiparesis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hemiplegia (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myocarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pericarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Temperature intolerance (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010897576	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (71d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010897680	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eosinophil count increased (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Papule (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897695	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897700	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Glomerulonephritis rapidly progressive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);IgA nephropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Urinary occult blood positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897709	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897714	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Circulatory collapse (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010897719	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010897724	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (41d - Not Recovered/Not Resolved - );Fatigue (41d - Not Recovered/Not Resolved - );Headache (41d - Not Recovered/Not Resolved - );Nausea (41d - Not Recovered/Not Resolved - );Paraesthesia (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010897729	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymph node pain (0d - Unknown - );Lymphadenopathy (0d - Unknown - );Rash (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010897764	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010897822	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Subdural hygroma (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010897864	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fear (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010897869	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pneumothorax (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010897874	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Angioedema (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - );Cough (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Extensive swelling of vaccinated limb (n/a - Unknown - );Headache (n/a - Unknown - );Lethargy (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rash (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010897939	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Cerebrovascular accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010897939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010898026	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898110	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898164	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (5d - Recovered/Resolved - Other Medically Important Condition);Physical deconditioning (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[VENLAFAXINE HYDROCHLORIDE] (C - Adjustment disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898192	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (15min - Unknown - );Ocular hypertension (15min - Unknown - );Retinal vein occlusion (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE SODIUM, HYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010898195	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Biliary colic (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ENBREL 50 MG [ETANERCEPT] (C - n/a - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010898223	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898228	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010898229	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastroenteritis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898235	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chronic gastritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Empyema (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Gastrooesophageal reflux disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Hepatic cyst (n/a - Unknown - Caused/Prolonged Hospitalisation);Hepatic steatosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Lower respiratory tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung opacity (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphoma (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Mass (n/a - Unknown - Caused/Prolonged Hospitalisation);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nephrolithiasis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleural thickening (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Serum ferritin increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010898306	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Facial paralysis (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - );Vaccination site hypersensitivity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010898519	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898596	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TREMFYA [GUSELKUMAB] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898615	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat tightness (n/a - Not Recovered/Not Resolved - );Vaccination site hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010898616	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898631	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898652	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Clumsiness (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - );Wheezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010898668	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898672	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [61d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898692	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898696	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898723	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Unknown - [n/a - n/a - n/a])|[LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE HYDROCHLORIDE] (S - Rhinitis - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010898727	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematochezia (n/a - Unknown - Caused/Prolonged Hospitalisation);Intestinal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash papular (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010898785	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010898813	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Incontinence (4d - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sinusitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898825	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010898896	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema migrans (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[DOCUSATE SODIUM, GLYCEROL, DOCUSATE SODIUM, GLYCEROL 85%] (C - Constipation - n/a - [n/a - n/a - Rectal])|[PHENOXYMETHYLPENICILLIN POTASSIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898912	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovering/Resolving - Disabling);Extensive swelling of vaccinated limb (0d - Recovering/Resolving - Disabling);Fatigue (0d - Recovering/Resolving - Disabling);Headache (0d - Recovering/Resolving - Disabling);Injection site reaction (0d - Recovering/Resolving - Disabling);Myalgia (0d - Recovering/Resolving - Disabling);Pyrexia (0d - Recovering/Resolving - Disabling);Skin disorder (0d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010898919	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010898963	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010898963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899047	Spontaneous	2021-12-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010899118	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Echocardiogram abnormal (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010899174	Spontaneous	2021-12-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010899174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010873628	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873659	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Swelling (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010873671	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual acuity reduced (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010873700	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873706	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873734	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Poor quality sleep (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, OLMESARTAN, OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873754	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Parotid gland enlargement (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873776	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873779	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/60/2008, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008-LIKE VIRUS, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, NIB-121), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873800	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873811	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873813	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010873827	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010873828	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Conjunctivitis (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873838	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dysstasia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010873849	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873887	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873891	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873920	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010873982	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - n/a])	[ATENOLOL] (C - n/a - n/a - [n/a - 25mg - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 125ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874032	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Transaminases increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874048	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema nodosum (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874118	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874165	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Otitis media (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874213	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874218	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874230	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874272	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Gastrointestinal pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010874393	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Hyperpyrexia (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874409	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hepatic steatosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Unknown - Caused/Prolonged Hospitalisation);Myositis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874410	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Left ventricular failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874411	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary microemboli (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874415	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyarthritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874432	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retroperitoneal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874464	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874495	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874496	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874497	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874508	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874525	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Disabling);Anosmia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010874527	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874528	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874530	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874535	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Bone pain (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874544	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874547	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Oropharyngeal pain (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874552	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 1000mg - Oral])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874555	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Asthenia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874556	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010874564	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010874578	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874591	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010874668	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010874765	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Insomnia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010874894	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - Life Threatening, Other Medically Important Condition);Head discomfort (n/a - Unknown - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010874903	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010874907	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010874916	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (4d - Recovered/Resolved - );Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - );Influenza like illness (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874917	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874919	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010874924	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rosacea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010874941	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010874943	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010874945	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Pulse absent (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010874955	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010874958	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010874960	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthma (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010874960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875007	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Chest pain (0d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Feeling hot (n/a - Unknown - );Headache (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875008	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pH abnormal (132d - Recovered/Resolved With Sequelae - Life Threatening, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hypertension (n/a - Unknown - Life Threatening, Other Medically Important Condition);Malaise (n/a - Unknown - Life Threatening, Other Medically Important Condition);Peripheral embolism (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Life Threatening, Other Medically Important Condition);Rash (n/a - Unknown - Life Threatening, Other Medically Important Condition);Skin ulcer (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010875013	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Protein urine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875018	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875021	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875023	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875029	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875033	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875035	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DROSPIRENONE, ETHINYLESTRADIOL] (C - Contraception - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875037	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875038	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875041	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (24h - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875045	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875050	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875051	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010875053	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875188	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Conjunctival haemorrhage (n/a - Unknown - );Intentional dose omission (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010875293	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875294	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875298	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875299	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (16h - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875301	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adenovirus infection (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Still's disease (n/a - Unknown - Other Medically Important Condition);Synovitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875303	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hallucination (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010875316	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875318	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875321	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875322	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875335	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875338	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875383	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Amnesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010875384	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875386	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diabetes mellitus inadequate control (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INSULIN ASPART [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|INSULIN GLARGINE [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875397	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875398	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875399	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875400	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypopnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875410	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875432	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood test abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovering/Resolving - Other Medically Important Condition);Electrocardiogram QRS complex prolonged (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Exercise tolerance decreased (n/a - Unknown - Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);QRS axis abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[SELEGILINE] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875469	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Crohn's disease (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010875471	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875473	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - Aortic valve replacement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875726	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875733	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875735	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nephrotic syndrome (n/a - Recovered/Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875744	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875747	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875754	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875760	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Toxic skin eruption (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875777	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875779	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875781	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (22d - Recovered/Resolved - Other Medically Important Condition);Palpitations (22d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (22d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875811	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Cough (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Irritability (n/a - Recovering/Resolving - );Memory impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875820	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypnagogic hallucination (6d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (3d - Recovered/Resolved - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875845	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Unknown - );Chest pain (n/a - Unknown - );Muscular weakness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875847	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875848	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875849	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Overdose (n/a - Unknown - );Sudden cardiac death (n/a - Fatal - Results in Death);Syncope (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010875853	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875859	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875861	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875867	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Impaired work ability (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010875871	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875873	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875879	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875881	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875884	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperventilation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash macular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010875887	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010875898	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (1455min - Recovered/Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - );Vaccination site vesicles (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875899	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Body temperature abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomegaly (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010875902	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875903	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875911	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010875912	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010875948	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Encephalitis autoimmune (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010875948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010876097	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (5d - Recovered/Resolved - Other Medically Important Condition);Fatigue (5d - Recovered/Resolved - Other Medically Important Condition);Headache (5d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (5d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876099	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010876100	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010876145	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876165	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876167	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876170	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876171	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876200	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis acneiform (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876417	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876422	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876429	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876434	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (1wk - Recovered/Resolved - );Chills (1wk - Recovered/Resolved - );Fatigue (1wk - Recovered/Resolved - );Headache (1wk - Recovered/Resolved - );Myalgia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876436	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876438	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876449	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010876452	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876460	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010876473	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010876475	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL BP, DIPHENHYDRAMINE HYDROCHLORIDE BP, CAFFEINE BP, PHENYLEPHRINE HYDROCHLORIDE BP, CODEINE PHOSPHATE BP] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010876594	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876632	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876637	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Inflammatory marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Night sweats (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Organising pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010876643	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876647	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010876650	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876656	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876674	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Not Recovered/Not Resolved - );COVID-19 immunisation (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - Disabling);Limb discomfort (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Periarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [ELASOMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010876689	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876712	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876753	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010876776	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site bruising (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010876859	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (78d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010876922	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876925	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010876945	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010876945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877050	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Unknown - Disabling);Dizziness (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Injection site reaction (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010877067	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877068	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );International normalised ratio increased (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877069	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010877073	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877075	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877081	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877084	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877085	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010877086	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877094	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877096	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877107	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877110	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Sinus bradycardia (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[OLMESARTAN MEDOXOMIL, AMLODIPINE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877112	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877120	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed mood (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nightmare (1d - Recovered/Resolved - );Status epilepticus (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877121	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877122	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (3wk - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877123	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877124	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877138	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877143	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Flank pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877147	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877150	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877151	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877155	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Myofascial pain syndrome (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877157	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877159	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877165	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Unknown - );Oedema peripheral (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877166	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart failure with reduced ejection fraction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hyperglycaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoperfusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Left ventricular dilatation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Left ventricular dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Right ventricular dilatation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tricuspid valve incompetence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ventricular tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877169	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877170	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insulin resistance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877178	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired quality of life (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877179	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877180	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877183	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877185	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877194	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877197	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (3d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877198	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877199	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877202	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dysphagia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Loss of personal independence in daily activities (n/a - Unknown - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877204	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877205	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Atrioventricular block second degree (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Liver function test increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877206	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877207	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chronic obstructive pulmonary disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877210	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood immunoglobulin E increased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Unknown - );Gamma-glutamyltransferase increased (n/a - Unknown - );Headache (n/a - Unknown - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[AMLODIPINE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BILASTINE] (C - Urticaria - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FLURBIPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[LIMAPROST ALFADEX] (C - n/a - n/a - [n/a - n/a - Oral])|[PEMAFIBRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877213	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877226	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Pleuritic pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877231	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877232	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Sluggishness (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877233	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877242	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877244	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877249	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877250	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877252	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Cerebral haemorrhage (n/a - Fatal - Results in Death);Cerebral ventricular rupture (n/a - Fatal - Results in Death, Other Medically Important Condition);Depressed level of consciousness (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Endotracheal intubation (n/a - Unknown - );Hypertensive emergency (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 5mg - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - 4mg - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - 5mg - n/a])|[LANSOPRAZOLE] (C - Gastrostomy - n/a - [n/a - 15mg - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - 1g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010877255	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877257	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877261	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877263	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877273	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomegaly (n/a - Recovering/Resolving - );Cardiomyopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877278	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877281	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877287	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - );Premature baby (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010877288	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877295	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sepsis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Septic shock (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877297	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Testis discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877299	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Movement disorder (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877303	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877306	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877311	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (20min - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Sinus tachycardia (1d - Recovered/Resolved - Other Medically Important Condition);Ventricular tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EDOXABAN [EDOXABAN] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|ENTRESTO [VALSARTAN, SACUBITRIL] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza - n/a - [1d - n/a - n/a])|[ATORVASTATIN] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac failure - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Cardiac failure - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877312	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877313	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877315	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tonsillitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877319	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Arthritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Atelectasis (n/a - Unknown - Caused/Prolonged Hospitalisation);Generalised oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation);Ocular hyperaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877322	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010877323	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877325	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877331	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877333	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877334	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paresis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877335	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dry skin (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Not Recovered/Not Resolved - );Skin warm (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877369	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Unknown - );Respiratory tract irritation (n/a - Not Recovered/Not Resolved - );Sinusitis (n/a - Unknown - );Wheezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010877440	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877441	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877450	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877455	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877479	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Urticaria (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010877483	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hyperacusis (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOMETHADONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 3.5mL - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877564	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Constipation (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Diplegia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dysaesthesia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dysphagia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hepatitis E (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary oedema (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Urinary retention (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Vocal cord paralysis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[MINOXIDIL] (C - Alopecia - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010877621	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );SARS-CoV-2 antibody test negative (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	OCREVUS [OCRELIZUMAB] (C - Primary progressive multiple sclerosis - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[OXCARBAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877722	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral coldness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sciatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010877763	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877807	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (60d - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010877815	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010877885	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010877889	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (1mo - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1mo - Recovered/Resolved - Other Medically Important Condition);Malaise (1mo - Recovered/Resolved - Other Medically Important Condition);Toothache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010877902	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BUDESONIDE, BUDESONIDE, MICRONISED] (C - n/a - n/a - [95d - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [95d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877909	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - );Exposure via breast milk (n/a - Not Recovered/Not Resolved - );Faeces discoloured (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877915	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Polymerase chain reaction positive (11d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877916	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877931	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877935	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010877975	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010877996	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010877996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878031	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878048	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (13d - Recovered/Resolved - );Dyspepsia (163d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Sleep disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010878106	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878116	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Grip strength decreased (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878125	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878133	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Odynophagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oesophageal irritation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oesophageal oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pharyngeal oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [88d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010878243	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );SARS-CoV-2 antibody test negative (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	OCREVUS [OCRELIZUMAB] (C - Relapsing-remitting multiple sclerosis - n/a - [n/a - 600mg - Intravenous (not otherwise specified)])|[CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, COLECALCIFEROL CONCENTRATE (OILY FORM)] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST, TIMOLOL, TIMOLOL MALEATE, LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[MENATETRENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 0mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878314	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiovascular disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nervous system disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010878320	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878333	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878364	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Somnolence (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878374	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fine motor skill dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010878403	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac murmur (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010878404	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878443	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aspiration (n/a - Not Recovered/Not Resolved - Disabling);Dysphagia (n/a - Not Recovered/Not Resolved - Disabling);Dysphonia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hypertrophy (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Night sweats (n/a - Not Recovered/Not Resolved - Disabling);Stenosis (n/a - Not Recovered/Not Resolved - Disabling);Weight increased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878493	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878568	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878597	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878639	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010878676	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010878682	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[MICRONISED SPIRONOLACTONE, POTASSIUM CANRENOATE, SPIRONOLACTONE, SPIRONOLACTONE BP] (C - n/a - n/a - [n/a - n/a - Oral])|[PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878691	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Unknown - );Application site pain (n/a - Unknown - );Ear discomfort (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878700	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878703	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878705	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878706	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878713	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hepatitis acute (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010878717	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878757	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010878764	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010878901	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878909	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878911	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (8d - Recovered/Resolved - );Tachycardia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010878941	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Hypoaesthesia (34d - Not Recovered/Not Resolved - );Injection site erythema (1d - Recovering/Resolving - );Injection site pain (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010878942	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diverticulitis (14d - Recovered/Resolved - );Pyrexia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878943	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (88d - Not Recovered/Not Resolved - );Dyspnoea (88d - Not Recovered/Not Resolved - );Fatigue (88d - Not Recovered/Not Resolved - );Limb discomfort (88d - Not Recovered/Not Resolved - );Pyrexia (88d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010878963	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878965	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (11d - Not Recovered/Not Resolved - );Depression (11d - Not Recovered/Not Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - );Hyperhidrosis (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878970	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (25d - Recovering/Resolving - );Disturbance in attention (25d - Recovering/Resolving - );Dizziness (25d - Not Recovered/Not Resolved - );Headache (24d - Recovering/Resolving - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010878975	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878994	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Not Recovered/Not Resolved - );Dizziness (1d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010878995	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010878995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879001	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879004	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Tinnitus (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879012	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blepharospasm (1d - Unknown - );Blood urine present (1d - Unknown - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (1d - Unknown - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879031	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - );Oropharyngeal pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879041	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (52d - Not Recovered/Not Resolved - );Tachycardia (52d - Not Recovered/Not Resolved - );Ventricular extrasystoles (52d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879042	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (66d - Not Recovered/Not Resolved - );Limb discomfort (66d - Not Recovered/Not Resolved - );Myalgia (66d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010879047	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879050	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (4d - Not Recovered/Not Resolved - );Nasopharyngitis (4d - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879074	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (20d - Recovered/Resolved With Sequelae - );Cough (20d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010879081	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (11d - Not Recovered/Not Resolved - );Dizziness (11d - Not Recovered/Not Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879082	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010879090	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879107	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010879120	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879121	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved With Sequelae - );Paraesthesia (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010879162	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Autoimmune arthritis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010879166	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Oral herpes (2d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879170	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovering/Resolving - );Paraesthesia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879173	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Head discomfort (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879182	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010879184	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (33d - Not Recovered/Not Resolved - );Fatigue (33d - Not Recovered/Not Resolved - );Limb discomfort (34d - Not Recovered/Not Resolved - );Myalgia (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010879186	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (9d - Recovered/Resolved - );Injection site erythema (7d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879188	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Weight bearing difficulty (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879190	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (14d - Recovering/Resolving - );Myalgia (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879191	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010879195	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010879206	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Sudden hearing loss (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879219	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879226	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Interstitial lung disease (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010879255	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Nervous system disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral nerve paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010879259	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879268	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879282	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Tinnitus (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879284	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (49d - Not Recovered/Not Resolved - );Muscle rupture (49d - Not Recovered/Not Resolved - );Muscle strain (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010879291	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (47d - Not Recovered/Not Resolved - );Dizziness (47d - Not Recovered/Not Resolved - );Palpitations (47d - Not Recovered/Not Resolved - );Tinnitus (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879311	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879321	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010879332	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (7d - Recovering/Resolving - );Malaise (7d - Recovering/Resolving - );Menstrual disorder (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879334	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010879343	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879349	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (56d - Not Recovered/Not Resolved - );Hyperhidrosis (56d - Not Recovered/Not Resolved - );Limb discomfort (56d - Not Recovered/Not Resolved - );Myalgia (56d - Not Recovered/Not Resolved - );Pyrexia (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010879353	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (12d - Not Recovered/Not Resolved - );Influenza (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879356	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010879370	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - );Cough (6d - Recovered/Resolved - );Dyspnoea (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879383	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - );Tachycardia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010879530	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879679	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010879684	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010879940	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Anxiety (n/a - Unknown - );Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BILASTINE] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010879976	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010879976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880004	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (4d - Recovering/Resolving - Disabling);Chills (4d - Recovering/Resolving - Disabling);Fatigue (4d - Recovering/Resolving - Disabling);Headache (4d - Recovering/Resolving - Disabling);Malaise (4d - Recovering/Resolving - Disabling);Myalgia (4d - Recovering/Resolving - Disabling);Nausea (4d - Recovering/Resolving - Disabling);Pyrexia (4d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880024	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DIAZEPAM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880044	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880086	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Headache (2d - Recovered/Resolved - Disabling);Injection site reaction (2d - Recovered/Resolved - Disabling);Nausea (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880107	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rhinitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])|[COLCHICINE] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880198	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Unknown - Disabling);Haematoma (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Vein discolouration (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010880204	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Injection site pain (n/a - Recovering/Resolving - Disabling);Lymphadenopathy (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880306	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Unknown - );Erythema (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880329	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - Disabling);Shoulder injury related to vaccine administration (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880334	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880335	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	VITAPRO [NOT AVAILABLE] (C - n/a - n/a - )|[GLUCOSAMINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880339	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	CALANUS [NOT AVAILABLE] (C - n/a - n/a - )|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CLOPIDOGREL] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880372	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880373	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nasal congestion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880374	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880375	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sinus bradycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880379	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (24h - Recovered/Resolved - );Pyrexia (22h - Recovered/Resolved - );Tremor (22h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880382	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880386	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880389	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880391	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLOBENZAPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880401	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010880404	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880407	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Impaired quality of life (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880409	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880413	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880415	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880418	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drooling (n/a - Unknown - );Multiple sclerosis (n/a - Unknown - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Unknown - );Sickle cell disease (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880420	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880421	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880423	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880426	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovering/Resolving - Disabling);Parosmia (n/a - Recovering/Resolving - Disabling);Taste disorder (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010880429	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Pallor (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880438	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypokinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880440	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Youn, T.. Cytotoxic Lesion of the Corpus Callosum (CLOCCs) after SARS-CoV-2 mRNA Vaccination. J Korean Med Sci. 2021;36(31):10.3346/jkms.2021.36.e228. doi:10.3346/jkms.2021.36.e228	18-64 Years	Not Specified	No	Male	Central nervous system lesion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880442	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880443	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880449	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880451	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Stress cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880454	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880455	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880460	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880468	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypereosinophilic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880492	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (6d - Recovered/Resolved - );Feeling abnormal (3d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880497	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Premature baby (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010880499	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])|[L-TRYPTOPHAN, TRYPTOPHAN] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALERIAN OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880509	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880523	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (16h - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (16h - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880567	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Malaise (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010880607	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure measurement (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Dysaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Hyperaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Muscle contracture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Tremor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880643	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (1d - Recovered/Resolved - );Sleep disorder (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880650	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880651	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abscess (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Alopecia (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Folliculitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Furuncle (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880656	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880660	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Balance disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysarthria (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880664	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010880669	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880675	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );Dysstasia (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Grip strength decreased (n/a - Unknown - );Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Periorbital swelling (n/a - Unknown - );Pruritus (n/a - Unknown - );Sensory disturbance (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880681	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880686	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage subcutaneous (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Skin exfoliation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880689	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880700	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880707	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tendonitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880709	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880714	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Unknown])	DULAGLUTIDE [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880719	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Artery dissection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Coeliac artery stenosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Splenic infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880721	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Injection site pain (n/a - Recovered/Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - Intramuscular])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880724	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - );Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhinorrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880726	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute sinusitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dehydration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880733	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880741	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880744	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Muscle tightness (n/a - Unknown - );Myalgia (n/a - Unknown - );Respiratory disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880746	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Bell's palsy (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880749	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880750	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Campylobacter colitis (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (11d - Recovered/Resolved - );Enterocolitis haemorrhagic (n/a - Recovering/Resolving - Other Medically Important Condition);Haematochezia (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880756	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (35d - Recovered/Resolved With Sequelae - );Headache (35d - Recovered/Resolved With Sequelae - );Myalgia (35d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010880773	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Insomnia (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880776	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (51d - Not Recovered/Not Resolved - );Feeling hot (51d - Not Recovered/Not Resolved - );Limb discomfort (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010880779	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880788	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death, Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death, Other Medically Important Condition);Fatigue (n/a - Unknown - );Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Lethargy (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition);Sputum discoloured (n/a - Fatal - Results in Death, Other Medically Important Condition);Walking disability (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010880794	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880806	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880808	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880811	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880812	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - );Immunisation (n/a - Unknown - );Physical disability (n/a - Unknown - );Supraventricular extrasystoles (n/a - Unknown - );Ventricular extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880823	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactoid reaction (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880828	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate decreased (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010880830	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypophagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880832	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hepatic cirrhosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Prostate cancer (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010880842	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010880852	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes dermatitis (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880856	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880857	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Joint swelling (109d - Recovered/Resolved With Sequelae - );Limb discomfort (n/a - Recovered/Resolved With Sequelae - );Rheumatic disorder (109d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010880858	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (47d - Recovering/Resolving - );Syncope (47d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880861	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880866	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (33d - Recovering/Resolving - );Fatigue (33d - Recovering/Resolving - );Headache (33d - Recovering/Resolving - );Malaise (33d - Recovering/Resolving - );Muscle spasms (33d - Recovering/Resolving - );Myalgia (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880876	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880888	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Renal failure (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880893	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heart rate increased (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880895	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880913	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (7d - Recovering/Resolving - );Pyrexia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880921	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Malaise (5d - Not Recovered/Not Resolved - );Sleep disorder (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880926	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (59d - Not Recovered/Not Resolved - );Dyspnoea exertional (59d - Not Recovered/Not Resolved - );Fatigue (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880930	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (13d - Not Recovered/Not Resolved - );Dizziness (0d - Unknown - );Headache (15d - Not Recovered/Not Resolved - );Influenza (16d - Not Recovered/Not Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Nasopharyngitis (16d - Not Recovered/Not Resolved - );Ocular hyperaemia (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880948	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Blood pressure increased (30min - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Heart rate increased (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010880953	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880961	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Gastric dilatation (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880962	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Influenza (1d - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880966	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010880988	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880989	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010880994	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010880994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881202	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coagulopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral artery thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - Unknown - [n/a - 500mg - n/a])|[RAMIPRIL] (C - n/a - Unknown - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881272	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881276	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881281	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881283	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881284	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881314	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881317	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Biopsy kidney abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Oesophageal perforation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Purulence (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Quadriplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010881323	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Photopsia (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition);Vitreous floaters (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881325	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881327	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881333	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Inflammatory pain (n/a - Unknown - Other Medically Important Condition);Joint injury (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Tendon discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881336	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Obsessive-compulsive disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881337	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881339	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881340	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CLARITHROMYCIN] (C - Infected bite - n/a - [5d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881341	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010881357	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881360	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881374	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881375	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Diarrhoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injection site pain (3d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881376	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881380	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881381	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - Life Threatening);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening);Urinary incontinence (n/a - Recovered/Resolved - Life Threatening);Vomiting (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010881384	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Heart rate abnormal (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Influenza like illness (n/a - Unknown - Disabling);Lethargy (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling);Tachycardia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrioventricular block - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULPHATE BP] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010881393	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881395	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ear pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881428	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881429	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881433	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Impaired quality of life (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[MINOCYCLINE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881436	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881438	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Myelitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENBREL [ETANERCEPT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881442	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881444	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (11d - Recovered/Resolved - );Headache (n/a - Unknown - );Lymphadenitis (17d - Recovered/Resolved - );Lymphadenopathy (13d - Recovered/Resolved - );Neutrophil percentage decreased (n/a - Unknown - Other Medically Important Condition);Pyrexia (382h - Recovered/Resolved - );White blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881455	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881456	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881458	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Exercise tolerance decreased (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010881460	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Aortic dissection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coronary artery stenosis (n/a - Unknown - Other Medically Important Condition);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Myocardial ischaemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia aspiration (n/a - Recovering/Resolving - Other Medically Important Condition);Renal impairment (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881464	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Breast swelling (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881496	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881498	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881502	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881510	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bedridden (n/a - Not Recovered/Not Resolved - Disabling);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881512	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ecchymosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Gingival bleeding (n/a - Unknown - Caused/Prolonged Hospitalisation);Haematochezia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pharyngeal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Platelet count decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Skin haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881513	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Splenomegaly (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ventricular dysfunction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881515	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881521	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881535	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881540	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	VIMPAT [LACOSAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881542	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881624	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881732	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Hypoaesthesia (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Paraesthesia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010881738	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881740	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881741	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881747	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (12d - Not Recovered/Not Resolved - );Myalgia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881752	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (32d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010881762	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010881785	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881790	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010881795	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010881799	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Disabling)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010881851	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombocytopenia (32d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881854	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881856	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Urinary incontinence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881858	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881862	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881871	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010881880	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881884	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Concussion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Craniofacial fracture (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye contusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fall (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mass (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in jaw (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881893	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SOLIFENACIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010881898	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Bursitis (n/a - Recovering/Resolving - Disabling);Condition aggravated (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Sleep disorder (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	XGEVA [DENOSUMAB] (C - Neoplasm malignant - n/a - [n/a - n/a - Subcutaneous])|ZYTIGA [ABIRATERONE ACETATE] (C - Neoplasm malignant - n/a - [n/a - 1000mg - Oral])|[LEUPRORELIN, LEUPRORELIN ACETATE] (C - Neoplasm malignant - n/a - [n/a - n/a - Intramuscular])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 25mg - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010881899	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial necrosis marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Toothache (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010881919	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010881920	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010881923	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010881923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882034	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882040	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882062	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Balance disorder (1wk - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (10d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (7d - Recovered/Resolved - );Vertigo (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882073	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Phantosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 400ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882088	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882092	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Physical deconditioning (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 10mg - Oral])|[BENZBROMARONE] (C - Hyperuricaemia - n/a - [n/a - 25mg - Oral])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 12.5mg - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - 660mg - Oral])|[PILSICAINIDE HYDROCHLORIDE] (C - Arrhythmia - n/a - [n/a - 150mg - Oral])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010882162	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882165	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [67d - 3{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882175	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882178	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Sudden death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010882181	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882196	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882197	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882205	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Head injury (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882211	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardio-respiratory arrest (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Seizure (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010882214	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - );Phlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882223	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (72h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (72h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882231	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882233	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Petit mal epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [107d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882234	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882235	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis (n/a - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	STELARA 130 MG CONCENTRATE FOR SOLUTION FOR INFUSION [USTEKINUMAB] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882249	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vestibular neuronitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882262	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882264	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882266	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (29d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882267	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882270	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882275	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882276	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peritonitis bacterial (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882281	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	CLOPIDOGREL BESILATE [CLOPIDOGREL BESILATE] (C - Ischaemic cardiomyopathy - Unknown - [n/a - 75mg - Oral])|FORXIGA 10 MG FILM-COATED TABLETS [DAPAGLIFLOZIN] (C - Type 2 diabetes mellitus - Unknown - [n/a - n/a - Oral])|IRBESARTAN [IRBESARTAN] (C - Hypertension - Unknown - [n/a - 150mg - Oral])|NOVOMIX 30 100 U/ML SUSPENSION FOR INJECTION [INSULIN ASPART, INSULIN ASPART PROTAMINE] (C - Type 2 diabetes mellitus - Unknown - [n/a - 41[iU] - Subcutaneous])|[ALLOPURINOL] (C - Hyperuricaemia - Unknown - [n/a - 100mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Hypercholesterolaemia - Unknown - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Chronic kidney disease - Unknown - [n/a - 40mg - Oral])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - Unknown - [n/a - 75ug - Oral])|[METOPROLOL FUMARATE] (C - Hypertension - Unknown - [n/a - n/a - Oral])|[NORFLOXACIN] (C - Urinary tract infection - Unknown - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882282	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882283	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882293	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882307	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[DIPHTHERIA TOXOID, TETANUS TOXOID, POLIOMYELITIS VIRUS (INACTIVATED) TYPE 1 PRODUCED IN VERO CELLS, POLIOMYELITIS VIRUS (INACTIVATED) TYPE 2 PRODUCED IN VERO CELLS, POLIOMYELITIS VIRUS (INACTIVATED) TYPE 3 PRODUCED IN VERO CELLS, ALUMINIUM HYDROXIDE, DIPHTHERIA TOXOID, TETANUS TOXOID, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS, ALGELDRATE] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010882309	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [22d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010882314	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glaucoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Posterior capsule opacification (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882315	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882318	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882330	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])|EUCREAS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (S - Diabetes mellitus - Drug withdrawn - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882334	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882341	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guttate psoriasis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882347	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882359	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Trisomy 21 (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010882368	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster meningoradiculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882369	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Formication (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gait inability (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882372	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Miller Fisher syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882379	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882384	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Generalised tonic-clonic seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882385	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882392	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Intervertebral discitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Septic arthritis staphylococcal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882399	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (1d - Recovered/Resolved - Other Medically Important Condition);Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010882493	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882495	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arterial occlusive disease (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010882496	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (110d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010882512	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (8d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Malaise (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - 1{DF} - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010882579	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (6d - Recovered/Resolved - );Palpitations (6d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010882619	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882670	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (5d - Recovering/Resolving - );Myalgia (5d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882710	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ROSUVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882719	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular hypokinesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882732	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired quality of life (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882738	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882740	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Mucke, V.. First description of immune complex vasculitis after COVID-19 vaccination with BNT162b2: a case report.. BMC Infectious Diseases. 2021;21(1):10.1186/s12879-021-06655-x. doi:10.1186/s12879-021-06655-x	65-85 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882793	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010882815	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882819	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882821	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Mental fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882836	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882843	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Amnesia (0d - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010882844	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleuritic pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882865	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010882943	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010882944	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882951	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882956	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 1.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010882957	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Torticollis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010882986	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010882990	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010882992	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010882992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010883004	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010883005	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883006	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010883007	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010883033	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883036	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883046	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Balance disorder (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883065	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - Anticoagulant therapy - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883072	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883074	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883085	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883086	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010883098	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Tendon disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883117	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883122	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010883124	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (1d - Recovered/Resolved - );Immunisation reaction (24h - Recovered/Resolved - );Micturition urgency (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[HYDROCHLOROTHIAZIDE, NEBIVOLOL, HYDROCHLOROTHIAZIDE, NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883141	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1mo - Recovered/Resolved - );Headache (1mo - Recovered/Resolved - );Sleep disorder (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883142	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1wk - Recovered/Resolved - );Headache (48h - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883143	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883160	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amaurosis fugax (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883162	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883163	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883165	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883168	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883173	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883180	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883189	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883190	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883194	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (40min - Recovered/Resolved - );Paraesthesia (40min - Recovered/Resolved - );Presyncope (40min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883200	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883213	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovered/Resolved - );Hallucination (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Insomnia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883224	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Post herpetic neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883245	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883249	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883252	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883255	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883260	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883264	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cervicobrachial syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883283	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883284	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883289	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Sneezing (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883292	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883294	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883296	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883321	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883337	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883341	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883342	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883353	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883355	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883356	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acrodermatitis enteropathica (3d - Recovered/Resolved - );Disease recurrence (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883358	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Delirium (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883359	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883362	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883367	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883370	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883380	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883382	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883385	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Photophobia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883389	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883391	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - );Sneezing (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883401	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883408	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883409	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[VALERIAN EXTRACT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883418	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883420	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883423	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883429	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883433	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883437	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883438	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883445	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883446	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883449	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883454	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883455	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883458	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883461	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883465	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883468	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883469	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883470	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883482	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883488	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883489	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883491	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883492	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883495	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883498	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883501	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883503	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883508	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883511	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883518	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883522	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883526	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883528	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883529	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883530	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883544	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Breast pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883556	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883558	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COVID-19 MRNA VACCINE MODERNA (CX-024414) [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - Not applicable - [29d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883559	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883565	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883573	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Recovered/Resolved - );Tongue oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883576	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883605	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (2d - Recovered/Resolved - );Axillary pain (2h - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883609	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (6d - Recovering/Resolving - );Pain in extremity (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883632	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883633	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883640	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [20d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883654	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883655	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis bullous (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010883657	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010883667	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883670	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883676	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (15d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883691	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Disabling);Glaucomatocyclitic crises (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Intraocular pressure increased (n/a - Recovering/Resolving - Disabling);Iritis (n/a - Recovered/Resolved - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Plantar fasciitis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010883763	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - Other Medically Important Condition);Laryngeal oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Total lung capacity decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010883793	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010883797	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010883800	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Autoantibody positive (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - );Brain fog (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - );Post-acute COVID-19 syndrome (n/a - Not Recovered/Not Resolved - );Visual acuity reduced (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010883804	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010883824	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883826	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erysipelas (n/a - Unknown - );Swollen tongue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CRANBERRY] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERNA CANALICULUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883836	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883840	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Hyposmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883842	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010883913	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (2d - Recovered/Resolved - );Brain fog (2d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010883913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010884004	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Appendicitis (187d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884250	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Intestinal infarction (n/a - Fatal - Results in Death);Intestinal ischaemia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010884412	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Insulin-requiring type 2 diabetes mellitus - n/a - )|LEVEMIR [INSULIN DETEMIR] (C - Type 2 diabetes mellitus - n/a - )|NOVORAPID [INSULIN ASPART] (C - Type 2 diabetes mellitus - n/a - )|[AMISULPRIDE] (C - Schizoaffective disorder - n/a - )|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - )|[BECLOMETASONE, BECLOMETASONE DIPROPIONATE] (C - Hypersensitivity - n/a - )|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - )|[FENOFIBRATE MICRONISED] (C - n/a - n/a - )|[INFLUENZA VIRUS] (C - Influenza - n/a - )|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - )|[PROMETHAZINE HYDROCHLORIDE] (C - n/a - n/a - )|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - )|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Schizoaffective disorder depressive type - n/a - )|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884439	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010884478	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884479	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884482	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884489	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884494	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint stiffness (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010884503	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010884504	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Irregular breathing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product use issue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884519	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Recovering/Resolving - );Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (1wk - Recovered/Resolved - );Chest pain (n/a - Recovering/Resolving - );Chills (1wk - Recovered/Resolved - );Dry mouth (n/a - Recovering/Resolving - );Eye irritation (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hair texture abnormal (n/a - Recovering/Resolving - );Headache (3wk - Recovered/Resolved - );Injection site inflammation (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site warmth (3d - Recovered/Resolved - );Lip dry (n/a - Recovering/Resolving - );Lip swelling (2d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1wk - Recovered/Resolved - );Pain (2wk - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - );Pyrexia (1wk - Recovered/Resolved - );Rheumatic disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Swollen tongue (1d - Recovered/Resolved - );Visual impairment (n/a - Recovering/Resolving - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010884554	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Night sweats (n/a - Not Recovered/Not Resolved - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010884556	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010884557	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010884572	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884577	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Grip strength decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884587	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884729	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Autoimmune disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884733	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - );Illness (n/a - Unknown - );Speech disorder (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010884745	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Underdown, M.. Thrombocytopenia in a teen with sickle cell disease following COVID-19 vaccination.. Pediatr-Blood-Cancer. 2021;68(12):e29271	12-17 Years	Not Specified	No	Male	Hypersplenism (n/a - Unknown - );Sickle cell anaemia with crisis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884753	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Mental fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[ALPROSTADIL] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE HYDROCHLORIDE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[CLONAZEPAM] (C - Muscle relaxant therapy - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, VITAMIN B12] (C - Multiple sclerosis relapse - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010884809	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010884839	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (15min - Recovered/Resolved - );Hypotension (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010884854	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010884862	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Intervertebral disc disorder (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Sciatica (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010884938	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - );Investigation abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010884949	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Paraesthesia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010884952	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010884978	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Unknown - Other Medically Important Condition);Menstruation delayed (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010884999	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (6d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010884999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010885013	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Dysphoria (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Respiratory disorder (n/a - Unknown - Other Medically Important Condition);Throat tightness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010885031	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885037	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Kawasaki's disease (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010885039	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885048	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885065	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885071	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885075	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885084	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885089	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885090	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Ear pain (n/a - Recovered/Resolved - );Food allergy (1958min - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010885094	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885139	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885151	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010885177	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885220	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Performance status decreased (n/a - Recovered/Resolved - );Pericardial effusion (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010885250	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885387	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (48h - Recovered/Resolved - Other Medically Important Condition);Chills (48h - Recovered/Resolved - Other Medically Important Condition);Cough (48h - Recovered/Resolved - Other Medically Important Condition);Headache (48h - Recovered/Resolved - Other Medically Important Condition);Impaired work ability (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (48h - Recovered/Resolved - Other Medically Important Condition);Myalgia (48h - Recovered/Resolved - Other Medically Important Condition);Nausea (48h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (48h - Recovered/Resolved - Other Medically Important Condition);Tachycardia (48h - Recovered/Resolved - Other Medically Important Condition);Vomiting (48h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	OZEMPIC [SEMAGLUTIDE] (C - Type 2 diabetes mellitus - n/a - [647d - .5mg - Subcutaneous])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [3y - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010885408	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885409	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885420	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885470	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010885488	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885489	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dyspnoea (5d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885491	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885497	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (19d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Seizure (19d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885517	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885518	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885523	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885526	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885529	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885533	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885541	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885557	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885594	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphatic disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885606	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885614	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885648	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885650	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885656	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885659	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885663	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885669	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885670	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885783	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885784	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885790	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885791	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Coronavirus infection (n/a - Recovered/Resolved - );Cough (26d - Recovered/Resolved - );Headache (10d - Recovered/Resolved - );Pyrexia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010885792	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Circulatory collapse (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885795	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Application site erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885798	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885802	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885809	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885814	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885821	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885825	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885836	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010885907	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coronavirus infection (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885921	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010885923	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885925	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010885932	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885937	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885945	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885949	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885951	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010885959	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885964	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010885992	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010885992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886002	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010886022	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886023	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886027	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886030	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886039	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886044	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886066	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010886117	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	TOZINAMERAN [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [1d - 1{DF} - n/a])|[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])|[TIOTROPIUM BROMIDE] (C - Emphysema - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010886121	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886126	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886152	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Paranasal sinus discomfort (n/a - Not Recovered/Not Resolved - );Restlessness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010886165	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886191	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886215	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886226	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886227	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886243	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010886264	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886273	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886275	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886276	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscular weakness (n/a - Recovering/Resolving - );Stomatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PREDNISOLONE] (C - Myalgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886283	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain lower (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886288	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Speech disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	GREPID [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010886299	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoacusis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886314	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886337	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010886350	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Supraventricular tachycardia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LEVETIRACETAM ACCORD [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypometabolism - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 20mg - Oral])|[CHLORPROTHIXENE HYDROCHLORIDE] (C - Sedative therapy - n/a - [n/a - n/a - Oral])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - Oral])|[VITAMINS NOS] (C - Vitamin D deficiency - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010886352	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - n/a])	[IBUPROFEN] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010886360	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886361	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886451	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886494	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886497	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886523	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010886554	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886555	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886563	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886566	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886585	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010886591	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (173d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleural effusion (173d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010886611	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (182d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010886632	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886645	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886649	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886658	Spontaneous	2021-12-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Illness (n/a - Unknown - Disabling);Impaired work ability (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010886667	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886713	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010886723	Spontaneous	2021-12-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010886723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862580	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (8d - Recovered/Resolved - );Hyperpyrexia (7d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862582	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862619	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - );Gastrointestinal disorder (n/a - Unknown - );Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Somnolence (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862750	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Body temperature increased (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Chills (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Diarrhoea (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Heart rate increased (5d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010862751	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cold sweat (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin I increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010862762	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Nausea (n/a - Unknown - );Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862765	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sinus pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862770	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eye haemorrhage (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862771	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862775	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010862779	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862780	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862785	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862786	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Cardiac disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010862788	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Unknown - );Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Parosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product odour abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862791	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862792	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862794	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paresis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862797	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862799	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Stevens-Johnson syndrome (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862801	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dry mouth (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862808	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Muscle atrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862809	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling jittery (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (57h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Peripheral vein thrombosis - n/a - [n/a - 2.5mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 2.5mg - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010862810	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862813	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862816	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862837	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[QUETIAPINE, QUETIAPINE FUMARATE] (C - Bipolar I disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010862848	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling);Blindness transient (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypertension (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010862926	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	CELECOXIB [CELECOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|REPATHA [EVOLOCUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|SEMAGLUTIDE [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010862934	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862938	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862941	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010862943	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute lymphocytic leukaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010862945	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862948	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Neuropathy peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Type III immune complex mediated reaction (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[TOPIRAMATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010862953	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - 81mg - Oral])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010862957	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bronchitis (n/a - Unknown - );Eye movement disorder (n/a - Unknown - Other Medically Important Condition);Eyelid ptosis (n/a - Unknown - );Myasthenia gravis (n/a - Unknown - Other Medically Important Condition);Neurological symptom (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862959	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Microangiopathy (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Pruritus (n/a - Unknown - );Retinal haemorrhage (n/a - Unknown - Other Medically Important Condition);Vasodilatation (n/a - Unknown - );Vitreous floaters (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862965	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Encephalitis california (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Nerve degeneration (n/a - Unknown - );Nerve injury (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)] (S - n/a - Unknown - [1d - n/a - Intramuscular])	[HYDROCODONE] (C - n/a - n/a - [n/a - n/a - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862983	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862990	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hilar lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenopathy mediastinal (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010862995	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010863002	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periarthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tendonitis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010863003	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010863232	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010863260	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Periorbital swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition);Screaming (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010863266	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010863273	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neuropathy peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (S - n/a - Unknown - [n/a - 1000mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010863304	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|[THIAMAZOLE] (S - Graves' disease - n/a - [n/a - 5mg - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010863369	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010863375	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010863474	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010863479	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (2d - Recovered/Resolved - );Discomfort (2d - Recovered/Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010863481	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010863485	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010863496	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Hypersomnia (n/a - Unknown - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting projectile (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010863502	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle swelling (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010863502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010864142	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure congestive (n/a - Fatal - Results in Death);Small cell lung cancer (n/a - Unknown - Other Medically Important Condition);Trismus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010864144	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypopnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010864153	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Headache (24h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	[IBUPROFEN] (C - Teething - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010864154	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010864155	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Gingival pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Sleep apnoea syndrome (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010864158	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864170	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010864171	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864173	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864174	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864177	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010864184	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Antisynthetase syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diffuse alveolar damage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - );Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010864205	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010864211	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864214	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periarthritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864215	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010864220	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864384	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	RIVAROXABAN 2.5MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010864395	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864453	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1wk - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864595	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Rash macular (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864640	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864665	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	VITAMINBJØRNER JUNGEL [BIOTIN, CYANOCOBALAMINE, FOLIC ACID, NICOTINAMIDE, VITAMIN A, VITAMIN B6, VITAMIN C, VITAMIN E, VITAMINE D3] (C - n/a - n/a - )|[TERBINAFINE, TERBINAFINE HYDROCHLORIDE] (C - Onychomycosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864669	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METHOTREXATE] (C - Psoriasis - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864680	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Hyperventilation (1d - Recovered/Resolved - );Paralysis (1d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010864700	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, COLECALCIFEROL, MAGNESIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864704	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864706	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864710	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pityriasis rosea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864713	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Oropharyngeal pain (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864719	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Arthralgia (1wk - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Myalgia (1wk - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864740	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1h - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864742	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (3d - Recovered/Resolved - );Swelling (n/a - Recovering/Resolving - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864768	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864770	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010864802	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864804	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864805	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Injection site paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864806	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010864811	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Diarrhoea (12h - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864880	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (2d - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Chills (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Neck pain (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864955	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diplopia (n/a - Recovering/Resolving - );Facial paralysis (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010864970	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010864979	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864982	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cataract (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010864989	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pulmonary embolism (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010864991	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010864996	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertrichosis (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Skin discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010864996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010865037	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865039	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865041	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lip swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865043	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865045	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865053	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Disabling, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Cardiac disorder (n/a - Not Recovered/Not Resolved - Disabling);Cardiac failure (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Depressed mood (n/a - Unknown - Disabling);Depression (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Flank pain (n/a - Not Recovered/Not Resolved - Disabling);Hot flush (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010865056	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal faeces (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865058	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865062	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865069	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865074	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Palpitations - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - Extrasystoles - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865078	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Creutzfeldt-Jakob disease (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865080	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865085	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865087	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865089	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - Disabling);Chills (4d - Recovered/Resolved - Disabling);Fatigue (4d - Recovered/Resolved - Disabling);Headache (4d - Recovered/Resolved - Disabling);Injection site reaction (4d - Recovered/Resolved - Disabling);Myalgia (4d - Recovered/Resolved - Disabling);Nausea (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010865092	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010865098	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010865101	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Parkinson's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865105	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865107	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Toothache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865136	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865137	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865139	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865141	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865161	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Paranasal sinus hypersecretion (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaginal discharge (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010865162	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Extrasystoles (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865169	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dehydration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Enteritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865174	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865178	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865187	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Glassy eyes (n/a - Unknown - );Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865197	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchial carcinoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Malaise (3d - Unknown - );Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865198	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary web syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865199	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (3d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865201	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865210	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Joint swelling (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010865212	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Monoplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Product administered to patient of inappropriate age (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865216	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865228	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865230	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Axillary mass (n/a - Unknown - Disabling, Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010865231	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Dyskinesia (n/a - Unknown - );Eyelid function disorder (1mo - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - );Trigeminal neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865232	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865235	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865237	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Nervousness (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865245	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865246	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - );Hypersensitivity (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Lymph node pain (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010865259	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865260	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharitis (n/a - Unknown - Other Medically Important Condition);Corneal erosion (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Ophthalmic herpes zoster (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865267	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (5d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (4d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Blood pH - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865269	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fibrin D dimer increased (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010865273	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Other Medically Important Condition);Cardiac failure (n/a - Unknown - Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Myocardial fibrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tachycardia (n/a - Unknown - );Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COCAINE] (C - Substance use - n/a - [1d - n/a - n/a])|[KETAMINE] (C - Substance use - n/a - [2d - n/a - n/a])|[METHYLENEDIOXYMETHAMPHETAMINE] (C - Substance use - n/a - [2d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865278	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865280	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865281	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865286	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865289	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Mobility decreased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010865290	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865292	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dermatitis allergic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010865305	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])|[HEPATITIS B VACCINE] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])	[CODEINE] (C - Gastrointestinal pain - Unknown - [n/a - n/a - n/a])|[COVID-19 VACCINE] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865312	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Arthralgia (4d - Recovered/Resolved - Disabling);Myalgia (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010865362	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Embolic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865368	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (13d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Drug ineffective (13d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (13d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010865559	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010865582	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010865629	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865647	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haematoma (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010865650	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010865659	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010865674	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myasthenia gravis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010865678	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Cardiac asthma (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - );Dyspnoea exertional (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Rhinovirus infection (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010865682	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovered/Resolved With Sequelae - Disabling);Anosmia (n/a - Recovered/Resolved With Sequelae - Disabling);Parosmia (n/a - Not Recovered/Not Resolved - Disabling);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010865699	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemoglobin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010865727	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010865737	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010865738	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010865762	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Recovered/Resolved - Other Medically Important Condition);Peak expiratory flow rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010865768	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Somnolence (0d - Recovered/Resolved - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010865977	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Disabling);Eye pain (n/a - Recovering/Resolving - Disabling);Eyelid pain (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010865977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010866006	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010866007	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866145	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Iridocyclitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866150	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Unknown - );Injection site erythema (n/a - Unknown - );Injection site pruritus (n/a - Unknown - );Injection site warmth (n/a - Unknown - );Papule (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866171	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (4d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chills (4d - Recovered/Resolved - );Hyperpyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010866172	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010866406	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010866408	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aortic dissection (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010866461	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866469	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (5d - Recovered/Resolved - );Dyspnoea (6d - Recovered/Resolved - );Feeling hot (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010866471	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866516	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (33d - Recovered/Resolved - );Headache (33d - Recovered/Resolved - );Myalgia (33d - Recovered/Resolved - );Vaccination site pain (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010866526	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010866531	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (33d - Recovered/Resolved - );Headache (33d - Recovered/Resolved - );Injection site pain (33d - Recovered/Resolved - );Myalgia (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010866544	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dactylitis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866547	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Muscular weakness (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866548	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Not Recovered/Not Resolved - );Hyperhidrosis (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866553	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrioventricular block complete (n/a - Unknown - Life Threatening);Cardiogenic shock (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	INSULIN GLARGINE [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 2.5mg - Oral])|[MELPERONE] (C - n/a - n/a - [n/a - 25mg - Oral])|[METAMIZOLE, METAMIZOLE MAGNESIUM, METAMIZOLE SODIUM] (C - n/a - n/a - [n/a - 1500mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 2000mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - Oral])|[RISPERIDONE] (C - n/a - n/a - [n/a - 1mg - Oral])|[TORASEMIDE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010866563	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866566	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010866580	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010866595	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010866607	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010866640	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	XELEVIA [SITAGLIPTIN] (C - n/a - n/a - [n/a - 100mg - Oral])|[MICRONISED SPIRONOLACTONE, POTASSIUM CANRENOATE, SPIRONOLACTONE, SPIRONOLACTONE BP] (C - n/a - n/a - [n/a - 25mg - Oral])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866643	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010866645	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010866649	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866654	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (13d - Not Recovered/Not Resolved - );Fungal skin infection (13d - Not Recovered/Not Resolved - );Pruritus (13d - Not Recovered/Not Resolved - );Rash (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866656	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (5d - Unknown - );Myalgia (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866660	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (64d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010866674	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010866679	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010866680	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866817	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TADALAFIL 5 MG  (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866867	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune hepatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866874	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (30min - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010866876	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tenosynovitis (5mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010866881	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010866939	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010866939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867052	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867057	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867060	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867067	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867069	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867071	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867089	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867276	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site oedema (n/a - Recovered/Resolved - );Administration site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (36h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867359	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867360	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867361	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867363	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867365	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867370	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Vertigo positional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867376	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867377	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Eye pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867394	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867490	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Back pain (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867538	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (32d - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (32d - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010867550	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Disabling);Constipation (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Nightmare (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867564	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010867567	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867568	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness exertional (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867569	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867570	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867571	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867577	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867579	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Diplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Monoplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Sinusitis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010867589	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Recovering/Resolving - Disabling);Chest pain (n/a - Recovering/Resolving - Disabling);Eye pain (n/a - Recovering/Resolving - Disabling);Groin pain (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Lymph node pain (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal pain (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867590	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867591	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867595	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867599	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867604	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867605	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Sepsis (16d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010867612	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867616	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Constipation (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Urinary retention (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867617	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Irritability (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash macular (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Thyroxine decreased - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867622	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Heart rate abnormal - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Heart rate abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867627	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Life Threatening, Disabling);Pulmonary embolism (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Renal failure (n/a - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010867628	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Disabling);Delirium (n/a - Recovering/Resolving - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Poor quality sleep (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867631	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (4d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (4d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867633	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867635	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - );Erectile dysfunction (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867656	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (n/a - Unknown - Other Medically Important Condition);Eye inflammation (n/a - Unknown - Other Medically Important Condition);Eye swelling (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867657	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Facial paralysis (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010867663	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Illness (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Impaired work ability (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Vomiting (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867667	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart rate abnormal - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867677	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Generalised tonic-clonic seizure (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tremor (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010867699	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Ischaemic stroke (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010867701	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema (n/a - Unknown - Other Medically Important Condition);Eczema asteatotic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867706	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (10d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867708	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[BACLOFEN] (C - Pain - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Prostatic disorder - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure abnormal, Cardiac disorder - n/a - [n/a - n/a - n/a])|[OXYCODONE, OXYCODONE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatic disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867721	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867722	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tonic convulsion (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Seizure - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867724	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867728	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867729	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (1d - Unknown - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Unknown - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (1d - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Spinal pain - n/a - [n/a - 500mg - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Spinal pain - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867732	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867734	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate irregular (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867735	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AZELASTINE, AZELASTINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[HYPROMELLOSE] (C - Dry eye - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Dyspnoea - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867738	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867741	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Constipation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Piriformis syndrome (n/a - Unknown - Other Medically Important Condition);Sciatica (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010867761	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death);Syncope (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010867768	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FLUPENTIXOL DECANOATE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867773	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic pigmented purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867777	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrial flutter (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867793	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867808	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - );Deafness unilateral (1348h - Recovered/Resolved - Disabling, Other Medically Important Condition);Depression (n/a - Unknown - );Ear discomfort (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010867810	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867819	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Chills (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Malaise (3d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Palpitations (2d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010867847	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Supraventricular tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867872	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Disabling);COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010867927	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Achenbach syndrome (n/a - Not Recovered/Not Resolved - );Breast pain (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010867936	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010867961	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867964	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867967	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010867968	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867978	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (2d - Recovered/Resolved - Life Threatening);Chest pain (2d - Recovered/Resolved - Life Threatening);Dyspnoea (2d - Recovered/Resolved - Life Threatening);Fatigue (n/a - Unknown - Life Threatening);Malaise (n/a - Unknown - Life Threatening);Myalgia (n/a - Unknown - Life Threatening);Myocarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010867979	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alcohol poisoning (n/a - Fatal - Results in Death, Other Medically Important Condition);Condition aggravated (n/a - Fatal - Results in Death, Other Medically Important Condition);Decreased appetite (n/a - Fatal - Results in Death, Life Threatening);General physical health deterioration (n/a - Fatal - Results in Death);Hepatic failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Hyperventilation (n/a - Unknown - );Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [21d - n/a - Oral])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[LINAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[POLAPREZINC] (C - Hypozincaemia - n/a - [188d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010867982	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867988	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem haemorrhage (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hepatic function abnormal (n/a - Unknown - Life Threatening);Hyperbilirubinaemia (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010867990	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010867991	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory distress (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867993	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010867996	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010867996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010868004	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868005	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868006	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868048	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Tooth disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868121	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2h - Recovering/Resolving - Life Threatening);Heart rate increased (2h - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE, PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - Hypertension - Not applicable - [1y - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010868201	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868252	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Leukopenia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868256	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868257	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010868263	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868270	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868274	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010868276	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ophthalmic herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868279	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gastrointestinal microorganism overgrowth (123d - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010868290	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868296	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868309	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Feeling hot (26d - Not Recovered/Not Resolved - );Heavy menstrual bleeding (26d - Not Recovered/Not Resolved - );Hyperhidrosis (26d - Not Recovered/Not Resolved - );Mood swings (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010868311	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (55d - Not Recovered/Not Resolved - );Rash (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868331	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868337	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Anorectal discomfort (26d - Not Recovered/Not Resolved - );Arrhythmia (26d - Not Recovered/Not Resolved - );Influenza like illness (26d - Not Recovered/Not Resolved - );Sensitive skin (26d - Not Recovered/Not Resolved - );Throat irritation (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868341	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (4d - Recovering/Resolving - );Injection site induration (4d - Recovering/Resolving - );Injection site swelling (4d - Recovering/Resolving - );Vaccination site reaction (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868446	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868449	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868500	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868501	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868503	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868504	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868506	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	General physical health deterioration (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868509	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (3d - Recovered/Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010868510	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868527	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash papular (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Gastrointestinal pain - n/a - [11d - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868535	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868538	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868540	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868541	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868543	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868560	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868566	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Asthenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Ataxia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Balance disorder (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Coordination abnormal (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Diarrhoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Diplopia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Disorientation (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dysstasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Electrocardiogram abnormal (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Hallucination (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Hyperhidrosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Hyperphagia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Hypoaesthesia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Malaise (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Miller Fisher syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Motor dysfunction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Polyuria (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Tachycardia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Tremor (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Vertigo (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Vision blurred (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Visual impairment (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010868648	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Recovering/Resolving - );Joint stiffness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868652	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868654	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchospasm (n/a - Recovering/Resolving - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoxia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	COAPROVEL [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MISOPROSTOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868659	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868661	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868669	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Arthropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868673	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868676	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868682	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthropod bite (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010868697	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010868707	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aortic dilatation (n/a - Fatal - Results in Death);Cardiac disorder (n/a - Fatal - Results in Death);Confusional state (n/a - Fatal - Results in Death);Dysphagia (n/a - Fatal - Results in Death);Dysphonia (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Headache (n/a - Fatal - Results in Death);Muscle contractions involuntary (n/a - Fatal - Results in Death);Myalgia (n/a - Fatal - Results in Death);Paralysis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010868738	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868748	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868750	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Recovering/Resolving - );Ear pain (n/a - Recovering/Resolving - );Facial paralysis (n/a - Recovering/Resolving - );Herpes zoster (n/a - Unknown - );Pharyngeal swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868839	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868846	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010868848	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868849	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Pyrexia (370min - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vision blurred (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868851	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 180mg - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[THEOPHYLLINE, THEOPHYLLINE ANHYDROUS, THEOPHYLLINE MONOHYDRATE] (C - n/a - n/a - [n/a - 200mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868875	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Lymphadenitis (91h - Recovered/Resolved - );Myalgia (n/a - Unknown - );Pyrexia (43h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010868881	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868885	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868889	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868890	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868931	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Fatal - Results in Death);General physical health deterioration (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [51d - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[LINAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[POLAPREZINC] (C - Hypozincaemia - n/a - [188d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010868932	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Fatal - Results in Death);Diabetes mellitus (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010868933	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myositis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010868937	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868939	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved With Sequelae - );Nausea (56h - Recovered/Resolved With Sequelae - );Pain (n/a - Recovered/Resolved With Sequelae - );Vomiting (2d - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010868940	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROXYCARBAMIDE [HYDROXYCARBAMIDE] (C - Essential thrombocythaemia - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Essential thrombocythaemia - n/a - [n/a - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - Meniere's disease - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 100ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010868942	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - Blood cholesterol normal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010868986	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Aortic aneurysm (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - );Discomfort (n/a - Unknown - );Dizziness exertional (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Heart rate abnormal (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate increased (n/a - Unknown - );Loss of consciousness (n/a - Unknown - );Memory impairment (n/a - Unknown - );Night sweats (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010868993	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paresis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hospitalisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010868993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869002	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Hospitalisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Night sweats (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - 150mg - Oral])|TYSABRI [NATALIZUMAB] (C - Multiple sclerosis - n/a - [n/a - 300mg - Intravenous (not otherwise specified)])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - Immunisation - n/a - [n/a - n/a - Intramuscular])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869067	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869072	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pharyngeal paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Throat irritation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869074	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010869084	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Illness (n/a - Recovering/Resolving - Life Threatening);Immunisation (n/a - Unknown - Life Threatening);Interchange of vaccine products (n/a - Unknown - Life Threatening);Off label use (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010869085	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869307	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869308	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869313	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869316	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869318	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869337	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition);Vitreous haze (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869346	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010869357	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869363	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - .5mL - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010869384	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010869437	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Ankylosing spondylitis (n/a - Recovering/Resolving - );Condition aggravated (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	SIMPONI [GOLIMUMAB] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869448	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysarthria (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869449	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869461	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869466	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869470	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869474	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869475	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869478	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869498	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial ischaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869499	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/FLORIDA/4/2006-LIKE STRAIN, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/SOUTH AUSTRALIA/55/2014 STRAIN, A/SWITZERLAND/9715293/2013 (H3N2) - LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/WISCONSIN/67/2005 (H3N2), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN, B/MALAYSIA/2506/2004 - LIKE STRAIN, B/BEIJING/184/93-LIKE STRAIN (B/YAMANASHI/166/98), A/SYDNEY/5/97 (H3N2)-LIKE STRAIN (A/SYDNEY/5/97 REASS. RESVIR 13), A/BEIJING/262/95 (H1N1) - LIKE STRAIN (A/BEIJING/262/95 REASS. X-127), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NIB-65), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/02/2012, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, IVR-175), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869502	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869503	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Epstein-Barr virus infection reactivation (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Odynophagia (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869505	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Purpura (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (S - Arrhythmia - Dose not changed - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869511	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869514	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869515	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site abscess (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869518	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869519	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869521	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869526	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869527	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intrameningeal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869530	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869536	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869540	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Upper respiratory tract congestion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869548	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869551	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extensive swelling of vaccinated limb (8d - Recovered/Resolved - );Lymphangitis (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869556	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Epistaxis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869559	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869561	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869565	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869566	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869567	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869577	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869582	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869584	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dehydration (n/a - Recovering/Resolving - );Epistaxis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869588	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injected limb mobility decreased (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869590	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869599	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869603	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctival haemorrhage (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869608	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869609	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation reaction (2d - Recovered/Resolved - );Vertigo (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869611	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (7d - Recovered/Resolved - );Pain in extremity (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869612	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869618	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869619	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869620	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (2mo - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869621	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869622	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010869625	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869630	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869631	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869636	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869638	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869639	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Unknown])|JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (S - Immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869651	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [20d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869653	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [20d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869656	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Migraine (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869657	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869659	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869661	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [22d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869668	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010869669	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869673	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Erythema multiforme (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869674	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869676	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869678	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869684	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869685	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869686	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869691	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blindness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869692	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869698	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - );Renal pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869700	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovered/Resolved - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869705	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (3wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869707	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (48h - Recovered/Resolved - );Vomiting (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869721	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869872	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Peripheral artery thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|XELJANZ [TOFACITINIB, TOFACITINIB CITRATE] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010869877	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869898	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869929	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Recovered/Resolved - );Varicose vein (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869937	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010869941	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010869943	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (3d - Recovering/Resolving - );Immunisation reaction (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869946	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Spinal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869961	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010869995	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010869995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870006	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral swelling (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870023	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Male	Exposure via breast milk (n/a - Unknown - );Poor feeding infant (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870047	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Toothache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870050	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870103	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Fujita, K.. Two cases of stroke associated with COVID-19 infection. The 2nd Annual Meeting of the Japan Society of Vascular and Interventional Neuro. 2021;2:29	18-64 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870104	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870118	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (1d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870123	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Arthritis (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870155	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870163	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Septic embolus (n/a - Unknown - Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870170	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870171	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870180	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870183	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis atopic (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870198	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac index increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gamma-glutamyltransferase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870207	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Freezing phenomenon (1d - Recovered/Resolved With Sequelae - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010870211	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Emotional distress (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870235	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870242	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870245	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010870311	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870390	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870393	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870411	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Cardiac discomfort (n/a - Unknown - );Diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Stress (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870413	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870421	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chronic graft versus host disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870431	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Rhinorrhoea (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870433	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Breast enlargement (n/a - Unknown - Other Medically Important Condition);Diverticular fistula (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870441	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870444	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Limb operation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870473	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870480	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (44d - Recovering/Resolving - );Malaise (44d - Recovering/Resolving - );Pain in extremity (44d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010870498	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870500	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (2d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - );Muscle spasms (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pharyngeal swelling (2d - Recovering/Resolving - );Tinnitus (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870513	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (24d - Not Recovered/Not Resolved - );Malaise (24d - Not Recovered/Not Resolved - );Vitreous floaters (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010870527	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870529	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Herpes zoster (11d - Not Recovered/Not Resolved - );Rash (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870538	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Joint stiffness (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870539	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Performance status decreased (1d - Recovered/Resolved - );Poor quality sleep (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870548	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (8d - Not Recovered/Not Resolved - );Dizziness (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870555	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Constipation (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870559	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain (1d - Not Recovered/Not Resolved - );Abnormal faeces (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Flushing (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870571	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (12d - Not Recovered/Not Resolved - );Dyspnoea (12d - Not Recovered/Not Resolved - );Heart rate increased (12d - Not Recovered/Not Resolved - );Palpitations (12d - Not Recovered/Not Resolved - );Tachycardia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870574	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - );Muscle spasms (0d - Recovered/Resolved - );Petechiae (3d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870609	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870612	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Tenderness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870655	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010870673	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Liver function test abnormal (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CANNABIDIOL [CANNABIDIOL] (C - Stiff person syndrome - n/a - [n/a - n/a - n/a])|LEVETIRACETAM [LEVETIRACETAM] (C - Seizure - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - Stiff person syndrome - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Stiff person syndrome - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Stiff person syndrome - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULPHATE BP] (C - Pain - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010870674	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Autoimmune hepatitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatitis acute (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010870705	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870706	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870717	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870718	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870719	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870720	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870750	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[RAMIPRIL] (C - Hypertension - Dose not changed - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870855	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Restless legs syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010870860	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Tooth abscess - n/a - [6d - n/a - n/a])|[DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)] (C - Immunisation - n/a - [1d - n/a - n/a])|[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010870887	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010870890	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010870890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871112	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ALOGLIPTIN [ALOGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Burn oesophageal - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[VENLAFAXINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871115	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cyanosis (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperventilation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral coldness (n/a - Recovering/Resolving - Other Medically Important Condition);Respiration abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010871121	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010871122	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Stevens-Johnson syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871123	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871125	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010871127	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871128	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871129	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Illness (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010871132	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Autoimmune demyelinating disease (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait inability (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Grip strength decreased (n/a - Unknown - );Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyporeflexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - );Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paresis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871133	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871139	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster meningoencephalitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HYALURONIC ACID] (C - n/a - n/a - [n/a - n/a - Ophthalmic])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOXONIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871155	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Cardiac arrest (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Electrocardiogram QT prolonged (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypoxic-ischaemic encephalopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myoclonus (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulseless electrical activity (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Shock (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - );Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATOMOXETINE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[ATOMOXETINE] (C - n/a - n/a - [n/a - n/a - Oral])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010871160	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871219	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Antiphospholipid syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Petechiae (n/a - Recovering/Resolving - Other Medically Important Condition);Purpura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Antiphospholipid syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010871220	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871221	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871235	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010871237	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphoma (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010871244	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871293	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (7d - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (7d - Recovered/Resolved - );Influenza like illness (7d - Recovered/Resolved - );Pharyngeal inflammation (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871328	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871343	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injection related reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871351	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871382	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin ulcer (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[METHOTREXATE] (S - Lymphomatoid papulosis - Dose not changed - [n/a - 12.5mg - Subcutaneous])	ZYPREXA [OLANZAPINE] (C - n/a - n/a - )|[VALPROATE SEMISODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871394	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Coma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Retching (n/a - Unknown - Caused/Prolonged Hospitalisation);Sepsis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary incontinence (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871399	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Caused/Prolonged Hospitalisation);Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - );Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspepsia (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Interstitial lung disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mallory-Weiss syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Oesophageal rupture (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871436	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010871483	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (12h - Recovered/Resolved - );Dizziness (12h - Recovered/Resolved - );Headache (12h - Recovered/Resolved - );Nausea (12h - Recovered/Resolved - );Presyncope (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871520	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010871529	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871571	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Bursitis (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871595	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fall (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Life Threatening, Other Medically Important Condition);Loss of consciousness (5min - Recovered/Resolved - Other Medically Important Condition);Mydriasis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010871600	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871611	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010871628	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (0d - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Vaccination site movement impairment (n/a - Unknown - Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871631	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010871661	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - );Myopericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010871719	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oxygen saturation decreased (n/a - Fatal - Results in Death);Pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010871720	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871758	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - );Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871832	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomegaly (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010871845	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Infectious mononucleosis (n/a - Unknown - Other Medically Important Condition);Liver function test increased (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Sensation of foreign body (n/a - Unknown - );Splenomegaly (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010871869	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010871974	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010871974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872004	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood potassium decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Red blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Sensory loss (n/a - Unknown - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010872007	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DUOPLAVIN [ACETYLSALICYLIC ACID, CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010872095	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010872101	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN, IBUPROFEN BP, IBUPROFEN LYSINE, IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872146	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872214	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010872223	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010872234	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872235	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Eye swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010872301	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Musculoskeletal discomfort (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872634	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (3d - Recovering/Resolving - Disabling);Extensive swelling of vaccinated limb (3d - Recovering/Resolving - Disabling);Fatigue (3d - Recovering/Resolving - Disabling);Headache (3d - Recovering/Resolving - Disabling);Injection site reaction (3d - Recovering/Resolving - Disabling);Malaise (3d - Recovering/Resolving - Disabling);Myalgia (3d - Recovering/Resolving - Disabling);Pyrexia (3d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010872639	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010872668	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation irregular (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872675	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010872676	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010872705	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - );Lymphoedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872718	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (7min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fluid intake reduced (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hypophagia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - 50mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE] (C - Hypertension - n/a - [n/a - 2{DF} - n/a])|[DONEPEZIL HYDROCHLORIDE] (C - Dementia - n/a - [n/a - 10mg - n/a])|[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - 5mg - n/a])|[MAGNESIUM OXIDE, MAGNESIUM OXIDE, LIGHT] (C - Constipation - n/a - [n/a - 500mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - 850mg - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - 30mg - n/a])|[NORTRIPTYLINE, NORTRIPTYLINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 150mg - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - 500mg - n/a])|[SERTRALINE] (C - Depression - n/a - [n/a - 200mg - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010872759	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Blood pressure decreased (n/a - Unknown - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Dizziness (n/a - Unknown - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Injection site reaction (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Sleep disorder (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010872807	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010872811	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010872815	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010872841	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Capillary leak syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoalbuminaemia (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010872864	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Aliberti, R. Zoster reactivation and central nervous system involvement, adverse reaction to Sars-CoV-2 vaccine. Portuguese Journal of Internal Medicine. 2021;28:657-658	65-85 Years	Not Specified	No	Male	Herpes zoster meningoencephalitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Herpes zoster reactivation (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010872869	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010872967	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Cardiac fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	TRAVATAN [TRAVOPROST] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])|[CLOPIDOGREL, CLOPIDOGREL BESILATE, CLOPIDOGREL HYDROGEN SULFATE] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[GLYCERYL TRINITRATE] (C - Chest pain - n/a - [n/a - n/a - n/a])|[KETOCONAZOLE, KETOCONAZOLE PH. EUR.] (C - Rash macular - n/a - [n/a - n/a - Cutaneous])|[MIRTAZAPINE] (C - Insomnia - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010872967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010873185	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nystagmus (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010873189	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010873257	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lacrimation increased (n/a - Recovered/Resolved - Disabling);Photophobia (n/a - Recovered/Resolved - Disabling);Vision blurred (68d - Recovered/Resolved - Disabling);Visual impairment (n/a - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010873271	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010873274	Spontaneous	2021-12-06 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010873290	Spontaneous	2021-12-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010873290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855854	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010855861	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855870	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pruritus (1d - Not Recovered/Not Resolved - );Unevaluable event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855875	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intervertebral disc protrusion (43d - Recovered/Resolved With Sequelae - );Muscle tightness (43d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010855881	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (7d - Not Recovered/Not Resolved - );Muscular weakness (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855884	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (42d - Recovered/Resolved - );Erectile dysfunction (27d - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010855890	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site hypoaesthesia (114d - Not Recovered/Not Resolved - );Injection site pain (114d - Not Recovered/Not Resolved - );Vaccination site movement impairment (114d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855894	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855896	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (1d - Recovered/Resolved - );Anosmia (1d - Recovered/Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855898	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (0d - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855926	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperacusis (11d - Recovering/Resolving - );Parosmia (11d - Recovering/Resolving - );Therapeutic response unexpected (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855940	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pruritus (20d - Not Recovered/Not Resolved - );Urticaria (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855950	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoparesis (5d - Not Recovered/Not Resolved - );Sensory level abnormal (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855951	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010855954	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (1wk - Unknown - );Myositis (1wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855957	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855959	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855960	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (49d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010855977	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Lymphoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malignant neoplasm progression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010855978	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010855990	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856001	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856011	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856026	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856042	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Recovered/Resolved With Sequelae - );Depression (n/a - Recovered/Resolved With Sequelae - );Dizziness (n/a - Recovered/Resolved With Sequelae - );Immunisation (n/a - Recovered/Resolved With Sequelae - );Sleep disorder (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010856058	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (29d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856063	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856067	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (0d - Recovered/Resolved - );Hypoaesthesia oral (0d - Recovered/Resolved - );Language disorder (0d - Recovered/Resolved - );Migraine (0d - Recovered/Resolved - );Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856068	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral coldness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856069	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypokinesia (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Muscle discomfort (n/a - Unknown - );Muscle twitching (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856078	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856082	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856094	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingival bleeding (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856095	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyarthritis (70d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010856108	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (14d - Not Recovered/Not Resolved - );Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856131	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (84d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856136	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (107d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856148	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Not Recovered/Not Resolved - );Hallucination, olfactory (8d - Not Recovered/Not Resolved - Other Medically Important Condition);Parosmia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010856153	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (83d - Not Recovered/Not Resolved - );Headache (83d - Unknown - );Paraesthesia (83d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856155	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (3d - Not Recovered/Not Resolved - );Migraine (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856164	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856189	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856190	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856193	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856198	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal inflammation (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856224	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (12d - Recovered/Resolved With Sequelae - );Visual impairment (12d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010856231	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (41d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856232	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Night sweats (36d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856233	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856242	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovering/Resolving - );Vision blurred (0d - Recovering/Resolving - );Visual impairment (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856245	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856247	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010856254	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856257	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (7d - Not Recovered/Not Resolved - );Muscular weakness (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856263	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (5d - Not Recovered/Not Resolved - );Heart rate increased (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856267	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematospermia (27d - Unknown - );Urogenital haemorrhage (27d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856272	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (4d - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010856278	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Physical fitness training (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856281	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoglycaemia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856290	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (2d - Recovered/Resolved - );Cough (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Sensitive skin (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856305	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (0d - Recovered/Resolved With Sequelae - );Dizziness (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010856312	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (52d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856326	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856327	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856336	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Recovered/Resolved - Other Medically Important Condition);Headache (31d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856337	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (2d - Recovered/Resolved - );Menstrual disorder (9d - Not Recovered/Not Resolved - );Oligomenorrhoea (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856348	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856356	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (1d - Recovered/Resolved - );Sudden hearing loss (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856363	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856367	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (28d - Not Recovered/Not Resolved - );Gastrointestinal pain (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856381	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual acuity reduced (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856383	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Insomnia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856407	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (0d - Unknown - );Muscle tightness (0d - Unknown - );Vaccination site erythema (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856411	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Insomnia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856419	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (36d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856425	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Allergy to animal (12d - Not Recovered/Not Resolved - );Hypersensitivity (12d - Not Recovered/Not Resolved - );Mite allergy (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856442	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood glucose increased (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856445	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blindness (33d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ocular discomfort (33d - Recovered/Resolved With Sequelae - );Photophobia (33d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010856446	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856447	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856456	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (74d - Recovering/Resolving - Other Medically Important Condition);Arrhythmia (74d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856465	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - );Herpes zoster (6d - Not Recovered/Not Resolved - );Hypoacusis (6d - Not Recovered/Not Resolved - );Hypoaesthesia (6d - Not Recovered/Not Resolved - );Lymphadenopathy (6d - Not Recovered/Not Resolved - );Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856471	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856480	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856533	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (3d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Paraesthesia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856545	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pulmonary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856546	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (48d - Recovering/Resolving - );Erythema (48d - Recovering/Resolving - );Osteoarthritis (48d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856550	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856551	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856592	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune thyroiditis (14d - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (14d - Not Recovered/Not Resolved - );Fatigue (26d - Not Recovered/Not Resolved - );Hypothyroidism (14d - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010856597	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Not Recovered/Not Resolved - );Oligomenorrhoea (n/a - Not Recovered/Not Resolved - );Polymenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856600	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Nasopharyngitis (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856605	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856615	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac disorder (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856626	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (2d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856628	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle rupture (0d - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856637	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (11d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010856653	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856658	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (26d - Not Recovered/Not Resolved - );Peripheral vein thrombosis (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856670	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856681	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dental cyst (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856684	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856685	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (n/a - Not Recovered/Not Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856694	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856716	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Unknown - );Hypoacusis (2d - Not Recovered/Not Resolved - );Tachycardia (3d - Not Recovered/Not Resolved - );Tinnitus (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856725	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856728	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Not Recovered/Not Resolved - );Taste disorder (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856736	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856755	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (12d - Recovering/Resolving - Other Medically Important Condition);Sudden hearing loss (12d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856758	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856760	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Contusion (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856771	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (5d - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Limb discomfort (1d - Unknown - );Menstrual disorder (n/a - Not Recovered/Not Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856777	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - );Pneumonitis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010856785	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Thermometry abnormal (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856786	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seasonal allergy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856789	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (34d - Not Recovered/Not Resolved - );Hot flush (34d - Not Recovered/Not Resolved - );Hypoaesthesia (34d - Not Recovered/Not Resolved - );Myalgia (34d - Not Recovered/Not Resolved - );Vaccination site pain (34d - Not Recovered/Not Resolved - );Vaccination site swelling (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856808	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856812	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (7d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010856824	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856825	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856836	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856837	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (3d - Recovering/Resolving - Other Medically Important Condition);Chest pain (3d - Recovering/Resolving - );Odynophagia (3d - Recovering/Resolving - );Oropharyngeal pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856843	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Petechiae (17d - Not Recovered/Not Resolved - );Thrombocytopenia (17d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856846	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2mo - Not Recovered/Not Resolved - );Myalgia (2mo - Not Recovered/Not Resolved - );Myofascial pain syndrome (2mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856847	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856862	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (37d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Arrhythmia (37d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (37d - Recovered/Resolved With Sequelae - );Hypertension (37d - Recovered/Resolved With Sequelae - );Hypotonia (37d - Recovered/Resolved With Sequelae - );Nausea (37d - Recovered/Resolved With Sequelae - );Poisoning (37d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Product communication issue (37d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010856868	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (9d - Recovered/Resolved - );Feeling hot (14d - Recovering/Resolving - );Injection site pain (44d - Recovered/Resolved - );Lymphadenopathy (35d - Recovering/Resolving - );Musculoskeletal stiffness (14d - Recovered/Resolved - );Neck pain (14d - Recovered/Resolved - );Night sweats (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010856869	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Penile vein thrombosis (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010856872	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - );Tenderness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856888	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856894	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Visual impairment (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856899	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Headache (0d - Recovered/Resolved - );Influenza (0d - Unknown - );Swelling face (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856900	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856911	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856926	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856949	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (12d - Recovering/Resolving - );Dyspnoea (29d - Recovering/Resolving - );Nausea (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856964	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (6d - Not Recovered/Not Resolved - );Abnormal faeces (6d - Not Recovered/Not Resolved - );Constipation (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856978	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site hypersensitivity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856982	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (20d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010856990	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010856993	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - );Inner ear disorder (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010856993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010857005	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857019	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness unilateral (26d - Not Recovered/Not Resolved - Other Medically Important Condition);Sudden hearing loss (26d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857024	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (7d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857029	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tremor (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010857038	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Discomfort (5d - Recovering/Resolving - );Limb discomfort (4d - Recovering/Resolving - );Nasal vestibulitis (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857050	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857052	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857054	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Ear discomfort (22d - Not Recovered/Not Resolved - );Head discomfort (22d - Not Recovered/Not Resolved - );Headache (22d - Not Recovered/Not Resolved - );Hypertension (9d - Not Recovered/Not Resolved - );Hypoaesthesia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857086	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857087	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857103	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857120	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857125	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (45d - Recovering/Resolving - );Neck pain (45d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857130	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857131	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (52d - Not Recovered/Not Resolved - );Pain in extremity (52d - Not Recovered/Not Resolved - );Peripheral swelling (52d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857133	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010857143	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Petechiae (17d - Not Recovered/Not Resolved - );Thrombocytopenia (17d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857167	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (1d - Not Recovered/Not Resolved - );Disorientation (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Hyperhidrosis (1d - Not Recovered/Not Resolved - );Hypotonia (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Muscle tightness (1d - Not Recovered/Not Resolved - );Tension headache (1d - Not Recovered/Not Resolved - );Weight bearing difficulty (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857180	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seasonal allergy (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857202	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857203	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood urine present (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857217	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pelvic venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - );Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857218	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857219	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857220	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857238	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Stomatitis (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857239	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Malaise (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857252	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857253	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Not Recovered/Not Resolved - );Insomnia (7d - Not Recovered/Not Resolved - );Nausea (7d - Not Recovered/Not Resolved - );Vomiting (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857259	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857261	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dental cyst (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857262	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Abdominal distension (n/a - Recovered/Resolved - );Gastric dilatation (n/a - Recovered/Resolved - );Hypophagia (n/a - Recovered/Resolved - );Mucosal inflammation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857283	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857286	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paranasal sinus discomfort (52d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857303	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (12d - Recovering/Resolving - Other Medically Important Condition);Sudden hearing loss (12d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857308	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (42d - Not Recovered/Not Resolved - );Vaccination site erythema (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857318	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (41d - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (41d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857341	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857343	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857345	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857356	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857373	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Epistaxis (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site erythema (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovered/Resolved - );Injection site swelling (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857388	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Breast pain (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857389	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857390	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (4d - Not Recovered/Not Resolved - );Dyspnoea (4d - Not Recovered/Not Resolved - );Lip swelling (2d - Not Recovered/Not Resolved - );Swelling face (1d - Not Recovered/Not Resolved - );Swollen tongue (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857397	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Psoriatic arthropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010857399	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857431	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (n/a - Not Recovered/Not Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857432	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857445	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857447	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (60d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857453	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857470	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (54d - Recovered/Resolved With Sequelae - );Myalgia (54d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010857471	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes virus infection (38d - Recovered/Resolved - );Limb discomfort (38d - Recovered/Resolved - );Paraesthesia (38d - Recovered/Resolved - );Pyrexia (38d - Recovered/Resolved - );Skin burning sensation (38d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857479	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857480	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cheilitis (n/a - Not Recovered/Not Resolved - );Lip haemorrhage (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857507	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Hyperhidrosis (n/a - Unknown - );Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857509	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Throat irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857516	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Facial pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857517	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Altered state of consciousness (39d - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (39d - Not Recovered/Not Resolved - );Dizziness (39d - Not Recovered/Not Resolved - );Fatigue (39d - Not Recovered/Not Resolved - );Nausea (39d - Not Recovered/Not Resolved - );Visual impairment (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010857522	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857538	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857553	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Recovered/Resolved - );Menstrual disorder (n/a - Recovered/Resolved - );Menstruation delayed (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857555	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Catarrh (n/a - Unknown - );Chills (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Eyelid oedema (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857564	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden hearing loss (0d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857569	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010857571	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Polymenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857573	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857574	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857576	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Tendon pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857585	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Anxiety (1d - Recovering/Resolving - );Depressed mood (1d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857611	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857614	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Menstruation delayed (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857620	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (11d - Recovering/Resolving - );Headache (11d - Recovering/Resolving - );Pulpitis dental (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857633	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857642	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Injection site swelling (3d - Unknown - );Lymphadenopathy (1d - Recovered/Resolved - );Tinnitus (43d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010857645	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857656	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857661	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site mass (46d - Unknown - );Vaccination site reaction (46d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857663	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (5d - Recovering/Resolving - );Blood pressure increased (5d - Recovering/Resolving - );Body temperature increased (5d - Recovering/Resolving - );Headache (5d - Recovering/Resolving - );Limb discomfort (5d - Recovering/Resolving - );Nausea (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857664	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (39d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (39d - Recovered/Resolved With Sequelae - );Injection site pain (39d - Recovered/Resolved With Sequelae - );Palpitations (39d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010857667	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (44d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857675	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coordination abnormal (42d - Recovered/Resolved With Sequelae - );Disorientation (42d - Recovered/Resolved With Sequelae - );Memory impairment (42d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010857687	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Diarrhoea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857696	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (10d - Not Recovered/Not Resolved - );Headache (10d - Not Recovered/Not Resolved - );Paraesthesia (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857697	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epididymitis (16d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010857703	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857704	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (2d - Not Recovered/Not Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (1d - Unknown - );Feeling hot (0d - Recovered/Resolved - );Headache (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857719	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (161d - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (32d - Recovering/Resolving - );Rash (32d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857729	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dandruff (6d - Not Recovered/Not Resolved - );Erythema (6d - Not Recovered/Not Resolved - );Fatigue (8d - Recovering/Resolving - );Granuloma annulare (3d - Not Recovered/Not Resolved - );Lymphadenopathy (8d - Unknown - );Rash (3d - Not Recovered/Not Resolved - );Skin haemorrhage (6d - Not Recovered/Not Resolved - );Vaccination site reaction (6d - Not Recovered/Not Resolved - );Vision blurred (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857730	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (9d - Recovered/Resolved - );Maternal exposure during breast feeding (9d - Recovered/Resolved - );Menstrual disorder (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857732	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes virus infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857733	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Drug eruption (85d - Not Recovered/Not Resolved - );Neurodermatitis (85d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857743	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (15d - Recovering/Resolving - );Chest pain (15d - Not Recovered/Not Resolved - );Dyspnoea (15d - Not Recovered/Not Resolved - );Dyspnoea exertional (13d - Recovering/Resolving - );Hypoaesthesia (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (15d - Recovering/Resolving - );Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010857749	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Radial nerve palsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857753	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (30d - Not Recovered/Not Resolved - );Erectile dysfunction (30d - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of libido (30d - Not Recovered/Not Resolved - );Myalgia (30d - Not Recovered/Not Resolved - );Myositis (30d - Not Recovered/Not Resolved - );Pain in extremity (30d - Not Recovered/Not Resolved - );Tendon disorder (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010857758	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857762	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (2d - Recovering/Resolving - );Menstrual disorder (2d - Recovering/Resolving - );Polymenorrhoea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857763	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (2d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857767	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (3d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Vaccination site movement impairment (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857773	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857774	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (4d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - );Rash vesicular (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857776	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857779	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Not Recovered/Not Resolved - );Influenza like illness (9d - Not Recovered/Not Resolved - );Periorbital swelling (9d - Not Recovered/Not Resolved - );Pruritus (9d - Not Recovered/Not Resolved - );Vision blurred (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857785	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857809	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (3d - Recovered/Resolved - );Taste disorder (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857812	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (2069d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857818	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Chromaturia (3d - Not Recovered/Not Resolved - );Hallucination, visual (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (2d - Not Recovered/Not Resolved - );Psychomotor hyperactivity (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - );Urinary incontinence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010857820	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Cold sweat (0d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Hot flush (0d - Recovering/Resolving - );Hypotension (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Paraesthesia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857825	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pain (0d - Recovered/Resolved - );Sense of oppression (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857832	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - Other Medically Important Condition);Blister (11d - Recovered/Resolved With Sequelae - );Fatigue (2d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Nervousness (0d - Recovered/Resolved - );Rash (11d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010857835	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (n/a - Recovered/Resolved With Sequelae - );Guillain-Barre syndrome (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - );Muscular weakness (n/a - Recovered/Resolved With Sequelae - );Paraesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010857849	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857851	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovering/Resolving - );Rash (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857853	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle contractions involuntary (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857859	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857863	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (44d - Not Recovered/Not Resolved - );Somnolence (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857864	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Biliary colic (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857870	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Diarrhoea (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857898	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (1d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Intermenstrual bleeding (2d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Menstrual cycle management (2d - Recovered/Resolved - );Nasal congestion (1d - Recovered/Resolved - );Nasopharyngitis (1d - Recovered/Resolved - );Oligomenorrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857908	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857910	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857911	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasticity (261d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain (261d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010857919	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (3d - Not Recovered/Not Resolved - );Rash vesicular (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857920	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857927	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857932	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857933	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Chromaturia (3d - Not Recovered/Not Resolved - );Hallucination, visual (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (2d - Not Recovered/Not Resolved - );Psychomotor hyperactivity (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - );Urinary incontinence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010857935	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Oligomenorrhoea (69d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857938	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857939	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral venous disease (37d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010857947	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857951	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (4d - Not Recovered/Not Resolved - );Dizziness (2d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - );Fatigue (6d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (5d - Recovering/Resolving - );Myalgia (4d - Recovering/Resolving - );Nausea (5d - Recovering/Resolving - );Paraesthesia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857952	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857961	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857966	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Recovered/Resolved - );Herpes zoster reactivation (n/a - Not Recovered/Not Resolved - );Influenza (2d - Recovered/Resolved - );Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857967	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857971	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Paraesthesia (3d - Recovered/Resolved - );Peripheral swelling (3d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857995	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Thermometry abnormal (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010857997	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (49d - Not Recovered/Not Resolved - );Fatigue (49d - Not Recovered/Not Resolved - );Headache (49d - Not Recovered/Not Resolved - );Hot flush (49d - Not Recovered/Not Resolved - );Nausea (49d - Not Recovered/Not Resolved - );Pyrexia (49d - Not Recovered/Not Resolved - );Vision blurred (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010857999	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (99d - Not Recovered/Not Resolved - );Diarrhoea (99d - Not Recovered/Not Resolved - );Headache (99d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010857999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858017	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Local reaction (150d - Not Recovered/Not Resolved - );Parosmia (150d - Not Recovered/Not Resolved - );Taste disorder (150d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858028	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858033	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858034	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pruritus (0d - Recovered/Resolved - );Pustule (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858044	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858054	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (1d - Recovered/Resolved With Sequelae - );Paraesthesia (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010858061	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858062	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (8d - Recovered/Resolved - );Sinusitis (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858078	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858086	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Painful respiration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858088	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Pain in extremity (1d - Recovering/Resolving - );Peripheral coldness (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858090	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (1d - Recovered/Resolved - );Chest pain (1d - Recovered/Resolved - );Chills (9d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858092	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Burning sensation (43d - Not Recovered/Not Resolved - );Paraesthesia (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858101	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (34d - Not Recovered/Not Resolved - );Contusion (15d - Recovering/Resolving - );Myalgia (34d - Not Recovered/Not Resolved - );Rash (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858108	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (6d - Recovered/Resolved - );Fatigue (8d - Recovered/Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Myalgia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858110	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Recovering/Resolving - );Abdominal pain (1d - Recovering/Resolving - );Cough (1d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858114	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (71d - Unknown - );Influenza (71d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858120	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858135	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (2d - Recovering/Resolving - );Immunisation reaction (2d - Recovering/Resolving - );Swelling face (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858150	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858151	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Disability (39d - Not Recovered/Not Resolved - Other Medically Important Condition);Joint swelling (39d - Not Recovered/Not Resolved - );Manual lymphatic drainage (39d - Not Recovered/Not Resolved - );Peripheral swelling (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010858157	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858160	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858169	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858178	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858180	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (18d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Neck pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858196	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858198	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858206	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858209	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (1d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Groin pain (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - );Testicular pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858211	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovering/Resolving - );Hypertensive crisis (5d - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858229	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858234	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858241	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858253	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (4d - Recovering/Resolving - );Blood pressure decreased (4d - Recovering/Resolving - );Chills (4d - Recovering/Resolving - );Decreased appetite (4d - Recovering/Resolving - );Dizziness (4d - Recovering/Resolving - );Epistaxis (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Pyrexia (4d - Recovering/Resolving - );Vaccination site erythema (4d - Recovering/Resolving - );Vaccination site swelling (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858263	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - );Nausea (2d - Recovering/Resolving - );Vein discolouration (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858266	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blister (0d - Recovered/Resolved - );Erythema (0d - Recovered/Resolved - );Haematochezia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010858267	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (11d - Not Recovered/Not Resolved - );Throat tightness (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858285	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Trigeminal neuralgia (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858297	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (53d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858300	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Influenza (3d - Unknown - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - );Paraesthesia (7d - Not Recovered/Not Resolved - );Unevaluable event (7d - Not Recovered/Not Resolved - );Visual impairment (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858312	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure fluctuation (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858318	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (1d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Musculoskeletal stiffness (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Somnolence (0d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858321	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Musculoskeletal chest pain (1d - Recovering/Resolving - );Pain in extremity (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858323	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858325	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858331	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (66d - Recovering/Resolving - );Dyspepsia (66d - Recovering/Resolving - );Extrasystoles (66d - Recovering/Resolving - );Flatulence (66d - Recovering/Resolving - );Gastrocardiac syndrome (66d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858371	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858384	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovering/Resolving - );Rash (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858388	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (4d - Not Recovered/Not Resolved - );Depressed mood (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Feeling of despair (4d - Not Recovered/Not Resolved - );Mood swings (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858395	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Recovered/Resolved - );Hypomenorrhoea (n/a - Recovered/Resolved - );Oligomenorrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858400	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Bone pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858401	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858410	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858411	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858418	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (0d - Recovered/Resolved - );Back pain (0d - Recovered/Resolved - );Cough (3d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Food craving (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858422	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug eruption (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858424	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Musculoskeletal discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858435	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858465	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858468	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Heart rate increased (14d - Recovered/Resolved - );Pain in extremity (14d - Recovered/Resolved - );Somnolence (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858481	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010858484	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (15d - Recovered/Resolved - );Menstrual disorder (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858488	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858507	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858522	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (0d - Not Recovered/Not Resolved - );Headache (2d - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858528	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (7d - Recovering/Resolving - );Disorientation (7d - Recovering/Resolving - );Gait disturbance (7d - Recovering/Resolving - );Visual impairment (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858532	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (7d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858542	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Menstruation irregular (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858570	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Penile burning sensation (4d - Not Recovered/Not Resolved - );Penile erythema (4d - Not Recovered/Not Resolved - );Testicular pain (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858573	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (52d - Recovering/Resolving - );Polymenorrhoea (52d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858574	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip swelling (0d - Recovered/Resolved - );Urticaria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858576	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858590	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858622	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858625	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858629	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858637	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (0d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858653	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858662	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858680	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858696	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Varicose vein (0d - Unknown - );Vein discolouration (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858697	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain lower (10d - Recovered/Resolved - );Menstruation irregular (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858700	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Gingival discomfort (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858705	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858712	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (39d - Recovering/Resolving - );Menstrual disorder (39d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858721	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858722	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858723	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Death (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010858730	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Iritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858734	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Epistaxis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858745	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010858755	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858756	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858757	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain lower (24d - Not Recovered/Not Resolved - );Amenorrhoea (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858768	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858785	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Hyperhidrosis (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858794	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858796	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Unknown - );Feeling hot (0d - Unknown - );Hyperaesthesia (0d - Unknown - );Injection site pain (1d - Unknown - );Injection site swelling (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858817	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858818	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858848	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858852	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010858853	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858854	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (1d - Recovering/Resolving - );Fatigue (42d - Recovering/Resolving - );Injection site pain (44d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858860	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (12d - Recovering/Resolving - );Prostatitis (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858868	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute leukaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Non-tobacco user (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010858870	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858878	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Eye pain (3d - Recovering/Resolving - );Eye swelling (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Nausea (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858879	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonitis (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858882	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Skin cancer (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858886	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Orchitis noninfective (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858895	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Noninfective gingivitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858901	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (62d - Unknown - );Hormone level abnormal (62d - Unknown - );Menstrual discomfort (62d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858913	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Aphasia (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Monoplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858914	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858917	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (20d - Not Recovered/Not Resolved - );Sleep disorder (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858920	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (36d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Polymenorrhoea (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858928	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (3d - Recovering/Resolving - Other Medically Important Condition);Myositis (3d - Recovering/Resolving - );Urine abnormality (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858934	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal tenderness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858939	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010858941	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858949	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Not Recovered/Not Resolved - );Fatigue (14d - Not Recovered/Not Resolved - );Influenza (14d - Not Recovered/Not Resolved - );Swelling (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858950	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (27d - Recovering/Resolving - );Hypotension (27d - Recovering/Resolving - );Nausea (28d - Recovering/Resolving - );Paraesthesia (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858955	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010858959	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Not Recovered/Not Resolved - );Malaise (7d - Not Recovered/Not Resolved - );Temperature intolerance (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858960	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Papilloedema (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010858965	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858974	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (80d - Recovering/Resolving - );Menstrual disorder (80d - Recovering/Resolving - );Ovulation disorder (80d - Recovering/Resolving - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010858975	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010858997	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - );Fine motor skill dysfunction (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010858997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859004	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (6d - Not Recovered/Not Resolved - );Paraesthesia (6d - Not Recovered/Not Resolved - );Paresis (6d - Not Recovered/Not Resolved - );Tenderness (6d - Not Recovered/Not Resolved - );Tension headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859012	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (50d - Not Recovered/Not Resolved - );Dysgeusia (50d - Not Recovered/Not Resolved - );Taste disorder (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859019	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nervous system disorder (1d - Unknown - );Paraesthesia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859026	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859050	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation (n/a - Unknown - );No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859072	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Blood pressure increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859084	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859085	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859093	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859097	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (7d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859100	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859107	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysphagia (1d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - );Oedema mucosal (1d - Recovering/Resolving - );Rash (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859108	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (28d - Not Recovered/Not Resolved - );Pain in extremity (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859111	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site erythema (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859124	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859126	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (28d - Not Recovered/Not Resolved - );Pain in extremity (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859131	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (41d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859133	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cystitis noninfective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859137	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859141	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (0d - Recovering/Resolving - );Diarrhoea (0d - Recovered/Resolved - );Fatigue (0d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Photopsia (0d - Recovering/Resolving - );Somnolence (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859150	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859153	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Dysaesthesia (26d - Not Recovered/Not Resolved - );Paraesthesia (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859160	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature decreased (1d - Unknown - );Fatigue (1d - Unknown - );Hypotonia (1d - Unknown - );Influenza (1d - Unknown - );Paraesthesia (1d - Unknown - );Restlessness (1d - Unknown - );Venous pressure increased (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859178	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain lower (24d - Recovered/Resolved - );Heavy menstrual bleeding (24d - Recovered/Resolved - );Polymenorrhoea (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859182	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859189	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859192	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lip swelling (29d - Recovered/Resolved - );Swelling face (29d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859200	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Post herpetic neuralgia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010859223	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Memory impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859231	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010859239	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Faeces discoloured (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859247	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (3d - Recovered/Resolved - );Diarrhoea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859248	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (87d - Recovered/Resolved - );Influenza like illness (87d - Recovered/Resolved - );Injection site pain (87d - Recovered/Resolved - );Myalgia (87d - Recovered/Resolved - );Pain in extremity (87d - Recovered/Resolved - );Pyrexia (87d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859253	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859255	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure abnormal (0d - Recovering/Resolving - );Heart rate increased (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nervousness (0d - Recovering/Resolving - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859263	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gout (19d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859264	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - );Oedema peripheral (85d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859282	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859286	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (0d - Recovering/Resolving - Other Medically Important Condition);Sinus bradycardia (0d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859291	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859303	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859312	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (68d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859317	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859332	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Haematoma (10d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859355	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Alopecia (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859358	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010859360	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (22d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859367	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859373	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (69d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859374	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859387	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vitreous haemorrhage (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859397	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859399	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859401	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859406	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Therapeutic response unexpected (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859407	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859414	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (29d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859421	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (0d - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - );Influenza (1d - Unknown - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010859424	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (64d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859439	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient global amnesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859441	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859452	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoparesis (0d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859485	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Somnolence (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859489	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859498	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859506	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859517	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859549	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859554	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - );Blood insulin (n/a - Not Recovered/Not Resolved - );Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010859563	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoacusis (71d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010859564	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingivitis (42d - Recovered/Resolved - );Glossitis (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859573	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859575	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hyperhidrosis (3d - Recovered/Resolved - );Immunisation (1d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Night sweats (3d - Recovered/Resolved - );Oral herpes (34d - Recovering/Resolving - );Pyrexia (3d - Recovered/Resolved - );Rash (34d - Recovering/Resolving - );Rash pruritic (34d - Recovering/Resolving - );Sluggishness (2d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859588	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Haematoma (36d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859595	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (17d - Recovering/Resolving - );Dizziness (17d - Recovering/Resolving - );Dyspnoea (4d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (17d - Recovering/Resolving - );Hot flush (17d - Recovering/Resolving - );Pulmonary pain (4d - Recovered/Resolved - );Restlessness (4d - Recovered/Resolved - );Vision blurred (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859598	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling cold (13d - Not Recovered/Not Resolved - );Feeling hot (13d - Not Recovered/Not Resolved - );Hypoaesthesia (13d - Not Recovered/Not Resolved - );Immunisation reaction (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Paraesthesia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859599	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859600	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859603	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Recovering/Resolving - );Dyspnoea (6d - Recovering/Resolving - );Fatigue (6d - Recovering/Resolving - );Headache (6d - Recovering/Resolving - );Pain in extremity (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859617	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (0d - Unknown - );Disturbance in attention (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859624	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (22d - Not Recovered/Not Resolved - );Paraesthesia oral (22d - Not Recovered/Not Resolved - );Pruritus (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859628	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Penile exfoliation (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859630	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Trigeminal neuritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859631	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859650	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010859658	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859673	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859677	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859681	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859683	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859693	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (37d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859695	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - );Contusion (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859700	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859706	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859716	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859718	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (0d - Recovered/Resolved - );Somnolence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859728	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Micturition urgency (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859746	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859755	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010859762	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859768	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859774	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (56d - Not Recovered/Not Resolved - );Pruritus (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859779	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diverticulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010859790	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859797	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859848	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859850	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - );Vaccination site joint movement impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859867	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursa disorder (n/a - Not Recovered/Not Resolved - );Vaccination site joint discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859872	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (29d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859893	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Swelling of eyelid (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859898	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859900	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Haematoma (36d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859901	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859912	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (72d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859914	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859915	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (8d - Recovered/Resolved - );Thyroid cyst (n/a - Not Recovered/Not Resolved - );Tonsillar inflammation (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859943	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (9d - Not Recovered/Not Resolved - );Neuralgia (9d - Not Recovered/Not Resolved - );Tinnitus (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859954	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859956	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - );Somnolence (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859957	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (2d - Recovered/Resolved - );Photopsia (0d - Recovered/Resolved - );Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859961	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (34d - Not Recovered/Not Resolved - );Tinnitus (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010859975	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859976	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010859989	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010859996	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstruation delayed (4d - Recovering/Resolving - );Menstruation irregular (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010859996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860015	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (3d - Not Recovered/Not Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - );Peripheral coldness (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860018	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860060	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860061	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860062	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Poor peripheral circulation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860088	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860089	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860099	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (0d - Recovered/Resolved - );Osteoarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860104	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860114	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (2d - Not Recovered/Not Resolved - );Wrong technique in product usage process (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860133	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstruation delayed (4d - Recovering/Resolving - );Menstruation irregular (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860134	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860145	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye haemorrhage (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal injury (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous detachment (2d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860146	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010860153	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860154	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860157	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemihypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860161	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Hot flush (2d - Recovering/Resolving - );Influenza like illness (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860182	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epididymitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860193	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye haemorrhage (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal injury (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous detachment (2d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860195	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860203	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860210	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860216	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyelonephritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860219	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860220	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010860221	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Hypotonia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860227	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860242	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hepatic enzyme increased (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Transplant rejection (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860245	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860249	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lipoedema (7d - Recovered/Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860255	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860260	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860262	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860264	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860265	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860269	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860273	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860277	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860284	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860286	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860289	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860291	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860295	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860298	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860302	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860306	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860307	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860309	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860311	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860316	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860317	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860320	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860321	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860323	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860324	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860332	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860336	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860367	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860405	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860408	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860417	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860419	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860423	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860429	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860432	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860434	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860435	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860439	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860441	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860446	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860450	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860453	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860455	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Facial paralysis (2d - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860464	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860476	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010860478	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860479	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (23d - Not Recovered/Not Resolved - );Dizziness (23d - Not Recovered/Not Resolved - );Nausea (23d - Not Recovered/Not Resolved - );Tachycardia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860489	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (60d - Recovering/Resolving - );Rheumatoid arthritis (60d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860493	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anxiety (83d - Not Recovered/Not Resolved - );Fatigue (83d - Not Recovered/Not Resolved - );Headache (83d - Not Recovered/Not Resolved - );Sleep disorder (83d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860495	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860497	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Recovering/Resolving - );Lymphadenopathy (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860498	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860502	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010860514	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860520	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema (1d - Not Recovered/Not Resolved - );Pruritus (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - );Skin discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860530	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (9d - Recovering/Resolving - );Dyspnoea (31d - Recovering/Resolving - );Malaise (9d - Recovering/Resolving - );Somnolence (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860538	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Not Recovered/Not Resolved - );Pain in extremity (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860552	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860560	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860562	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Throat irritation (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860572	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Rash (n/a - Recovering/Resolving - );Varicella post vaccine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860575	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860577	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (21d - Recovering/Resolving - );Hypoaesthesia oral (62d - Recovering/Resolving - );Lymphadenopathy (62d - Recovering/Resolving - );Paraesthesia (62d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860578	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860579	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (3d - Recovered/Resolved - );Chest pain (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860583	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860585	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Not Recovered/Not Resolved - );Neck pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860592	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Influenza (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860600	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (63d - Recovered/Resolved With Sequelae - );Tremor (63d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010860603	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860605	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (51d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860606	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (0d - Recovered/Resolved - );Injection site erythema (0d - Recovered/Resolved - );Vaccination site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860612	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860616	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860624	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860626	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spider vein (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860635	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal disorder (25d - Not Recovered/Not Resolved - );Tinnitus (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860638	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860640	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Dizziness (75d - Unknown - );Headache (n/a - Unknown - );Visual impairment (75d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860646	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Unknown - );Cough (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860649	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860666	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860669	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (42d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860671	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza like illness (6d - Recovered/Resolved - );Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860673	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Multiple sclerosis relapse (6d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Sensory disturbance (6d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860674	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (71d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vestibular neuronitis (71d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860684	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (29d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (29d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (29d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860686	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (60d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010860704	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (10d - Not Recovered/Not Resolved - );Swelling (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860705	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (26d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860735	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860743	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860747	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (9d - Not Recovered/Not Resolved - );Pain in extremity (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860753	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (13d - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860754	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860757	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860782	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (1d - Unknown - );Palpitations (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860787	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860789	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860801	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860811	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860813	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860821	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860835	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860839	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site paraesthesia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860841	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Ear discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860843	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860844	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	No adverse event (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860856	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860862	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860871	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860882	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (48d - Not Recovered/Not Resolved - );Dyspnoea (48d - Not Recovered/Not Resolved - );Sleep disorder (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860891	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (80d - Recovering/Resolving - );Joint effusion (80d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860905	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye inflammation (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860907	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860910	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010860926	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Blood pressure increased (56d - Not Recovered/Not Resolved - );Dyspnoea (56d - Not Recovered/Not Resolved - );Fibrin D dimer increased (56d - Not Recovered/Not Resolved - );Headache (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860939	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860943	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Diarrhoea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860950	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860952	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860960	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Abdominal pain (n/a - Recovered/Resolved - );Renal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860964	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (55d - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (55d - Recovering/Resolving - );Somnolence (55d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860965	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010860968	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - );Limb discomfort (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860971	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Testicular pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860973	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860980	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860984	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (4d - Unknown - Other Medically Important Condition);Chills (21d - Unknown - );Dizziness (24d - Unknown - );Fatigue (35d - Unknown - );Hypotension (29d - Not Recovered/Not Resolved - );Infection susceptibility increased (29d - Not Recovered/Not Resolved - );Influenza (29d - Unknown - );Somnolence (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010860987	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010860992	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010860999	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010860999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861018	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861020	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (0d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861032	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (32d - Recovered/Resolved With Sequelae - );Diarrhoea (32d - Recovered/Resolved With Sequelae - );Gastrointestinal pain (32d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010861037	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (18d - Not Recovered/Not Resolved - );Rash (24d - Recovering/Resolving - );Rash pruritic (24d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861044	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pain in extremity (36d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010861045	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anogenital warts (n/a - Unknown - );Inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861062	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861074	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (159d - Recovering/Resolving - );Herpes zoster (159d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861075	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (17d - Recovered/Resolved With Sequelae - );Vaccination site pain (17d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010861080	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia intercostal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861087	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure abnormal (32d - Unknown - );Blood pressure increased (32d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861093	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Herpes virus infection (n/a - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861106	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (6d - Not Recovered/Not Resolved - );Myalgia (6d - Not Recovered/Not Resolved - );Pain in extremity (6d - Not Recovered/Not Resolved - );Peripheral swelling (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861109	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861111	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (69d - Not Recovered/Not Resolved - );Limb discomfort (69d - Not Recovered/Not Resolved - );Malaise (69d - Not Recovered/Not Resolved - );Night sweats (69d - Not Recovered/Not Resolved - );Tachycardia (73d - Recovering/Resolving - );Tendon sheath disorder (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861135	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (2d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861141	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (16d - Recovering/Resolving - );Hypoaesthesia oral (16d - Recovering/Resolving - );Muscle spasms (16d - Recovering/Resolving - );Myalgia (20d - Recovering/Resolving - );Visual impairment (16d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861142	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861149	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (8d - Unknown - );Rash (8d - Unknown - );Rash vesicular (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861154	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861155	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (7d - Recovering/Resolving - );Non-cardiac chest pain (7d - Recovering/Resolving - );Pain in extremity (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861158	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Angina pectoris (2d - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861169	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861177	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861178	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861187	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Unknown - );Lymphadenopathy (0d - Unknown - );Pyrexia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861196	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861197	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depressed level of consciousness (75d - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (75d - Not Recovered/Not Resolved - );Mental fatigue (75d - Not Recovered/Not Resolved - );Somnolence (75d - Not Recovered/Not Resolved - );Visual impairment (75d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010861206	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861207	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (15d - Not Recovered/Not Resolved - );Cardiovascular disorder (15d - Not Recovered/Not Resolved - );Heart rate increased (15d - Not Recovered/Not Resolved - );Musculoskeletal chest pain (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861209	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Medical device site bruise (5d - Not Recovered/Not Resolved - );Medical device site induration (5d - Not Recovered/Not Resolved - );Pain in extremity (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861212	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (n/a - Unknown - );Menstrual disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861214	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010861220	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (35d - Not Recovered/Not Resolved - );Oral lichen planus (19d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861234	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (3d - Recovered/Resolved - Other Medically Important Condition);Memory impairment (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861239	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (12d - Not Recovered/Not Resolved - );Pain in extremity (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861242	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861243	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (14d - Not Recovered/Not Resolved - );Gastritis (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861247	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Visual impairment (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861251	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (22d - Recovering/Resolving - );Paraesthesia (22d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861255	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861263	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Menstrual discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861267	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (68d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861273	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (13d - Not Recovered/Not Resolved - );Oedema peripheral (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861274	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861276	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Heart rate increased (70d - Unknown - );Parosmia (71d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861284	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Hypopnoea (2d - Recovering/Resolving - );Hypoventilation (2d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861319	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (1d - Unknown - );Oropharyngeal pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861329	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (30d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861343	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (82d - Recovered/Resolved With Sequelae - );Groin pain (82d - Recovered/Resolved With Sequelae - );Inguinal hernia (88d - Not Recovered/Not Resolved - );Limb discomfort (82d - Recovered/Resolved With Sequelae - );Myalgia (82d - Recovered/Resolved With Sequelae - );Pain in extremity (82d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010861348	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861350	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861351	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (30d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861360	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vocal cord paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861383	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010861386	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010861392	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Hypoaesthesia (1d - Recovered/Resolved - );Muscle spasms (1d - Recovered/Resolved - );Paralysis (1d - Recovered/Resolved - Other Medically Important Condition);Trismus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861394	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010861398	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010861401	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (62d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Transaminases increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010861406	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Pneumonia (2d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010861411	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Unknown - );Lacrimation increased (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861417	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010861423	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Not Recovered/Not Resolved - );Hyperhidrosis (10d - Not Recovered/Not Resolved - );Hypoaesthesia (10d - Not Recovered/Not Resolved - );Paraesthesia (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861435	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861447	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Visual field defect (156d - Recovered/Resolved - );Visual impairment (156d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861448	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861486	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861497	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861517	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypertonia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861520	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861523	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861526	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861527	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861530	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861552	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861568	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (219d - Not Recovered/Not Resolved - );Nausea (219d - Not Recovered/Not Resolved - );Ophthalmoplegia (219d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010861611	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010861736	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Recovered/Resolved - );Decreased appetite (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Paraesthesia (13d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ALPRAZOLAM] (C - n/a - Not applicable - )|[DIOSMIN, DIOSMIN, HESPERIDIN] (C - n/a - Not applicable - )|[PAROXETINE, PAROXETINE HYDROCHLORIDE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861760	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovered/Resolved - );Groin pain (5d - Not Recovered/Not Resolved - );Hyperaesthesia (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861764	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861777	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861813	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861815	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861828	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861829	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861892	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010861901	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861923	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861926	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861941	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010861944	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861954	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861957	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Disturbance in attention (4mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861958	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861968	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010861975	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010861980	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010861980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010862029	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862043	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (72h - Recovered/Resolved - );Vaccination site erythema (72h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862065	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Body temperature increased (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Vaccination site erythema (2d - Recovered/Resolved - );Vaccination site pruritus (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862072	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862076	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862077	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (12h - Recovered/Resolved - );Muscle spasms (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010862081	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862088	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (5min - Recovered/Resolved - );Dizziness (5min - Recovered/Resolved - );Nausea (5min - Recovered/Resolved - );Tremor (5min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010862094	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Disturbance in attention (n/a - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved - );Injected limb mobility decreased (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Puncture site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862100	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862101	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862134	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862183	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010862203	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Injection site swelling (1d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010862219	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Injection site swelling (1d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010862229	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010862240	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Body temperature increased (4d - Recovered/Resolved - );Chills (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862250	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010862251	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862258	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862263	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862344	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal pain upper (14d - Recovered/Resolved - );Splenomegaly (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862347	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abnormal dreams (3d - Recovered/Resolved - );Blood pressure increased (1wk - Recovered/Resolved - );Decreased appetite (1wk - Recovered/Resolved - );Diarrhoea (1wk - Recovered/Resolved - );Headache (1wk - Recovered/Resolved - );Nausea (1wk - Recovered/Resolved - );Neck pain (1wk - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Sacral pain (1wk - Recovered/Resolved - );Vomiting (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862382	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862389	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [22d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862390	Spontaneous	2021-12-05 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vertigo (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862407	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (36h - Recovered/Resolved - );Chills (12h - Recovered/Resolved - );Headache (30h - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (36h - Recovered/Resolved - );Myalgia (30h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862414	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862423	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Urticaria (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862430	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Axillary pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Localised oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862433	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010862455	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Joint stiffness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010862460	Spontaneous	2021-12-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Facial pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010862460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010851942	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blepharitis (n/a - Not Recovered/Not Resolved - );Dry eye (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852029	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010852185	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dermatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852206	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852217	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle rigidity (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852223	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852245	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852269	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852280	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010852281	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852282	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852337	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852377	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acetonaemia (1d - Recovered/Resolved - );Bone pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852379	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852381	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (1d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - );Rash macular (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[PARACETAMOL] (C - Myalgia - n/a - [n/a - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852388	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852398	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLCYSTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THEOPHYLLINE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852402	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852406	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ETHOSUXIMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852410	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal detachment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852433	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010852449	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852458	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010852463	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010852470	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (n/a - Recovering/Resolving - Other Medically Important Condition);Epididymitis (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010852483	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes dermatitis (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010852485	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852584	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Iridocyclitis (n/a - Unknown - Other Medically Important Condition);Macular oedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010852589	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Muscular weakness (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852591	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia oral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852592	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiratory fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852597	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 10mg - Oral])|[SULODEXIDE] (C - Vertigo - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010852625	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus genital (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852630	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010852652	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Dermatitis atopic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010852660	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852669	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852691	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (31d - Recovered/Resolved - );Fatigue (31d - Recovered/Resolved - );Nausea (31d - Recovered/Resolved - );Pain in extremity (31d - Recovered/Resolved - );Vomiting (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010852697	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vertigo (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010852701	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening);Catarrh (n/a - Not Recovered/Not Resolved - Life Threatening);Chills (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Hypoacusis (n/a - Not Recovered/Not Resolved - Life Threatening);Hypoxia (n/a - Not Recovered/Not Resolved - Life Threatening);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vertigo (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010852746	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute polyneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);CSF protein (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Demyelinating polyneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852770	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vision blurred (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852777	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Disabling);Eye irritation (n/a - Not Recovered/Not Resolved - Disabling);Halo vision (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010852778	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010852791	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Balance disorder (n/a - Recovered/Resolved - );Haematochezia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[TIOCONAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010852825	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Intermenstrual bleeding (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852831	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Musculoskeletal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852847	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids thrombosed (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852865	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010852867	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010852873	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852886	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852917	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (0d - Recovered/Resolved - Other Medically Important Condition);Erythema (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010852925	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852927	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852943	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010852973	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rhinitis allergic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852984	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852992	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010852997	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010852997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853031	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Not Recovered/Not Resolved - Disabling);Hemiplegia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010853090	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema nodosum (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary sarcoidosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	[OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010853126	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853128	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853131	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853135	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853147	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death);Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NIET GESPECIFICEERD GENEESMIDDEL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010853151	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	IRBESARTAN 150 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853156	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853163	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853176	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes virus infection (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853184	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853191	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypersensitivity (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853192	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site induration (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853196	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853206	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Restlessness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	MAAGZUURREMMER [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853207	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853209	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010853215	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[LITHIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853222	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed mood (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Panic attack (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CANNABIS SATIVA] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853235	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853242	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853252	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853256	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dermatitis (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853270	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853274	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CEFUROXIME AXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PIMECROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010853316	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010853340	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysmenorrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (7d - Recovered/Resolved - );Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - );Malaise (7d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Polymenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010853340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854048	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854071	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854120	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hypokinesia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854140	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Blood pressure decreased (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854162	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854180	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854305	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854312	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854313	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1h - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site haematoma (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	BRILIQUE 90 MG FILM-COATED TABLETS [TICAGRELOR] (C - n/a - n/a - [n/a - n/a - n/a])|MICARDIS 40 MG TABLETS [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854371	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854447	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854457	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854461	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854463	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Meningism (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010854473	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854497	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854557	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Eczema (n/a - Not Recovered/Not Resolved - );Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854612	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854614	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854621	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010854670	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Body temperature increased (n/a - Unknown - );Lymphadenitis (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site oedema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854701	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854740	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Constipation (2d - Recovered/Resolved - );Hot flush (2d - Recovered/Resolved - );Meningism (2d - Recovered/Resolved - );Pain in extremity (10d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010854826	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Nocturia (n/a - Unknown - );Renal impairment (n/a - Unknown - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010854830	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854836	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (15d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010854905	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010854905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855084	Spontaneous	2021-12-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Cough (5d - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Productive cough (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855204	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Recovered/Resolved - );Axillary pain (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855330	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855463	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855561	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855569	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855631	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loose tooth (95d - Not Recovered/Not Resolved - );Toothache (95d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855652	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (86d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855653	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855654	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (29d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010855656	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855660	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855661	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes virus infection (65d - Not Recovered/Not Resolved - );Seasonal allergy (65d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855669	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (36d - Recovered/Resolved With Sequelae - );Rash (36d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010855670	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (125d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855671	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Weight bearing difficulty (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855675	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855678	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855680	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855681	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Influenza (128d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010855682	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (90d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855684	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855686	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855687	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855690	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855691	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Movement disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855692	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (16d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (17d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (18d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (16d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855694	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Limb discomfort (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Rash (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855695	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (137d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010855704	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Myalgia (201d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855711	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855714	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855715	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (144d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory distress (144d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855733	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Noninfective gingivitis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855735	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855737	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855750	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855763	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in jaw (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855766	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010855770	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Night sweats (36d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855771	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855792	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Extrasystoles (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010855795	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (119d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010855798	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855816	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010855831	Spontaneous	2021-12-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasal herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010855831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839290	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune disorder (n/a - Fatal - Results in Death);Diarrhoea (n/a - Unknown - );Joint swelling (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010839488	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839574	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Fatal - Results in Death);Suspected COVID-19 (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010839575	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839592	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010839607	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune disorder (n/a - Fatal - Results in Death);Cardiac disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010839622	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839680	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839706	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Depressed mood (n/a - Unknown - );Malaise (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839735	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839766	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839773	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839796	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute sinusitis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839831	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839843	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Muscle fatigue (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - );Tachycardia (n/a - Recovered/Resolved With Sequelae - );Tendonitis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010839874	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	SUNOSI [SOLRIAMFETOL] (C - n/a - n/a - [n/a - n/a - n/a])|XYREM [SODIUM OXYBATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839875	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010839886	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839898	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839903	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Vaccination site joint pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839904	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010839906	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839923	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasal polyps (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839925	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839964	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839967	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Epistaxis (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839977	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840059	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840081	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (0d - Fatal - Results in Death);Myocardial ischaemia (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010840087	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840111	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010840130	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840154	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840183	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840202	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010840203	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Life Threatening);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Life Threatening);Malaise (n/a - Recovered/Resolved With Sequelae - Life Threatening);Seizure (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010840214	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840217	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (64d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840229	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - );Choking sensation (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Foreign body sensation in eyes (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010840230	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840239	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840255	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010840262	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Other Medically Important Condition);Dysaesthesia (3d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840271	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840284	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840285	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840289	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010840296	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010840300	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840306	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved With Sequelae - Disabling);Rash (n/a - Recovered/Resolved With Sequelae - Disabling);Swelling face (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010840313	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Erythema (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypotension (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010840324	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - 10[drp] - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 100mg - n/a])|[TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840325	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840327	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (1d - Recovered/Resolved - Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Respiratory disorder (1d - Recovered/Resolved - Other Medically Important Condition);Urinary incontinence (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840332	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840334	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory failure (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840339	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory failure (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840376	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010840419	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840432	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOVORAPID 100 E/ML, OPLOSSING VOOR INJECTIE IN FLACON. [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840539	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])|[HEPATITIS A VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840707	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LYRICA [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840748	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840756	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Skin discolouration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Wheezing (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840758	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Decreased appetite (n/a - Unknown - );Rash papular (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840769	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Fatal - Results in Death);Suspected COVID-19 (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010840780	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 50ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840786	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840790	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE (INACTIVATED)] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - Unknown - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Mixed anxiety and depressive disorder - Unknown - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - Not applicable - [1d - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - Unknown - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE] (C - Immunisation - Not applicable - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840793	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition);Pleuritic pain (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840798	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840803	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Cardiovascular disorder (n/a - Unknown - );Diarrhoea (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840804	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - Unknown])|TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Unknown])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840820	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (40d - Recovered/Resolved - Other Medically Important Condition);Exercise tolerance decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010840925	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	EDOXABAN 60MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FENTANYL] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN ASPART, INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010840979	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840981	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010840982	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010840992	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dupuytren's contracture (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010840997	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010840997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841000	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Nasopharyngitis (n/a - Unknown - );Off label use (n/a - Fatal - Results in Death);Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010841001	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Axillary pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010841039	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Mobility decreased (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Myasthenic syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010841044	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841049	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841052	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Cough (n/a - Unknown - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Eyelid oedema (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Pruritus (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - 1{DF} - n/a])|[IMIDAPRIL HYDROCHLORIDE] (C - Angina pectoris - n/a - [n/a - 2{DF} - n/a])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841055	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tooth fracture (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841056	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure systolic increased (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841058	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010841062	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841063	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Fatal - Results in Death);Acute myocardial infarction (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010841105	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010841122	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841178	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hiccups (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CANDESARTAN] (C - n/a - n/a - [n/a - 8mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841181	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Multisystem inflammatory syndrome in children (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841183	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841290	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841296	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Dysphagia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841304	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841309	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[PARACETAMOL] (C - Adverse drug reaction, Headache, Pyrexia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841317	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841330	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (3d - Recovered/Resolved - );Dysstasia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010841344	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cholelithiasis (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841345	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Oral lichenoid reaction (n/a - Recovering/Resolving - );Oral pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - )|[MOMETASONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841359	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Libido decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841361	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841618	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010841619	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye allergy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841628	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Respiratory distress (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - n/a])|[HUMAN PAPILLOMAVIRUS VACCINE] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841638	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral nerve injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010841641	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841652	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleuropericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	EVOLOCUMAB [EVOLOCUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Unknown])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROMORPHONE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Unknown])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010841657	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pyrexia (n/a - Unknown - Other Medically Important Condition);Systemic inflammatory response syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841667	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Axillary pain (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mental impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841671	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[METAMIZOLE, METAMIZOLE SODIUM, METAMIZOLE SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841678	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841679	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (n/a - Unknown - Disabling, Other Medically Important Condition);Burning sensation (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010841682	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841685	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841688	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841697	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841698	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841706	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Infection (n/a - Not Recovered/Not Resolved - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841715	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841716	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010841794	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010841803	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841815	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841872	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841876	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841894	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Sinusitis (n/a - Unknown - Disabling, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010841896	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Breast cancer male (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010841946	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010841946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842040	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842064	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (n/a - Not Recovered/Not Resolved - );Sensation of foreign body (n/a - Recovering/Resolving - );Vaccination site erythema (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vaccination site pruritus (1d - Recovered/Resolved - );Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842109	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rheumatoid arthritis (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	CIMZIA [CERTOLIZUMAB PEGOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842324	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inflammatory marker increased (n/a - Recovered/Resolved - );Polyarthritis (n/a - Recovered/Resolved - );Rheumatoid arthritis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842345	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1[drp] - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842364	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842387	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842424	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood pressure increased (1h - Recovered/Resolved - );Dyspnoea (1h - Recovered/Resolved - );Localised oedema (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010842474	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - );Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Unknown - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CLONIXIN LYSINATE] (C - n/a - n/a - )|[POTASSIUM CHLORIDE, AMMONIUM CHLORIDE, CALCIUM GLUCONATE, POTASSIUM CITRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842551	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010842596	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic lymphocytic leukaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OBINUTUZUMAB [OBINUTUZUMAB] (C - Chronic lymphocytic leukaemia - n/a - [n/a - n/a - n/a])|VENETOCLAX [VENETOCLAX] (C - Chronic lymphocytic leukaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842603	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010842607	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842610	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010842618	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842625	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fibrin D dimer increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842645	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [62d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010842651	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ileus (n/a - Unknown - Life Threatening, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Sepsis (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010842652	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842658	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842664	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);External ear disorder (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842666	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842668	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (90min - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842672	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842677	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anxiety (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chronic kidney disease (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Genitals enlarged (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Renal disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Renal failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Retinopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Stress (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010842688	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842693	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842696	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842705	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842707	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - 300mg - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842715	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hallucination (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842717	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842721	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Tonsillitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842723	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842732	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842735	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842737	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CODEINE] (C - Pain - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PHENOXYMETHYLPENICILLIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842744	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - );Sweating fever (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - );Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842757	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010842758	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac death (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Electrolyte imbalance (n/a - Unknown - );Hepatic function abnormal (n/a - Unknown - );Hyperglycaemia (n/a - Unknown - );Hyperkalaemia (n/a - Unknown - Other Medically Important Condition);Hyponatraemia (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Shock (n/a - Unknown - Other Medically Important Condition);Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010842762	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Craniofacial fracture (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Rib fracture (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842774	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842811	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842837	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010842840	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842847	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Chills (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Pyrexia (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010842855	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842860	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Trigeminal neuritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010842959	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842961	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - );Tenosynovitis stenosans (n/a - Not Recovered/Not Resolved - );Trigger finger (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842966	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lactose intolerance (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010842978	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010842978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843035	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Unknown - );Productive cough (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALFACALCIDOL] (C - n/a - n/a - [n/a - 1ug - Oral])|[BACLOFEN] (C - n/a - n/a - [n/a - 10mg - Oral])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - 10mg - Oral])|[TRANDOLAPRIL] (C - n/a - n/a - [n/a - 2mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843163	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843244	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Chills (3d - Unknown - Disabling);Fatigue (3d - Unknown - Disabling);Pyrexia (3d - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010843354	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glioblastoma (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010843382	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010843394	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Infant	Yes	Not Specified	Mucous stools (72h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843458	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Infection (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 5mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010843469	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843482	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Alopecia (4mo - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010843512	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (10d - Recovered/Resolved - )	BORTEZOMIB [BORTEZOMIB] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|DARATUMUMAB [DARATUMUMAB] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843516	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843528	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843535	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (16d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site haematoma (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	MICARDIS 40 MG TABLETS [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010843614	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843747	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843808	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010843836	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (58d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010843836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844024	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844066	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - 2{DF} - Respiratory (inhalation)])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - n/a - n/a - [n/a - 200ug - Nasal])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - 5mg - Oral])|[TERBUTALINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844154	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010844167	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844181	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3d - Unknown - Disabling);Fatigue (3d - Unknown - Disabling);Headache (3d - Unknown - Disabling);Myalgia (3d - Unknown - Disabling);Nausea (3d - Unknown - Disabling);Pyrexia (3d - Unknown - Disabling);Vaccination site swelling (3d - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - Unknown - [n/a - 1g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010844196	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Furuncle (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844199	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lyme disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844202	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition);Suspected COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010844204	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010844206	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Liver disorder (2mo - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|OCREVUS [OCRELIZUMAB] (S - n/a - Drug withdrawn - [1d - n/a - Intravenous (not otherwise specified)])	PREVENAR 13 [ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197, ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197, PNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197] (C - n/a - n/a - [1d - n/a - n/a])|SHINGRIX [RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, STIMULON, MONOPHOSPHORYL LIPID A] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844210	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[HEPARINOID] (C - Dry skin - n/a - [n/a - n/a - Topical])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844232	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (10h - Recovered/Resolved - Life Threatening);Myalgia (10h - Recovered/Resolved - );Pyrexia (10h - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010844251	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844277	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844282	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844287	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010844289	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolism venous (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844292	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (15s - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010844295	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844297	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844299	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Glossodynia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Microsleep (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010844307	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844313	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Joint stiffness (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010844316	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Arrhythmia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844318	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Disturbance in attention (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010844385	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXOCOBALAMIN, HYDROXOCOBALAMIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010844431	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844446	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal behaviour (n/a - Unknown - );Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Epilepsy (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Hemiparesis (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010844449	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844456	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypothyroidism (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844460	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010844473	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Injection site swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844475	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844514	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844592	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844674	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010844689	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010844701	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844702	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Influenza (1d - Recovering/Resolving - );Limb discomfort (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844705	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening);Pleural effusion (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010844707	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (3d - Not Recovered/Not Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Hypoaesthesia oral (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Nasal congestion (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844724	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye oedema (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Injection site swelling (6d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Oedema peripheral (4d - Recovered/Resolved - );Rash (4d - Recovered/Resolved - );Vaccination site reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844725	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844730	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Eye oedema (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ophthalmic vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844738	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844748	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844759	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010844764	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Neck pain (3d - Not Recovered/Not Resolved - );Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844838	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal infarction (62d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Small intestine operation (62d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombosis (62d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844840	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010844845	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844846	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844851	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844852	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Unknown - );Vaccination site reaction (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844853	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844859	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Recovered/Resolved - );Headache (10d - Recovered/Resolved - );Myalgia (10d - Recovered/Resolved - );Pyrexia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844871	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010844872	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (12d - Unknown - );Feeling hot (12d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844878	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010844891	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010844897	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (33d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010844903	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (7d - Not Recovered/Not Resolved - );Paraesthesia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844910	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (10d - Not Recovered/Not Resolved - );Dizziness (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844924	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure abnormal (16d - Not Recovered/Not Resolved - );Cardiovascular disorder (16d - Not Recovered/Not Resolved - );Chills (16d - Not Recovered/Not Resolved - );Dyspnoea (16d - Not Recovered/Not Resolved - );Fatigue (16d - Not Recovered/Not Resolved - );Feeling hot (16d - Not Recovered/Not Resolved - );Oedema (16d - Not Recovered/Not Resolved - );Restlessness (16d - Not Recovered/Not Resolved - );Tachycardia (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010844928	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010844930	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pneumonia (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Venous thrombosis (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010844947	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Photophobia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010844947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845026	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845042	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Body temperature increased (3h - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845072	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845125	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845128	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845149	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845159	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010845161	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845167	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010845172	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845177	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845182	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aortic thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral artery thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845186	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845204	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845257	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845266	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845267	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845270	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845271	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845276	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845334	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845354	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Ischaemic heart disease prophylaxis - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Atrial fibrillation - n/a - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845360	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010845516	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - n/a - [n/a - 1{DF} - Unknown])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Unknown])	[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845547	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845548	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845669	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Acute myocardial infarction (5d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010845670	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010845683	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845697	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845703	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Retinopathy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010845749	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010845763	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010845816	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	GREPID 75 MG FILM-COATED TABLETS [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010845824	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nystagmus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[SELENIUM SULFIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845826	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Bronchiolitis (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010845827	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chronic pigmented purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FLUTICASONE PROPIONATE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845873	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010845990	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Hypotonia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010845997	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010845997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846032	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846033	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846037	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846041	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (1d - Recovered/Resolved - );Gastrointestinal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846045	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846048	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure increased (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLIUM SATIVUM BULB] (C - n/a - n/a - [n/a - n/a - n/a])|[ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBINOXAMINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM, POTASSIUM ION] (C - n/a - n/a - [n/a - n/a - n/a])|[MOLSIDOMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846052	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Fatal - Results in Death);Cardiac failure acute (n/a - Fatal - Results in Death);Cardio-respiratory arrest (0d - Recovered/Resolved - Life Threatening);Cerebral infarction (n/a - Fatal - Results in Death);Hemiplegia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoxic-ischaemic encephalopathy (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Metabolic acidosis (n/a - Unknown - Life Threatening);Post cardiac arrest syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ventricular tachycardia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Peripheral arterial occlusive disease - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846056	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Lyme disease (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846060	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Akathisia (n/a - Unknown - );Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Nausea (1h - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846063	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - );Glucose urine present (n/a - Unknown - );Mean cell volume decreased (n/a - Unknown - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wheezing (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846064	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846073	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - );Chest pain (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010846077	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cyanopsia (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Visual snow syndrome (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846080	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cold sweat (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846084	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846100	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertensive crisis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Taste disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846101	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846118	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Fatal - Results in Death);Cardiac arrest (n/a - Fatal - Results in Death);Cerebral haematoma (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Fatal - Results in Death);Respiratory arrest (n/a - Fatal - Results in Death);Subarachnoid haemorrhage (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846119	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pyoderma gangrenosum (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846120	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed mood (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial ischaemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846127	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846134	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Abnormal behaviour (n/a - Unknown - );Breath sounds abnormal (n/a - Unknown - );Cardiac failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypophagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pallor (n/a - Unknown - );Pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Torticollis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846141	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010846143	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846151	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846156	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Neck pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846158	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846161	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial fibrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846162	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (6h - Recovered/Resolved - );Dyspnoea (6h - Recovered/Resolved - );Headache (6h - Recovered/Resolved - );Myalgia (6h - Recovered/Resolved - );Oropharyngeal pain (6h - Recovered/Resolved - );Throat tightness (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010846169	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846175	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846179	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846184	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial necrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846193	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Testicular swelling (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Varicocele (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846196	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pyrexia (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846204	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846211	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myositis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846212	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846219	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (7d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - Thyroiditis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846220	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846223	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846224	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (7d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846226	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tongue biting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846227	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846229	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure increased - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846234	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypopnoea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846235	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846245	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846253	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846285	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic shock (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846286	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Meningitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846293	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846296	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Impaired driving ability (1d - Recovered/Resolved - Other Medically Important Condition);Mental impairment (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846297	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular insufficiency (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Hypersomnia (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846308	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle atrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nerve degeneration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846309	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Plasma cell myeloma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846310	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematochezia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846314	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010846319	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846328	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Recovered/Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010846331	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Overdose (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product preparation error (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .4mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846334	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (5d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (5d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846338	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Urinary tract infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846339	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846343	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846346	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846357	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Retinal artery occlusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846361	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846366	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (8min - Recovered/Resolved - Other Medically Important Condition);Diplopia (8min - Recovered/Resolved - );Vision blurred (8min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846367	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846371	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Essential tremor - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846380	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846381	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010846392	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846486	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Throat tightness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846497	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - );Throat tightness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846568	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846584	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846664	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (31650min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Eosinophilia (n/a - Unknown - Caused/Prolonged Hospitalisation);General physical health deterioration (31650min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Goitre (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (31650min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Coronary artery disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846717	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - );Antibody test positive (n/a - Unknown - );Asthenia (n/a - Not Recovered/Not Resolved - );Blood creatine phosphokinase increased (n/a - Unknown - Other Medically Important Condition);Blood creatinine decreased (n/a - Unknown - );Butterfly rash (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Dermatomyositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diplopia (n/a - Unknown - );Erythema (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Glomerular filtration rate increased (n/a - Unknown - );Hepatic steatosis (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Unknown - );Miliaria (n/a - Unknown - );Movement disorder (n/a - Not Recovered/Not Resolved - );Muscle oedema (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myositis (n/a - Unknown - );Nail disorder (n/a - Unknown - );Night sweats (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash (n/a - Unknown - );Rhabdomyolysis (n/a - Unknown - Other Medically Important Condition);Seasonal allergy (n/a - Unknown - );Testicular cyst (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[VITAMINS NOS] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010846745	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Body temperature fluctuation (n/a - Not Recovered/Not Resolved - Disabling);Cold sweat (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TERBUTALINE SULFATE, TERBUTALINE SULFATE PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010846750	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846798	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tendon injury (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846820	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Restlessness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010846823	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Unknown - );Cerebral infarction (n/a - Fatal - Results in Death, Disabling);Thrombosis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[DALTEPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010846841	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (0d - Recovered/Resolved - );Hypertension (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846844	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010846848	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Butterfly rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chronic cutaneous lupus erythematosus (n/a - Unknown - Other Medically Important Condition);Cutaneous vasculitis (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - );Hypersensitivity vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (6d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - );Rash papular (n/a - Unknown - );Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMBROXOL HYDROCHLORIDE] (C - Asthma, Bronchitis chronic - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, RIBOFLAVIN, DEXTRIN] (C - Carnitine deficiency, Dysphagia - n/a - [n/a - n/a - n/a])|[BACILLUS SUBTILIS, LACTOMIN, BIFIDOBACTERIUM] (C - Chronic gastritis, Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - Asthma, Bronchitis chronic - n/a - [n/a - n/a - n/a])|[DAIKENCHUTO, GINGER, GINSENG, ZANTHOXYLUM FRUIT, GINSENG] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[DEXTRIN, FISH OIL, MINERALS NOS, VITAMINS NOS, AMINO ACIDS, MILK PROTEIN CONCENTRATE, RAPESEED OIL] (C - Carnitine deficiency, Dysphagia - n/a - [n/a - n/a - n/a])|[GINSENG, RIKKUNSHITO] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Chronic gastritis, Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[LEVOCARNITINE] (C - Carnitine deficiency, Dysphagia - n/a - [n/a - n/a - n/a])|[MOSAPRIDE, MOSAPRIDE CITRATE] (C - Chronic gastritis, Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PRANLUKAST, PRANLUKAST HYDRATE] (C - Asthma, Bronchitis chronic - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010846916	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010846916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010847039	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010847151	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010847161	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Drug eruption (n/a - Unknown - Other Medically Important Condition);Eczema (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Oral mucosal erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rhinitis allergic (n/a - Unknown - Other Medically Important Condition);Toxic skin eruption (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847167	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Left ventricular hypertrophy (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010847173	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847174	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (21d - Recovered/Resolved - );Aspartate aminotransferase increased (n/a - Unknown - );Bacterial prostatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Gamma-glutamyltransferase increased (n/a - Unknown - );Liver function test increased (n/a - Recovered/Resolved - );Neutrophil count increased (21d - Recovered/Resolved - );Prostatic specific antigen increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010847180	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Accident (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847181	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847184	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aspartate aminotransferase increased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Fibrin degradation products increased (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - Nephrotic syndrome - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010847186	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Cerebrovascular accident (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010847187	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847189	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eyelid ptosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Liver disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Myasthenia gravis (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rhabdomyolysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE BESILATE, AZILSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010847355	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847365	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Erysipelas (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847366	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Endometriosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Endometritis - n/a - [n/a - n/a - n/a])|OZEMPIC [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISACODYL] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIBOLONE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847367	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse event (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847374	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847445	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Corneal graft rejection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847523	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010847529	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (5d - Recovered/Resolved - );Chills (4d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Hyperhidrosis (5d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010847536	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010847554	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010847560	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (4h - Recovered/Resolved - );Malaise (4h - Recovered/Resolved - );Paraesthesia (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010847596	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010847598	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysuria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Meningitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Prostatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847601	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010847609	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847611	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847622	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (11min - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010847624	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010847636	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010847681	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	BETMIGA [MIRABEGRON] (C - Incontinence - n/a - [n/a - n/a - n/a])|GANFORT [TIMOLOL MALEATE, BIMATOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[GALANTAMINE] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010847688	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENTRESTO [SACUBITRIL VALSARTAN SODIUM HYDRATE, VALSARTAN, SACUBITRIL] (C - Cardiac failure - n/a - [n/a - 200mg - n/a])|XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - 10mg - n/a])|[AZOSEMIDE] (C - Cardiac failure - n/a - [n/a - 60mg - n/a])|[DONEPEZIL HYDROCHLORIDE] (C - Dementia - n/a - [n/a - 5mg - n/a])|[FUROSEMIDE] (C - Cardiac failure - n/a - [n/a - 20mg - n/a])|[MIRABEGRON] (C - Hypertonic bladder - n/a - [n/a - 25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010847768	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (110h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847770	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Formication (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010847771	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Nephrolithiasis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010847772	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed mood (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AZELASTINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - Intervertebral disc degeneration - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[IBUPROFEN, IBUPROFEN PH. EUR.] (C - Intervertebral disc degeneration - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847840	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847871	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Hypertension (3d - Recovered/Resolved - Other Medically Important Condition);Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [6mo - 1{DF} - Intramuscular])	TOLURA [TELMISARTAN] (C - Hypertension - Unknown - )|TWYNSTA [AMLODIPINE, TELMISARTAN] (C - Hypertension - Unknown - )|[BETAXOLOL HYDROCHLORIDE] (C - Hypertension - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847905	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Encephalitis viral (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010847908	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010847936	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abnormal sensation in eye (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vaccination site joint swelling (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010847989	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010847991	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010847991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848001	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness bilateral (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Oropharyngeal discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848003	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Altered state of consciousness (n/a - Recovered/Resolved With Sequelae - Life Threatening, Disabling, Other Medically Important Condition);Arrhythmia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Disabling, Other Medically Important Condition);Cardiac arrest (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dehydration (n/a - Recovered/Resolved With Sequelae - );Ejection fraction abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Fall (n/a - Recovered/Resolved With Sequelae - Life Threatening, Disabling);Hepatic enzyme increased (n/a - Recovered/Resolved With Sequelae - );Hypoxic-ischaemic encephalopathy (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved With Sequelae - );Left ventricular hypertrophy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Portal venous gas (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved With Sequelae - );Superior mesenteric artery syndrome (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ventricular fibrillation (n/a - Recovered/Resolved With Sequelae - Life Threatening, Disabling, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010848005	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Heart rate increased (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypertension (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vertigo (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848018	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848019	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848033	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848053	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848057	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848122	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848151	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848152	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848154	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848160	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848161	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (35d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848177	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848178	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848181	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848189	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848196	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|[MIDAZOLAM] (S - Inguinal hernia - n/a - [1d - 4mg - Intravenous (not otherwise specified)])|[TRAMADOL HYDROCHLORIDE] (S - Analgesic intervention supportive therapy - n/a - [1d - 100mg - Intravenous drip])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010848201	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vitreous detachment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848213	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	AMIKACIN [AMIKACIN] (C - n/a - n/a - )|[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - )|[ENOXAPARIN, ENOXAPARIN SODIUM] (C - n/a - n/a - )|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - )|[PARACETAMOL] (C - n/a - n/a - )|[PIPERACILLIN] (C - n/a - n/a - )|[TAZOBACTAM SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010848224	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Life Threatening);Vaccination failure (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010848225	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Life Threatening);Vaccination failure (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010848228	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848247	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848251	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848255	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Tetany (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848256	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Polycythaemia - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848258	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Polycythaemia - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848262	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848277	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848278	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumothorax (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848281	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	SIMBRINZA [BRINZOLAMIDE, BRIMONIDINE TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE, RISEDRONATE MONOSODIUM, RISEDRONATE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848284	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848289	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848291	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848310	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Meningoradiculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Weight decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848321	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neutropenia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848324	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848330	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848332	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Transient ischaemic attack (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848343	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848345	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pancreatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[FENOFIBRATE, FENOFIBRATE MICRONISED] (S - Hypertriglyceridaemia - Dose not changed - [n/a - 20mg - Oral])|[FLUOXETINE HYDROCHLORIDE] (S - Depression - Dose not changed - [n/a - 20mg - Oral])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (S - Hypertension - Dose not changed - [n/a - 20mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848347	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (2h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848364	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010848370	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Orchitis (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848375	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Chest discomfort (6d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (6d - Recovered/Resolved - Other Medically Important Condition);Palpitations (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010848376	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - Other Medically Important Condition);Radiculopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848386	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Gastrointestinal disorder (7d - Recovered/Resolved - Other Medically Important Condition);Hyperlipasaemia (29d - Recovered/Resolved - Other Medically Important Condition);Immunisation reaction (5d - Recovered/Resolved - Other Medically Important Condition);Weight decreased (157d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010848408	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Dry eye (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Restlessness (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010848409	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (2d - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition);Screaming (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848412	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (2mo - Recovered/Resolved - Other Medically Important Condition);Pruritus (2mo - Recovered/Resolved - Other Medically Important Condition);Rash erythematous (2mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CLOBAZAM] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010848431	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848439	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848441	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848443	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848445	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848447	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848449	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848466	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovering/Resolving - );Hypertensive crisis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848467	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848476	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848479	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848484	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010848489	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848493	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848494	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848498	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848501	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848505	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site haematoma (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848523	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vitreous floaters (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010848528	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848529	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Gastrointestinal disorder (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848536	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848538	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Hypotension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848540	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Affective disorder (10d - Recovered/Resolved - );Eczema (3d - Recovered/Resolved - );Migraine (12d - Recovered/Resolved - );Nausea (12d - Recovered/Resolved - );Paraesthesia (12d - Recovered/Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - );Sleep disorder (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848545	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Asthenopia (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - )|[NEBIVOLOL] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848555	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848556	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848568	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848572	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848573	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848582	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848583	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848584	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848585	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848586	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848589	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848594	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848595	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848598	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848600	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848606	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ADENURIC [FEBUXOSTAT] (C - Hyperuricaemia - Dose not changed - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Hypercholesterolaemia - Dose not changed - [n/a - 10mg - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848609	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848617	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848618	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (8d - Recovered/Resolved - );Headache (8d - Recovered/Resolved - );Immunisation reaction (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848619	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848627	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848628	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Bursitis (n/a - Not Recovered/Not Resolved - );Enthesopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848629	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848631	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848633	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - );Polyarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[BROMAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848634	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848638	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848639	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848641	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848643	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848644	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848645	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (6wk - Recovered/Resolved - );Paraesthesia (6wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848646	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848651	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (18h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848653	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848656	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [24d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848666	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Enthesopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848686	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848690	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848705	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Epistaxis (n/a - Recovered/Resolved - );Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848706	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848707	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848712	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848719	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848720	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - )|RENUTRYL [ACIDE ASCORBIQUE, AROME/PARFUM, BEURRE (HUILE DE), CARRAGAHEEN, CASEINE SODIQUE, CHLORHYDRATE DE PYRIDOXINE, CHLORURE DE POTASSIUM, DIMETHYL-7,8 (D-RIBITYL-1')-10 3H,10H-BENZO[G]PTERIDINEDIONE-2,4, EAU PURIFIEE, GLYCEROL (PALMITOSTEARATE DE), HUILE DE SOJA RAFFINEE, HYDROXYDE DE POTASSIUM, LACTOPROTEINES ((MAMMIFERE/VACHE/LAIT)), LAIT ECREME, LEVURE LACTIQUE, MAGNESIUM (OXYDE DE), MANGANESE (SULFATE DE) MONOHYDRATE, NICOTINAMIDE, NITRATE DE THIAMINE, PALMITATE DE RETINOL, PANTOTHENATE DE CALCIUM, SIROP DE GLUCOSE DESHYDRATE 20-23, SODIUM (TRIPOLYPHOSPHATE DE), SULFATE FERREUX, SACCHAROSE] (C - n/a - n/a - )|SILODOSIN [SILODOSIN] (C - n/a - n/a - )|[ALVERINE CITRATE, SIMETICONE] (C - n/a - n/a - )|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - n/a - n/a - )|[LOPERAMIDE HYDROCHLORIDE] (C - n/a - n/a - )|[PHLOROGLUCINOL DIHYDRATE] (C - n/a - n/a - )|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848721	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[ISPAGHULA] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848726	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848728	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848732	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendonitis (2mo - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848737	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848738	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848740	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848741	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848745	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848751	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848752	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848759	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Angioedema (24h - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010848761	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848767	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010848824	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010848824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849002	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849003	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2h - Recovered/Resolved - );Vaccination site pain (2h - Recovered/Resolved - );Vertigo (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849005	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849036	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849065	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849078	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in jaw (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849081	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849139	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Gastrointestinal pain (n/a - Recovering/Resolving - );Illness (n/a - Recovering/Resolving - );Near death experience (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849145	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Back pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Injection site reaction (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849157	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849197	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Accommodation disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Impaired work ability (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Recovered/Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849232	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Feeling hot (n/a - Recovered/Resolved - );Muscle spasms (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [7y - 1{DF} - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [10y - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010849278	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849343	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear disorder (n/a - Not Recovered/Not Resolved - );Hearing disability (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010849348	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010849357	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849391	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Vomiting (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010849466	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010849473	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010849476	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010849480	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Urinary tract obstruction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849482	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Lebedev, L.. Minimal Change Disease Following the Pfizer-BioNTech COVID-19 Vaccine. American Journal of Kidney Diseases. 2021;78(1):142-145. doi:10.1053/j.ajkd.2021.03.010.	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Glomerulonephritis minimal lesion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849488	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chest pain (3d - Recovered/Resolved - );Mobility decreased (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849496	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (3d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849509	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (4d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849511	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ascites (n/a - Unknown - Caused/Prolonged Hospitalisation);Death (n/a - Fatal - Results in Death);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immobile (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	IKERVIS 1 MG/ML [CICLOSPORIN] (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 47.5mg - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 50mg - n/a])|[CETRIMIDE, HYPROMELLOSE] (C - n/a - Dose not changed - [n/a - 8{DF} - n/a])|[COLECALCIFEROL] (C - n/a - Dose not changed - [n/a - 30[drp] - n/a])|[FUROSEMIDE] (C - n/a - Dose not changed - [n/a - 80mg - n/a])|[HYPROMELLOSE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[MAGNESIUM CARBONATE, MAGNESIUM OXIDE, MAGNESIUM OXIDE] (C - n/a - Dose not changed - [n/a - 365mg - n/a])|[PANTOPRAZOLE SODIUM] (C - n/a - Dose not changed - [n/a - 40mg - n/a])|[PHENPROCOUMON] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - Dose not changed - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010849523	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (8h - Recovered/Resolved - );Condition aggravated (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849526	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849540	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (45min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849567	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (0d - Recovered/Resolved - );Feeling cold (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849575	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Sinus pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010849576	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010849626	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849652	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849665	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849747	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010849803	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849808	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010849812	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010849814	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849818	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Apraxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Carotid artery stenosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral infarction (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[BENIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FAMOTIDINE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[ISOSORBIDE MONONITRATE] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849822	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Apathy (n/a - Unknown - );Brain fog (n/a - Unknown - );Burning sensation (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Exercise tolerance decreased (n/a - Unknown - );Head discomfort (n/a - Unknown - );Hypertension (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Muscle discomfort (n/a - Unknown - );Muscle twitching (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Myalgia (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - );Panic attack (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Polyneuropathy (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010849826	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849860	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010849928	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849956	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (20d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849963	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait inability (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849964	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Encephalitis autoimmune (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Noninfective encephalitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010849970	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myalgia (2d - Unknown - );Pulmonary pain (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849971	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010849984	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (38d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010849989	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010849996	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Aphasia (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebral haemorrhage (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hemiparesis (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010849996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010850000	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010850011	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - Not applicable - [n/a - n/a - Unknown])	[OMEPRAZOLE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010850033	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010850132	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (2d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850134	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010850136	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Hypokinesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010850145	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010850161	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Joint swelling (n/a - Unknown - );Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010850189	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010850215	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	HYDROCHLOROTHIAZIDE, IRBESARTAN [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - Unknown - [n/a - 100mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - 100mg - n/a])|[ALPHA-LIPOIC ACID MEGLUMINE, ALPHA-LIPOIC ACID, MEGLUMINE SALT, THIOCTIC ACID] (C - n/a - Unknown - [n/a - 600mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - Unknown - [n/a - 5mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - 2.5mg - n/a])|[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - n/a - Unknown - [n/a - 107.5mg - n/a])|[GLICLAZIDE] (C - n/a - Unknown - [n/a - 30mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850231	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pollakiuria (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thirst (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Type 1 diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Weight decreased (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010850247	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Unknown - );Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anxiety (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Eye pruritus (n/a - Unknown - );Immune system disorder (n/a - Not Recovered/Not Resolved - );Irregular sleep wake rhythm disorder (n/a - Unknown - );Pharyngeal swelling (n/a - Unknown - );Skin mass (n/a - Unknown - );Throat irritation (n/a - Unknown - );Tongue disorder (n/a - Unknown - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010850272	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850292	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (0d - Recovered/Resolved - Other Medically Important Condition);Urticaria (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010850301	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850304	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (26d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010850311	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850313	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850384	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - );Poor quality product administered (n/a - Unknown - );Product preparation error (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[WATER FOR INJECTION, WATER FOR INJECTION - BP] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850389	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010850431	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation);Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010850473	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coronary artery stenosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular hypokinesia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010850476	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of control of legs (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Proctitis (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - Anaemia - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Myalgia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[SOLIFENACIN SUCCINATE] (C - Pollakiuria - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010850479	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850484	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850519	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010850586	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Fall (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010850588	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Atrioventricular block (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Unknown])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Unknown])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[EZETIMIBE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010850589	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Tremor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])|[INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010850688	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );Cardiac failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010850713	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Hypersomnia (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	[IBUPROFEN] (C - Teething - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010850739	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (12h - Recovered/Resolved - );Lymph node pain (n/a - Recovering/Resolving - );Vaccination site movement impairment (36h - Recovered/Resolved - );Vaccination site reaction (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850766	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010850775	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Infant	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850808	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye irritation (3d - Recovered/Resolved - );Hyperhidrosis (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850900	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850929	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PERINDOPRIL TERT-BUTYLAMINE, AMLODIPINE, PERINDOPRIL TERT-BUTYLAMINE, AMLODIPINE BESILATE] (C - Hypertension - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010850978	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Diakoumakou, S.. COMPLETE ABDOMINAL AORTIC OCCLUSION IN A PATIENT WITH COVID19 INFECTION. 24th PANHELLENIC CONGRESS OF INTERNAL MEDICINE. 2021;220	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010850979	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010850979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010851004	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851246	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BETAMETHASONE DIPROPIONATE (PH. EUR.), FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010851256	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (24h - Recovered/Resolved - Other Medically Important Condition);Lip swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010851350	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851351	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (3d - Recovered/Resolved - );Decreased appetite (3d - Recovering/Resolving - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851356	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851370	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010851377	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (2d - Recovered/Resolved - );Hypertension (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851384	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Dyspepsia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851396	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851402	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851409	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010851423	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851429	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[ISPAGHULA HUSK] (C - Constipation - Drug withdrawn - [25d - 3.5g - Oral])|[MAGNESIUM BROMIDE, MAGNESIUM FLUORIDE, MAGNESIUM HYDROXIDE] (C - Constipation - Drug withdrawn - [25d - 53mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010851433	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851442	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Systemic inflammatory response syndrome (8d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])|[B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010851452	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851488	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphopenia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851562	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (8h - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010851605	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest pain (n/a - Unknown - Other Medically Important Condition);Hiatus hernia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010851692	Spontaneous	2021-12-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Borrelia infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010851784	Spontaneous	2021-12-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (68d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pulmonary embolism (68d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010851784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010824849	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	[HUMAN ANTI-D IMMUNOGLOBULIN] (S - n/a - Unknown - [n/a - n/a - n/a])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010825012	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash papular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825027	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825044	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010825045	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria chronic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825080	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Flushing (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825098	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - );Puncture site erythema (n/a - Recovered/Resolved With Sequelae - );Puncture site pruritus (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010825110	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825258	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825263	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825275	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825286	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825304	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Hepatic failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010825306	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825310	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825313	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825317	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825322	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825324	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825332	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825335	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825380	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825383	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Respiratory fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825403	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010825420	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Skin reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825423	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825428	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010825451	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825474	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825476	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vertigo (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825508	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825510	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825529	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825533	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	5q minus syndrome (n/a - Not Recovered/Not Resolved - Disabling);Anaemia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, NEBIVOLOL, HYDROCHLOROTHIAZIDE, NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010825536	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	KEPPRA 750 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010825570	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Platelet aggregation abnormal - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Blood uric acid increased - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE, METOPROLOL TARTRATE BP] (C - Hypertension - n/a - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - Peptic ulcer - n/a - [n/a - n/a - Oral])|[SULODEXIDE] (C - Skin ulcer - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825576	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825625	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Bradykinesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825638	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825648	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Groin pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Leukopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal colic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825651	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825664	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	ABASAGLAR [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|HUMALOG 100 U/ML SOLUTION FOR INJECTION IN VIAL [INSULIN LISPRO] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - 100mg - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - 20mg - n/a])|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 10mg - n/a])|[TORASEMIDE, TORASEMIDE SODIUM] (C - Hypertension - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825669	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825671	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea at rest (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - 150mg - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - 2mg - Oral])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 5mg - Oral])|[MAGALDRATE, MAGALDRATE ANHYDROUS] (C - n/a - n/a - [n/a - 800mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825679	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Endocarditis (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825698	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Catarrh (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Life Threatening);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010825723	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (23d - Recovered/Resolved - );Cough (23d - Recovered/Resolved - );Vaccination failure (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	BRINZOLAMIDE [BRINZOLAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|JANUMET 50 MG/1,000 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, SITAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|LATANOPROST [LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[IVABRADINE OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIMOLOL, TIMOLOL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010825748	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825749	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial pain (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825750	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825755	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes virus infection (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010825756	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Trigeminal neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	NEUPRO 2 MG/24 H 4 MG/24 H 6 MG/24 H 8 MG/24 HTRANSDERMAL PATCH [ROTIGOTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SELEGILINE, SELEGILINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825757	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cluster headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825760	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010825763	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal vein thrombosis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010825765	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010825766	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825768	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825773	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ileus paralytic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral motor neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Quadriplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HUMAN NORMAL IMMUNOGLOBULIN, HUMAN NORMAL IMMUNOGLOBULIN (IV), IMMUNOGLOBULIN A, IMMUNOGLOBULIN G, IMMUNOGLOBULIN M] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOSULPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MICRONISED SPIRONOLACTONE, POTASSIUM CANRENOATE, SPIRONOLACTONE, SPIRONOLACTONE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825778	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825786	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825789	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina unstable (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010825791	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010825792	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825799	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypocapnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoxia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010825801	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachyarrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010825804	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010825908	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Supraventricular extrasystoles (113d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010825908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010826048	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (1d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826148	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Pulmonary congestion (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FUROSEMIDE, FUROSEMIDE SODIUM] (C - Blood pressure abnormal - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826152	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - );Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826161	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826169	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral artery embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826171	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coronary artery disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Interstitial lung disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826182	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood immunoglobulin E increased (n/a - Not Recovered/Not Resolved - );Pleuritic pain (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826185	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematemesis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary sepsis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Septic shock (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALPRAZOLAM] (C - Sedative therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010826189	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - );Dizziness (n/a - Recovering/Resolving - );Emotional distress (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypersomnia (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Skin odour abnormal (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826194	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pollakiuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary incontinence (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010826203	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826211	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826218	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826224	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Visual field defect (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Major depression - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)] (C - Vitamin D - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[TESTOSTERONE UNDECANOATE] (C - Secondary hypogonadism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826226	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826232	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826245	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826247	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Limb mass (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826251	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypotension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826255	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hiccups (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826261	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826262	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haematuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826272	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826281	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Delirium (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Headache (n/a - Unknown - );Heat stroke (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Panic attack (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826416	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back disorder (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826557	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Anaemia (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Peptic ulcer (n/a - Unknown - Other Medically Important Condition);Upper gastrointestinal haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826558	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (3d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826569	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haematocrit decreased (n/a - Unknown - );Therapeutic response unexpected (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826574	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826578	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - );Urinary retention (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826585	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Grip strength decreased (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Movement disorder (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010826602	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826607	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826609	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826610	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Recovering/Resolving - Disabling);Apnoea (n/a - Recovering/Resolving - Disabling);Depressed mood (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Unknown - Disabling);Feeling abnormal (n/a - Unknown - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Heart rate increased (n/a - Recovering/Resolving - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Unknown - Disabling);Libido disorder (n/a - Unknown - Disabling);Loss of personal independence in daily activities (n/a - Recovering/Resolving - Disabling);Memory impairment (n/a - Unknown - Disabling);Mental fatigue (n/a - Unknown - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010826619	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826623	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826630	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010826665	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010826666	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826670	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826671	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826726	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[TEICOPLANIN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010826765	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular hypokinesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010826766	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826769	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010826771	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Disabling);Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010826773	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Lymphadenitis (n/a - Not Recovered/Not Resolved - Life Threatening);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Life Threatening);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Rash (n/a - Not Recovered/Not Resolved - Life Threatening);Varicella (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010826773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010827027	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gout (n/a - Recovering/Resolving - );Mouth ulceration (n/a - Unknown - );Pain (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010827097	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827103	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (n/a - Recovered/Resolved - Other Medically Important Condition);Tongue ulceration (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827115	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827117	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (28d - Recovered/Resolved - Other Medically Important Condition);Cyanosis (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (28d - Recovered/Resolved - Disabling);Heart rate increased (28d - Recovered/Resolved - Other Medically Important Condition);Hypothermia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (171h - Recovered/Resolved - );Palpitations (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[OXYBUTYNIN HYDROCHLORIDE] (C - Bladder dysfunction - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - Urinary tract infection - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827126	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fallot's tetralogy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827129	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (7d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827134	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827136	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flushing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827141	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alveolar lung disease (n/a - Fatal - Results in Death);Anaphylactic reaction (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Fatal - Results in Death);Fall (n/a - Unknown - );Heat illness (n/a - Unknown - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary oedema (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010827142	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827144	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Orthostatic hypotension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827149	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827155	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Palpitations (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827156	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827158	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827160	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827165	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Karer, M.. Subcutaneous injection of mRNA vaccines against severe acute respiratory syndrome coronavirus 2: an option for severe bleeding disorders or anticoagulated patients?.. Blood Coagulation &amp; Fibrinolysis. 2021;32(6):423-424. doi:10.1097/MBC.0000000000001048	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010827170	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Nephritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827187	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (2h - Recovered/Resolved With Sequelae - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010827189	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Cardiac disorder (n/a - Unknown - );Cytokine storm (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - );International normalised ratio abnormal (n/a - Unknown - );Stevens-Johnson syndrome (n/a - Unknown - Other Medically Important Condition);Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827191	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827196	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (12h - Recovered/Resolved - Other Medically Important Condition);Headache (48h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827197	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Enlarged uvula (n/a - Unknown - Caused/Prolonged Hospitalisation);Laryngeal oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Laryngitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827198	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827200	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Illusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUPRENORPHINE] (C - Back pain - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827204	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827225	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Cardiac hypertrophy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Heart rate decreased (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827226	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827228	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827659	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010827675	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Life Threatening);Breast pain (n/a - Recovered/Resolved - Other Medically Important Condition);Coronary artery disease (n/a - Recovered/Resolved - Life Threatening);Coronary artery stenosis (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010827763	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010827765	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pleurisy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827767	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac pacemaker insertion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827779	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - );Decreased appetite (4d - Recovered/Resolved - );Diarrhoea (4d - Recovered/Resolved - );Dyspnoea (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Heart rate increased (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - );Vaccination site warmth (4d - Recovered/Resolved - );Weight decreased (4d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827785	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827788	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827789	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827795	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827797	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827799	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827802	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Depression (n/a - Recovering/Resolving - );Hypercoagulation (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010827807	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Paroxysmal nocturnal haemoglobinuria (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827808	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bacterial prostatitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Benign prostatic hyperplasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Prostatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (151h - Recovered/Resolved - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827813	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827816	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[RAMIPRIL] (S - Blood pressure increased, Heart rate increased - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827818	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827824	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - );Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nasal congestion (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827831	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthropathy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010827835	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827848	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010827890	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010827920	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - Thyroidectomy - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010827987	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Dizziness (2d - Recovered/Resolved - );Insomnia (n/a - Unknown - );Irritability (n/a - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Tension headache (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, COLECALCIFEROL, MAGNESIUM] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - [n/a - 40ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010827987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828017	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[NOSCAPINE, NOSCAPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828019	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Hypotension (n/a - Unknown - );Nausea (n/a - Unknown - );Vaccination site pain (n/a - Recovering/Resolving - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828033	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Vision blurred (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828035	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Vertigo positional (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828083	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Dizziness (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828100	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood glucose increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828204	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Ocular discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828305	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness transient (n/a - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Unknown - );Hyperhidrosis (1d - Recovered/Resolved - );Insomnia (n/a - Unknown - );Neck pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Tenderness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010828378	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010828389	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coordination abnormal (n/a - Recovering/Resolving - );Tremor (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|SIMBRINZA 10 MG/ML + 2 MG/ML EYE DROPS, SUSPENSION [BRINZOLAMIDE, BRIMONIDINE TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|TRAVOPROST 40 ΜG/ML - EYE DROPS  (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010828398	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Lymphadenitis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828482	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - );Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes simplex (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828564	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ear disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune system disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828575	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Type 2 diabetes mellitus - n/a - [n/a - 2000mg - n/a])|LANTUS [INSULIN GLARGINE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828578	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Sputum increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828579	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828586	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pruritus (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010828590	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	GUANFACINE [GUANFACINE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Tic - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828593	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tension headache (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828607	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MEDROXYPROGESTERONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Tenosynovitis stenosans - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010828609	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nerve injury (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010828610	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperaesthesia teeth (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neuralgia (11d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Tooth abscess (n/a - Unknown - Other Medically Important Condition);Trigeminal neuralgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828617	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828619	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fluid retention (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828624	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart disease congenital (174d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010828626	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828627	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Sinus congestion (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010828630	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Psychomotor hyperactivity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MELATONIN [MELATONIN] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828632	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828637	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828641	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (4d - Recovered/Resolved - Other Medically Important Condition);Lymph node pain (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828644	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Death (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010828657	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute leukaemia (n/a - Fatal - Results in Death, Life Threatening);Cerebral haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010828662	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828666	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828669	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Endocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828672	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828676	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828677	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema multiforme (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828692	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (195h - Recovered/Resolved - );Headache (195h - Recovered/Resolved - );Nasopharyngitis (195h - Recovered/Resolved - );Pyrexia (195h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828705	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (3d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010828706	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828710	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Recovering/Resolving - );Colitis ulcerative (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828712	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Myocardial ischaemia (n/a - Fatal - Results in Death);Tachycardia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010828717	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Paroxysmal nocturnal haemoglobinuria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828730	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Crying (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828738	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Sinus headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828740	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828742	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828749	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nipple pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828751	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828752	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arterial occlusive disease (n/a - Unknown - Other Medically Important Condition);Giant cell arteritis (n/a - Unknown - Other Medically Important Condition);Visual acuity reduced (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828770	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Poor quality sleep (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828771	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Injection site mass (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010828803	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acne (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828804	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired quality of life (n/a - Unknown - Disabling);Impaired work ability (n/a - Unknown - Disabling);Limb injury (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010828810	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Muscle injury (194d - Recovering/Resolving - Disabling, Other Medically Important Condition);Muscular weakness (n/a - Unknown - );Myalgia (n/a - Unknown - );Tenderness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010828816	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Catarrh (n/a - Unknown - );Cough (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828819	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828820	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Painful respiration (n/a - Unknown - );Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition);Weight increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828831	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - );Tenderness (250d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010828832	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828835	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828836	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Parkinsonism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828842	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Recovering/Resolving - );Erythema (n/a - Unknown - );Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|REMSIMA [INFLIXIMAB] (S - Crohn's disease - Drug withdrawn - [1d - n/a - n/a])|[DIMETINDENE MALEATE] (S - n/a - Unknown - [n/a - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828845	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828851	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Carpal collapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828872	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - );Joint swelling (n/a - Recovering/Resolving - );Oedema (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828891	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828897	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010828900	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[METHYLPHENIDATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 54mg - n/a])|[RISPERIDONE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828908	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematoma (n/a - Recovered/Resolved - );Inflammation (n/a - Unknown - );Joint swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010828909	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Disabling);Headache (341h - Recovered/Resolved - );Pain (53h - Recovered/Resolved - );Pyrexia (53h - Recovered/Resolved - );VIth nerve disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010828932	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Face oedema (5d - Recovered/Resolved - );Skin disorder (5d - Recovered/Resolved - );Urticaria (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828940	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthropod bite (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Micturition disorder (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Psoriasis (n/a - Recovering/Resolving - );Rash erythematous (n/a - Recovering/Resolving - );Rash macular (n/a - Recovering/Resolving - );Skin disorder (n/a - Recovering/Resolving - );Skin exfoliation (n/a - Recovering/Resolving - );Ulcer (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[MOMETASONE] (C - n/a - Unknown - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ROSUVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828945	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Throat irritation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BILASTINE] (C - Allergy prophylaxis - Not applicable - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010828966	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828980	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Faeces discoloured (n/a - Unknown - );Headache (n/a - Unknown - );Influenza (n/a - Unknown - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828982	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010828992	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010828997	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (18d - Not Recovered/Not Resolved - );Headache (8d - Recovering/Resolving - );Influenza like illness (16d - Not Recovered/Not Resolved - );Limb discomfort (16d - Not Recovered/Not Resolved - );Malaise (18d - Not Recovered/Not Resolved - );Nausea (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010828997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010829073	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829091	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010829096	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hepatic enzyme increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010829097	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010829101	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malnutrition (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010829136	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Drug eruption (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010829142	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (14d - Recovered/Resolved - );Arthralgia (14d - Recovered/Resolved - );Fatigue (14d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010829188	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010829219	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Hypersensitivity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010829228	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Constipation (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinary retention (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Influenza immunisation - Dose not changed - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010829232	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (115d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010829267	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010829296	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Recovering/Resolving - );Injection site haematoma (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010829304	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010829362	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010829364	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829371	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829372	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829373	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829374	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829653	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010829683	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829713	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010829907	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010829988	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010829988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830029	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site reaction (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LYRICA 75 MG [PREGABALIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[DICLOFENAC SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830094	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830103	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010830104	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010830105	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830163	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (30min - Recovered/Resolved - );Pruritus (30min - Recovered/Resolved - );Rash (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	VICTOZA [LIRAGLUTIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830297	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830302	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (0d - Recovering/Resolving - );Influenza like illness (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830306	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (13d - Not Recovered/Not Resolved - );Fatigue (13d - Not Recovered/Not Resolved - );Headache (9d - Not Recovered/Not Resolved - );Myalgia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830325	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830333	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Blood pressure decreased (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Sleep disorder (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830335	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (1d - Not Recovered/Not Resolved - );Dysphagia (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Laryngeal pain (1d - Recovering/Resolving - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Somnolence (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830343	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (36d - Recovering/Resolving - );Vomiting (29d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010830344	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830360	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site movement impairment (127d - Not Recovered/Not Resolved - );Injection site pain (127d - Not Recovered/Not Resolved - );Limb discomfort (126d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010830361	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830386	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Hypoaesthesia (4d - Recovering/Resolving - );Paraesthesia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830387	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (2d - Recovered/Resolved - );Disturbance in attention (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Hyperaesthesia (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830394	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (9d - Recovered/Resolved - Other Medically Important Condition);Palpitations (9d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010830398	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830405	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010830408	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myalgia (59d - Not Recovered/Not Resolved - );Vaccination site reaction (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010830415	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830423	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (66d - Not Recovered/Not Resolved - );Muscular weakness (66d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010830431	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (6d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830432	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (4d - Not Recovered/Not Resolved - );Nasopharyngitis (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830434	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830443	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site induration (3d - Not Recovered/Not Resolved - );Injection site pain (3d - Not Recovered/Not Resolved - );Injection site swelling (3d - Not Recovered/Not Resolved - );Injection site warmth (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830448	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (6d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830451	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (4d - Unknown - );Headache (4d - Unknown - );Visual impairment (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830462	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010830478	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010830481	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010830509	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ALLOPURINOL] (C - n/a - Not applicable - )|[VALSARTAN] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010830539	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diabetes mellitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eyelid oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|REMICADE [INFLIXIMAB] (S - Colitis ulcerative - n/a - [202d - n/a - Intravenous (not otherwise specified)])	[AZATHIOPRINE] (C - Colitis ulcerative - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010830540	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Congenital Anomaly)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	Severe reaction
EU-EC-10010830740	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830771	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Blood pressure abnormal (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	IRBESARTAN 75 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830791	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830794	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dupuytren's contracture (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830802	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Hypoaesthesia (n/a - Recovering/Resolving - );Injection site inflammation (5d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Injection site swelling (5d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830811	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Dizziness (n/a - Recovering/Resolving - );Fatigue (5d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hyperresponsive to stimuli (n/a - Recovering/Resolving - );Injection site haematoma (8d - Recovered/Resolved - );Injection site swelling (8d - Recovered/Resolved - );Malaise (8d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (8d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830924	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010830957	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010830961	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010830961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831024	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Insomnia (n/a - Unknown - );Mobility decreased (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831027	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	EXELON [RIVASTIGMINE] (C - Cognitive disorder - n/a - [n/a - n/a - Transdermal])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - Oral])|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Coronary artery disease - n/a - [n/a - 50mg - Oral])|[TERBINAFINE, TERBINAFINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831038	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831044	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia intercostal (n/a - Recovering/Resolving - Other Medically Important Condition);Painful respiration (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831080	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - );Vaccination failure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831082	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuralgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831090	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831113	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831154	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening);Angina pectoris (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010831189	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes simplex (n/a - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831221	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );Arterial occlusive disease (n/a - Unknown - Other Medically Important Condition);Bronchitis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831231	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831233	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831234	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831237	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831253	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Thrombosis - n/a - [n/a - 5mg - Oral])|TECENTRIQ [ATEZOLIZUMAB] (C - Bladder cancer - n/a - [50d - 1200mg - Intravenous (not otherwise specified)])|[DICLOXACILLIN] (C - Bursitis - n/a - [12d - 500mg - Oral])|[PREDNISOLONE] (C - Neoplasm malignant - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010831434	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Disabling);Lymphadenopathy (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010831446	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831451	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (8d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831455	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831460	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831463	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Endometriosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Endometritis - n/a - [n/a - n/a - n/a])|OZEMPIC [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISACODYL] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIBOLONE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831469	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010831470	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831474	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831480	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010831490	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial fibrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831495	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Neuralgia (8d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010831501	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Disabling);Night sweats (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010831509	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831514	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint stiffness (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831515	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Viral infection (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010831517	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831519	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Unknown - Other Medically Important Condition);Neck mass (n/a - Unknown - Other Medically Important Condition);Skin reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831526	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010831537	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831538	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831540	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Presyncope (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831541	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831543	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831544	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831545	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TERBINAFINE] (C - Fungal infection - n/a - [46d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831547	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831548	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blister (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831553	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OLANZAPINE [OLANZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831554	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Skin mass (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831555	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting projectile (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831557	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831572	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ataxia (n/a - Unknown - Disabling);Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Influenza (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010831578	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death);Erythema (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Inflammation (n/a - Unknown - );Intestinal ischaemia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010831579	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831584	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831619	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831703	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831704	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831711	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831714	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831718	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831719	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831724	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831736	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010831737	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (28d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Maximal voluntary ventilation (n/a - Recovering/Resolving - Other Medically Important Condition);Myositis (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831766	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Gynaecomastia (n/a - Unknown - );Overdose (n/a - Unknown - );Product preparation error (n/a - Unknown - );Product use issue (n/a - Unknown - );Wrong product administered (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831783	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HYDROXYCARBAMIDE [HYDROXYCARBAMIDE] (C - Essential thrombocythaemia - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, ACETYLSALICYLIC ACID] (C - Essential thrombocythaemia - n/a - [n/a - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - Meniere's disease - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010831788	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Restless legs syndrome (61d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831795	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Leukocytosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831815	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acne (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin discolouration (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831820	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Erythema (50h - Recovered/Resolved - Other Medically Important Condition);Movement disorder (n/a - Recovering/Resolving - Disabling);Muscle spasms (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Pyrexia (145h - Recovered/Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010831881	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831882	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Syncope (30s - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831895	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831901	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Respiratory arrest (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep apnoea syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831904	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - );Dehydration (n/a - Not Recovered/Not Resolved - );Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Unknown - );Hypokalaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831909	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831910	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831912	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cranial nerve palsies multiple (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diplopia (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831913	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831919	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Conjunctivitis (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010831923	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - );Infection susceptibility increased (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831925	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831926	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Embolism (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831929	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haemoptysis (n/a - Unknown - );Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831937	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Squamous cell carcinoma (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831938	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831944	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831947	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Death (n/a - Fatal - Results in Death);Platelet count decreased (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010831950	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831951	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831954	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Onderko, L.. Myocarditis in the Setting of Recent COVID-19 Vaccination. Case Reports in Cardiology. 2021;10.1155/2021/6806500. doi:10.1155/2021/6806500	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831955	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010831963	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831969	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oral blood blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Platelet count decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831970	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fall (n/a - Unknown - );Herpes zoster (n/a - Unknown - );Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010831971	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010831973	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831975	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010831982	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ophthalmoplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010831993	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010831993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832058	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832122	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (11d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832168	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832169	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832174	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832187	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (46min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832192	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Blood pressure fluctuation (n/a - Unknown - );Blood uric acid increased (n/a - Unknown - );Conjunctival hyperaemia (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Eczema (n/a - Unknown - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Malaise (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Papule (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pruritus (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Somnolence (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832195	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Skin abrasion (n/a - Unknown - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832199	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832211	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010832215	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hemiparesis (82470min - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (82470min - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832225	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Antiphospholipid syndrome (n/a - Unknown - Other Medically Important Condition);Cardiolipin antibody positive (n/a - Unknown - );Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Oedema peripheral (n/a - Unknown - );Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832235	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute respiratory distress syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Acute respiratory failure (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diffuse alveolar damage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Graft versus host disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interstitial lung disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory distress (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachypnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Use of accessory respiratory muscles (n/a - Unknown - Caused/Prolonged Hospitalisation);Vital capacity decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[ITRACONAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832242	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[NAFTOPIDIL] (C - Benign prostatic hyperplasia, Dysuria - n/a - [n/a - n/a - Oral])|[PREDNISOLONE, PREDNISOLONE ACETATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - Oral])|[TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[VIBEGRON] (C - Hypertonic bladder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010832248	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death);Oedema peripheral (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010832257	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832268	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eye movement disorder (n/a - Recovered/Resolved - Life Threatening);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening);Pallor (n/a - Unknown - );Seizure (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010832280	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832282	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Influenza like illness (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832286	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - );Anxiety (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fear (n/a - Not Recovered/Not Resolved - );Feeling drunk (n/a - Not Recovered/Not Resolved - );Nervousness (n/a - Not Recovered/Not Resolved - );Panic attack (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TICLOPIDINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832303	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (20d - Recovered/Resolved - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Muscle spasms (n/a - Recovering/Resolving - Disabling);Pruritus (n/a - Recovering/Resolving - Disabling);Tachycardia (41d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010832307	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Skin laceration (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832308	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010832312	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Other Medically Important Condition);Death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	METFORMIN HYDROCHLORIDE, VILDAGLIPTIN [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010832317	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832336	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyslalia (n/a - Not Recovered/Not Resolved - );Fine motor skill dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[AZELNIDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832337	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Onderko, L.. Myocarditis in the Setting of Recent COVID-19 Vaccination. Case Reports in Cardiology. 2021;1-5. doi:10.1155/2021/6806500	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832346	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832356	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Blister (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832366	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832367	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (81h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (9h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832368	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832369	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyslalia (n/a - Unknown - Caused/Prolonged Hospitalisation);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BIFIDOBACTERIUM] (C - Constipation - n/a - [n/a - n/a - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - Chronic eosinophilic rhinosinusitis - n/a - [n/a - n/a - Nasal])|[PROCATEROL HYDROCHLORIDE, PROCATEROL HYDROCHLORIDE HYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832378	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832383	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832392	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Emergency care (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Ankylosing spondylitis - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832394	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832397	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Thrombolysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832399	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Spanopoulou, C.. Nosocomial dispersion of COVID-19 INFECTION in a fully vaccinated immunocompromised patient by streptococcus pneumoniae pneumonia.. 24th PANHELLENIC CONGRESS OF INTERNAL MEDICINE. 2021;133	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CICLOSPORIN] (C - Glomerulonephritis membranous, Pemphigoid - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Glomerulonephritis membranous, Pemphigoid - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832414	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (11d - Recovered/Resolved - );Influenza like illness (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832428	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832431	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010832432	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (15d - Not Recovered/Not Resolved - );Fatigue (15d - Not Recovered/Not Resolved - );Headache (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832437	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010832441	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovering/Resolving - );Sleep disorder (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832448	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832459	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832464	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Influenza like illness (4d - Recovered/Resolved - );Limb discomfort (4d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Neuralgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832471	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovering/Resolving - );Paraesthesia (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832479	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Flank pain (2d - Recovering/Resolving - );Micturition urgency (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Night sweats (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832491	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832498	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Carotid artery perforation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832501	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (29d - Not Recovered/Not Resolved - );Headache (37d - Not Recovered/Not Resolved - );Injection site pain (37d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010832502	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Muscle spasms (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832504	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832510	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832535	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832540	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832551	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Platelet count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832554	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832556	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac cirrhosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832557	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Other Medically Important Condition);Stridor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832558	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Monoparesis (13d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010832569	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832575	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (7h - Recovered/Resolved - );Movement disorder (7h - Recovered/Resolved - );Muscle spasms (7h - Recovered/Resolved - );Pyrexia (7h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832576	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832578	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site nerve damage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832580	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation);Face injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010832586	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (18046min - Recovered/Resolved - Other Medically Important Condition);Erythema (27d - Recovered/Resolved - Other Medically Important Condition);Localised infection (18046min - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (51d - Recovered/Resolved - Other Medically Important Condition);Purulent discharge (16d - Recovered/Resolved - Other Medically Important Condition);Swelling (27d - Recovered/Resolved - Other Medically Important Condition);Vaccination site abscess (n/a - Recovered/Resolved - );Vaccination site induration (51d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	METFORMIN HYDROCHLORIDE, VILDAGLIPTIN [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[GLIMEPIRIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[LUSEOGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010832640	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832646	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (7d - Unknown - );Oropharyngeal pain (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832647	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832669	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832670	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832675	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832678	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832684	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832686	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832688	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832800	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010832829	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010832834	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832836	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832838	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site erythema (7d - Recovered/Resolved - );Vaccination site swelling (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010832845	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010832847	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832848	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832850	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urge incontinence (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Atrial flutter - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010832924	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Macule (n/a - Unknown - );Rash pruritic (n/a - Unknown - );Skin mass (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010832924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833067	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Pain (n/a - Unknown - );Sensitive skin (n/a - Unknown - );Skin irritation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833077	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - Immunology test, Vitamin D decreased - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010833082	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833108	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Respiratory distress (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010833109	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Impaired driving ability (n/a - Unknown - Other Medically Important Condition);Imperception (n/a - Unknown - Other Medically Important Condition);Speech disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010833141	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833148	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833201	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Asthenia (n/a - Unknown - );Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833204	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (1d - Recovered/Resolved - );Blood pressure decreased (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833226	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833302	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833306	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (4d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833311	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833321	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Macular degeneration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - )|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010833322	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010833324	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010833390	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Influenza (n/a - Unknown - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010833448	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010833449	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010833453	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010833457	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010833540	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833544	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833559	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - );Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Neuralgic amyotrophy (n/a - Recovering/Resolving - Disabling);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	AJOVY [FREMANEZUMAB] (C - Migraine - n/a - [n/a - n/a - Subcutaneous])|[ACITRETIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010833563	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833565	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 100mg - Oral])|[SIMVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - 10mg - Oral])|[TORASEMIDE] (C - n/a - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010833568	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833584	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010833703	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833709	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Nodule (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833720	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010833843	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [6d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010833848	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010833851	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010833857	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INSULIN DEGLUDEC [INSULIN DEGLUDEC] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|INSULIN LISPRO [INSULIN LISPRO] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010833862	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010833878	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood glucose increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INSULIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833884	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010833912	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Nasal congestion (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833933	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010833978	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833979	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010833982	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010833986	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - );Heart rate increased (n/a - Recovered/Resolved With Sequelae - );Respiratory rate increased (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010833986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010834027	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834028	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834030	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834032	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834033	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834034	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834038	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834047	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834074	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834100	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010834101	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010834134	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010834145	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vestibular neuronitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010834150	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site discomfort (n/a - Not Recovered/Not Resolved - );Injection site induration (n/a - Not Recovered/Not Resolved - );Injection site reaction (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834192	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010834197	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834198	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010834244	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010834245	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010834296	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - Disabling);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010834297	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Eczema (n/a - Unknown - );Pruritus (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834303	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010834357	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Feeling cold (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Myalgia (1d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010834376	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (15h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010834379	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834383	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HARTMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010834387	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010834403	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010834407	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mydriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834444	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4h - Recovering/Resolving - );Paraesthesia oral (4h - Recovering/Resolving - );Stiff tongue (4h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834485	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (48h - Recovered/Resolved - Disabling);Headache (48h - Recovered/Resolved - Disabling);Myalgia (48h - Recovered/Resolved - Disabling);Pyrexia (48h - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010834571	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Portal vein thrombosis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	IRON [IRON] (C - n/a - n/a - [n/a - n/a - n/a])|[NADOLOL] (C - Varices oesophageal - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010834580	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834588	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834598	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Cough (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834601	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834606	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834610	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (24h - Recovered/Resolved - Other Medically Important Condition);Injected limb mobility decreased (24h - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834651	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834655	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834657	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834663	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834729	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834772	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010834834	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lip swelling (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834873	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Infection (n/a - Unknown - Other Medically Important Condition);Productive cough (20d - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010834950	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysphonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Mental status changes (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010834955	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myasthenia gravis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ELIQUIS [APIXABAN] (C - Cardiovascular disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cardiovascular disorder - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PYRIDOSTIGMINE BROMIDE] (C - Myasthenia gravis - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - Cardiovascular disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010834960	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834961	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010834964	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cyanosis (3d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pallor (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010834966	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Vaccination site erythema (1d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010834969	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block second degree (n/a - Fatal - Results in Death);Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Chills (n/a - Unknown - );Cold sweat (n/a - Unknown - );Gaze palsy (n/a - Unknown - );Myotonic dystrophy (n/a - Fatal - Results in Death);Petit mal epilepsy (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition);Ventricular fibrillation (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CARBOCISTEINE] (C - Bronchitis chronic - n/a - [n/a - n/a - n/a])|[CASSIA, SENNA GLYCOSIDES STANDARDIZED 60%, SENNOSIDES CALCIUM SALTS] (C - Constipation - n/a - [789d - n/a - n/a])|[CILOSTAZOL] (C - Sinus node dysfunction - n/a - [514d - n/a - n/a])|[LANSOPRAZOLE] (C - Duodenal ulcer, Gastric ulcer - n/a - [787d - n/a - n/a])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - n/a])|[PANTETHINE] (C - Constipation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010834971	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Lymph node pain (n/a - Recovered/Resolved With Sequelae - );Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010834971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010835150	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - );Fungal skin infection (n/a - Unknown - );Infant irritability (n/a - Unknown - );Oral fungal infection (n/a - Unknown - );Tongue fungal infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835185	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835186	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010835188	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - );Dyspnoea (0d - Unknown - );Headache (0d - Unknown - );Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835194	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Atrioventricular block (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835195	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835222	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (0d - Not Recovered/Not Resolved - );Hyperaesthesia (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835234	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835235	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835242	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835244	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835245	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835248	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835259	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Central nervous system inflammation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835269	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pallor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[PARACETAMOL] (C - Pyrexia - n/a - [5d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835273	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain in extremity (1d - Recovering/Resolving - );Tenderness (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010835282	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Sensation of foreign body (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835309	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abnormal sensation in eye (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835327	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835338	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vascular purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835354	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835355	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835357	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835360	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site joint pain (3wk - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010835361	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835372	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835373	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835376	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Subarachnoid haemorrhage (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835381	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835397	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835405	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835422	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835423	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[FLUINDIONE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835426	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835432	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835436	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835439	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - );Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [27d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835440	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [40d - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835441	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835447	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835448	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835452	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835467	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	BIKTARVY 50 MG/200 MG/25 MG FILM-COATED TABLETS [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - HIV infection - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835469	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Crohn's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835475	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PHLOROGLUCINOL DIHYDRATE, PHLOROGLUCINOL, TRIMETHYLPHLOROGLUCINOL, TRIMETHYLPHLOROGLUCINOL, PHLOROGLUCINOL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[PYRIDOSTIGMINE BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835484	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (15d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	SILODYX 8 MG HARD CAPSULES [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835487	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835497	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835511	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal rigidity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835527	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral artery thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral ischaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835528	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal pain (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Osteoarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835530	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835536	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - );Loss of consciousness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835564	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835570	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835586	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835597	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - );Head injury (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835598	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral venous disease (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE] (S - Hepatitis A immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835615	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pancreatitis acute (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010835617	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835635	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835643	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835664	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendon disorder (3mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835674	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (15d - Recovered/Resolved - );Lymphangitis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835679	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835680	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835709	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835718	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835721	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (n/a - Recovered/Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835726	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Arthritis (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835728	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - );Vaccination site haematoma (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835734	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835736	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835750	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835754	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835759	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (4d - Recovering/Resolving - );Lymphadenopathy (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835764	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010835767	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[INDAPAMIDE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835778	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835782	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Decreased appetite (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835784	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835788	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular extrasystoles (4wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835791	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Eosinophil count increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835793	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (5d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835803	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835815	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Gingivitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010835817	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835818	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835821	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835823	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835828	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835829	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835830	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835833	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835837	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835840	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovered/Resolved - );Gastrointestinal disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835841	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intraocular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835847	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835849	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835856	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835860	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835863	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835865	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (1d - Recovered/Resolved - );Constipation (n/a - Not Recovered/Not Resolved - );Dyspnoea (1d - Recovered/Resolved - );Peripheral coldness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010835866	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835877	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010835883	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835896	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Portal vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835909	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835911	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010835926	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835990	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );Infection (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010835998	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (3h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure abnormal (3h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate irregular (3h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (3h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010835998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836020	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836041	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836060	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836062	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836118	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836132	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836188	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - );Head injury (n/a - Recovering/Resolving - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836228	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836248	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fall (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836258	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836260	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836263	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Somnolence (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836278	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836281	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836304	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836313	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836335	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Renal failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836338	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836346	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Fatal - Results in Death);Haemolysis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010836352	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epididymitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836357	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836358	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836361	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836362	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836407	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836421	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836430	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836432	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836436	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Fatigue (n/a - Fatal - Results in Death);Nasal congestion (n/a - Fatal - Results in Death);Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Fatal - Results in Death);Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CIALIS [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010836441	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (135h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (63h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Limb discomfort (15h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Blood disorder - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Blood uric acid - n/a - [n/a - 300mg - Oral])|[BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HYDROCHLORIDE] (C - Inner ear disorder - n/a - [n/a - 16mg - Oral])|[NEBIVOLOL] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])|[SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836443	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids thrombosed (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [664h - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836445	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836451	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Disabling);Inflammation (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Skin irritation (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010836453	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gaze palsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836527	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836637	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Antiplatelet therapy - n/a - )|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836799	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral haemorrhage (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010836800	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836801	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836807	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|XARELTO [RIVAROXABAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836809	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Rhinitis (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836810	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836811	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Unknown - Life Threatening, Disabling);Muscle twitching (n/a - Unknown - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010836817	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure systolic increased (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836821	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836824	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Biliary cyst (n/a - Unknown - Caused/Prolonged Hospitalisation);Body temperature increased (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Liver function test increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010836827	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep deficit (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836835	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Impaired healing (n/a - Not Recovered/Not Resolved - );Joint injury (n/a - Not Recovered/Not Resolved - );Pulpitis dental (3d - Recovered/Resolved - );Toothache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010836881	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836888	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836889	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Exposure during pregnancy (n/a - Recovered/Resolved - Other Medically Important Condition);Foetal hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836897	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Blood pressure decreased (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010836898	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Antiplatelet therapy - n/a - )|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010836914	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836922	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836983	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010836987	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (36d - Recovered/Resolved - );Gait disturbance (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010836988	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010836989	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute kidney injury (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Plasma cell myeloma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010836996	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACRIVASTINE] (C - Multiple allergies - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010836996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010837008	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837019	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Mental impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Essential hypertension - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Essential hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837021	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837022	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in jaw (2d - Recovered/Resolved - );Paranasal sinus discomfort (n/a - Unknown - );Toothache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837026	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Limb discomfort (n/a - Recovered/Resolved - );Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 20mg - Oral])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010837031	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837044	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010837064	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CARVEDILOL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hypercholesterolaemia, Hyperlipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010837066	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010837134	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837137	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Abortion spontaneous (n/a - Fatal - Results in Death, Congenital Anomaly)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010837167	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010837218	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aphthous ulcer (10d - Recovered/Resolved - );Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Oropharyngeal pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837258	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837262	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (18d - Not Recovered/Not Resolved - );Headache (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837290	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837296	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837302	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837314	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837324	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aspartate aminotransferase increased (n/a - Unknown - );Blood creatine phosphokinase increased (n/a - Unknown - Other Medically Important Condition);Blood lactate dehydrogenase increased (n/a - Unknown - );Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Gamma-glutamyltransferase decreased (n/a - Unknown - );Heart rate decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837357	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site lymphadenopathy (n/a - Not Recovered/Not Resolved - );Application site pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Chills (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837374	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6h - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (6h - Recovered/Resolved - );Nausea (6h - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837378	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837381	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Left ventricular hypertrophy (n/a - Unknown - Caused/Prolonged Hospitalisation);Lipase increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010837448	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010837511	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory distress (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837536	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837563	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010837638	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837642	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	SUBOXONE [BUPRENORPHINE, NALOXONE, NALOXONE HYDROCHLORIDE DIHYDRATE, BUPRENORPHINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837659	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010837722	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837743	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010837777	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Unknown - );Feeling cold (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010837843	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|IMBRUVICA 420 MG FILM-COATED TABLETS [IBRUTINIB] (S - Waldenstrom's macroglobulinaemia - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010837904	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (10min - Recovered/Resolved - Other Medically Important Condition);Cold sweat (15min - Recovered/Resolved - );Hypotension (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837911	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010837934	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (18735min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tic (18735min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010837934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010838030	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010838185	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Hypoaesthesia (3mo - Recovered/Resolved - );Paraesthesia (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838196	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838247	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838296	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (5d - Recovered/Resolved - );Asthenia (0d - Recovered/Resolved - );Pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838297	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838299	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838341	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838352	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838367	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838371	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838380	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ataxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010838404	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Papillophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838409	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site induration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838418	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	[DEXKETOPROFEN TROMETAMOL] (C - Analgesic therapy - Unknown - )|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - Dose not changed - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010838425	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	NOVORAPID FLEXPEN 100 U/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN ASPART] (C - Hyperglycaemia - n/a - [n/a - n/a - n/a])|TOUJEO SOLOSTAR 300 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - Hyperglycaemia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Myalgia - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Myalgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838428	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site inflammation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838440	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute coronary syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010838446	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838453	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838463	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (n/a - Recovering/Resolving - );Skin reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838501	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Temperature regulation disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838503	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depressed level of consciousness (n/a - Unknown - );Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838509	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838545	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838563	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838568	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	[ACENOCOUMAROL] (C - Atrial fibrillation - Unknown - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Dyslipidaemia - Unknown - [n/a - 10mg - Oral])|[ENALAPRIL] (C - Hypertension - Unknown - [n/a - 5mg - Oral])|[FUROSEMIDE] (C - Cardiac failure - Unknown - [n/a - 40mg - Oral])|[LANSOPRAZOLE] (C - n/a - Unknown - [n/a - 30mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838570	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838572	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitiligo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010838657	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010838683	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010838690	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - );Rash erythematous (n/a - Unknown - );Rash macular (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838692	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838737	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death);Feeling abnormal (n/a - Unknown - );Paranoia (n/a - Unknown - );Vaccination failure (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010838783	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838790	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (0d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838797	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838837	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure congestive (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Oedema (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010838843	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010838921	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010838921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010839040	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amenorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839061	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839097	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DISULFIRAM] (C - Alcoholism - n/a - [n/a - n/a - n/a])|[METHADONE] (C - Drug withdrawal maintenance therapy - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010839120	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	BETMIGA [MIRABEGRON] (C - Incontinence - n/a - [n/a - n/a - Oral])|[DESMOPRESSIN, DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SOLIFENACIN, SOLIFENACIN SUCCINATE] (C - Hypertonic bladder - n/a - [n/a - n/a - Oral])|[SOLIFENACIN, SOLIFENACIN SUCCINATE] (C - Incontinence - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839185	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010839210	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	CHOLESTAGEL [COLESEVELAM, COLESEVELAM HYDROCHLORIDE] (C - Diarrhoea - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Myxoedema - n/a - [n/a - n/a - n/a])|[LOPERAMIDE HYDROCHLORIDE] (C - Diarrhoea - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839218	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839244	Spontaneous	2021-12-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010839421	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010839433	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010839441	Spontaneous	2021-12-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Alopecia totalis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010839441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810986	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811117	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Recovered/Resolved With Sequelae - );Inflammation (n/a - Recovered/Resolved With Sequelae - );Migraine (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010811124	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Delusion (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Gait disturbance (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811139	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811142	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Supraventricular extrasystoles (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811172	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811238	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (120d - Recovered/Resolved - );Asthenia (120d - Recovered/Resolved - );Chills (120d - Recovered/Resolved - );Hot flush (120d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010811282	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811296	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010811298	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811319	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811328	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (2d - Recovered/Resolved - );Feeling abnormal (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811335	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Pain (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811337	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811342	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811343	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811358	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[NAPHAZOLINE NITRATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811370	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811373	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811380	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811434	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811451	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (n/a - Recovering/Resolving - );Injection site urticaria (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811467	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811474	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811475	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Recovering/Resolving - );Trigeminal neuralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811487	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811498	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Life Threatening);Blood fibrinogen increased (n/a - Not Recovered/Not Resolved - Life Threatening);Bone pain (n/a - Not Recovered/Not Resolved - Life Threatening);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Life Threatening);Epilepsy (n/a - Not Recovered/Not Resolved - Life Threatening);Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Red blood cell sedimentation rate increased (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010811502	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811542	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811556	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811566	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811570	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811590	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sense of oppression (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811594	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811602	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010811615	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811621	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dehydration (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Intraocular pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Vitreous detachment (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010811634	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811639	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Pityriasis (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811654	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Mononeuropathy (n/a - Not Recovered/Not Resolved - Disabling);Motor dysfunction (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010811671	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811689	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Thyroiditis subacute (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811690	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Gastritis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811702	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chillblains (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperpyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010811714	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811715	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811719	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscle spasms (n/a - Recovered/Resolved With Sequelae - );Myoclonus (n/a - Recovered/Resolved With Sequelae - );Paraesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010811721	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811779	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastric haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010811780	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema multiforme (n/a - Unknown - Other Medically Important Condition);Toxic skin eruption (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])|[METHOTREXATE, METHOTREXATE SODIUM] (S - n/a - n/a - [n/a - n/a - n/a])	EDOXABAN [EDOXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|INSULIN ASPART SANOFI [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010811792	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010811816	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Injection site inflammation (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site warmth (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010811935	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Blood pressure increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010811936	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010811936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010812543	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010812549	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812553	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812558	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Choking sensation (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812568	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tracheal stenosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812576	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010812578	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pleuritic pain (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812581	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812600	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved With Sequelae - );Chest pain (n/a - Recovered/Resolved With Sequelae - );Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010812608	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812613	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812619	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injury (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812620	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812622	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812628	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE] (S - n/a - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Mixed anxiety and depressive disorder - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812632	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812640	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812644	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812647	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling);Muscle atrophy (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling);Weight decreased (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010812648	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (4d - Recovered/Resolved - Other Medically Important Condition);Chest pain (4d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (4d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812650	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812651	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812652	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812655	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812656	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );CSF test abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Demyelinating polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812659	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ataxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Miller Fisher syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neutrophil count decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Protein total increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010812664	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010812666	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812669	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812671	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812672	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pleuritic pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812677	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812681	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812687	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Muscle spasms (n/a - Recovering/Resolving - Disabling);Pruritus (26d - Recovered/Resolved - Disabling);Rash (n/a - Unknown - Disabling);Tachycardia (11d - Recovered/Resolved - Disabling);Vertigo (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010812688	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dehydration (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812690	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812694	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Parosmia (n/a - Unknown - );Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812695	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812698	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812704	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatinine increased (n/a - Unknown - );Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812710	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PIOGLITAZONE [PIOGLITAZONE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812717	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bundle branch block right (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812726	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812731	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematochezia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812733	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acidosis (n/a - Unknown - Other Medically Important Condition);Blood glucose increased (n/a - Unknown - Other Medically Important Condition);Cardio-respiratory arrest (n/a - Unknown - Life Threatening, Other Medically Important Condition);Cardiomegaly (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - );Fibrin D dimer increased (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Thrombocytopenia (n/a - Fatal - Results in Death, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Fatal - Results in Death, Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|INVEGA [PALIPERIDONE] (S - n/a - Not applicable - [n/a - n/a - Oral])	[EPINASTINE] (C - n/a - n/a - [n/a - n/a - Oral])|[FLUNITRAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])|[GINSENG, GLYCYRRHIZA GLABRA] (C - n/a - n/a - [n/a - n/a - Oral])|[MOSAPRIDE, MOSAPRIDE CITRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010812738	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010812743	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Apnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010812897	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010812897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010813451	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010813522	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813525	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813535	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813537	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813539	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (28h - Recovered/Resolved - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - 25mg - n/a])|OZEMPIC [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - Pain in extremity - n/a - [n/a - 25mg - n/a])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - 5mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 89mg - n/a])|[CIPROFLOXACIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLOBENZAPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 50mg - n/a])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010813540	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813541	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813545	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813547	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813548	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - );CSF pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hydrocephalus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813569	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Other Medically Important Condition);Acute myocardial infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813570	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Demyelination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813572	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diverticulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010813575	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813585	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813586	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - );Hypercoagulation (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813587	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813589	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813595	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813596	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813600	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813601	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral haematoma (n/a - Unknown - Other Medically Important Condition);Cerebral thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Jugular vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Migraine (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010813606	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813612	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010813613	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST-T segment abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813616	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813626	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - Other Medically Important Condition);Chest pain (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Fall (0d - Recovered/Resolved - Other Medically Important Condition);Headache (0d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (0d - Recovered/Resolved - Other Medically Important Condition);Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813675	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010813820	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Nocturnal dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010813823	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Enterocolitis haemorrhagic (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematochezia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	INTUNIV [GUANFACINE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - Oral])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010813833	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010813851	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010813857	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010813858	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[EPINEPHRINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813866	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813867	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatine phosphokinase abnormal (n/a - Unknown - );Fatigue (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813868	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813870	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Monoplegia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813873	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010813875	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010813875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010814079	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010814122	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral venous sinus thrombosis (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (13d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - Not applicable - [n/a - 20mg - Oral])|MIRABEGRON [MIRABEGRON] (C - n/a - Not applicable - [n/a - 50mg - Oral])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010814181	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814184	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Malaise (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814225	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814230	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814231	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814236	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814237	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814238	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Atypical pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Body temperature increased (4d - Recovered/Resolved - Other Medically Important Condition);Bronchospasm (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - );Oxygen saturation decreased (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010814239	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Appendicitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010814285	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Skin burning sensation (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814310	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acquired haemophilia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haematoma muscle (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Melaena (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Subdural haematoma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010814322	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010814330	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814331	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (54d - Recovering/Resolving - );Electrocardiogram abnormal (54d - Recovering/Resolving - );Fatigue (54d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010814333	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[VITAMIN D] (C - n/a - n/a - [n/a - 1000[iU] - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814350	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010814356	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Micturition urgency (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814393	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (6d - Not Recovered/Not Resolved - );Dizziness (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814395	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Groin pain (20d - Not Recovered/Not Resolved - );Limb discomfort (20d - Not Recovered/Not Resolved - );Testicular pain (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814396	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010814398	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (8d - Not Recovered/Not Resolved - );C-reactive protein increased (8d - Not Recovered/Not Resolved - );Chills (8d - Not Recovered/Not Resolved - );Decreased appetite (8d - Not Recovered/Not Resolved - );Pyrexia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814400	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010814404	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - );Eosinophilic pneumonia (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Renal failure (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010814442	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Headache (7d - Unknown - );Influenza like illness (7d - Unknown - );Pyrexia (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814445	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814530	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Life Threatening);Cardioversion (n/a - Recovering/Resolving - Life Threatening);Heart rate increased (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010814626	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010814677	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010814740	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (4h - Recovered/Resolved - Disabling);Influenza like illness (n/a - Recovered/Resolved - Disabling);Musculoskeletal stiffness (n/a - Recovered/Resolved - Disabling);Nasopharyngitis (n/a - Recovered/Resolved - Disabling);Pain in extremity (n/a - Recovered/Resolved - Disabling);Pain of skin (n/a - Recovered/Resolved - Disabling);Palpitations (4h - Recovered/Resolved - Disabling);Sleep disorder (n/a - Recovered/Resolved - Disabling);Temperature regulation disorder (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010814782	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010814914	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac tamponade (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema peripheral (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010814914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815028	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (12d - Not Recovered/Not Resolved - );Influenza (12d - Not Recovered/Not Resolved - );Pyrexia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815029	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (11d - Not Recovered/Not Resolved - );Dizziness (11d - Not Recovered/Not Resolved - );Influenza like illness (11d - Not Recovered/Not Resolved - );Lymphadenopathy (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815031	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815037	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815063	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (7d - Not Recovered/Not Resolved - );Noninfective encephalitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815065	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815080	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoparesis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815085	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thalamic infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815086	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovering/Resolving - );Rash (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815091	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Spinal pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815102	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);COVID-19 (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory failure (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815149	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815216	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815222	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Fibrosis (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pulse abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815230	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815235	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815238	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis infective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815241	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815247	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Cognitive disorder (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815252	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815254	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815258	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Cheyne-Stokes respiration (n/a - Unknown - Other Medically Important Condition);Dermatitis (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Melanocytic naevus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Transient ischaemic attack (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815260	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815262	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Injury (n/a - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Loss of control of legs (n/a - Unknown - Other Medically Important Condition);Migraine (1d - Recovered/Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition);Organic erectile dysfunction (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815264	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815267	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815270	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood bilirubin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fear (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gilbert's syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mental disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Panic attack (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Panic disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815272	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Change of bowel habit (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Confusional state (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Gastrointestinal sounds abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Respiration abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a - More in ICSR])|[DICLOFENAC DIETHYLAMINE, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - 5mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815273	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - );Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Subclavian vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815275	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lyme disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815280	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - 50000[iU] - Oral])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 36mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815283	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815284	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815291	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010815298	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Language disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815329	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumothorax (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815336	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (3h - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815340	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815351	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815353	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb deformity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb mass (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815357	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815358	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Illness (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815359	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (17d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (17d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815366	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815369	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815371	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010815373	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815374	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815384	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815385	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Anxiety (32d - Recovered/Resolved - Other Medically Important Condition);Axillary pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (34d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (32d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815391	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815396	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Sepsis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815405	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cardiac disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Monoplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Thrombosis in device (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010815415	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tinnitus (1d - Recovered/Resolved - Other Medically Important Condition);Upper limb fracture (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815422	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815424	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (62d - Recovered/Resolved - Other Medically Important Condition);Dizziness (4d - Recovered/Resolved - Other Medically Important Condition);Gout (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (4d - Recovered/Resolved - Other Medically Important Condition);Nausea (33d - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010815429	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - Disabling, Other Medically Important Condition);Hypokinesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Swelling (n/a - Unknown - Disabling, Other Medically Important Condition);Swollen joint count (n/a - Unknown - Disabling, Other Medically Important Condition);Tender joint count (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010815441	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - Disabling);Body temperature (n/a - Unknown - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Decreased appetite (n/a - Unknown - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Influenza (n/a - Not Recovered/Not Resolved - Disabling);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010815453	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815457	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010815460	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815464	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815474	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal symptom (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815479	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815480	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Amyloidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Physical deconditioning (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815486	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815490	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Illness (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - );Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815494	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (108d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (108d - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (53d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815497	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oral herpes (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815499	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815510	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lactic acidosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815517	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815522	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acne (n/a - Unknown - );Pruritus (n/a - Unknown - );Swelling face (n/a - Unknown - );Wound (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815530	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Secretion discharge (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815533	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815540	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815550	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (42h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815551	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815567	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815572	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovered/Resolved - );Mobility decreased (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815575	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815577	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815583	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815592	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 8mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815594	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815595	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815599	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815602	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Local reaction (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815611	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[ESOMEPRAZOLE MAGNESIUM DIHYDRATE] (C - n/a - n/a - [n/a - 20mg - Oral])|[FINASTERIDE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815618	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010815664	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash pruritic (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815667	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Chromaturia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Hypotension (6d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Pollakiuria (n/a - Not Recovered/Not Resolved - );Urine odour abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815751	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (0d - Recovered/Resolved - );Diarrhoea (4wk - Recovered/Resolved - );Dizziness (4wk - Recovered/Resolved - );Dyspnoea (4wk - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Gastroenteritis viral (n/a - Recovered/Resolved - );Malaise (4wk - Recovered/Resolved - );Nausea (4wk - Recovered/Resolved - );Vomiting (4wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010815779	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertensive crisis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010815810	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Rash vesicular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	BRINTELLIX [VORTIOXETINE] (C - Depression - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[ALFACALCIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Diuretic therapy - n/a - [n/a - n/a - n/a])|[ISOSORBIDE DINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[PROPRANOLOL HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815825	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram T wave inversion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010815888	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])|[INFLUENZA QUADRIVALENT VACCINE (RDNA)] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010815975	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010815976	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010815988	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010815988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010816005	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (18d - Recovered/Resolved - );Myocardial infarction (18d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010816018	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010816074	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	SPIKEVAX [ELASOMERAN] (S - Product used for unknown indication - Unknown - [n/a - 1{DF} - Unknown])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010816110	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010816322	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010816548	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Increased upper airway secretion (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Restlessness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010816557	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bronchospasm (2d - Recovered/Resolved - Other Medically Important Condition);Rash (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010816662	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Bradycardia (10d - Recovered/Resolved - );Extrasystoles (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010816667	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - );Peripheral swelling (7d - Recovered/Resolved - );Skin discolouration (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010816678	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pruritus (n/a - Recovering/Resolving - );Papule (n/a - Recovering/Resolving - );Rash erythematous (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010816679	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - );Panic reaction (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NIET GESPECIFICEERD GENEESMIDDEL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010816713	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Impaired driving ability (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010816790	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Recovering/Resolving - );Muscular weakness (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010816793	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[NAPROXEN] (C - Inflammation - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[PIMOZIDE] (C - Tourette's disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010816802	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2mo - Recovered/Resolved - );Nausea (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010816849	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	[DIPHTHERIA TOXOID, TETANUS TOXOID, HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ] (S - Immunisation - Not applicable - [n/a - n/a - Unknown])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010816851	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (8d - Recovered/Resolved - );Gastritis (8d - Recovered/Resolved - );Nausea (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010816959	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010816959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817067	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (2mo - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hospitalisation (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010817099	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817293	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (3d - Unknown - );Rash (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010817295	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817297	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (7d - Unknown - );Musculoskeletal chest pain (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010817305	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscle spasms (n/a - Recovering/Resolving - Disabling);Pain (n/a - Recovering/Resolving - Disabling);Sciatica (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010817307	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (46d - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Palpitations (16d - Recovering/Resolving - );Paraesthesia (16d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010817320	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (13d - Not Recovered/Not Resolved - );Lymphadenopathy (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817329	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Malaise (13d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010817347	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817363	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (13d - Not Recovered/Not Resolved - );Limb discomfort (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817364	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817369	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Blood pressure fluctuation (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Malaise (13d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010817394	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817404	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Abnormal faeces (n/a - Unknown - );Fatigue (n/a - Unknown - );Gastrointestinal pain (n/a - Unknown - );Headache (n/a - Unknown - );Hot flush (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817407	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010817409	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mesenteric artery thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Portal vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010817439	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817440	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817445	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Autoimmune disorder (18d - Not Recovered/Not Resolved - );Musculoskeletal pain (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817684	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM] (C - Dyspepsia - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE, METOPROLOL TARTRATE PH. EUR.] (C - Blood pressure measurement - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817706	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Prehypertension (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010817707	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site paraesthesia (6d - Unknown - );Lymph node pain (6d - Unknown - );Lymphadenopathy (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817710	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817780	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817782	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Basilar artery thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010817792	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACENOCOUMAROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010817794	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (8d - Recovered/Resolved - );Urticaria (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CLEMASTINE, CLEMASTINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817902	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010817919	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010817919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818155	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature fluctuation (n/a - Recovering/Resolving - );Brain fog (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [79d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818164	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Crohn's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - );Diarrhoea haemorrhagic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818167	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	AERIUS [DESLORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - Oral])|[BETULA VERRUCOSA (108), ALUMINIUM HYDROXIDE] (C - Seasonal allergy - n/a - [n/a - n/a - Subcutaneous])|[PHLEUM PRATENSE (225), ALUMINIUM HYDROXIDE] (C - Seasonal allergy - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818178	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Lymphadenitis (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818189	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818195	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Recovered/Resolved - );Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818246	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818274	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cellulitis (240d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Femoral artery embolism (240d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skin ulcer (240d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Superficial vein thrombosis (240d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818398	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Libido decreased (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818411	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	APROVEL [IRBESARTAN] (C - Hypertension - n/a - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818416	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818419	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010818428	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness unilateral (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010818432	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818441	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperacusis (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Primary stabbing headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818443	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010818467	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site oedema (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818484	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Recovering/Resolving - Life Threatening);Pain in extremity (n/a - Recovering/Resolving - Life Threatening);Peripheral swelling (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010818538	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818540	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Fatal - Results in Death);Pneumonia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818542	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818543	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818544	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Intraocular pressure increased (n/a - Not Recovered/Not Resolved - );Iridocyclitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818546	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818548	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Unknown - );Cerebral disorder (n/a - Recovering/Resolving - );Discomfort (n/a - Not Recovered/Not Resolved - );Dry throat (n/a - Recovering/Resolving - );Dysphonia (n/a - Not Recovered/Not Resolved - );Eye oedema (n/a - Recovering/Resolving - );Haemoptysis (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Inflammation (n/a - Recovering/Resolving - );Inflammatory pain (n/a - Recovering/Resolving - );Laryngeal inflammation (n/a - Recovering/Resolving - );Laryngeal oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (26d - Recovered/Resolved - Life Threatening);Nasal discharge discolouration (n/a - Recovering/Resolving - );Odynophagia (n/a - Recovering/Resolving - );Oxygen saturation decreased (n/a - Recovering/Resolving - );Pain (n/a - Recovered/Resolved - );Pharyngeal swelling (38445min - Recovered/Resolved - Life Threatening);Pneumonia (23d - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Productive cough (n/a - Unknown - );Pulmonary oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Sinusitis (n/a - Recovering/Resolving - );Teething (n/a - Recovering/Resolving - );Throat irritation (n/a - Recovering/Resolving - );Tonsillar disorder (n/a - Recovering/Resolving - );Toothache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BERBERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DAPAGLIFLOZIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[FISH OIL] (C - Blood triglycerides abnormal - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[MONTELUKAST SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[THIOCTIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010818551	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Pericardial effusion (n/a - Fatal - Results in Death);Troponin abnormal (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818553	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818558	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818559	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818561	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myopericarditis (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818562	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Haematemesis (n/a - Fatal - Results in Death);Haemoptysis (n/a - Fatal - Results in Death);Troponin increased (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818563	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818567	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818570	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Depressed mood (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818578	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - );Glomerulonephritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Henoch-Schonlein purpura (n/a - Not Recovered/Not Resolved - );IgA nephropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818579	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818582	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Impaired work ability (n/a - Unknown - );Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818586	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blindness (n/a - Unknown - Other Medically Important Condition);Iridocyclitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818587	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818590	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Emotional distress (n/a - Unknown - Disabling);Mental disorder (n/a - Unknown - Disabling);Paranoia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010818593	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Tachycardia (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818594	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysarthria (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hallucination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - );Pneumonia aspiration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818600	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Disabling);Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Phantosmia (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010818603	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - );Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Flushing (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Trismus (n/a - Not Recovered/Not Resolved - );Wheezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818604	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818610	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818611	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010818613	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death);Myocardial ischaemia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818620	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Skin reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - );Vaccination site warmth (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818634	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818636	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818646	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site papule (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818675	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Disabling);Herpes zoster (n/a - Recovering/Resolving - Disabling);Lymphadenopathy (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010818774	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrioventricular block (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial ischaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [93d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818780	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pain in jaw (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818784	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818801	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Subarachnoid haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818802	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (1d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818804	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure chronic (n/a - Fatal - Results in Death, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition);Shock (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL HYDROGEN SULFATE [CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[MEXILETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[POTASSIUM CITRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[SUVOREXANT] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818807	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Electric shock sensation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Migraine (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Sleep disorder due to general medical condition, insomnia type (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010818809	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Unknown - );Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - );Renal failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (n/a - Unknown - );Spinal pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818824	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Coeliac disease (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Feeling abnormal (n/a - Unknown - Disabling);Hypertension (n/a - Not Recovered/Not Resolved - Disabling);Illness (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Myocarditis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling);Tachycardia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010818825	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (6d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Taste disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818826	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carcinoembryonic antigen increased (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (24d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperventilation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010818827	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010818829	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Dysphoria (0d - Recovered/Resolved - );Feeling cold (0d - Recovered/Resolved - );Heart rate decreased (0d - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - );Palpitations (0d - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818831	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818832	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010818834	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818844	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Unknown - Other Medically Important Condition);Incorrect route of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])	APIXABAN [APIXABAN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818852	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site swelling (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010818858	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Prinzmetal angina (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin T increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 60mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818862	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818866	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hallucination (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818867	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818872	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear haemorrhage (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818873	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Renal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatitis - n/a - [n/a - n/a - n/a])|[TOLTERODINE TARTRATE] (C - Prostatitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010818902	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818907	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (9043min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Head discomfort (9043min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818910	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Unknown - Disabling, Other Medically Important Condition);Eye swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ocular hyperaemia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010818916	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial necrosis marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818917	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Productive cough (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818919	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovered/Resolved - );Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Recovered/Resolved - );COVID-19 (8d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );General physical health deterioration (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Heart alternation (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818921	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dysarthria (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818923	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818926	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Anaphylactic shock (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818935	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818937	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818938	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Unknown - Disabling, Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Disabling, Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Disabling);Retinal artery occlusion (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Thrombosis (n/a - Unknown - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010818947	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eructation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pollakiuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818978	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010818987	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818988	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Encephalitis autoimmune (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010818989	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (0d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (29h - Recovered/Resolved - Other Medically Important Condition);Tremor (29h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010818994	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010818994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819001	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819003	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819006	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819009	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (3405min - Recovered/Resolved - Other Medically Important Condition);Dizziness (3405min - Recovered/Resolved - );Headache (3405min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819012	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (3wk - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010819015	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[LEUPRORELIN] (C - Prostate cancer stage III - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostate cancer stage III - n/a - [200d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819020	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819025	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819026	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (524min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (524min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Bradycardia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Discomfort (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysphoria (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (524min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate decreased (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (524min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Orthostatic hypotension (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (524min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010819027	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819030	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819042	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Movement disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010819044	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819045	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819046	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819048	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819051	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819052	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819056	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Loss of consciousness (1min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819057	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - Other Medically Important Condition);Illness (5d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819061	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819062	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819066	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erectile dysfunction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819067	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819068	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Intervertebral discitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sepsis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010819069	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Haemorrhage subcutaneous (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819075	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819076	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired quality of life (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819085	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819087	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819109	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 30ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010819110	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819116	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Oropharyngeal pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819150	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819161	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819164	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - );Vaccination failure (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819227	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovering/Resolving - Life Threatening);Impaired work ability (n/a - Recovering/Resolving - Life Threatening);Loss of consciousness (n/a - Recovering/Resolving - Life Threatening);Vaccination site pain (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Arrhythmia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010819251	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819254	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819255	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819261	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819262	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819263	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819265	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819266	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819297	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010819308	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Kahn, B.. Multisystem inflammation and organ dysfunction after BNT162b2 Messenger RNA Coronavirus Disease 2019 Vaccination. Critical Care Explorations. 2021;3(11):10.1097/CCE.0000000000000578. doi:10.1097/CCE.0000000000000578	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Capillary leak syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Deafness neurosensory (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multisystem inflammatory syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010819309	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cellulitis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Photopsia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DIPHTHERIA TOXOID, TETANUS TOXOID, HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010819359	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thyroiditis subacute (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010819377	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (5d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	XARELTO 15 MG [RIVAROXABAN] (C - Deep vein thrombosis - n/a - [n/a - 15mg - Oral])|[DALTEPARIN SODIUM] (C - Deep vein thrombosis - n/a - [n/a - 1{DF} - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819459	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Otitis externa (n/a - Recovering/Resolving - );Otitis media (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819475	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819499	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenitis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819500	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Ventricular extrasystoles (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819511	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819514	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal sensation in eye (n/a - Unknown - );Eye pain (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Hypoaesthesia eye (n/a - Unknown - );Hypoaesthesia oral (n/a - Unknown - );Prostatic specific antigen increased (n/a - Unknown - );Venous occlusion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010819518	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819533	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819535	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010819542	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819543	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819546	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819558	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819559	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819560	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819564	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010819568	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Shock (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819569	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Alopecia (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hormone level abnormal (n/a - Unknown - Other Medically Important Condition);Vaginal haemorrhage (29d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819570	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819574	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819576	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819577	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Feeling of body temperature change (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010819582	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819587	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819590	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819591	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Mesenteric haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 60mg - Oral])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - 81mg - Oral])|[CARVEDILOL] (C - n/a - n/a - [n/a - 6.25mg - Oral])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 1000mg - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - 1000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010819630	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819631	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819635	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010819636	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - );Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Flushing (n/a - Not Recovered/Not Resolved - );Trismus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819647	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819703	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819704	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010819739	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Peritonsillar abscess (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tonsillitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010819751	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819917	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010819961	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (1mo - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010819988	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010819988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820051	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820054	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Nausea (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820060	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Karer, M.. Subcutaneous injection of mRNA vaccines against severe acute respiratory syndrome coronavirus 2: an option for severe bleeding disorders or anticoagulated patients?.. Blood Coagulation &amp; Fibrinolysis. 2021;32(6):423-424. doi:10.1097/MBC.0000000000001048	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820073	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820099	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Unknown - );Cardiac tamponade (n/a - Fatal - Results in Death);Malaise (n/a - Unknown - );Myocardial infarction (n/a - Fatal - Results in Death);Myocardial rupture (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820270	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820271	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820290	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Chatzileontiadou, S.. SUCCESSFUL OUTCOME FOR A PATIENT WITH NEWLY-DIAGNOSED SYMPTOMATIC MULTIPLE MYELOMA AND SERIOUS CORONAVIRUS DISEASE-19 INFECTION WITH TOCILIZUMAB ADMINISTRATION. Haema. 2021;12(suppl. 1):398-399	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820293	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Garcia, J.. Acute myocarditis after administration of the BNT162b2 vaccine against COVID-19. Revista Espanola de Cardiologia. 2021;74(9):812-814. doi:10.1016/j.rec.2021.04.005	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820384	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010820385	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (24h - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820386	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820388	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820390	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cardiac failure (2wk - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820402	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatic disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[SIMVASTATIN] (C - Hypercholesterolaemia - Not applicable - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820407	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820409	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Meniere's disease (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820414	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010820432	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820450	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Axonal and demyelinating polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	JULUCA 50 MG/25 MG FILM-COATED TABLETS [RILPIVIRINE, DOLUTEGRAVIR] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LOPERAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALPROATE SEMISODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820467	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myelitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820475	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820492	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (27d - Fatal - Results in Death);Vaccination failure (27d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 2{DF} - Intramuscular])|[LOSARTAN POTASSIUM] (S - Hypertension - n/a - [n/a - 1{DF} - Oral])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[D,L-LYSINE ACETYLSALICYLATE] (C - Cardiovascular event prophylaxis - n/a - [n/a - 1{DF} - Oral])|[FLECAINIDE ACETATE] (C - Atrial fibrillation - n/a - [n/a - 2{DF} - Oral])|[SIMVASTATIN] (C - Cardiovascular event prophylaxis - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820500	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);General physical health deterioration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematemesis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Occipital neuralgia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820503	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820504	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820506	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820509	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010820515	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (3wk - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ophthalmic herpes zoster (3wk - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820521	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820523	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820538	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010820541	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820544	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010820545	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010820550	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820560	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820564	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein occlusion (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010820569	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death);Chest pain (1h - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820573	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Sudden death (1d - Fatal - Results in Death);Vomiting (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (S - Influenza immunisation - Not applicable - [1d - .5mL - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820574	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820581	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820586	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820588	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Left ventricular dysfunction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820589	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820614	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adolescent	No	Male	Polymyalgia rheumatica (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010820629	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Bone pain (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820665	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (n/a - Unknown - );Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010820667	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820684	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820689	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Erysipelas (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820713	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820716	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820717	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820722	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiogenic shock (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypoxia (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pleuritic pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820724	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature abnormal (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition);Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820728	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820729	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertension (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Insomnia (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Restlessness (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Stress (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820733	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved With Sequelae - );Chills (n/a - Recovered/Resolved With Sequelae - );Immunisation (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - );Vaccination site pain (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010820737	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820743	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac aneurysm (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820744	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR segment depression (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820745	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amputation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820756	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Multisystem inflammatory syndrome in children (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820758	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (26d - Recovered/Resolved - Other Medically Important Condition);Dizziness (5d - Recovered/Resolved - Other Medically Important Condition);Fatigue (106d - Recovered/Resolved - Other Medically Important Condition);Gout (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Malaise (139d - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010820759	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hallucination (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Antidepressant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820762	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820765	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone pain (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820766	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820769	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820774	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820779	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820783	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820788	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arthritis reactive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Autoimmune disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperkeratosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neoplasm malignant (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Penis disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010820792	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac death (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820794	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death);Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010820795	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (3d - Recovered/Resolved - Other Medically Important Condition);Headache (8d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (5d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (9d - Recovered/Resolved - Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LINAGLIPTIN [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820799	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injection site pain (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820879	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LEVEMIR [INSULIN DETEMIR] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010820886	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820898	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Child	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010820936	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820943	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820952	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820955	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling hot (3d - Recovered/Resolved - );Immunisation reaction (3d - Recovered/Resolved - );Vascular pain (3d - Recovered/Resolved - );Vasodilatation (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820962	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010820969	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820970	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Loss of consciousness (1d - Recovered/Resolved - );Musculoskeletal stiffness (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010820979	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820988	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820997	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus genital (n/a - Recovered/Resolved - );Scrotal erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	AVASTIN [BEVACIZUMAB] (C - Colorectal cancer recurrent - Dose not changed - [1d - n/a - Intravenous (not otherwise specified)])|[FLUOROURACIL] (C - Colorectal cancer recurrent - Dose not changed - [1d - n/a - Intravenous (not otherwise specified)])|[FOLINIC ACID] (C - Colorectal cancer recurrent - Dose not changed - [1d - n/a - Intravenous (not otherwise specified)])|[OXALIPLATIN] (C - Colorectal cancer recurrent - Dose not changed - [1d - n/a - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010820999	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010820999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821013	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hiccups (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821016	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rectal haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821028	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821032	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821040	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Papule (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821041	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821042	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821054	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821058	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821067	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821069	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821073	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (2wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821080	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle contractions involuntary (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821084	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821088	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821093	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821094	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821095	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821100	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821103	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Petechiae (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821105	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Petechiae (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821115	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Petechiae (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821138	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821141	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821161	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821162	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821168	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agitation (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Unknown - Other Medically Important Condition);Hyperacusis (n/a - Unknown - Other Medically Important Condition);Orthostatic intolerance (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010821169	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821187	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821189	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821198	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010821202	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coordination abnormal (n/a - Recovered/Resolved - );Loss of personal independence in daily activities (n/a - Recovered/Resolved - Other Medically Important Condition);Movement disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESOMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010821206	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling hot (n/a - Unknown - Disabling);Fibromyalgia (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Joint warmth (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010821220	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821222	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821225	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821256	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3mo - Recovering/Resolving - );Influenza like illness (48h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821261	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821263	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Muscle atrophy (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010821266	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821269	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821273	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821290	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (48h - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821294	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821316	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Breast discharge (n/a - Not Recovered/Not Resolved - );Breast pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[SPIRONOLACTONE] (S - n/a - n/a - [n/a - n/a - n/a])	PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - n/a - n/a - )|[SOTALOL HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821336	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821341	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821342	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dizziness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - Oral])|SILODOSIN [SILODOSIN] (C - Prostatic adenoma - n/a - [n/a - 8mg - n/a])|[AVOCADO OIL UNSAPONIFIABLES, SOYBEAN OIL UNSAPONIFIABLES, SOYA OIL, AVOCADO OIL] (C - n/a - n/a - [n/a - 300mg - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - Thrombosis prophylaxis - n/a - [n/a - 75mg - n/a])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - 10mg - Oral])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Prostatic adenoma - n/a - [n/a - 320mg - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821343	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (18d - Recovered/Resolved - );Myalgia (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821349	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821350	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821351	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821354	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821355	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821357	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821358	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821360	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821362	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821373	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821383	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Unknown - );Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821386	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821388	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821392	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821394	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821401	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (S - Cardiac murmur - Drug withdrawn - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821406	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821409	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (1d - Recovered/Resolved - );Diplegia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821418	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821425	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821429	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821440	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821442	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821449	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thyroid disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821462	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Oedema peripheral (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - );Urine analysis abnormal (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821464	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Sleep disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821473	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (15min - Recovered/Resolved - );Nausea (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821506	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (1wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821514	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821532	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821533	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Immunisation reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821548	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (3wk - Recovered/Resolved - );Pruritus (3wk - Recovered/Resolved - );Rash (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ETORICOXIB] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821551	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821556	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821559	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821567	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tremor (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821569	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010821580	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821591	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821592	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821596	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821600	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erysipelas (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821681	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010821693	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821753	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood lactate dehydrogenase increased (n/a - Unknown - );Eczema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|TRULICITY 0.75 MG [DULAGLUTIDE] (S - Diabetes mellitus - Dose not changed - [n/a - n/a - Subcutaneous])	MICARDIS [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TOFOGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010821767	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Temperature regulation disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821776	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (n/a - Recovering/Resolving - );Heavy menstrual bleeding (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821777	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Spinal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821784	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 30ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821794	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Embolism (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010821806	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821816	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amenorrhoea (15d - Recovered/Resolved - );Asthenia (15d - Recovered/Resolved - );Feeling hot (15d - Recovered/Resolved - );Hot flush (15d - Recovered/Resolved - );Limb discomfort (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821827	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010821839	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (18d - Recovering/Resolving - );Fatigue (18d - Recovering/Resolving - );Headache (11d - Recovering/Resolving - );Sluggishness (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821899	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tendonitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821900	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821902	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Areflexia (n/a - Unknown - );Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821904	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010821914	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010821914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822005	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822009	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Coordination abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822015	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010822016	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822033	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822034	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822042	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (45min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822051	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822059	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovered/Resolved - );Anosmia (n/a - Recovered/Resolved - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Nasal congestion (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822118	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site discomfort (n/a - Recovering/Resolving - );Periarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822125	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822126	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LINSEED OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, DEXPANTHENOL, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010822133	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822140	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );Eye irritation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Visual acuity reduced (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822150	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822159	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822171	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822172	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822206	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822213	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822215	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822217	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822223	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822224	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure fluctuation (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Dizziness (n/a - Unknown - );Extrasystoles (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010822323	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	REPAGLINIDE [REPAGLINIDE] (C - n/a - Unknown - )|TRAJENTA [LINAGLIPTIN] (C - n/a - Unknown - )|XARELTO [RIVAROXABAN] (C - n/a - Unknown - )|[ALLOPURINOL] (C - n/a - Unknown - )|[EZETIMIBE, ROSUVASTATIN, ROSUVASTATIN ZINC] (C - n/a - Unknown - )|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - Unknown - )|[SPIRONOLACTONE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822401	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822408	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822416	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822426	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Injection related reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822427	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822428	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822466	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[LORATADINE] (C - Seasonal allergy - n/a - [28d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822470	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010822506	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010822565	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac disorder (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822569	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Palpitations (41d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822571	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010822572	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822573	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010822580	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Disease progression (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822581	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822582	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood cholesterol increased (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart valve incompetence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - 10mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - 1.25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822586	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822600	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010822624	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate irregular (0d - Recovered/Resolved - );Hypertension (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[APIXABAN] (C - n/a - n/a - [n/a - n/a - Oral])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - Oral])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010822673	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune dermatitis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822683	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Other Medically Important Condition);Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Disturbance in attention (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Formication (n/a - Unknown - Other Medically Important Condition);Hyperaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Painful respiration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Skin haemorrhage (n/a - Unknown - Other Medically Important Condition);Time perception altered (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822696	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Dyspnoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Hypertension (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010822733	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash vesicular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822740	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822750	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Stomatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822767	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822785	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nightmare (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822792	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Psoriasis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010822794	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Photopsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BEMFOLA [FOLLITROPIN ALFA, FOLLITROPIN ALFA (GENETICAL RECOMBINATION)] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822804	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperventilation (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Rhabdomyolysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachypnoea (n/a - Unknown - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010822813	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Heart rate irregular (n/a - Not Recovered/Not Resolved - Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010822820	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Extrasystoles (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010822829	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Personality disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822834	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822836	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (11d - Recovered/Resolved - );Malaise (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010822856	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Disabling);Cold sweat (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010822869	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822907	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010822909	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune neutropenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	IMATINIB ACCORD 100 MG FILM-COATED TABLETS [IMATINIB] (C - n/a - n/a - [n/a - 200mg - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010822931	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertensive crisis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010822956	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovered/Resolved - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010822960	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mobility decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010822960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010823001	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823006	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Balance disorder (n/a - Unknown - Other Medically Important Condition);Eyelid disorder (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Vaccination site bruising (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823014	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (14d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823033	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blue toe syndrome (3d - Recovered/Resolved - Other Medically Important Condition);Cachexia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Eye discharge (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Photophobia (n/a - Recovered/Resolved - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal pain (n/a - Unknown - Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TERBUTALINE SULFATE, TERBUTALINE SULFATE PH. EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823053	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823055	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Recovering/Resolving - Disabling);Heart rate irregular (n/a - Recovering/Resolving - Disabling);Peripheral coldness (n/a - Not Recovered/Not Resolved - Disabling);Thyroglossal cyst (n/a - Not Recovered/Not Resolved - Disabling, Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Analgesic therapy - n/a - [n/a - 325mg - n/a])|[AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE - BP] (C - Sleep disorder - n/a - [n/a - 8mg - Oral])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010823086	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823132	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site joint pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823171	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[HUMAN NORMAL IMMUNOGLOBULIN, HUMAN NORMAL IMMUNOGLOBULIN (IV)] (S - n/a - Unknown - [n/a - 10g - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823192	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Completed suicide (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Movement disorder (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Nausea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Parkinson's disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010823197	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823273	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823295	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823331	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823332	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Electrocardiogram ST segment depression (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823334	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823438	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823522	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823578	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823590	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010823601	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823633	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Arthropathy (n/a - Not Recovered/Not Resolved - );Dry eye (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Fibromyalgia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823671	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Herpes zoster (n/a - Unknown - );Ophthalmic herpes zoster (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010823710	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster infection neurological (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010823767	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition);Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010823812	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site joint pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823824	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiovascular insufficiency (n/a - Unknown - Other Medically Important Condition);Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823842	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site reaction (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010823911	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010823955	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010823955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010824019	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Disease recurrence (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Sacroiliac joint dysfunction (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010824083	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824090	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vaccination site inflammation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824116	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824124	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010824127	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824132	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Respiratory failure - Dose not changed - [n/a - 1{DF} - Respiratory (inhalation)])|[CYANOCOBALAMIN] (C - Vitamin B12 deficiency - Dose not changed - [n/a - 1{DF} - Intramuscular])|[LIDOCAINE, TRIAMCINOLONE, PENTOSAN POLYSULFATE SODIUM, TRIAMCINOLONE ACETONIDE, PENTOSAN POLYSULFATE SODIUM, LIDOCAINE HYDROCHLORIDE] (C - Haemorrhoids - Dose not changed - [n/a - 1{DF} - Topical])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - Hypertension - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010824135	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824139	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824146	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824162	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824181	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824190	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[IBUPROFEN, IBUPROFEN ARGININE] (C - Tooth abscess - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824204	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824213	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824224	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824236	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010824239	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010824242	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010824257	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010824268	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010824290	Spontaneous	2021-12-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature fluctuation (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatitis (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Retching (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[IBUPROFEN LYSINE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN, CAFFEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEFENAMIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - .5{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010824348	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nephrolithiasis (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - );Skin disorder (n/a - Unknown - );Urticaria (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010824350	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Asthenia (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Frustration tolerance decreased (n/a - Unknown - );Intentional product misuse (n/a - Unknown - );Night sweats (n/a - Unknown - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	HUMIRA [ADALIMUMAB] (S - Rheumatoid arthritis - Drug withdrawn - [n/a - 40mg - Subcutaneous])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010824351	Spontaneous	2021-12-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010824351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796627	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796663	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Emotional distress (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Feeling hot (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Pruritus (n/a - Unknown - );Urticaria chronic (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796671	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796719	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796720	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796734	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	IgA nephropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint effusion (n/a - Not Recovered/Not Resolved - );Proteinuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796748	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796754	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Coordination abnormal (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hallucination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796865	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010796872	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Pneumonitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010796897	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Disabling);Hypersensitivity (n/a - Unknown - Disabling);Ischaemic stroke (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	APROVEL [IRBESARTAN] (C - Hypertension - n/a - [n/a - 300mg - Oral])|[ACETYLSALICYLIC ACID] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - 1.25mg - Oral])|[COLECALCIFEROL] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[FOLIC ACID] (C - Anaemia - n/a - [n/a - 5mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Arteriosclerosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010796919	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010796924	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Recovered/Resolved - );Disorientation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[IBUPROFEN, IBUPROFEN BP, IBUPROFEN LYSINE, IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796969	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796976	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796978	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796985	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Haematochezia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797006	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010797027	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797037	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Tachycardia (n/a - Unknown - );Trismus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010798782	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous floaters (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798801	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798825	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798841	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Somnolence (4d - Recovered/Resolved - );Vertigo (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798860	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate decreased (n/a - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Irritability (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - );Thinking abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[HUMAN NORMAL IMMUNOGLOBULIN, IMMUNOGLOBULIN G] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010798907	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (14d - Recovered/Resolved - );Hemiparesis (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	MICARDIS 80 MG TABLETS [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799027	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799033	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Motor dysfunction (n/a - Recovering/Resolving - );Reduced facial expression (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799035	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799058	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799072	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799091	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Localised oedema (n/a - Recovered/Resolved - );Lymph node pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799094	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799097	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799105	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799111	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Supraventricular extrasystoles (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010799124	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799171	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Calculus urinary (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Renal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799188	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799226	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	ZYPREXA [OLANZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLURAZEPAM, FLURAZEPAM MONOHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010799228	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Retinal vein thrombosis (n/a - Not Recovered/Not Resolved - Disabling);Toothache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010799229	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010799235	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799247	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fatigue (n/a - Fatal - Results in Death);Leukopenia (n/a - Fatal - Results in Death);Platelet count decreased (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Sepsis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010799278	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coronavirus pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010799280	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Coronavirus pneumonia (37d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (37d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	ADENURIC 80 MG FILM-COATED TABLETS [FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[BIOTIN, CALCIUM PANTOTHENATE, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, VITAMIN B6, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS (II) GLYCINE SULFATE COMPLEX] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010799281	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coronavirus pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010799329	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799334	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799336	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799383	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799414	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799446	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799457	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799520	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010799585	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799705	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010799707	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Unknown - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 80mg - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - 125mg - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799729	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010799736	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myalgia (n/a - Unknown - );Oral pain (n/a - Recovered/Resolved With Sequelae - Disabling);Pain (n/a - Not Recovered/Not Resolved - );Teething (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010799749	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010799756	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799763	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799778	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799794	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (3d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition);Sinus congestion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010799796	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Injection related reaction (1d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799972	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010799990	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Embolism (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Life Threatening);Peripheral swelling (n/a - Recovering/Resolving - Life Threatening);Pulmonary oedema (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010799990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010800017	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010800026	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010800035	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Breast pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800048	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800113	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal exposure during pregnancy (n/a - Unknown - Life Threatening);Premature baby (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010800117	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Venous thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800143	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Renal cancer (n/a - Not Recovered/Not Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010800149	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800278	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Enthesopathy (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - n/a - n/a - )|[MELOXICAM] (C - n/a - n/a - )|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010800329	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Fatal - Results in Death);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010800441	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010800463	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infectious mononucleosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010800665	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dermatitis acneiform (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Eye pruritus (n/a - Recovering/Resolving - );Eye swelling (n/a - Recovering/Resolving - );Eyelid irritation (n/a - Recovering/Resolving - );Lacrimation increased (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Wound (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010800764	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restless legs syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800789	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010800869	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Platelet count decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ECABET SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[VILDAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800895	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dermatitis (n/a - Unknown - Other Medically Important Condition);Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800903	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800915	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800920	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800924	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800926	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Retinal artery occlusion (n/a - Not Recovered/Not Resolved - Disabling);Sudden visual loss (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010800932	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bullous impetigo (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800935	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Circulatory collapse (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Unresponsive to stimuli (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800936	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800942	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nerve root injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010800943	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800952	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block second degree (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Myopericarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericardial effusion (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010800964	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010800974	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010800987	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010800987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801011	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801020	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010801091	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood creatine phosphokinase MB increased (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Restlessness (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801176	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tonic clonic movements (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801177	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801178	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypervolaemia (n/a - Unknown - );Pleural effusion (n/a - Unknown - );Pneumonia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801180	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensation of foreign body (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801181	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chest pain (n/a - Unknown - );Delirium (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pollakiuria (n/a - Unknown - );Thirst (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A, PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT), PNEUMOCOCCAL VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801188	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801191	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801192	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801195	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801198	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - );Hemiparesis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801199	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801200	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801201	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801205	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pancreatitis acute (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801206	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801207	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyskinesia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801208	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801215	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Periarthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801217	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801218	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801220	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801222	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparesis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801224	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure congestive (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801225	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801234	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertensive emergency (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801236	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovered/Resolved - );Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801242	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801245	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801246	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801249	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neutropenic sepsis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801250	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801251	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801252	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801254	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Headache (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801255	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801257	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - );Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801261	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Urinary retention (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801263	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801265	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801266	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pneumonia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801269	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801272	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - );Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801273	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801275	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801285	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801286	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801289	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801290	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Haemoptysis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Muscle spasms (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801291	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801294	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801296	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Colitis ischaemic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801297	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801300	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Septic shock (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801304	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rhonchi (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensation of foreign body (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801307	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Hypertensive urgency (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Ocular hyperaemia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801308	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801313	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Disabling);Hypoaesthesia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801315	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801319	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);Periorbital swelling (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801322	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801324	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drooling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial asymmetry (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801325	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010801328	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchospasm (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperventilation (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhonchi (n/a - Unknown - Caused/Prolonged Hospitalisation);Wheezing (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801330	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Eructation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801333	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801334	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Epigastric discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801335	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801338	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Peripheral swelling (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801339	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801388	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010801395	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Visual impairment (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801397	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801400	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801405	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010801409	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801410	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])|[GLUCOSE, ANHYDROUS, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CITRIC ACID, POTASSIUM CHLORIDE, SODIUM CHLORIDE, GLUCOSE, DISODIUM HYDROGEN CITRATE, SODIUM CHLORIDE] (C - Gastroenteritis - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Headache - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Nasopharyngitis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Tension headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801411	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801412	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801413	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801419	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (8d - Recovered/Resolved - Other Medically Important Condition);Fatigue (8d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (8d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801420	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801421	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801425	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Disabling, Other Medically Important Condition);Hypokinesia (n/a - Unknown - Disabling, Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010801426	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801428	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Anal fistula (n/a - Unknown - Congenital Anomaly);Maternal exposure during pregnancy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Premature baby (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Transplacental])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - Transplacental])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801621	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801632	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801648	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801652	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle swelling (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801659	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801664	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801669	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paresis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801673	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|DULAGLUTIDE [DULAGLUTIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [342d - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOCETIRIZINE DIHYDROCHLORIDE] (C - Skin irritation - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801674	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis reactive (3d - Recovered/Resolved - Other Medically Important Condition);Mobility decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801675	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801703	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertensive emergency (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801706	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lacrimation increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Periorbital swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801709	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Heart rate irregular (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801710	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Confusional state (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (3d - Recovered/Resolved - Other Medically Important Condition);Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Migraine with aura (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801712	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801713	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fall (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lacunar stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Musculoskeletal disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Major depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801714	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801715	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachyarrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010801731	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amnesia (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Brain fog (n/a - Unknown - Disabling, Other Medically Important Condition);Dizziness (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Impaired work ability (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Influenza like illness (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vestibular neuronitis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801773	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (22h - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Disorientation (22h - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperventilation (22h - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010801778	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Erythema (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801782	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801784	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801798	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CITALOPRAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801804	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801816	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801832	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial asymmetry (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801838	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010801841	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Irritable bowel syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801844	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801849	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801854	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801858	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Increased viscosity of upper respiratory secretion (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010801859	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Dysuria (n/a - Unknown - );Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Myelitis transverse (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - );Sensory loss (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801864	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801868	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bicytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801871	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801872	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801878	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801879	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Faeces discoloured (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Gastric cancer (n/a - Fatal - Results in Death);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Mobility decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010801888	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010801890	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801894	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801895	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010801901	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal hypokinesia (n/a - Recovering/Resolving - Other Medically Important Condition);Maternal exposure timing unspecified (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010801904	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010801904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010802199	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (0d - Unknown - );Formication (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802204	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802206	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac ventricular thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010802223	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802232	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010802234	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (n/a - Recovering/Resolving - );Exercise tolerance decreased (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010802239	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010802241	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802244	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dementia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010802256	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802262	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Epistaxis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010802267	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (74d - Recovered/Resolved With Sequelae - );Pain in extremity (74d - Recovered/Resolved With Sequelae - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010802316	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Sinusitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802334	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Inflammation (n/a - Recovered/Resolved With Sequelae - );Influenza (n/a - Recovered/Resolved With Sequelae - );Limb discomfort (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010802364	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Hypoaesthesia oral (4d - Recovering/Resolving - );Paraesthesia (4d - Recovering/Resolving - );Swollen tongue (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802367	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010802376	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Flank pain (36d - Unknown - );Malaise (36d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010802418	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aortic valve incompetence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Aortic valve stenosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arteriospasm coronary (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac operation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Exercise tolerance decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010802434	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Photophobia (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation, Influenza immunisation - Not applicable - [1d - 1{DF} - Unknown])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010802588	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Transient acantholytic dermatosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802619	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802623	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802689	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Insomnia (1d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802690	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Autoimmune hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ocular icterus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010802731	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3wk - Recovered/Resolved - );Headache (1wk - Recovered/Resolved - );Hypoaesthesia (n/a - Recovering/Resolving - );Vaccination site pain (1wk - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802810	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Eczema (n/a - Not Recovered/Not Resolved - );Eye swelling (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin erosion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010802818	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010802924	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - );Sudden death (0d - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Syncope (0d - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010802924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010803024	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death);Spinal stroke (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ELIQUIS 5 MG [APIXABAN] (C - Atrial fibrillation - Unknown - [n/a - 2{DF} - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[COLECALCIFEROL] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010803063	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Skin sensitisation (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803130	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Herpes zoster (2wk - Recovered/Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Skin disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[METHOTREXATE, METHOTREXATE DISODIUM, METHOTREXATE SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010803173	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibromyalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BETMIGA [MIRABEGRON] (C - Bladder irritation - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010803273	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803278	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Unknown - [n/a - n/a - Unknown])|OCREVUS [OCRELIZUMAB] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803293	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (30d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (5min - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (5min - Recovered/Resolved - );Palpitations (3mo - Recovered/Resolved - );Testicular pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010803296	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Peripheral swelling (30d - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (30d - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (30d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010803307	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|IMMUNOTHERAPIE (IMMUUNTHERAPIE) [NOT AVAILABLE] (S - Lung cancer metastatic - Not applicable - [n/a - n/a - n/a])|[PREDNISOLONE] (S - Product used for unknown indication - Not applicable - [n/a - n/a - n/a])	[RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803308	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash vesicular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803345	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Tendon rupture (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010803361	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Contusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010803430	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (3d - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803437	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010803470	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypotension (13d - Recovered/Resolved - Disabling);Oxygen saturation decreased (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010803515	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bone pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803543	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Chills (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[PROPIOMAZINE, PROPIOMAZINE MALEATE] (C - n/a - n/a - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010803597	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Neck pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010803622	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010803633	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (9d - Recovered/Resolved - );Restless legs syndrome (4d - Not Recovered/Not Resolved - );Vaccination site hypersensitivity (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803662	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (9d - Not Recovered/Not Resolved - );Urticaria (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803671	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - );Musculoskeletal stiffness (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Pain in extremity (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803693	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803696	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803701	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Muscular weakness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803705	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803728	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803730	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010803808	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803893	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Atrial fibrillation (16d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (1d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010803924	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ZEBINIX [ESLICARBAZEPINE ACETATE] (C - Partial seizures - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010803932	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Oral herpes (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010803932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804029	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Gout (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804032	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804036	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804146	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Unknown - );Vascular pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804155	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804414	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])|[DIPHTHERIA TOXOID, TETANUS TOXOID, HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - Dose not changed - [n/a - n/a - Unknown])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol increased - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804422	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804475	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Decreased appetite (4d - Recovered/Resolved - );Diarrhoea (4d - Recovered/Resolved - );Hyperhidrosis (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - );Tremor (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010804562	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804584	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804586	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804588	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010804591	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804601	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804603	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804617	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Chromaturia (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oral discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804618	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804619	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Disabling);Chest pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010804631	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Mental impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804639	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coordination abnormal (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Demyelination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diplopia (75d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal osteoarthritis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804641	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804650	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804653	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010804661	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (6d - Recovered/Resolved - );Fatigue (14d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pain in extremity (3mo - Recovered/Resolved - );Pyrexia (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804670	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (5d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Injection site swelling (5d - Recovered/Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010804673	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010804682	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sunburn (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804685	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blindness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ocular vascular disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema (n/a - Not Recovered/Not Resolved - );Photopsia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804688	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rheumatoid arthritis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XELJANZ [TOFACITINIB, TOFACITINIB CITRATE] (C - Rheumatoid arthritis - n/a - [n/a - 10mg - Oral])|[METHOTREXATE SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - 25mg - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804693	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804698	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Paranasal sinus inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Sinonasal obstruction (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804702	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (11d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804706	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804708	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010804712	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	General physical health deterioration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Seronegative arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|[NAPROXEN] (C - Pain - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010804718	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804720	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (14wk - Recovering/Resolving - Other Medically Important Condition);Dizziness (14wk - Recovered/Resolved - Other Medically Important Condition);Fatigue (14wk - Recovered/Resolved - Other Medically Important Condition);Hypersomnia (14wk - Recovered/Resolved - Other Medically Important Condition);Inner ear inflammation (14wk - Recovered/Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (14wk - Recovered/Resolved - Other Medically Important Condition);Malaise (14wk - Recovered/Resolved - Other Medically Important Condition);Nasal inflammation (14wk - Recovered/Resolved - Other Medically Important Condition);Rash (14wk - Recovered/Resolved - Other Medically Important Condition);Sinus disorder (14wk - Recovered/Resolved - Other Medically Important Condition);Vertigo (14wk - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804814	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804820	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804821	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804822	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804824	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010804825	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804826	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804827	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804830	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (2h - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (2h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|SPIRONOLACTONE [SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804831	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Motor developmental delay (n/a - Unknown - Disabling, Other Medically Important Condition);Tic (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010804832	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804833	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804837	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial asymmetry (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804840	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swelling face (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804841	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Unknown - Caused/Prolonged Hospitalisation);Glossitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Mouth ulceration (n/a - Unknown - Caused/Prolonged Hospitalisation);Ocular hyperaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804842	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804843	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Leukoencephalopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804845	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804848	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anisocytosis (n/a - Not Recovered/Not Resolved - );Autoimmune anaemia (n/a - Unknown - Other Medically Important Condition);Blood iron decreased (n/a - Recovered/Resolved - );Coagulopathy (n/a - Unknown - );Haemoglobin decreased (n/a - Recovering/Resolving - );Platelet anisocytosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IRON [IRON] (C - Iron deficiency - n/a - [n/a - n/a - Oral])|[PIRACETAM] (C - Multiple sclerosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804853	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Defaecation urgency (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804854	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lip swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Periorbital swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Throat irritation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804858	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804866	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Respiratory distress (n/a - Recovered/Resolved - Other Medically Important Condition);Wheezing (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804867	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010804868	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804869	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Orthopnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010804873	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Mental impairment (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LYMECYCLINE] (C - Rosacea - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010804876	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Polyarthritis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804877	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804879	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010804880	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804881	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804885	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Aphthous ulcer (n/a - Unknown - );Blepharospasm (n/a - Unknown - );Conjunctivitis (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Hyperthyroidism (n/a - Unknown - Other Medically Important Condition);Mood swings (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Restlessness (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vision blurred (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804886	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010804887	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Psychotic disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010804889	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010804893	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010804893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010805039	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805043	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805044	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Back pain (n/a - Unknown - Disabling, Other Medically Important Condition);Burning sensation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Condition aggravated (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hyperventilation (n/a - Unknown - Disabling, Other Medically Important Condition);Hypopnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Insomnia (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010805049	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805050	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805051	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805054	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immobile (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (1d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805060	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805062	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805065	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805070	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (5d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Prophylaxis - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Prophylaxis, Supraventricular tachycardia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805072	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Uveitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805074	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805076	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Constipation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805080	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805081	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805088	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805091	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinary incontinence (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805096	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805099	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Dyspepsia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (4d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pollakiuria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805104	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805112	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NORTRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805118	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - 4{DF} - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 8{DF} - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805120	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805121	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLCHICINE] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805123	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805125	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastrointestinal stoma output increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805160	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805164	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805166	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805180	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805185	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805192	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805193	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805194	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010805196	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805214	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805215	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pre-existing condition improved (n/a - Recovered/Resolved - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805217	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805219	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805220	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina unstable (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805221	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Musculoskeletal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805230	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805237	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Neck pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805245	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain lower (n/a - Unknown - );Headache (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805249	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Scleroderma (n/a - Unknown - Other Medically Important Condition);Systemic scleroderma (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805254	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805265	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805267	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805272	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Head discomfort (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (3d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805276	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805278	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805294	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805295	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Skin warm (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805297	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (17d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhagic stroke (405h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Haemorrhagic transformation stroke (17d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 8mg - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 40mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - Oral])|[TRIMETAZIDINE, TRIMETAZIDINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805301	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	OCREVUS [OCRELIZUMAB] (C - Relapsing-remitting multiple sclerosis - n/a - [n/a - 600mg - Intravenous (not otherwise specified)])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805322	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (2h - Recovered/Resolved - Other Medically Important Condition);Presyncope (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805324	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (2d - Recovered/Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805325	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805326	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805374	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805379	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805386	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site inflammation (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805429	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010805432	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coronary angioplasty (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	IMRALDI [ADALIMUMAB] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805433	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805436	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805448	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805453	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (3d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805463	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Platelet count decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ECABET SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[VILDAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805465	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic shock (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010805471	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010805472	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010805476	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805539	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ESSENTIAL OIL OF PEPPERMINT, PEPPERMINT OIL] (C - Irritable bowel syndrome - n/a - [n/a - n/a - Oral])|[LACTOBACILLUS ACIDOPHILUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805541	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805545	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1h - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2h - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805586	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Purpura (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805587	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805692	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (16h - Recovered/Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (16h - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (16h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805693	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Sinus rhythm (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805704	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersomnia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805705	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Tachycardia (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010805713	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805726	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010805728	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010805732	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805746	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (21d - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Lethargy (17d - Recovered/Resolved - Disabling);Migraine (5d - Recovered/Resolved - Disabling);Nasal congestion (16d - Recovered/Resolved - Disabling);Nausea (3d - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010805850	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805852	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010805857	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010805863	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - );Peripheral coldness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010805907	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (14d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (14d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010805921	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest discomfort (2wk - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Palpitations (3wk - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010805921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806011	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Recovered/Resolved - );Dizziness (7d - Recovered/Resolved - Other Medically Important Condition);Hypotension (7d - Recovered/Resolved - Other Medically Important Condition);Syncope (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IPILIMUMAB [IPILIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|NIVOLUMAB [NIVOLUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806104	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Unknown - Disabling);Blood pressure fluctuation (n/a - Unknown - Disabling);Blood pressure increased (n/a - Unknown - Disabling);Cardiac discomfort (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Head discomfort (n/a - Unknown - Disabling);Hypersensitivity (n/a - Unknown - Disabling);Loss of personal independence in daily activities (n/a - Unknown - Disabling);Panic attack (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010806113	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (5h - Recovered/Resolved - );Eye irritation (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (3h - Recovered/Resolved - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Somnolence (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806139	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Urticaria (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010806179	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806187	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806193	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic reaction (0d - Recovered/Resolved - Life Threatening);Immunisation (n/a - Unknown - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Palpitations (n/a - Unknown - Life Threatening);Throat tightness (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010806197	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid irritation (n/a - Recovered/Resolved - );Facial discomfort (n/a - Recovered/Resolved - );Facial pain (30d - Recovered/Resolved - );Facial paralysis (30d - Recovered/Resolved - Other Medically Important Condition);Facial paresis (30d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806198	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Irritability (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Monoparesis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806201	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806204	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoplegia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806211	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burns third degree (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806216	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806217	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806218	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Body temperature increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806219	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806220	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806247	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010806279	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Retinal detachment (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806282	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dermatitis allergic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	SIMPONI [GOLIMUMAB] (C - n/a - n/a - [93d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806456	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Product administration error (n/a - Unknown - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806460	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Ischaemic stroke (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806461	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Arrhythmia supraventricular - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Arrhythmia supraventricular - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806465	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (6d - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806467	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806473	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806481	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806519	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806588	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806589	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806611	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010806619	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806621	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dehydration (n/a - Unknown - );Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - 81mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a - More in ICSR])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - 1000mg - n/a])|[CARVEDILOL] (C - Blood pressure abnormal - n/a - [n/a - 25mg - n/a])|[FUROSEMIDE] (C - Fluid retention - n/a - [n/a - 20mg - n/a - More in ICSR])|[GABAPENTIN] (C - Diabetes mellitus, Neuropathy peripheral - n/a - [n/a - 3{DF} - n/a])|[ISOSORBIDE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - 2mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure abnormal - n/a - [n/a - 100mg - n/a - More in ICSR])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 2000mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 50mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol abnormal - n/a - [n/a - 40mg - n/a])|[TICAGRELOR] (C - Anticoagulant therapy - n/a - [n/a - 180mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010806622	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pH increased - n/a - [n/a - n/a - n/a])|[BENZATROPINE] (C - Blood pH abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806631	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010806637	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovered/Resolved - );Injection site lymphadenopathy (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806665	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Foaming at mouth (n/a - Unknown - );Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - );Illness (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010806676	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806682	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806684	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806685	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806688	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806693	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastritis (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806698	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806701	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806703	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806707	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806709	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806711	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806717	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806721	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806723	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash papular (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806725	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Expired product administered (1d - Recovered/Resolved - );Gastrointestinal motility disorder (10d - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Vaccination site discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806729	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [43d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806732	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatic disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806737	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	XULTOPHY 100 UNITS/ML + 3.6 MG/ML SOLUTION FOR INJECTION [LIRAGLUTIDE, INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806739	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806741	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (2d - Recovered/Resolved - );Vaccination site pain (61d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010806742	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[FLUINDIONE] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )|[NEBIVOLOL] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - )|[SPIRONOLACTONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806743	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806747	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - )|[ESCITALOPRAM] (C - n/a - n/a - )|[VALPROATE SEMISODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806757	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806764	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Stomatitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806765	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806768	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806776	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ATORVASTATIN CALCIUM, EZETIMIBE, ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806777	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806819	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806820	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ESOMEPRAZOLE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806823	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal chest pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806827	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendonitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806836	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806842	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (18h - Recovered/Resolved - );Osteochondritis (n/a - Recovered/Resolved - );Pyrexia (18h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806860	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806862	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis bullous (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806866	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806869	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Livedo reticularis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[DROSPIRENONE, ETHINYLESTRADIOL] (S - Contraception - Drug withdrawn - [n/a - n/a - Oral])	[DOMPERIDONE] (C - Nausea - n/a - [n/a - n/a - Oral])|[PARACETAMOL, BELLADONNA DRY EXTRACT, CAFFEINE, OPIUM, PARACETAMOL, CAFFEINE, OPIUM, PARACETAMOL, CAFFEINE, OPIUM EXTRACTS, PARACETAMOL, CAFFEINE, OPIUM, PREPARED] (C - Migraine - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806870	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806872	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806873	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphoedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806886	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806888	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (2wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ADALIMUMAB [ADALIMUMAB] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806890	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806891	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806893	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806894	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (6d - Recovered/Resolved - );Urticaria (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806895	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAFTIDROFURYL OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806898	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806900	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806901	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site joint pain (n/a - Not Recovered/Not Resolved - );Injection site joint swelling (n/a - Not Recovered/Not Resolved - );Injection site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806906	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806915	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	GENVOYA 150 MG/150 MG/200 MG/10 MG FILM-COATED TABLETS [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, COBICISTAT, ELVITEGRAVIR] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806916	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Infant	Yes	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806917	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (48h - Recovered/Resolved - );Arthralgia (48h - Recovered/Resolved - );Chest pain (48h - Recovered/Resolved - );Myalgia (48h - Recovered/Resolved - );Vaccination site pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806919	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806923	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806927	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (14d - Recovered/Resolved - );Dizziness (14d - Recovered/Resolved - );Headache (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806935	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Oral herpes (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806940	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806943	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806946	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806952	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Photophobia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010806960	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806963	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis (3d - Recovered/Resolved - );Condition aggravated (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010806992	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010806992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807217	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807285	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807291	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010807299	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epilepsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807361	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807394	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807403	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807418	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[CLONAZEPAM] (C - Partial seizures - Not applicable - [n/a - n/a - Oral])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - Hypertension - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807425	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807426	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);VIth nerve paralysis (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807427	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807434	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807449	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pleural effusion (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807451	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807454	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Loss of consciousness (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010807457	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807460	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - Micturition urgency - n/a - [n/a - n/a - Oral])|SILODOSIN [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - .5{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807465	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [37d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807474	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Orthostatic hypotension (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807475	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807476	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807478	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Parkinson's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807479	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807488	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [26d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807493	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cognitive disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Renal failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])|[AZATHIOPRINE] (C - Renal transplant - n/a - [n/a - 75mg - Oral])|[CICLOSPORIN] (C - Renal transplant - n/a - [n/a - 140mg - Oral])|[PREDNISONE] (C - Renal transplant - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807494	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807501	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807512	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807523	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807528	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (4d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010807537	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (123d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebrovascular accident (123d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807538	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807540	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Orchitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Testicular abscess (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807569	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807590	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010807594	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010807595	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epstein-Barr virus infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807624	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (23d - Recovered/Resolved With Sequelae - );Chest pain (23d - Recovered/Resolved With Sequelae - );Myalgia (23d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010807625	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807630	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807638	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Sepsis (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010807649	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ABASAGLAR KWIKPEN 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - n/a - n/a - [n/a - 28[iU] - Subcutaneous])|NOVORAPID PENFILL 100 E/ML INJEKTIONSVÄTSKA, LÖSNING, I CYLINDERAMPULLER. [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807654	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807655	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (9d - Recovering/Resolving - );Dizziness (48d - Not Recovered/Not Resolved - );Paraesthesia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010807696	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain neoplasm malignant (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807699	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoglycaemia (4h - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOVORAPID [INSULIN ASPART] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010807700	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Hypoaesthesia oral (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Monoplegia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010807706	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807712	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neoplasm malignant (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807720	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010807745	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807780	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807784	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Eye irritation (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807786	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807790	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ear discomfort (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807850	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807871	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gait disturbance (14d - Recovered/Resolved - );Muscular weakness (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807888	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807897	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PAROXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010807901	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807913	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807919	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807939	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (4d - Recovered/Resolved - );Swelling face (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807941	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PEGASYS 135 MICROGRAMS SOLUTION FOR INJECTION [PEGINTERFERON ALFA-2A] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIAMCINOLONE ACETONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807960	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - );Immobile (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle tightness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807975	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807977	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infusion related hypersensitivity reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807978	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LACIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010807990	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - Anaemia vitamin B12 deficiency - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010807994	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vaccination site discomfort (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010807998	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010807998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010808000	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abnormal clotting factor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Menstrual disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010808002	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Deep vein thrombosis - n/a - [n/a - 10mg - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - 2mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010808011	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808091	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[METHYLPREDNISOLONE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[PROPRANOLOL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808110	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[METHYLPREDNISOLONE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[PROPRANOLOL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808152	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808205	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Swelling (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808217	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LISDEXAMFETAMINE DIMESYLATE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010808244	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [24d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808262	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010808308	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010808310	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010808383	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010808385	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808397	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (8d - Recovered/Resolved - );Myalgia (8d - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808403	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Staring (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808471	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010808472	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Blood bilirubin increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fall (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Fibromyalgia (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nervous system disorder (n/a - Not Recovered/Not Resolved - );Ophthalmic migraine (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Retinal migraine (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010808496	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cyanosis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertensive crisis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010808556	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - );Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808557	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808565	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808567	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808569	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Catarrh (n/a - Unknown - );Chalazion (n/a - Unknown - );Cough (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808589	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010808597	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Fatigue (n/a - Unknown - );Injection site inflammation (6d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Injection site swelling (6d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808605	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808642	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808645	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (6d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - );Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (6d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010808666	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Constipation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808681	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (4d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyslalia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysstasia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Platelet factor 4 decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	INSULIN HUMAN [INSULIN HUMAN] (C - Diabetes mellitus management - n/a - [n/a - 69[iU] - n/a])|LEVEMIR [INSULIN DETEMIR] (C - Diabetes mellitus management - n/a - [n/a - 23[iU] - Subcutaneous])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - 10mg - Oral])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010808683	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - 20mg - n/a])|[SODIUM HYDROGEN CARBONATE] (C - Excessive cerumen production - n/a - [n/a - 12[iU] - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010808685	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010808703	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808718	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctival haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010808778	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808784	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808803	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808819	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (15min - Recovered/Resolved - );Dizziness (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808821	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808858	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CORTISONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808859	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Purpura (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808860	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Hunger (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010808882	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hallucination (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (3d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010808915	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010808917	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Near drowning (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010808921	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Metastases to skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010808999	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010808999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010809009	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809019	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphatic disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010809020	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Brain fog (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition);Pupillary disorder (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010809026	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved - );Haematochezia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010809048	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovered/Resolved - );Condition aggravated (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - Sinusitis - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - Arthritis, Raynaud's phenomenon - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - Insomnia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809061	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809131	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809155	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Multisystem inflammatory syndrome in children (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010809186	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[SIMETICONE] (C - n/a - Dose not changed - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809357	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809378	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XELJANZ 11 MG PROLONGED-RELEASE TABLETS [TOFACITINIB] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809431	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010809436	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010809442	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010809444	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovered/Resolved - );Cardiac disorder (n/a - Unknown - );Chest discomfort (n/a - Recovered/Resolved - );Gait inability (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Recovered/Resolved - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010809464	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthropod bite (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lyme disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Meningitis bacterial (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010809467	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809489	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Karer, M.. Subcutaneous injection of mRNA vaccines against severe acute respiratory syndrome coronavirus 2: an option for severe bleeding disorders or anticoagulated patients?.. Blood Coagulation &amp; Fibrinolysis. 2021;32(6):423-424. doi:10.1097/MBC.0000000000001048	18-64 Years	Not Specified	No	Male	Local reaction (n/a - Unknown - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Subcutaneous])	RIVAROXABAN [RIVAROXABAN] (C - Anticoagulant therapy - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809549	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010809562	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Delusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mental status changes (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nervous system disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - 5mg - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - 3.125mg - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LACTULOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - 10mg - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Psychotic disorder - n/a - [n/a - 100mg - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 100mg - Oral])|[SIMVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - 10mg - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - .4mg - Oral])|[TORASEMIDE] (C - n/a - n/a - [n/a - 100mg - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010809608	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling guilty (n/a - Not Recovered/Not Resolved - );Immune system disorder (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809638	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010809639	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	INFLECTRA [INFLIXIMAB] (C - Colitis ulcerative - n/a - [n/a - 800mg - n/a])|[AZATHIOPRINE, AZATHIOPRINE BP, AZATHIOPRINE PH. EUR.] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010809677	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809678	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010809683	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1h - Recovered/Resolved - );Fatigue (1h - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (1h - Recovered/Resolved - );Syncope (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010809771	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010809773	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809804	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809887	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010809942	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Bursitis (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010809999	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010809999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810001	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810007	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Recovering/Resolving - );Epicondylitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810009	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810010	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pulmonary embolism (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010810024	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swollen tongue (1d - Recovered/Resolved - );Tongue pruritus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810028	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Subdural haematoma (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - n/a - Dose not changed - [n/a - 50mg - Oral])|PRAVAFENIX 40 MG/160 MG HARD CAPSULES [PRAVASTATIN SODIUM, FENOFIBRATE] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])|RASILEZ 150 MG FILM-COATED TABLETS [ALISKIREN] (C - n/a - Dose not changed - [n/a - 150mg - Oral])|[ACENOCOUMAROL] (C - n/a - Drug withdrawn - [n/a - 1{DF} - Oral])|[ALLOPURINOL] (C - n/a - Dose not changed - [n/a - 100mg - Oral])|[CYANOCOBALAMIN] (C - n/a - Dose not changed - [n/a - 1000ug - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Dose not changed - [n/a - 20mg - Oral])|[FOLIC ACID] (C - n/a - Dose not changed - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010810062	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dizziness (2d - Fatal - Results in Death);Hypertension (2d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010810120	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye infarction (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010810151	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Anxiety (n/a - Not Recovered/Not Resolved - );Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - );Blood pressure decreased (n/a - Recovering/Resolving - );Brain fog (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Cold sweat (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Recovering/Resolving - );Cough (n/a - Unknown - );Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Unknown - );Hypoaesthesia (n/a - Recovering/Resolving - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Oesophageal pain (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovering/Resolving - );Pharyngeal mass (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Rhinalgia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Recovering/Resolving - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010810212	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010810274	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010810370	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Enthesopathy (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810410	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (10d - Recovered/Resolved - );Fatigue (10d - Recovered/Resolved - );Hyperhidrosis (10d - Recovered/Resolved - );Pyrexia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010810596	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Hypoglycaemia (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010810597	Spontaneous	2021-11-30 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bacteroides bacteraemia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Febrile neutropenia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemophagocytic lymphohistiocytosis (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Liver injury (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Shock (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010810608	Spontaneous	2021-11-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010810608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786380	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disorientation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	INSULIN LISPRO SANOFI [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 3{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786381	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pleuropericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786403	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovered/Resolved With Sequelae - Life Threatening);Alveolitis (n/a - Recovered/Resolved With Sequelae - Life Threatening);Antineutrophil cytoplasmic antibody (n/a - Recovered/Resolved With Sequelae - Life Threatening);Pulmonary renal syndrome (n/a - Recovered/Resolved With Sequelae - Life Threatening);Respiratory failure (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pyrexia - n/a - [n/a - 600mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786482	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Bursitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	KEPPRA 250 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786517	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3h - Recovered/Resolved - );Dehydration (1d - Recovered/Resolved - );Delirium (3h - Recovered/Resolved - Other Medically Important Condition);Dysuria (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Recovered/Resolved - );Hangover (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - );Product use issue (n/a - Unknown - );Renal pain (3h - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (S - Influenza immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786527	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Derealisation (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Panic attack (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Panic disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - Bipolar II disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010786541	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening);Immunisation (n/a - Unknown - Life Threatening);Interchange of vaccine products (n/a - Unknown - Life Threatening);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening);Product use issue (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786584	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Life Threatening);Chest pain (n/a - Unknown - Life Threatening);Cough (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Myocardial infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786587	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial asymmetry (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786597	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786598	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786599	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786601	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Hyperhidrosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786606	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Hypotension (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786608	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786611	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786619	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Life Threatening);Acute myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dyspepsia (n/a - Recovering/Resolving - Life Threatening);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786623	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Staphylococcal scalded skin syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786625	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786626	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786628	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786634	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening);Seizure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786636	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786637	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786641	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786643	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786645	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786647	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Epigastric discomfort (n/a - Unknown - Life Threatening);Hyperhidrosis (n/a - Unknown - Life Threatening);Peripheral swelling (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786650	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786653	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786655	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786663	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786665	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786668	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786682	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786684	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786686	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786689	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786691	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786694	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786697	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786704	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786705	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786707	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait inability (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786708	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786709	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Disabling);Hemiparesis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786710	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Apathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coordination abnormal (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786712	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Hemianopia homonymous (n/a - Unknown - Disabling, Other Medically Important Condition);Superior sagittal sinus thrombosis (n/a - Unknown - Disabling, Other Medically Important Condition);Vision blurred (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786718	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786721	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral artery thrombosis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786724	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lethargy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786726	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heat stroke (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786727	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786732	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drooling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lagophthalmos (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786733	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Speech disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010786734	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786737	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786738	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786739	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sensation of foreign body (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786741	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786743	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786749	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786750	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786752	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786754	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mouth haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Petechiae (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786755	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786759	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Disabling);Hemiparesis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786761	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786763	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786766	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786767	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786768	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786769	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786770	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786773	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786775	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786776	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786777	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786778	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786779	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786780	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hemiparesis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786782	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786786	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial asymmetry (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786787	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786793	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute pulmonary oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertensive emergency (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory rate increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786795	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abnormal behaviour (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Disorganised speech (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyskinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hallucination, auditory (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hallucination, visual (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Soliloquy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somatic hallucination (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786796	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786797	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786798	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786799	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure during pregnancy (n/a - Unknown - Congenital Anomaly);Tachycardia foetal (n/a - Unknown - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	Severe reaction
EU-EC-10010786800	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786801	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786802	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Adverse event (n/a - Unknown - );Dermatitis allergic (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786808	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786811	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Jaundice (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786818	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786819	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ataxia (n/a - Recovering/Resolving - Disabling);Fall (n/a - Recovering/Resolving - Disabling);Hemiparesis (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Ischaemic stroke (n/a - Recovering/Resolving - Disabling);Muscular weakness (n/a - Recovering/Resolving - Disabling);Sensory loss (n/a - Recovering/Resolving - Disabling);Somnolence (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786822	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786823	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Orthopnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786824	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786828	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786829	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786830	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786831	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786834	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Not Recovered/Not Resolved - Disabling);Facial asymmetry (n/a - Not Recovered/Not Resolved - Disabling);Hemiparesis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786837	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure systolic increased (n/a - Unknown - );Oropharyngeal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Throat tightness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786838	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786839	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Life Threatening);Dizziness (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786840	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - Other Medically Important Condition);Dysphoria (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Feeling cold (0d - Recovered/Resolved - );Heart rate decreased (0d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (0d - Recovered/Resolved - );Movement disorder (0d - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Shock (0d - Recovered/Resolved - Other Medically Important Condition);Somnolence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786872	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (8d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Somnolence (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Uveitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786887	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786890	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786894	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis exfoliative generalised (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - );Rash (n/a - Recovering/Resolving - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786895	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peroneal nerve palsy (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786901	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786902	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anorgasmia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Erectile dysfunction (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DIHYDROCODEINE TARTRATE, PARACETAMOL, PARACETAMOL BP, DIHYDROCODEINE TARTRATE BP, PARACETAMOL, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786903	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (21h - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786909	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);C-reactive protein increased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Confusional state (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fall (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hyponatraemia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Mobility decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vasculitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Weight decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010786910	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786913	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786918	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786919	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Viral myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786922	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786924	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [1d - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE] (C - Pneumonia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786931	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786933	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786936	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (1d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786940	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786942	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786946	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786951	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Multiple sclerosis (n/a - Unknown - Other Medically Important Condition);Neurological symptom (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786955	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010786956	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACICLOVIR, ACICLOVIR SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786957	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Depressed mood (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786959	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786970	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Depressed mood (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786979	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Oesophagitis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786992	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (56d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010786993	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Deep vein thrombosis - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Transplant - n/a - [n/a - n/a - n/a])|[AZATHIOPRINE, AZATHIOPRINE BP, AZATHIOPRINE PH. EUR.] (C - Transplant - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010786995	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787001	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787002	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysmenorrhoea (n/a - Unknown - Disabling, Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Polymenorrhoea (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010787034	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787038	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787046	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787051	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787066	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - );Anxiety (n/a - Unknown - );Asthenia (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Faeces discoloured (n/a - Unknown - );Fatigue (n/a - Unknown - );Fear (n/a - Unknown - );Gastrointestinal haemorrhage (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787080	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Male	Cardiac arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Unknown - );Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010787081	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TICAGRELOR [TICAGRELOR] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cholestasis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787088	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010787096	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Benign prostatic hyperplasia (n/a - Recovered/Resolved - );Urinary retention (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787103	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787105	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010787106	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787108	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Hemiparesis (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787111	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Life Threatening);Dyspnoea (n/a - Recovered/Resolved - Life Threatening);Faeces discoloured (n/a - Recovered/Resolved - Life Threatening);Lethargy (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010787115	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787116	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Recovering/Resolving - Other Medically Important Condition);Eczema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787117	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Post-traumatic epilepsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787121	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787126	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787128	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787129	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787133	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787135	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787136	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paresis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787137	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787138	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial asymmetry (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787139	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea paroxysmal nocturnal (n/a - Recovering/Resolving - Other Medically Important Condition);Orthopnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787142	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Life Threatening);Hypotension (n/a - Recovered/Resolved - Life Threatening);Nausea (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010787143	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematuria (n/a - Unknown - Other Medically Important Condition);Suprapubic pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787144	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787145	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787146	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787147	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787149	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787159	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787160	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787162	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787163	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787164	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787165	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787166	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787168	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787175	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787177	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Life Threatening);Cough (n/a - Recovered/Resolved - Life Threatening);Dizziness (n/a - Recovered/Resolved - Life Threatening);Dyspnoea (n/a - Recovered/Resolved - Life Threatening);Headache (n/a - Recovered/Resolved - Life Threatening);Hypotension (n/a - Recovered/Resolved - Life Threatening);Lethargy (n/a - Recovered/Resolved - Life Threatening);Sensation of foreign body (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010787179	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787180	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787181	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787182	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787183	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787185	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787188	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block (n/a - Recovering/Resolving - Life Threatening);Bradycardia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Life Threatening);Presyncope (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010787191	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bacteraemia (n/a - Unknown - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Metabolic acidosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787192	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787193	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787195	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787197	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787198	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infective exacerbation of chronic obstructive airways disease (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787201	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787204	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psychogenic seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787205	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787206	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Upper gastrointestinal haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787207	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787209	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787214	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787215	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787217	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787222	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial asymmetry (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787223	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dermatitis exfoliative (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787228	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Upper gastrointestinal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787229	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787230	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787232	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787234	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787235	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyskinesia (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787236	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787239	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787240	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787247	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787250	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute lung injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Contusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787252	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphoid tissue hyperplasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mesenteric lymphadenitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787254	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787255	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787257	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787260	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787263	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787267	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periorbital oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787269	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787274	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787275	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Haematemesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Melaena (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787277	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787282	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787285	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787289	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Lichen planus (n/a - Unknown - Other Medically Important Condition);Osteoarthritis (n/a - Unknown - );Skin depigmentation (n/a - Unknown - Other Medically Important Condition);Vitiligo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787294	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Deafness (n/a - Not Recovered/Not Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010787295	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (15min - Recovered/Resolved - Other Medically Important Condition);Dizziness (15min - Recovered/Resolved - );Feeling abnormal (15min - Recovered/Resolved - );Nausea (15min - Recovered/Resolved - );Pallor (15min - Recovered/Resolved - );Presyncope (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787298	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787302	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787303	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787305	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787307	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010787310	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787312	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (30s - Recovered/Resolved - Other Medically Important Condition);Hypoglycaemia (n/a - Unknown - );Loss of consciousness (30s - Recovered/Resolved - Other Medically Important Condition);Syncope (30s - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787324	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787326	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787330	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Abdominal rigidity (n/a - Unknown - );Agitation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Allergy to chemicals (n/a - Unknown - );Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eructation (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flatulence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flushing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787343	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Rash erythematous (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787366	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787440	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - n/a - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787482	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787496	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [33d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010787504	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wound (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787516	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787520	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787523	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acquired diaphragmatic eventration (25d - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010787533	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787534	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - );Bronchitis (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Recovered/Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pain (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DESLORATADINE, MONTELUKAST SODIUM] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787543	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787550	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787552	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Thank you for making your profession with dedication!. Viata Medicala. 2021;44(1656):1	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787605	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787609	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paranasal sinus discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010787610	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sputum increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787611	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787620	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urinary tract infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urosepsis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787622	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Intervertebral discitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Osteomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Spinal stenosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010787712	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Muscle haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787718	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema (n/a - Not Recovered/Not Resolved - );Renal impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010787885	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Disturbance in attention (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787890	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787904	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787918	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010787924	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ZMA [NOT AVAILABLE] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787935	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ETORICOXIB] (C - Gout - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787940	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787959	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010787981	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Disabling);Chromaturia (n/a - Unknown - Disabling);Confusional state (n/a - Unknown - Disabling);Delirium (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Recovering/Resolving - Disabling);Product use issue (n/a - Unknown - Disabling);Renal pain (n/a - Unknown - Disabling)	[INFLUENZA VIRUS] (S - Influenza immunisation - Not applicable - [1d - n/a - Unknown])|[TOZINAMERAN] (S - COVID-19 immunisation, Immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010787981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010788049	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010788064	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Papule (n/a - Recovered/Resolved - );Skin reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788066	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788074	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling);Ataxia (n/a - Recovering/Resolving - Disabling);Constipation (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Guillain-Barre syndrome (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010788078	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (13d - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788079	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasal oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788086	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bronchospasm (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash erythematous (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachyarrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788090	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788094	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010788095	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[BISACODYL] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[BUPROPION] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[MEMANTINE] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[MODAFINIL] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Cardiac disorder, Cerebrovascular accident, Narcolepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788096	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperacusis (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol increased - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010788111	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788112	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperglycaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ketosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Migraine (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788116	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788118	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Erythema (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis with thrombocytopenia syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OPDIVO [NIVOLUMAB] (C - Lung adenocarcinoma stage II - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788141	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010788271	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788272	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788274	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010788277	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pH increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788281	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788282	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788286	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Other Medically Important Condition);COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed mood (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mass (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788295	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788296	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788298	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788308	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure diastolic decreased (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Dysphoria (0d - Recovered/Resolved - );Feeling abnormal (0d - Recovered/Resolved - );Gaze palsy (0d - Recovered/Resolved - Other Medically Important Condition);Pallor (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010788324	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac failure congestive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Periorbital oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Periorbital swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Testicular swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Wheezing (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788366	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788389	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788392	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788394	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness postural (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788423	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (S - Trigeminal neuralgia - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010788447	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788449	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788468	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (17d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788524	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic disc disorder (n/a - Recovering/Resolving - Disabling);Tremor (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010788545	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Formication (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788584	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010788589	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788592	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788594	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010788777	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (5h - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (5h - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010788859	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010788978	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Genital rash (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - );Skin warm (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010788978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789045	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (8h - Recovered/Resolved - );Headache (12h - Recovered/Resolved - );Malaise (8h - Recovered/Resolved - );Pyrexia (9h - Recovered/Resolved - );Vaccination site oedema (15h - Recovered/Resolved - );Vaccination site pain (15h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789049	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (5d - Recovered/Resolved - Life Threatening);Chest pain (5d - Recovered/Resolved - Life Threatening);Tachycardia (5d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010789066	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Bone pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010789073	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site erythema (12h - Recovered/Resolved - );Administration site oedema (1d - Recovered/Resolved - );Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789104	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789111	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789113	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789117	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Application site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Immune system disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010789118	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Apathy (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789121	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789123	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemianaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789139	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dementia (n/a - Unknown - Other Medically Important Condition);Hyponatraemia (12d - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010789160	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789171	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Life Threatening);Arterial thrombosis (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010789176	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010789178	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cellulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789188	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010789201	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diplopia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drooling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eyelid ptosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gastrooesophageal reflux disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myasthenia gravis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myasthenic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789211	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Unknown - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010789217	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Anxiety (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pelvic pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789230	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010789232	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789239	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood chloride decreased (n/a - Unknown - );Blood creatine increased (n/a - Unknown - );Dermatitis atopic (n/a - Unknown - );Eosinophil count increased (n/a - Unknown - );Erythema (n/a - Unknown - );Erythema multiforme (n/a - Recovering/Resolving - Other Medically Important Condition);Monoblast count increased (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789240	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789248	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bleeding time prolonged (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010789256	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OLOPATADINE [OLOPATADINE] (C - Dermatitis allergic - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Cerebral infarction - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[MAGNESIUM HYDROXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])|[TENELIGLIPTIN HYDROBROMIDE HYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789258	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Speech disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010789260	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (6d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789278	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ecchymosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Petechiae (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789291	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hyperaesthesia (n/a - Unknown - );Mucosal inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789292	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhagic stroke (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010789355	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010789368	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789369	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Unknown - );Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	DUOTRAV 40 MICROGRAMS/ML+ 5 MG/ML EYE DROPS SOLUTION [TIMOLOL, TRAVOPROST] (C - n/a - n/a - [n/a - 1[drp] - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 1[drp] - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 40mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 5mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 70mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 75mg - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[KETOROLAC TROMETAMOL] (C - n/a - n/a - [n/a - 1[drp] - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789394	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789424	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789429	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010789752	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (52d - Recovering/Resolving - );Petechiae (52d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010789768	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010789783	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010789788	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010789790	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789809	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (69d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010789810	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (27d - Not Recovered/Not Resolved - );Rash (27d - Not Recovered/Not Resolved - );Tinnitus (73d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010789812	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (27d - Not Recovered/Not Resolved - );Rash (27d - Not Recovered/Not Resolved - );Tinnitus (73d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010789822	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal pain (3d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Omphalitis (3d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789823	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypotonia (42d - Recovered/Resolved - );Injection site pain (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010789826	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (27d - Recovering/Resolving - );Pleural effusion (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010789831	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010789842	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789849	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010789886	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010789886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010790063	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010790076	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010790088	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790093	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	International normalised ratio abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010790099	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790111	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (107d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010790119	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (2min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010790228	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790326	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ALLOPURINOL] (C - n/a - n/a - )|[AMLODIPINE, RAMIPRIL] (C - n/a - n/a - )|[ATORVASTATIN] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010790482	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790509	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hypertension (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010790519	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010790575	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Disabling);Anosmia (n/a - Unknown - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010790579	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Heart rate irregular (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pulmonary function test decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010790628	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790759	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010790779	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Presyncope (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Antidepressant therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790789	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (27d - Not Recovered/Not Resolved - );Rash (27d - Not Recovered/Not Resolved - );Tinnitus (73d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010790792	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Hyperhidrosis (2d - Not Recovered/Not Resolved - );Paraesthesia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790797	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010790834	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010790838	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (49d - Not Recovered/Not Resolved - );Fatigue (51d - Not Recovered/Not Resolved - );Feeling hot (51d - Not Recovered/Not Resolved - );Headache (50d - Not Recovered/Not Resolved - );Limb discomfort (48d - Not Recovered/Not Resolved - );Malaise (51d - Not Recovered/Not Resolved - );Paraesthesia (51d - Not Recovered/Not Resolved - );Tachycardia (47d - Not Recovered/Not Resolved - );Vomiting (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010790841	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790846	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (29d - Unknown - Other Medically Important Condition);Myocarditis (29d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010790850	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790878	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010790888	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune neutropenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010790976	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010790980	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Carditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VENLAFAXINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010790980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010791309	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010791310	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Bedridden (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CITALOPRAM HYDROBROMIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010791332	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (3d - Recovered/Resolved - );Application site swelling (3d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Performance status decreased (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010791466	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010791546	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010791608	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010791664	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (2wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (2wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - );Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010791757	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010791763	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid ptosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sick leave (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010791941	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010791945	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - );Blindness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Tendon rupture (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[CEFACLOR, CEFACLOR MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXCARBAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010791951	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010791962	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Dizziness (n/a - Unknown - );Fibrin D dimer increased (n/a - Unknown - );Heart rate decreased (n/a - Unknown - );Hypotension (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Orthostatic hypotension (n/a - Unknown - );Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010791963	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[QUAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010791964	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature (3d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Delirium (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010791967	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vestibular neuronitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010791977	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Cardiac failure (n/a - Unknown - Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010791981	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Magnetic resonance imaging - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Magnetic resonance imaging - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010791984	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (0d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Influenza (3d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010791986	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - );Vaccination site warmth (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010791996	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Hyperventilation (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010791997	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Other Medically Important Condition);Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INCRUSE [UMECLIDINIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010791997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010792000	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MICARDIS [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Cerebral infarction - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])|[BENZBROMARONE] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792004	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - );Erectile dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792019	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cardiac arrest (n/a - Fatal - Results in Death);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Renal failure (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010792024	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792026	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Autoimmune haemolytic anaemia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemolysis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Jaundice (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ECULIZUMAB [ECULIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOBETASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010792027	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792035	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest discomfort (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Immune system disorder (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010792037	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792042	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Contusion (0d - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site bruising (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792046	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Tachycardia (6mo - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (6mo - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792063	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TECFIDERA [DIMETHYL FUMARATE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010792106	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Basal ganglia stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792179	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792182	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[METOPROLOL, METOPROLOL TARTRATE] (C - Blood pressure abnormal - n/a - [n/a - 25mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792184	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792186	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792190	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myelitis (28d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792194	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Constipation (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Enterocolitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Intestinal ulcer (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792197	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arthritis (n/a - Unknown - );Henoch-Schonlein purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - );Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792202	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792207	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure systolic increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Bundle branch block right (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation);Liver disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Adenine phosphoribosyl transferase deficiency - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792212	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Anxiety (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Throat tightness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792215	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010792231	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792241	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (18d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALENDRONATE SODIUM HYDRATE] (C - Osteoporosis prophylaxis - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Prophylaxis - n/a - [n/a - n/a - Oral])|[PREDNISOLONE] (C - Optic neuritis - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - Infection prophylaxis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792243	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (22min - Recovered/Resolved - Other Medically Important Condition);Anaphylactic reaction (22min - Recovered/Resolved - Other Medically Important Condition);Cyanosis (22min - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (22min - Recovered/Resolved - Other Medically Important Condition);Hypotension (22min - Recovered/Resolved - Other Medically Important Condition);Lip disorder (22min - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (22min - Recovered/Resolved - Other Medically Important Condition);Nausea (22min - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (22min - Recovered/Resolved - Other Medically Important Condition);Pallor (22min - Recovered/Resolved - Other Medically Important Condition);Shock (22min - Recovered/Resolved - Other Medically Important Condition);Tachycardia (22min - Recovered/Resolved - Other Medically Important Condition);Tachypnoea (22min - Recovered/Resolved - Other Medically Important Condition);Throat irritation (22min - Recovered/Resolved - Other Medically Important Condition);Throat tightness (22min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792249	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Intermenstrual bleeding (n/a - Recovered/Resolved - );Menstruation irregular (n/a - Recovered/Resolved - );Uterine haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792250	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792252	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myasthenia gravis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792253	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792259	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Erectile dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792260	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Fatal - Results in Death);Anxiety (n/a - Fatal - Results in Death);Cerebrovascular accident (n/a - Fatal - Results in Death, Other Medically Important Condition);Decreased appetite (n/a - Fatal - Results in Death);Depressed level of consciousness (n/a - Fatal - Results in Death);Lethargy (n/a - Fatal - Results in Death);Migraine (n/a - Fatal - Results in Death);Sepsis (n/a - Fatal - Results in Death);Tremor (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010792284	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792288	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792291	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792297	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (2d - Recovered/Resolved - );Syncope (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (3d - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792300	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Atrioventricular block (n/a - Unknown - );Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792301	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Constipation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gastrointestinal inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Intestinal ulcer (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792304	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac hypertrophy (n/a - Recovered/Resolved - );Cardiomegaly (n/a - Recovered/Resolved - );Chest pain (n/a - Unknown - );Electrocardiogram QT shortened (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792306	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Foetal hypokinesia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010792307	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Depression (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Glossodynia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lethargy (33d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myalgia (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Night sweats (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in jaw (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792308	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 50mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792372	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - Life Threatening);Back pain (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);General physical health deterioration (n/a - Unknown - Life Threatening);Heart rate increased (n/a - Unknown - Life Threatening);Muscular weakness (n/a - Unknown - Life Threatening);Palpitations (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [84d - n/a - n/a])	[ATENOLOL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TESTOSTERONE] (C - Androgen replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010792384	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site movement impairment (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792414	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792415	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792417	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Blood iron increased (n/a - Unknown - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Unknown - );Inflammation (n/a - Unknown - );Serum ferritin increased (n/a - Unknown - );Trunk injury (n/a - Recovered/Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010792419	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792421	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010792425	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792426	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792433	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain injury (n/a - Recovering/Resolving - Life Threatening);Carotid artery thrombosis (n/a - Recovering/Resolving - Life Threatening);Embolic stroke (n/a - Recovering/Resolving - Life Threatening);Hallucination, visual (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Vision blurred (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010792438	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Eczema (n/a - Recovered/Resolved - );Type IV hypersensitivity reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792440	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition);Rhabdomyolysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - 10mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 1.25mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 1.25mg - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 400mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792446	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792447	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Mitral valve incompetence (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792454	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Skin irritation (n/a - Recovering/Resolving - );Vaccination site mass (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - );Vaccination site vesicles (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792455	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Eczema (n/a - Recovered/Resolved - );Type IV hypersensitivity reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792457	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792458	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[BUDESONIDE, BUDESONIDE, MICRONISED] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792461	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - );Drug interaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Panic attack (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (I - n/a - Dose reduced - [n/a - 50mg - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 4mg - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010792524	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node palpable (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792562	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Eczema (n/a - Recovered/Resolved - );Type IV hypersensitivity reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792640	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010792643	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ischaemic cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010792653	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bronchospasm (n/a - Unknown - );Oedema (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Presyncope (n/a - Unknown - );Superficial vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010792664	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (8d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Feeling hot (8d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Joint swelling (1d - Not Recovered/Not Resolved - );Limb discomfort (8d - Not Recovered/Not Resolved - );Lymphangitis (1d - Not Recovered/Not Resolved - );Malaise (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792665	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (69d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010792670	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (16d - Recovered/Resolved With Sequelae - );Joint swelling (4d - Recovering/Resolving - );Limb discomfort (16d - Recovered/Resolved With Sequelae - );Myalgia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010792686	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792710	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792722	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Brachial pulse decreased (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Hypotension (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792758	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Malaise (6d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010792765	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (66d - Not Recovered/Not Resolved - );Asthenia (66d - Not Recovered/Not Resolved - );Limb discomfort (66d - Not Recovered/Not Resolved - );Movement disorder (66d - Not Recovered/Not Resolved - );Myalgia (66d - Not Recovered/Not Resolved - );Pain (66d - Not Recovered/Not Resolved - );Somnolence (66d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010792878	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792883	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792893	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792911	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010792995	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (7d - Recovered/Resolved - );Chest pain (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Tachycardia (7d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010792995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010793188	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Malaise (1s - Recovered/Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793256	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Thrombocytopenia (100d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - Unknown - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[BUMETANIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010793292	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abnormal dreams (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenopia (n/a - Recovering/Resolving - Other Medically Important Condition);Gait inability (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nightmare (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793303	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793307	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	ENTYVIO [VEDOLIZUMAB] (C - n/a - n/a - )|[MESALAZINE] (C - n/a - n/a - )|[OXCARBAZEPINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010793318	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793326	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793330	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793356	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (9d - Recovered/Resolved - );Vaccination failure (9d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793357	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiomyopathy (n/a - Recovered/Resolved With Sequelae - Life Threatening, Other Medically Important Condition);Ventricular fibrillation (n/a - Recovered/Resolved With Sequelae - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])|RIBAVIRIN [RIBAVIRIN] (S - n/a - n/a - [n/a - n/a - Oral])|[INTERFERON ALFA] (S - n/a - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010793427	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793464	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010793465	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010793466	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dehydration (0d - Recovered/Resolved - Other Medically Important Condition);Dysphoria (n/a - Recovered/Resolved - Other Medically Important Condition);Dysstasia (0d - Recovered/Resolved - Other Medically Important Condition);Injury associated with device (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010793476	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachypnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010793483	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Sudden death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010793484	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793487	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010793493	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (2h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010793504	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793579	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (66d - Fatal - Results in Death);Autonomic nervous system imbalance (66d - Fatal - Results in Death);Balance disorder (66d - Fatal - Results in Death);Bedridden (66d - Fatal - Results in Death);Central nervous system lesion (66d - Fatal - Results in Death);Cognitive disorder (66d - Fatal - Results in Death);Feeling abnormal (66d - Fatal - Results in Death);Motor dysfunction (66d - Fatal - Results in Death);Nervous system disorder (66d - Fatal - Results in Death);Prion disease (66d - Fatal - Results in Death);Skin disorder (66d - Fatal - Results in Death);Speech disorder (66d - Fatal - Results in Death);Spontaneous haematoma (66d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010793580	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010793596	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (10d - Fatal - Results in Death);Drug ineffective (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Off label use (n/a - Fatal - Results in Death);Product use issue (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Unknown])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	[GABAPENTIN] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])|[LANSOPRAZOLE] (C - Prophylaxis - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010793661	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010793664	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ANORO [UMECLIDINIUM BROMIDE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010793669	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793672	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Diastolic hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793695	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Cough (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793718	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nasal congestion (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793723	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793738	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cataract (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Glaucoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010793807	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793824	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793825	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010793934	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - );Erythema of eyelid (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793935	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - );Product confusion (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010793941	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010793968	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiovascular disorder (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793973	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Axillary pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010793979	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Syncope (2min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010793979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794016	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vitamin B12 deficiency (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794033	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Intermenstrual bleeding (n/a - Unknown - Other Medically Important Condition);Polymenorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010794034	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Asthenia (48h - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (48h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010794044	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010794046	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening);Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010794059	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Influenza like illness (5d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Lymph node pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Puncture site pain (n/a - Recovered/Resolved - );Reversed hot-cold sensation (3d - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794096	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794104	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794108	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010794117	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794119	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Vision blurred (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794121	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794124	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794130	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash macular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794133	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794137	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794138	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794162	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794163	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (2.5mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794184	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794187	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (2d - Recovered/Resolved - );Thirst (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794189	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coronary artery disease (0d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (1d - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010794193	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794210	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Infant	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794212	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794213	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794215	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794217	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Anxiety (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Cholestasis (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794218	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Hypertension - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794220	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794228	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[DESLORATADINE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794233	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794238	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (6wk - Not Recovered/Not Resolved - );Rash papular (6wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794243	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794245	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Eczema (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nasal dryness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794248	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794251	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Erythema (n/a - Recovering/Resolving - );Neuralgia (n/a - Recovering/Resolving - );Oedema peripheral (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794258	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794263	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794268	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794269	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794271	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (8d - Not Recovered/Not Resolved - );Musculoskeletal stiffness (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794272	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794291	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794293	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794304	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794309	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Recovered/Resolved - );Peripheral venous disease (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COAPROVEL 300 MG/25 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794311	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Insomnia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794315	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depressed mood (2wk - Recovering/Resolving - );Fatigue (2wk - Recovering/Resolving - );Headache (2wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794324	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Lymphadenitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794334	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794338	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794339	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in jaw (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794340	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794352	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794354	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794363	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794393	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794414	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794415	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Gastrooesophageal reflux disease (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794421	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794426	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794428	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Pollakiuria (n/a - Recovering/Resolving - );Polyuria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794432	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794439	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pustular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794453	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis chronic (3wk - Recovered/Resolved - );Tracheitis (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794459	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Faeces discoloured (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794463	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794469	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794471	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794473	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradycardia (n/a - Recovered/Resolved - );Chest discomfort (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794474	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794478	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794485	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794495	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794498	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794500	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (62d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010794505	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794507	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenopia (1d - Recovered/Resolved - );Immunisation reaction (2d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794510	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794513	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794519	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794520	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794527	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794537	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794538	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794543	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794548	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Joint ankylosis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794557	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cardiac arrest (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010794562	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovered/Resolved - );Anosmia (n/a - Recovered/Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Recovered/Resolved - );Oral pain (n/a - Not Recovered/Not Resolved - );Visual acuity reduced (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794564	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[EBASTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[RILMENIDINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794567	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794568	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - )|[LEVOMEPROMAZINE, LEVOMEPROMAZINE EMBONATE, LEVOMEPROMAZINE HYDROCHLORIDE, LEVOMEPROMAZINE MALEATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794589	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Bone pain (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Prostatitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794594	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794597	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoidal haemorrhage (n/a - Recovering/Resolving - );Haemorrhoids (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794601	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794603	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (1wk - Recovered/Resolved - );Ageusia (1wk - Recovered/Resolved - );Asthenia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794604	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794622	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Affective disorder (1d - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Gait disturbance (23d - Recovering/Resolving - );Hypertension (24d - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])|[PREDNISOLONE METASULFOBENZOATE SODIUM] (S - Sciatica - Drug withdrawn - [13d - 80mg - Oral])	CHENODEOXYCHOLIC ACID [CHENODEOXYCHOLIC ACID] (C - n/a - n/a - )|[ALLOPURINOL] (C - n/a - n/a - )|[FINASTERIDE] (C - n/a - n/a - [n/a - 5mg - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 25mg - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794626	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794704	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010794708	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - n/a - Intramuscular])	BUPRENORPHINE [BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794709	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794710	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794718	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010794721	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010794724	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardio-respiratory arrest (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular fibrillation (11d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intradermal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010794726	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010794754	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Delirium (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urinary retention (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794755	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794758	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - );Renal disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Spleen disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Splenic infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Splenic rupture (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - 80[iU] - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794764	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - Disabling);Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010794772	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Transaminases increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[IBUPROFEN] (S - Malaise - Drug withdrawn - [6d - 1{DF} - Oral])|[IBUPROFEN] (S - Malaise - Drug withdrawn - [7d - 3{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010794776	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (9mo - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010794778	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010794788	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794791	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [ADALIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|VIREAD 245 MG FILM-COATED TABLETS [TENOFOVIR DISOPROXIL, TENOFOVIR DISOPROXIL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010794793	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oligoarthritis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794805	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Congenital absence of cranial vault (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010794808	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Ophthalmic herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010794813	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794829	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Radiculopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010794843	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794848	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])|[A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794856	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sensorimotor disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Symptom recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [155d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794879	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	GANFORT [TIMOLOL MALEATE, BIMATOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN EMBONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010794892	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	LINAGLIPTIN [LINAGLIPTIN] (C - n/a - Not applicable - )|TELMISARTAN [TELMISARTAN] (C - n/a - Not applicable - )|[ACETYLSALICYLIC ACID] (C - n/a - Not applicable - )|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - Not applicable - )|[GLICLAZIDE] (C - n/a - Not applicable - )|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794922	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794955	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794957	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010794963	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794969	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (46d - Unknown - );Hypotonia (46d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010794971	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (10d - Unknown - );Tachycardia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794979	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010794983	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (46d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010794984	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010794991	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010794994	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Injection site reaction (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMOXICILLIN, AMOXICILLIN SODIUM, AMOXICILLIN TRIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010794994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010795013	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795042	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010795044	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 2{DF} - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010795149	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site oedema (n/a - Unknown - );Vaccination site rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795193	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Disabling);Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - Dose increased - [2y - .5{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010795281	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795296	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010795333	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Tooth abscess (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795336	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795341	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Vaccination site discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795347	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Papule (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795394	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Odynophagia (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - 1{DF} - Intramuscular])	[BILASTINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795403	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010795415	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebrovascular disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010795416	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010795417	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010795420	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypophagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Embolism arterial - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795428	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795430	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795433	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795444	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795445	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - 5mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795446	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (42d - Recovered/Resolved - Disabling);Arthritis reactive (42d - Recovered/Resolved - Disabling);Withdrawal syndrome (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010795450	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010795462	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010795476	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Lethargy (6d - Not Recovered/Not Resolved - );Myalgia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795496	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	CIMZIA [CERTOLIZUMAB PEGOL] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795582	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795605	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (72h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - )|[PARACETAMOL, CAFFEINE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE, ANHYDROUS CAFFEINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795629	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795636	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795645	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795648	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Miliaria (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795718	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Disabling, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (35d - Recovered/Resolved - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010795730	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010795731	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Heart rate decreased (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010795738	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Fatal - Results in Death);Arrhythmia (n/a - Unknown - Other Medically Important Condition);Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Fatal - Results in Death);Cyanosis (n/a - Fatal - Results in Death);Embolism (n/a - Fatal - Results in Death);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[DIMETHYL POLYSILOXANE (SILICONE ANTIFOAM AF9010), DIMETICONE] (C - Abdominal distension, Aerophagia - n/a - [n/a - n/a - Oral])|[ELOBIXIBAT HYDRATE] (C - Constipation - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FERRIC SODIUM CITRATE] (C - Iron deficiency anaemia - n/a - [n/a - n/a - Oral])|[PANCREATIN, AMYLASE] (C - Dyspepsia - n/a - [n/a - n/a - Oral])|[RIBOFLAVIN SODIUM PHOSPHATE, ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CHOLINE CHLORIDE, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, LEVOCARNITINE, MENATETRENONE, NICOTINAMIDE, TRICAPRILIN, CORN OIL, FISH OIL, INULIN, PYRIDOXINE HYDROCHLORIDE, TOCOPHERYL ACETATE, FURSULTIAMINE HYDROCHLORIDE, CASEIN, SODIUM SALT, MILK PROTEIN CONCENTRATE] (C - Malnutrition - n/a - [n/a - n/a - Oral])|[THYROID] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010795780	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Injection site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795785	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795871	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death);Inflammation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010795872	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Disabling);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[FELODIPINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010795938	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [5s - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010795941	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010795950	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site haematoma (n/a - Not Recovered/Not Resolved - );Vascular injury (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795952	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Eyelid disorder (n/a - Unknown - );Eyelid ptosis (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Migraine with aura (2d - Recovered/Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010795966	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Constipation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795968	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Rash macular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795974	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010795975	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Insomnia (4d - Recovered/Resolved - );Neuropathy peripheral (149d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[THIAMINE HYDROCHLORIDE, CYANOCOBALAMIN] (C - Nutritional supplementation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010795975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010796029	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010796042	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling abnormal (3wk - Recovered/Resolved - );Loss of libido (3wk - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Peyronie's disease (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796053	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haematemesis (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796055	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Rash pruritic (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010796056	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [17d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010796063	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796074	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010796087	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac flutter - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796089	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796097	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796109	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site bruising (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Respiratory disorder (n/a - Recovering/Resolving - );Skin disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010796181	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood immunoglobulin E increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pharyngeal swelling (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796215	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796219	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suicidal ideation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat tightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796220	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (52d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010796252	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796291	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Vaccination site hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796317	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796341	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796442	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796457	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796471	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796483	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796486	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010796558	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796562	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Genital infection fungal (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paronychia (n/a - Recovered/Resolved - Other Medically Important Condition);Tonsillar hypertrophy (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796616	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010796650	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010796693	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (n/a - Not Recovered/Not Resolved - Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Irritability (n/a - Not Recovered/Not Resolved - Disabling);Mood swings (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010796757	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Purpura (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010796819	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ACENOCOUMAROL] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[ACENOCOUMAROL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BIOFLAVONOIDS, DIOSMIN, BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, FLAVONOIDS EXTRACTED FROM RUTACAE (AURANTIAE), MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010796876	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010796876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797126	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Anosmia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010797141	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Unknown - Life Threatening, Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Poor peripheral circulation (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010797190	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010797192	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovering/Resolving - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797377	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Eczema (n/a - Recovered/Resolved - );Type IV hypersensitivity reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797442	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Unknown - );Application site reaction (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797448	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Troponin I increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	[MINOCYCLINE] (C - Acne - Not applicable - [9d - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010797503	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010797529	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010797594	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site erythema (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797618	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Haematochezia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797724	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[CEFIXIME, CEFIXIME TRIHYDRATE] (C - Urinary tract infection - n/a - [9d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797726	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Odynophagia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010797747	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (4d - Recovered/Resolved - );Dizziness (5d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797752	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pancytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Petechiae (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[AMLODIPINE, OLMESARTAN, OLMESARTAN MEDOXOMIL, AMLODIPINE] (C - n/a - n/a - )|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - n/a - n/a - )|[FINASTERIDE] (C - n/a - n/a - )|[METAMIZOLE] (C - n/a - n/a - )|[OMEPRAZOLE] (C - n/a - n/a - )|[SIMVASTATIN] (C - n/a - n/a - )|[THIAMINE HYDROCHLORIDE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010797755	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Autoimmune hypothyroidism - Dose not changed - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pyrexia - Unknown - [n/a - n/a - n/a])|[PUMPKIN SEED OIL] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[TOMATO] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Arthralgia - Dose not changed - [n/a - n/a - n/a])|[VITIS VINIFERA (GRAPE) FRUIT EXTRACT] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797759	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[MESALAZINE] (C - Colitis ulcerative - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010797764	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	BRINTELLIX 15 MG FILM-COATED TABLETS [VORTIOXETINE] (C - Anxiety - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797784	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - )|[DIAZEPAM, SULPIRIDE] (C - n/a - n/a - )|[OLANZAPINE] (C - n/a - n/a - )|[OMEPRAZOLE] (C - n/a - n/a - )|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010797785	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010797822	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797835	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010797850	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (n/a - Unknown - );COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797870	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797871	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010797874	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010797876	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010797881	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amaurosis fugax (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797884	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Non-cardiac chest pain (n/a - Recovering/Resolving - );Vaccination site hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797891	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])|[B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Drug withdrawn - [1d - n/a - n/a])	[DEFLAZACORT] (C - Psoriatic arthropathy - Dose not changed - [n/a - 6mg - Oral])|[METHOTREXATE] (C - Psoriatic arthropathy - Dose not changed - [n/a - 15mg - Oral])|[NABUMETONE] (C - Psoriatic arthropathy - n/a - [n/a - 1000mg - Oral])|[PANTOPRAZOLE] (C - Prophylaxis against gastrointestinal ulcer - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010797903	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[EBASTINE] (C - Rhinitis allergic - n/a - [3d - n/a - n/a])|[MOMETASONE FUROATE] (C - Rhinitis allergic - n/a - [3d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797921	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discharge (n/a - Recovering/Resolving - );Dysuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010797976	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010797976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010798021	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010798024	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspepsia (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Scrotal swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798040	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	SIFROL [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypometabolism - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Lung disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Bronchospasm - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010798173	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - );Product confusion (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010798282	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	CIRCADIN [MELATONIN] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Rhinitis allergic - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - Asthma - n/a - [5d - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010798286	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798287	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010798338	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798367	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010798371	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oral pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798383	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010798398	Spontaneous	2021-11-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010798527	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - );Ventricular extrasystoles (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[VALPROIC ACID] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010798557	Spontaneous	2021-11-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010798557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785322	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (93d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785326	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Conjunctivitis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785334	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785336	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Conjunctivitis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785339	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785343	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785347	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Diarrhoea (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785351	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (131d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785352	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Restlessness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785370	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785380	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785382	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myalgia (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785383	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Influenza (2d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785387	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785451	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785526	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	RIVAROXABAN [RIVAROXABAN] (S - Deep vein thrombosis - Unknown - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])|[PROPOFOL] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])	[PARACETAMOL] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010785553	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785625	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785627	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Amnesia (2wk - Not Recovered/Not Resolved - );Dizziness (2wk - Not Recovered/Not Resolved - );Headache (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785631	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785635	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785636	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785653	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785657	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785658	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - );Injection site erythema (1wk - Recovering/Resolving - );Injection site pruritus (1wk - Recovering/Resolving - );Vaccination site irritation (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785663	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785664	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785670	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785673	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785676	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785684	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785709	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010785720	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010785732	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785742	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785745	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785791	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785825	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspepsia (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Pollakiuria (n/a - Unknown - );Puncture site pain (n/a - Unknown - );Retching (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785828	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Malaise (9d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785838	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (111d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010785842	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785860	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785868	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785876	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785894	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (97d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010785895	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Injection site pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Personality change (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785896	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785897	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal pain (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785898	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (65d - Recovering/Resolving - );Dyspnoea (0d - Recovered/Resolved - );Fatigue (65d - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785899	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785906	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (4d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785915	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (4d - Recovering/Resolving - );Blood pressure decreased (4d - Recovering/Resolving - );Fatigue (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785916	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785920	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Neck pain (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010785921	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (20d - Recovered/Resolved - );Dizziness (21d - Recovered/Resolved - );Fatigue (21d - Recovered/Resolved - );Headache (21d - Recovered/Resolved - );Influenza (21d - Recovered/Resolved - );Injection site pain (22d - Recovered/Resolved - );Malaise (21d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010785922	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785940	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785972	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Claustrophobia (n/a - Recovered/Resolved - );Condition aggravated (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785996	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );General physical health deterioration (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010786010	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (36h - Recovered/Resolved - );Influenza like illness (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786029	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (24h - Recovered/Resolved - );Headache (24h - Recovered/Resolved - );Pain (24h - Recovered/Resolved - );Pain of skin (24h - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786052	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786057	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Blood pressure increased (19d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (19d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Coronary artery disease (19d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786061	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplegia (87d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786065	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (154d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786066	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786068	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Macular oedema (39d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786086	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (69d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786088	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Giant cell arteritis (34d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786091	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyelonephritis (214d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786094	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786095	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786102	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (n/a - Unknown - );Dysmenorrhoea (n/a - Unknown - );Heavy menstrual bleeding (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[MIDODRINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010786103	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786120	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hemiparesis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010786146	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786152	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786153	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Initial insomnia (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786154	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786155	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (40d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (40d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (33d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Upper respiratory tract infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786160	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010786164	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema nodosum (5wk - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (5wk - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786170	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rheumatoid arthritis (119d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786176	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	VIth nerve paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786189	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786190	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (33d - Recovered/Resolved - );Vision blurred (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010786194	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (92d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010786195	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786202	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786206	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786207	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786209	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nephritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786212	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786214	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786220	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis transverse (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786242	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	APROVEL 300 MG FILM-COATED TABLETS [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786273	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Derealisation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Head discomfort (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myocarditis (165d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Visual impairment (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[SUMATRIPTAN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010786305	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786316	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010786319	Spontaneous	2021-11-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[NOT AVAILABLE] (S - n/a - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010786321	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Nasopharyngitis (10d - Recovered/Resolved - Life Threatening);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (4d - Recovered/Resolved - Life Threatening);Vaccination site pain (11d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010786345	Spontaneous	2021-11-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Ear congestion (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Headache (8d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010786345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780061	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010780063	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780080	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010780116	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010780127	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780140	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780152	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Unknown - );Balance disorder (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NIET GESPECIFICEERD GENEESMIDDEL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010780183	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])|[ALFUZOSIN HYDROCHLORIDE] (S - Benign prostatic hyperplasia - Drug withdrawn - [n/a - n/a - Oral])	[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780200	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780209	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780267	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anger (n/a - Not Recovered/Not Resolved - );Behaviour disorder (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Nervousness (n/a - Not Recovered/Not Resolved - );Restlessness (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	OLANZAPINE [OLANZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780276	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780277	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Musculoskeletal chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010780307	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (10d - Recovered/Resolved - );Palpitations (10d - Recovered/Resolved - );Tachycardia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/60/2008, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008, B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008-LIKE VIRUS, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/DARWIN/6/2021, IVR-227), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED] (S - Immunisation - Not applicable - [n/a - 1{DF} - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010780331	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780347	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780406	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780407	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780440	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780452	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781778	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (3wk - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Pharyngitis (n/a - Recovering/Resolving - );Pyrexia (20d - Recovered/Resolved - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781800	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010781818	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781820	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781831	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781873	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781939	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral sensory neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010781945	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010781947	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ACETAZOLAMIDE, ACETAZOLAMIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[CINNARIZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010781955	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diabetes mellitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010782086	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Peripheral vascular disorder (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010782183	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Life Threatening);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010782193	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Lymphadenitis (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782202	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Autoimmune disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood fibrinogen increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Red blood cell sedimentation rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010782210	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (0d - Recovered/Resolved - );Periorbital swelling (0d - Recovered/Resolved - );Urticaria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782244	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782251	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tremor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010782338	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782369	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782395	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782406	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782426	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782453	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782460	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782469	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782482	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nasopharyngitis (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782493	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782496	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782504	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010782535	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782539	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ORENCIA [ABATACEPT] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782918	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782922	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782924	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782928	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Thirst (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010782976	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Unknown - );Chills (n/a - Unknown - );Eye pain (n/a - Unknown - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Neck pain (n/a - Unknown - );Pain in jaw (n/a - Unknown - );Pyrexia (n/a - Unknown - );Taste disorder (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010782976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783110	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783112	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783145	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783185	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783253	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783262	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783289	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783298	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ADVAGRAF [TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|OZEMPIC SOLUTION FOR INJECTION IN PRE-FILLED PEN [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783300	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783350	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|IMIQUIMOD [IMIQUIMOD] (S - Product used for unknown indication - Drug withdrawn - [n/a - 1{DF} - Topical])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010783354	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783399	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010783408	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (49d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	AVAMYS 27.5 MICROGRAMS/SPRAY NASAL SPRAY SUSPENSION [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783413	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Migraine with aura (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783416	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783475	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783506	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Puncture site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783517	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal discomfort (7d - Recovered/Resolved - );Gait disturbance (7d - Recovered/Resolved - );Joint stiffness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783521	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypotonia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783523	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783525	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783528	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783529	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Neuralgic amyotrophy (n/a - Unknown - );Orthopnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783532	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783535	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783544	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - );Ophthalmic herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783545	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783546	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic fatigue syndrome (30d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010783547	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783552	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783555	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783558	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783584	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783591	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783604	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783606	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783618	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783621	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783622	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783634	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783637	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783638	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783640	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783644	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783645	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783646	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783649	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783653	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783655	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783658	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783661	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783665	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783668	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783677	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783682	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783685	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Fatigue (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783691	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783692	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783693	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783699	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783701	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010783708	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783711	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Vascular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783721	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783738	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010783746	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Pollakiuria (n/a - Not Recovered/Not Resolved - );Puncture site pain (n/a - Not Recovered/Not Resolved - );Urinary straining (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783756	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783762	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye inflammation (80d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010783769	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (6d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Urinary incontinence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RED YEAST RICE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010783785	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783814	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783819	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Systolic hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - n/a - n/a - [n/a - n/a - n/a])|RILUZOLE 50MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010783829	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783843	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (9d - Recovering/Resolving - );Palpitations (9d - Recovering/Resolving - );Performance status decreased (9d - Recovering/Resolving - );Tachycardia (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783851	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye irritation (42d - Unknown - );Eye pruritus (42d - Unknown - );Fatigue (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010783858	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783866	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Hypotonia (2d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783873	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovering/Resolving - );Paraesthesia (0d - Recovering/Resolving - );Vaccination site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783874	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783875	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (12d - Recovered/Resolved - );Nasal congestion (12d - Recovered/Resolved - );Pain in extremity (12d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - );Respiratory distress (12d - Recovered/Resolved - );Vertigo (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783879	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (2d - Recovering/Resolving - );Angina pectoris (3d - Not Recovered/Not Resolved - );Dyspnoea (10d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (10d - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - );Urinary incontinence (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783907	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783911	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783914	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783916	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Restlessness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783937	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (15d - Recovering/Resolving - );Fatigue (15d - Recovering/Resolving - );Influenza like illness (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010783939	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (30d - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Disturbance in attention (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Intermenstrual bleeding (3d - Recovered/Resolved - );Limb discomfort (30d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Thinking abnormal (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010783945	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (44d - Not Recovered/Not Resolved - );Myalgia (44d - Not Recovered/Not Resolved - );Vaccination site pain (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010783957	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (16d - Not Recovered/Not Resolved - );Influenza like illness (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783970	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010783977	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010783977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784006	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Angioedema (62d - Recovering/Resolving - );Rash (62d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784017	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (37d - Not Recovered/Not Resolved - );Ear discomfort (37d - Not Recovered/Not Resolved - );Fatigue (38d - Not Recovered/Not Resolved - );Headache (37d - Not Recovered/Not Resolved - );Somnolence (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784090	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pruritus (1d - Not Recovered/Not Resolved - );Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Injection site pruritus (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Not Recovered/Not Resolved - );Nasal pruritus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784124	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784129	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periorbital swelling (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784134	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - );Vaccination site reaction (1d - Recovering/Resolving - );Vision blurred (0d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784151	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (5d - Not Recovered/Not Resolved - );Pyrexia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784155	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784157	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784159	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Injection site erythema (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Injection site swelling (2d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Nausea (3d - Not Recovered/Not Resolved - );Sleep disorder (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784165	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784189	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (28d - Recovering/Resolving - );Haematoma (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784201	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784206	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (3d - Recovered/Resolved - );Vaccination site joint warmth (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784210	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (27d - Not Recovered/Not Resolved - );Limb discomfort (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784215	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Recovered/Resolved - );Cerebrovascular accident (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Migraine (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784221	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Erythema (6d - Recovered/Resolved - );Oedema peripheral (6d - Recovered/Resolved - );Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784222	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784223	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784227	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Recovered/Resolved - );Swelling face (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784237	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - );Influenza like illness (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Paraesthesia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784240	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Haematochezia (1d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784245	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784249	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Influenza (5d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784253	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (22d - Unknown - );Rash (22d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784263	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784274	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Muscle twitching (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784280	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784281	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (7d - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784306	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (12d - Not Recovered/Not Resolved - );Hot flush (12d - Not Recovered/Not Resolved - );Insomnia (12d - Not Recovered/Not Resolved - );Malaise (12d - Not Recovered/Not Resolved - );Nausea (12d - Not Recovered/Not Resolved - );Paraesthesia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784307	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (42d - Recovered/Resolved - );Rash (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784309	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovering/Resolving - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784331	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784354	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (31d - Recovering/Resolving - );Rash (31d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784368	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784371	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784373	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovering/Resolving - );Paraesthesia (1d - Recovering/Resolving - );Pruritus (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784377	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (6d - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Pyrexia (6d - Recovered/Resolved With Sequelae - );Vasculitis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010784379	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784384	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Alopecia (23d - Recovered/Resolved With Sequelae - );Arrhythmia (22d - Recovered/Resolved With Sequelae - );Diarrhoea (23d - Recovered/Resolved With Sequelae - );Erectile dysfunction (23d - Recovered/Resolved With Sequelae - );Fatigue (24d - Recovered/Resolved With Sequelae - );Headache (24d - Recovered/Resolved With Sequelae - );Intestinal obstruction (23d - Recovered/Resolved With Sequelae - );Malaise (24d - Recovered/Resolved With Sequelae - );Myalgia (17d - Recovered/Resolved With Sequelae - );Nausea (22d - Recovered/Resolved With Sequelae - );Paraesthesia (21d - Recovered/Resolved With Sequelae - );Pyrexia (24d - Recovered/Resolved With Sequelae - );Tachycardia (24d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010784400	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (95d - Not Recovered/Not Resolved - );Rash (95d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784410	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784413	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (7d - Not Recovered/Not Resolved - );Fatigue (7d - Not Recovered/Not Resolved - );Insomnia (7d - Not Recovered/Not Resolved - );Limb discomfort (7d - Not Recovered/Not Resolved - );Malaise (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - );Night sweats (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784415	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - );Influenza like illness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784418	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784445	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (21d - Recovered/Resolved - );Limb discomfort (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784453	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovering/Resolving - );Pain in extremity (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784455	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovered/Resolved With Sequelae - );Vaccination site movement impairment (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010784468	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784473	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784474	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784476	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (42d - Recovering/Resolving - );Rash (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784485	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784489	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784509	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784521	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Feeling hot (3d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784524	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (31d - Not Recovered/Not Resolved - );Rash (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784531	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac discomfort (26d - Recovered/Resolved - );Fatigue (26d - Recovered/Resolved - );Headache (26d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784554	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry throat (16d - Recovered/Resolved - );Fatigue (16d - Recovered/Resolved - );Feeling hot (16d - Recovered/Resolved - );Vaccination site pain (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784572	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784598	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784605	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Not Recovered/Not Resolved - );Feeling hot (9d - Not Recovered/Not Resolved - );Hyperhidrosis (9d - Not Recovered/Not Resolved - );Pyrexia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784628	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784781	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784789	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (5d - Not Recovered/Not Resolved - );Fatigue (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784825	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784827	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (4wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010784829	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010784830	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784834	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784838	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784845	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (182d - Not Recovered/Not Resolved - );Joint swelling (182d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784846	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784849	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (20d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784850	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (16d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010784856	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (169d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrial fibrillation (169d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784857	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (159d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebral infarction (159d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784858	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784860	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010784861	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary oedema (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784863	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010784869	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myalgia (27d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Type 1 diabetes mellitus (20d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784874	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010784876	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pericardial effusion (5d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (5d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010784883	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010784885	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (66d - Not Recovered/Not Resolved - );Weight bearing difficulty (66d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784890	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784894	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784896	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010784902	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784904	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - );Dry throat (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784921	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784930	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784932	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Middle ear inflammation (n/a - Not Recovered/Not Resolved - );Noninfective myringitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784936	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (13d - Not Recovered/Not Resolved - );Chills (13d - Not Recovered/Not Resolved - );Dyspnoea (13d - Not Recovered/Not Resolved - );Neck pain (13d - Not Recovered/Not Resolved - );Renal pain (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784938	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Somnolence (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784946	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (6d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784958	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010784960	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Not Recovered/Not Resolved - );Dyspnoea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010784973	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010784996	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Not Recovered/Not Resolved - );Chest discomfort (3d - Not Recovered/Not Resolved - );Chest pain (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010784996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785001	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (77d - Not Recovered/Not Resolved - );Headache (77d - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Visual impairment (77d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010785005	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (16d - Not Recovered/Not Resolved - );Cough (6d - Recovered/Resolved - );Dyspnoea (5d - Recovered/Resolved - );Fatigue (9d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Influenza (9d - Recovering/Resolving - );Paraesthesia (0d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785008	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (8d - Not Recovered/Not Resolved - );Injection site swelling (13d - Unknown - );Paraesthesia (11d - Unknown - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785048	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785060	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785076	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785081	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Not Recovered/Not Resolved - );Tinnitus (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785091	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure decreased (4d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785103	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010785105	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785108	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Diarrhoea (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785114	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (50d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Chest discomfort (16d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785120	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010785138	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785142	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785147	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785158	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Pain in extremity (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785182	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Insomnia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785189	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (36h - Recovered/Resolved - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785195	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785214	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785217	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785224	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785226	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785227	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785252	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785256	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785266	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785267	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785268	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785271	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785276	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785278	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785279	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785283	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Genital rash (n/a - Not Recovered/Not Resolved - );Tonsillar hypertrophy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010785285	Spontaneous	2021-11-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (2d - Recovered/Resolved - );Arthralgia (2d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Muscle spasms (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010785288	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785292	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785297	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010785309	Spontaneous	2021-11-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angiopathy (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arrhythmia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiac failure (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiomyopathy (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Coronary artery disease (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010785309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767920	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767973	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Bone pain (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768004	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010768027	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010768060	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved With Sequelae - );Bone pain (n/a - Recovered/Resolved With Sequelae - );Diarrhoea (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - );Somnolence (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010768062	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768078	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768108	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovering/Resolving - );Hemiparaesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768163	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768222	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Cerebrovascular accident (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Speech disorder (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010768223	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010769438	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010769457	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Epilepsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769483	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Haemoptysis (n/a - Unknown - );Lung disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010769535	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769541	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769543	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769572	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769582	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769605	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769615	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dysentery (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769642	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769645	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769648	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769651	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769660	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769662	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Oxygen saturation decreased (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010769666	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769672	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Recovered/Resolved - );Diplopia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769674	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010769681	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1M[iU] - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769707	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[SIMVASTATIN, EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769709	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769712	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769744	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopathy (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010769748	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumothorax (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769750	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mg/kg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769751	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010769766	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - );Underimmunisation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769768	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Irritability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010769772	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769799	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769808	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769810	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Crying (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769828	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Aphthous ulcer (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Oral herpes (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769844	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Life Threatening);Atrioventricular block (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010769856	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010769864	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[BETAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769882	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010769900	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769907	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769908	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769923	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769930	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769958	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Myoglobin blood increased (n/a - Unknown - Other Medically Important Condition);Myositis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010769979	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Skin reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	MIRAPEXIN [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - 300mg - Oral])|[THIOCOLCHICOSIDE, THIOCOLCHICOSIDE, ESCIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010769980	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pharyngeal oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010769982	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - Other Medically Important Condition);Superficial vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010769983	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010769983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010770004	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010770020	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010770036	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cognitive disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010770037	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Retching (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770041	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770048	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Epstein-Barr virus infection (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Injection site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010770054	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770065	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amaurosis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010770066	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770067	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010770068	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770070	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770089	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010770101	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Decreased activity (n/a - Fatal - Results in Death);Hyporeflexia (n/a - Fatal - Results in Death);Sopor (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[CLOZAPINE] (S - Depression - Dose not changed - [n/a - 300mg - Oral])|[METFORMIN HYDROCHLORIDE] (S - Diabetes mellitus - n/a - [n/a - 1000mg - Oral])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (S - n/a - Dose not changed - [n/a - 1500mg - Oral])	[FLUPHENAZINE DECANOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010770108	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Cardiac disorder (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010770118	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770128	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010770137	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010770154	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - );Deafness unilateral (n/a - Unknown - Other Medically Important Condition);Kearns-Sayre syndrome (n/a - Unknown - );Narcolepsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010770163	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010770269	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770783	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemiplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010770797	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - );Psoriatic arthropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010770803	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010770810	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Gastritis (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Mobility decreased (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010770973	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010770981	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010770981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010771115	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010771130	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771246	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [n/a - .5mL - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|TRAVOPROST [TRAVOPROST] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[ATORVASTATIN CALCIUM] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[MESALAZINE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[OMEPRAZOLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[TIMOLOL, TIMOLOL MALEATE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010771285	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771307	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771323	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771331	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Unknown - Other Medically Important Condition);Epistaxis (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Swollen tongue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771352	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771353	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Amphetamines positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771358	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Hyperventilation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771359	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site nerve damage (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771361	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Breast pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771362	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771394	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tunnel vision (0d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (0d - Recovered/Resolved - Other Medically Important Condition);Vitreous floaters (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771426	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010771445	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site bruising (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771446	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771447	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010771634	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Eye pain (n/a - Not Recovered/Not Resolved - Disabling);Eye pruritus (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	AZARGA [BRINZOLAMIDE, TIMOLOL, TIMOLOL MALEATE, BRINZOLAMIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|LUMIGAN [BIMATOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010771684	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (1mo - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - );Speech disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Subcutaneous])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - 5mg - n/a])|[HYPROMELLOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 4mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - n/a])|[TIMOLOL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010771695	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (2d - Recovered/Resolved - Other Medically Important Condition);Flushing (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Tremor (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010771784	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Limb mass (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010771850	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010771862	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin warm (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010771866	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic stenosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Bone pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Haemoptysis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Mitral valve incompetence (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Tricuspid valve disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010771868	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuromyelitis optica spectrum disorder (3mo - Recovering/Resolving - Caused/Prolonged Hospitalisation);Optic neuritis (3mo - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urinary retention (114d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010771888	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coronary artery thrombosis (0d - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Myocardial ischaemia (0d - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010771928	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010771928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772096	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (6h - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772159	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Cardiac failure acute (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ENTRESTO [SACUBITRIL VALSARTAN SODIUM HYDRATE, VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ACENOCOUMAROL] (C - n/a - n/a - [n/a - 4mg - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - 40mg - Oral])|[POTASSIUM HYDROGEN CARBONATE, CITRIC ACID ANHYDROUS, POTASSIUM CITRATE, POTASSIUM HYDROGEN CARBONATE, POTASSIUM CITRATE PH. EUR., CITRIC ACID, POTASSIUM HYDROGEN CARBONATE, POTASSIUM CITRATE, CITRIC ACID] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 25mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010772184	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772192	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772196	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772197	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772199	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772205	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening);Pyrexia (n/a - Unknown - );Troponin increased (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010772268	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fibrosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hospitalisation (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010772327	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772330	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Anosmia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772427	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772432	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772434	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772436	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772438	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772440	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772441	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772444	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772466	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772543	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovering/Resolving - );Arthralgia (1d - Recovering/Resolving - );Body temperature increased (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772549	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	OFEV [NINTEDANIB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772560	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772562	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772572	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772580	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (90d - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Unknown - );Hypokinesia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (90d - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010772593	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010772653	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Sick relative (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772654	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772667	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cluster headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772668	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772680	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772683	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial injury (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010772685	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMINAPHTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772690	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Platelet count abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772692	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772705	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772709	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL BP, DIPHENHYDRAMINE HYDROCHLORIDE BP, CAFFEINE BP, PHENYLEPHRINE HYDROCHLORIDE BP, CODEINE PHOSPHATE BP] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772710	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010772714	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal pain upper (2d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RITUXIMAB [RITUXIMAB] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Sjogren's syndrome - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772715	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772720	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772721	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Product administered to patient of inappropriate age (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772740	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Aphasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Delirium (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Paramnesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010772752	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772760	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772761	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772763	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010772765	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Gout (n/a - Recovering/Resolving - );Joint swelling (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772767	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772790	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772796	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010772887	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010772888	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772892	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010772893	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010772893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773136	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010773165	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Palatal oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pharyngeal oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tongue oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010773192	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773195	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773203	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773206	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773208	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773214	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773218	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773326	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (3d - Recovered/Resolved - );Chest discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010773327	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (9d - Unknown - Other Medically Important Condition);Bone pain (9d - Unknown - );Myalgia (9d - Unknown - );Pyrexia (9d - Unknown - );Vaccination site pain (9d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - Nasal])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[MONTELUKAST] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773331	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovered/Resolved - );Anosmia (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010773348	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Injection site reaction (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010773405	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - );Heart rate increased (n/a - Unknown - );Hypertension (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )|[DOCONEXENT, ICOSAPENT, FISH OIL, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010773410	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hospitalisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010773415	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010773445	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site paraesthesia (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (1h - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010773483	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010773489	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Abnormal faeces (n/a - Unknown - );Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773563	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (n/a - Unknown - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010773591	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773594	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773597	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773598	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773605	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773608	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773609	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773615	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773618	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Intensive care (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - );Myocarditis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010773647	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010773792	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010773794	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010773800	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773801	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010773838	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010773859	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Amaurosis fugax (0d - Recovered/Resolved - Other Medically Important Condition);Blindness transient (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773862	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773863	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (5h - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773865	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Joint swelling (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010773871	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALFUZOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773881	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773896	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773898	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010773902	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vitiligo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773942	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Oxygen saturation decreased (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010773945	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773954	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773972	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773973	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773978	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773980	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010773981	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Headache (n/a - Recovered/Resolved With Sequelae - Disabling);Nausea (n/a - Recovered/Resolved With Sequelae - Disabling);Vaccination site haematoma (n/a - Recovered/Resolved With Sequelae - Disabling);Vomiting (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010773992	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Unknown - Life Threatening);Asthenia (n/a - Unknown - Life Threatening);Blood pressure fluctuation (n/a - Unknown - Life Threatening);Cardiovascular symptom (n/a - Unknown - Life Threatening);Chest discomfort (n/a - Unknown - Life Threatening);Headache (n/a - Unknown - Life Threatening);Hypoaesthesia (n/a - Unknown - Life Threatening);Malaise (n/a - Unknown - Life Threatening);Tinnitus (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010773992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010774019	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - );Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774020	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010774021	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (7d - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUENZ TETRA [A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE STRAIN (A/HAWAII/66/2019, MEDI 326775), A/HONG KONG/2671/2019 (H3N2) - LIKE STRAIN (A/HONG KONG/2671/2019, MEDI 325078), B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, MEDI 306444), B/WASHINGTON/02/2019 - LIKE STRAIN (B/WASHINGTON/02/2019, MEDI 323797), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, MEDI 237514), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, MEDI 228029), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/BOLIVIA/559/2013, MEDI 255962), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/NEW CALEDONIA/71/2014, MEDI 263122), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/MICHIGAN/45/2015 (H1N1)PDM09 - LIKE STRAIN (A/SLOVENIA/2903/2015, MEDI 279432), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, MEDI 291690), B/COLORADO/06/2017-LIKE STRAIN (B/COLORADO/06/2017, MEDI 293454)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774025	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774028	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010774030	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010774032	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010774035	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774042	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010774043	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010774048	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - Other Medically Important Condition);Blood creatinine decreased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Chapped lips (5d - Recovered/Resolved - );Head discomfort (n/a - Unknown - );Hyperthermia (48d - Recovered/Resolved - Other Medically Important Condition);Inflammation (n/a - Unknown - );Monocyte count increased (n/a - Unknown - );Neck pain (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition);Stomatitis (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010774049	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774095	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Condition aggravated (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (92d - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - Disabling, Other Medically Important Condition);Lyme disease (n/a - Unknown - Disabling, Other Medically Important Condition);Lymphadenopathy (92d - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Urticarial vasculitis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010774099	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010774100	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine with aura (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (12h - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010774104	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Stress (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Gastric ulcer - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastric ulcer - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010774107	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Anosmia (n/a - Unknown - Other Medically Important Condition);Body temperature abnormal (n/a - Unknown - Other Medically Important Condition);COVID-19 (25d - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Drug ineffective (25d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Joint noise (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Sinusitis (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010774280	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	IIIrd nerve paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010774288	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774289	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Ill-defined disorder (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Retching (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010774296	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Retinal artery occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010774324	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	APROVEL 300 MG FILM-COATED TABLETS [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010774393	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Caused/Prolonged Hospitalisation);Anosmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyschromatopsia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - );Monoplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - );Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010774402	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Recovered/Resolved - );Vasculitis (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774445	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774446	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774448	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774458	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774460	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774464	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774465	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774466	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774469	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774535	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (4d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010774707	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	0-1 Month	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010774713	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Loss of employment (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010774821	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774828	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010774909	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010774942	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Autoimmune neuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 immunisation (n/a - Unknown - );Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diplopia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysphonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait inability (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Grip strength decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia oral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyporeflexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Unknown - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urinary retention (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccine positive rechallenge (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010774942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775020	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010775045	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775061	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Back pain (3h - Recovered/Resolved - );Chest pain (3h - Recovered/Resolved - );Headache (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (3h - Recovered/Resolved - );Slow response to stimuli (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775219	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (24h - Recovered/Resolved - );Dyspnoea (24h - Recovered/Resolved - );Fatigue (24h - Recovered/Resolved - );Pain in extremity (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010775238	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (35d - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010775240	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[COLESTIPOL, COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE BP] (C - Crohn's disease - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775383	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abdominal pain (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dry skin (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Formication (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pollakiuria (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010775537	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (36d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775541	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site swelling (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Defaecation urgency (n/a - Recovered/Resolved - );Restlessness (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010775624	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balanoposthitis (47d - Not Recovered/Not Resolved - Life Threatening);COVID-19 (47d - Not Recovered/Not Resolved - Life Threatening);Infectious mononucleosis (47d - Not Recovered/Not Resolved - Life Threatening);Stomatitis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010775634	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Foetal exposure during pregnancy (n/a - Unknown - Disabling, Congenital Anomaly);Trisomy 21 (n/a - Unknown - Disabling, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010775662	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775702	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle tightness (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Toothache (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775711	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775725	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775726	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009] (C - n/a - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775747	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010775773	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775774	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775783	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling);Tonsillolith (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[PROPIOMAZINE, PROPIOMAZINE MALEATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010775794	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovered/Resolved - );Eye pain (14d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - );Hypoaesthesia (14d - Not Recovered/Not Resolved - );Nausea (14d - Not Recovered/Not Resolved - );Vertigo (14d - Not Recovered/Not Resolved - );Vestibular disorder (14d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	NOVORAPID [INSULIN ASPART] (C - n/a - Not applicable - )|[CARVEDILOL] (C - n/a - Not applicable - )|[INSULIN GLARGINE] (C - n/a - Not applicable - )|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - )|[RAMIPRIL] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775805	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775820	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010775856	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAMETHASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOBETASOL PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPYLENE GLYCOL, LACTIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010775869	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010775913	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010775973	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Throat irritation (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010775973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010776020	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010776052	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])|[INFLUENZA VIRUS] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010776177	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010776178	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epididymitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776180	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain lower (n/a - Unknown - );Burning sensation (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010776216	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Circulatory collapse (n/a - Fatal - Results in Death);Pulmonary embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])|[ENOXAPARIN] (I - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010776227	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776250	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776252	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776254	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Myalgia intercostal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776269	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776271	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haematoma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Head discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776274	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776275	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776277	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ageusia (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersomnia (n/a - Not Recovered/Not Resolved - );Nasal congestion (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nasopharyngitis (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Upper respiratory tract congestion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776279	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776284	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776289	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776305	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776309	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776322	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthma (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Hallucination (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776323	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776332	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776339	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovered/Resolved - );Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovering/Resolving - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776340	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776348	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypokinesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Shoulder injury related to vaccine administration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776357	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010776361	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - );Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776364	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776365	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Muscle oedema (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010776368	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Body temperature abnormal (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Viral infection (n/a - Recovering/Resolving - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776379	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Faeces discoloured (n/a - Unknown - Other Medically Important Condition);Gastrointestinal haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Haematemesis (n/a - Unknown - Other Medically Important Condition);Shock haemorrhagic (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010776402	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Malaise (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010776409	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010776412	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010776506	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - Varicose vein - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776623	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776641	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010776663	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (3d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (3d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010776667	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010776695	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776698	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - 60mg - n/a])|JARDIANCE 10 MG FILM-COATED TABLETS [EMPAGLIFLOZIN] (C - n/a - Not applicable - [n/a - 10mg - n/a])|NOVORAPID 100 U/ML [INSULIN ASPART] (C - n/a - Not applicable - [n/a - 4[iU] - n/a])|PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - n/a - Not applicable - [n/a - 75mg - n/a])|TOUJEO [INSULIN GLARGINE] (C - n/a - Not applicable - [n/a - 26[iU] - n/a])|TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - Not applicable - [n/a - 5mg - n/a])|[ATORVASTATIN] (C - n/a - Not applicable - [n/a - 10mg - n/a])|[GABAPENTIN] (C - n/a - Not applicable - [n/a - 300mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - [n/a - 500mg - n/a])|[METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 100mg - n/a])|[NAFTIDROFURYL OXALATE] (C - n/a - Not applicable - [n/a - 200mg - n/a])|[RAMIPRIL] (C - n/a - Not applicable - [n/a - 2.5mg - n/a])|[TORASEMIDE] (C - n/a - Not applicable - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010776709	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776771	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature fluctuation (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010776802	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage subcutaneous (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010776803	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (5mo - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010776917	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776919	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[DISODIUM HYDROGEN CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYLEPHRINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010776950	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Shock (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776955	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010776960	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pancreatitis acute (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010776966	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Mental disorder - n/a - [n/a - n/a - n/a])|OLANZAPINE [OLANZAPINE] (C - Mental disorder - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010776966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010777174	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777178	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777179	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777189	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site joint pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777191	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777193	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777197	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777206	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777210	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777213	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777214	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (5h - Recovered/Resolved - );Pyrexia (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777221	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Balance disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777223	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777226	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777229	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ulnar tunnel syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777240	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777248	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777249	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777250	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (2d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777251	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777252	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777255	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777256	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777258	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777260	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777262	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777263	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777266	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777268	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777273	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777274	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777277	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[PARACETAMOL] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777279	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Joint swelling (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777280	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777286	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777287	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777291	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777292	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Blood creatine phosphokinase increased (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - Renal transplant - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - n/a])|[CICLOSPORIN] (C - Renal transplant - n/a - [n/a - n/a - n/a])|[FLUINDIONE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777294	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Synovial cyst (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777299	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777301	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777304	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Orchitis noninfective (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777314	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777322	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disorientation (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777331	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777336	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - Cardiovascular event prophylaxis - Unknown - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - Supraventricular tachycardia - Unknown - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - Hypercholesterolaemia - Unknown - [n/a - n/a - n/a])|[RAMIPRIL] (C - Cardiovascular event prophylaxis, Hypertension - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777340	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777351	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777361	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777365	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777372	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777377	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777379	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777383	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777385	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777386	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [218d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777393	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Allergy to arthropod sting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777394	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Syncope (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777395	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ligament pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777396	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Oedema peripheral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777398	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777402	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (6d - Recovered/Resolved - );Decreased appetite (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777406	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777408	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777411	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777419	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Lip oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777422	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777423	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Generalised oedema (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777434	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (4d - Recovered/Resolved - );Dyspnoea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777438	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (93d - Recovered/Resolved - );Insomnia (93d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[CANNABIS] (C - n/a - n/a - )|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010777441	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (29d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (29d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - Not applicable - [n/a - 5mg - n/a])|[ACETYLSALICYLIC ACID, MAGNESIUM OXIDE] (C - n/a - Not applicable - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - Not applicable - [n/a - 40mg - n/a])|[FOSINOPRIL SODIUM] (C - n/a - Not applicable - [n/a - 20mg - n/a])|[GLICLAZIDE] (C - n/a - Not applicable - [n/a - 120mg - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - Not applicable - [n/a - 60mg - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - 10mg - n/a])|[LEVOTHYROXINE SODIUM, HYDRATE] (C - n/a - Not applicable - [n/a - 100ug - n/a])|[METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 50mg - n/a])|[NAFTIDROFURYL OXALATE] (C - n/a - Not applicable - [n/a - 200mg - n/a])|[NIFEDIPINE] (C - n/a - Not applicable - [n/a - 10mg - n/a])|[SPIRONOLACTONE] (C - n/a - Not applicable - [n/a - 25mg - n/a])|[TROSPIUM CHLORIDE] (C - n/a - Not applicable - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010777474	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Negative thoughts (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CLONAZEPAM] (C - n/a - n/a - )|[DOPAMINE] (C - n/a - n/a - )|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - )|[VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010777637	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777650	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777651	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777664	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthropathy (n/a - Not Recovered/Not Resolved - );Myalgia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010777700	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety disorder (186d - Not Recovered/Not Resolved - );Arrhythmia (186d - Not Recovered/Not Resolved - );Axillary pain (186d - Not Recovered/Not Resolved - );Back pain (186d - Not Recovered/Not Resolved - );Dyspnoea (186d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010777861	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010777867	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010777868	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010777871	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010777877	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Brain fog (n/a - Unknown - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Disabling, Other Medically Important Condition);Enuresis (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Immune system disorder (n/a - Unknown - );Influenza like illness (n/a - Unknown - Disabling, Other Medically Important Condition);Vomiting (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010777880	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrioventricular block complete (n/a - Unknown - Caused/Prolonged Hospitalisation);Autonomic neuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Bladder dilatation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase MB increased (n/a - Unknown - );Body temperature increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Catecholamines urine increased (n/a - Unknown - );Initial insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Stress cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Unknown - );Urinary retention (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinoma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular hypokinesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[FOLIC ACID] (C - Mitochondrial cytopathy - n/a - [n/a - 5mg - Oral])|[FURSULTIAMINE] (C - Mitochondrial cytopathy - n/a - [n/a - n/a - Oral])|[HYDROCORTISONE] (C - Adrenal insufficiency - n/a - [n/a - n/a - Oral])|[LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[LEVOCARNITINE] (C - Mitochondrial cytopathy - n/a - [n/a - n/a - Oral])|[UBIDECARENONE] (C - Mitochondrial cytopathy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010777888	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Recovering/Resolving - Disabling);Chest pain (n/a - Recovered/Resolved With Sequelae - Disabling);Cold sweat (n/a - Recovering/Resolving - Disabling);Heart rate increased (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Pain (n/a - Unknown - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Tremor (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010777890	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010777899	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cyanosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010777909	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010777995	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010777996	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010777996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778000	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778001	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Coarctation of the aorta (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Mitral valve atresia (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Ventricular hypoplasia (n/a - Not Recovered/Not Resolved - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010778006	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Thyroiditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778013	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778014	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778021	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatic disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778031	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anuria (n/a - Recovered/Resolved - );Condition aggravated (22d - Recovered/Resolved - );Petit mal epilepsy (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778045	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Respiratory distress (0h - Fatal - Results in Death);Vasodilatation (0h - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010778050	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - )|ENTRESTO 49 MG/51 MG FILM-COATED TABLETS [VALSARTAN, SACUBITRIL] (C - n/a - n/a - )|HUMALOG [INSULIN LISPRO] (C - n/a - n/a - )|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|REPAGLINIDE [REPAGLINIDE] (C - n/a - n/a - )|[ALLOPURINOL] (C - n/a - n/a - )|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[COLCHICINE] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )|[DIGOXIN] (C - n/a - n/a - )|[DUTASTERIDE] (C - n/a - n/a - )|[INSULIN HUMAN] (C - n/a - n/a - )|[MACROGOL 3350] (C - n/a - n/a - )|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - )|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - )|[ZOPICLONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010778055	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Retinal artery occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778063	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778064	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhabdomyolysis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778072	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778074	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778078	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bradycardia (5h - Recovered/Resolved - Other Medically Important Condition);Confusional state (5h - Recovered/Resolved - Other Medically Important Condition);Fall (5h - Recovered/Resolved - Other Medically Important Condition);Hypotension (5h - Recovered/Resolved - Other Medically Important Condition);Malaise (5h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778085	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (3wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778086	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sinus bradycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|[BISOPROLOL FUMARATE, PERINDOPRIL ARGININE] (S - Myocardial ischaemia - Drug withdrawn - [30d - 1{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778106	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertension (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778125	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778135	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lung disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])|[METHOTREXATE] (S - Rheumatoid arthritis - Dose not changed - [n/a - 3{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778139	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778140	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypothermia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Photophobia (36h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778145	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778146	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010778150	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (24h - Recovered/Resolved - Other Medically Important Condition);Vomiting (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778151	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010778164	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Nephrotic syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[CICLOSPORIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778174	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778185	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778191	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Feeling cold (4d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778223	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (3mo - Unknown - );Asthenia (3mo - Unknown - );Chills (4h - Recovered/Resolved - );Facial nerve disorder (4h - Recovered/Resolved - );Muscular weakness (4h - Recovered/Resolved - );Myalgia (3mo - Unknown - );Paraesthesia (3mo - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778228	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial septal defect (n/a - Unknown - );Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Left-to-right cardiac shunt (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778305	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lung adenocarcinoma recurrent (n/a - Recovered/Resolved With Sequelae - Life Threatening);Neurone-specific enolase increased (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 75mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Dose not changed - [n/a - 50mg - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 10mg - n/a])|[COLECALCIFEROL] (C - n/a - Dose not changed - [n/a - 80[drp] - n/a])|[DOMPERIDONE, DOMPERIDONE MALEATE] (C - n/a - Dose not changed - [n/a - 10mg - n/a])|[FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE, FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE MONOHYDRATE] (C - n/a - Dose not changed - [n/a - 2{DF} - n/a])|[MAGNESIUM, MAGNESIUM L-GLUTAMATE TETRAHYDRATE, MAGNESIUM CITRATE NONAHYDRATE] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[METAMIZOLE SODIUM, METAMIZOLE SODIUM MONOHYDRATE] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[PANTOPRAZOLE SODIUM] (C - n/a - Dose not changed - [n/a - 40mg - n/a])|[PARACETAMOL] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[TRIAZOLAM] (C - n/a - Dose not changed - [n/a - .25mg - n/a])|[ZOLPIDEM TARTRATE] (C - n/a - Dose not changed - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010778335	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Hypoaesthesia (1d - Recovered/Resolved - );Peripheral swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778360	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778455	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778459	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Glomerular filtration rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Psoriasis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[BENZATHINE BENZYLPENICILLIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778465	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778469	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778472	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778475	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (6d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778477	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site induration (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (1h - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010778558	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abscess of salivary gland (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [3s - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778586	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	LCA, E.. Reported adverse effects following COVID-19 vaccination at a tertiary care hospital, focus on cerebral venous sinus thrombosis (CVST). Expert-Rev-Vaccine. 2021;20(8):1037-1042	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778589	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Injection site movement impairment (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010778590	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Underdown, M.. Thrombocytopenia in a teen with sickle cell disease following COVID-19 vaccination. Pediatric Blood and Cancer. 2021;68(12):10.1002/pbc.29271. doi:10.1002/pbc.29271	12-17 Years	Not Specified	No	Male	Sickle cell anaemia with crisis (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778605	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (10d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010778606	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bursitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010778614	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010778616	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CYCLOBENZAPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RIBOFLAVIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010778616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779087	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Nerve injury (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010779098	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hallucination (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Incoherent (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779115	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779118	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779120	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Jaundice neonatal (n/a - Recovered/Resolved - );Maternal exposure during pregnancy (n/a - Recovered/Resolved - Other Medically Important Condition);Premature baby (n/a - Recovered/Resolved - Other Medically Important Condition);Urine sodium abnormal (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [32d - 10mL - Transplacental])|[AMOXICILLIN SODIUM, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID] (C - n/a - n/a - [14d - 3g - Transplacental])|[ECONAZOLE NITRATE] (C - n/a - n/a - [3d - 450mg - Transplacental])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Transplacental])|[PHLOROGLUCINOL DIHYDRATE, PHLOROGLUCINOL, TRIMETHYLPHLOROGLUCINOL, TRIMETHYLPHLOROGLUCINOL, PHLOROGLUCINOL DIHYDRATE] (C - n/a - n/a - [1mo - 2{DF} - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779127	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (25d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Angina unstable - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - Angina unstable - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010779154	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779173	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood immunoglobulin E increased (n/a - Unknown - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eosinophil count increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Glomerulonephritis rapidly progressive (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity vasculitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Protein urine present (n/a - Unknown - Caused/Prolonged Hospitalisation);Purpura (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Total complement activity increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779174	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - 5mg - Oral])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779185	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Insomnia (5d - Recovered/Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[THIAMINE HYDROCHLORIDE, CYANOCOBALAMIN] (C - Nutritional supplementation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779186	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Disabling);Arthralgia (n/a - Recovering/Resolving - Disabling);Back pain (n/a - Recovering/Resolving - Disabling);Hemiparaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Skin burning sensation (n/a - Recovering/Resolving - Disabling);Vision blurred (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010779190	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779192	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Life Threatening);COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening);COVID-19 pneumonia (n/a - Unknown - Life Threatening);Decreased appetite (n/a - Unknown - Life Threatening);Drug ineffective (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Heart rate increased (n/a - Unknown - Life Threatening);Hypophagia (n/a - Unknown - Life Threatening);Malaise (n/a - Unknown - Life Threatening);Oxygen saturation decreased (n/a - Unknown - Life Threatening);Pyrexia (n/a - Unknown - Life Threatening);Respiratory rate increased (n/a - Unknown - Life Threatening);Somnolence (n/a - Recovered/Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010779198	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779203	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	No adverse event (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010779212	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Dystonia (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779214	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TELMISARTAN [TELMISARTAN] (C - Essential hypertension - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Type IIa hyperlipidaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779225	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Unknown - Disabling);Immunisation (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010779228	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diaphragmalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Pain in extremity - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Bone pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779369	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010779371	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010779406	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Back pain (n/a - Unknown - );Condition aggravated (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - );Movement disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779410	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779411	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Recovered/Resolved - Other Medically Important Condition);Dysphonia (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779414	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dysphagia (n/a - Unknown - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Oesophageal food impaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779415	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Stress (n/a - Unknown - Other Medically Important Condition);Supraventricular tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - Deep vein thrombosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779461	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Neoplasm malignant (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779501	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779503	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779509	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779517	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779524	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779528	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779541	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Complex regional pain syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Granulocyte count increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779579	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779620	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature increased (2d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779639	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779640	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779643	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779656	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (80d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEUPRORELIN ACETATE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779702	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779753	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Cold sweat (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010779775	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010779784	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010779785	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779807	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (14d - Not Recovered/Not Resolved - );Myalgia (4d - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010779847	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Folliculitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010779892	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (41d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779898	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010779901	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (12d - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myalgia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010779903	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial flutter (n/a - Recovered/Resolved - );Cardioversion (n/a - Recovered/Resolved - );Ejection fraction decreased (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (2d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Resuscitation (n/a - Recovered/Resolved - );Tachycardia (2d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010779905	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Hepatic pain (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010779971	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|PIOGLITAZONE [PIOGLITAZONE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010779974	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010779985	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (25d - Recovered/Resolved - );Hypoaesthesia (14d - Recovered/Resolved - );Memory impairment (n/a - Recovering/Resolving - );Transient ischaemic attack (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010779994	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peyronie's disease (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - n/a])	[ACICLOVIR] (C - n/a - n/a - [n/a - 200mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010779994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010780052	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780143	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Transient ischaemic attack (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010780458	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780578	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780663	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature fluctuation (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling of body temperature change (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersomnia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Middle insomnia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010780799	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Meningitis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nervous system disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010780805	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780809	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (8d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010780819	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010780837	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010780864	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780930	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[HYDROCORTISONE BUTYRATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[MEBENDAZOLE] (C - Enterobiasis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780947	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Disabling);Bursitis (n/a - Not Recovered/Not Resolved - Disabling);Mobility decreased (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010780972	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780983	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Hypersensitivity (6d - Recovered/Resolved - );Urticaria (6d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010780998	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010780998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010781014	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781040	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Type 1 diabetes mellitus (72d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010781041	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Disturbance in attention (74d - Not Recovered/Not Resolved - );Exercise tolerance decreased (74d - Not Recovered/Not Resolved - );Fatigue (64d - Not Recovered/Not Resolved - );Feeling hot (33d - Recovering/Resolving - );Myalgia (64d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010781042	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hyperhidrosis (0d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - Other Medically Important Condition);Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010781053	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781055	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Type 1 diabetes mellitus (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010781056	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781066	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781067	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781068	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dizziness (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781075	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781082	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010781090	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (20d - Recovered/Resolved - );Lymph node pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781094	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010781100	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781109	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neutropenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ABASAGLAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - Type 2 diabetes mellitus - Dose not changed - [n/a - n/a - Subcutaneous])|EKLIRA GENUAIR 322 MICROGRAMS INHALATION POWDER [ACLIDINIUM BROMIDE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Other])|JANUMET 50 MG/1000 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, SITAGLIPTIN] (C - Type 2 diabetes mellitus - Dose not changed - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Oral])|[CLOPIDOGREL] (C - Cerebral artery occlusion - Dose not changed - [n/a - n/a - Oral])|[LERCANIDIPINE HYDROCHLORIDE] (C - Essential hypertension - Dose not changed - [n/a - n/a - Oral])|[OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE] (C - Essential hypertension - Dose not changed - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - Chronic gastritis - Dose not changed - [n/a - n/a - Oral])|[PARACETAMOL] (C - Cervicobrachial syndrome - Dose not changed - [n/a - n/a - Oral])|[TRAZODONE HYDROCHLORIDE] (C - Insomnia - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010781111	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010781118	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781121	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781125	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest discomfort (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010781126	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781133	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010781144	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010781218	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781247	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	ALDARA [IMIQUIMOD] (C - Actinic keratosis - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT CLASSIFIED [NOT AVAILABLE] (C - Eczema - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|TECFIDERA [DIMETHYL FUMARATE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[ALVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[BACLOFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE, BETAMETHASONE, CLOTRIMAZOLE, CLOTRIMAZOLE PH. EUR., BETAMETHASONE DIPROPIONATE (PH. EUR.)] (C - Eczema - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010781248	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010781267	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pancreatic disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010781372	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781421	Spontaneous	2021-11-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781504	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye irritation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - Blood uric acid decreased - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010781507	Spontaneous	2021-11-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Weight bearing difficulty (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN PH. EUR., IBUPROFEN SODIUM, IBUPROFEN SODIUM DIHYDRATE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010781507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755480	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Libido decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755762	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755787	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755796	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755798	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755799	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755809	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neuralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755810	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Nuchal rigidity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755821	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Motor dysfunction (n/a - Recovered/Resolved - );Subcutaneous haematoma (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755844	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010755851	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755892	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010755894	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755914	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010755919	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755921	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - Hypercholesterolaemia - n/a - [n/a - 145mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755924	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - Hypercholesterolaemia - n/a - [n/a - 145mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755927	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755930	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755937	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (5d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Pruritus (5d - Recovered/Resolved - );Urticaria (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755939	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755949	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (21d - Recovered/Resolved - );Lymphadenopathy (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010755961	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal vein occlusion (60d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010755964	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010755966	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchospasm (n/a - Unknown - Life Threatening);Diarrhoea (n/a - Unknown - Life Threatening);Headache (n/a - Unknown - Life Threatening);Paraesthesia (n/a - Unknown - Life Threatening);Vertigo (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010755973	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755974	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haemorrhoidal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haemorrhoids (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010755975	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Injection site pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010755979	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755995	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (15d - Fatal - Results in Death);Interstitial lung disease (15d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010755996	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (25d - Fatal - Results in Death);Chest pain (25d - Fatal - Results in Death);Cough (25d - Fatal - Results in Death);Diarrhoea (25d - Fatal - Results in Death);Dyspnoea (25d - Fatal - Results in Death);Extrasystoles (25d - Fatal - Results in Death);Hyperhidrosis (25d - Fatal - Results in Death);Oxygen saturation decreased (25d - Fatal - Results in Death);Rales (25d - Fatal - Results in Death);Weight decreased (25d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010756003	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (8d - Recovered/Resolved - Other Medically Important Condition);Pleurisy (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756007	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Disabling);Coronary artery occlusion (n/a - Recovering/Resolving - Disabling);Infarction (n/a - Recovering/Resolving - Disabling);Pericarditis (n/a - Recovering/Resolving - Disabling);Respiratory disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010756015	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756021	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pallor (1d - Recovered/Resolved - Life Threatening);Pyrexia (1d - Recovered/Resolved - Life Threatening);Respiratory fatigue (1d - Recovered/Resolved - Life Threatening);Syncope (1d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010756028	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Intra-abdominal haematoma (n/a - Not Recovered/Not Resolved - Life Threatening);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010756029	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Unknown - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756037	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756072	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010756075	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756076	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Tendonitis (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010756188	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursal fluid accumulation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756197	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperglycaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756211	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	JARDIANCE 10 MG FILM-COATED TABLETS [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - 10mg - Oral])|PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - 75mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE] (C - n/a - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 25mg - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 30mg - Oral])|[PREDNISONE] (C - n/a - n/a - [n/a - 25mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756217	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Obstructive pancreatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	ACTOS [PIOGLITAZONE, PIOGLITAZONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756251	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Platelet aggregation abnormal - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANRENONE, POTASSIUM CANRENOATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756252	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (5d - Recovered/Resolved - Other Medically Important Condition);Myalgia (5d - Recovered/Resolved - Other Medically Important Condition);Palpitations (5d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Other Medically Important Condition);Skin reaction (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756263	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756292	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuropathy peripheral (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756299	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Life Threatening);Hyperpyrexia (n/a - Recovering/Resolving - Life Threatening);Tremor (n/a - Recovering/Resolving - Life Threatening);Ventricular tachycardia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	SILODYX 8 MG HARD CAPSULES [SILODOSIN] (C - n/a - n/a - [n/a - 8mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL] (C - n/a - n/a - [n/a - 50mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])|[MAGALDRATE, MAGALDRATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010756301	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Dysgeusia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );SARS-CoV-2 test (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010756309	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756315	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (10d - Recovered/Resolved - );Fatigue (10d - Recovered/Resolved - );Hyperhidrosis (10d - Recovered/Resolved - );Injection site pain (10d - Recovered/Resolved - );Lymphadenopathy (10d - Recovered/Resolved - );Nausea (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756334	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756347	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Cough (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010756378	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756395	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (40d - Recovered/Resolved - );Nausea (40d - Recovered/Resolved - );Vomiting (40d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010756448	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010756453	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Neuralgia (n/a - Unknown - );Neuritis (n/a - Unknown - );Radiculopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010756471	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756480	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	EFFICIB 50 MG/850 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID, ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, ACETYLSALICYLIC ACID, MAGNESIUM HYDROXIDE, ALGELDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756484	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756494	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756496	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756503	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010756520	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Mechanical urticaria (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Neuromuscular pain (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010756545	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756554	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756758	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Iritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Uveitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ETANERCEPT [ETANERCEPT] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756774	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arterial injury (n/a - Recovered/Resolved - Other Medically Important Condition);Embolism (n/a - Recovered/Resolved - Other Medically Important Condition);Ocular discomfort (n/a - Recovered/Resolved - );Oculomucocutaneous syndrome (n/a - Recovered/Resolved - Other Medically Important Condition);Retinal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Recovered/Resolved - Other Medically Important Condition);Venous occlusion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756777	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Vision blurred (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756782	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756786	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756795	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010756799	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (40min - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (40min - Recovered/Resolved - Other Medically Important Condition);Syncope (40min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756803	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Pallor (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756804	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756806	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756807	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sweating fever (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756819	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Unknown - );Rash (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756828	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756920	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756921	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure systolic decreased (n/a - Recovering/Resolving - );C-reactive protein increased (n/a - Recovering/Resolving - );Fibrin D dimer increased (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Serum ferritin increased (n/a - Recovering/Resolving - );Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756925	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756926	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial rub (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (75h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756927	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010756929	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (5min - Recovered/Resolved - );Dizziness (5min - Recovered/Resolved - );Dyspnoea (5min - Recovered/Resolved - );Headache (5min - Recovered/Resolved - );Respiratory distress (5min - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010756931	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010756956	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensitive skin (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010756956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010757150	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010757163	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757164	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Lip disorder (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757177	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Peripheral swelling (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757178	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010757216	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757219	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010757232	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arterial occlusive disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Radial pulse abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010757245	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010757418	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010757427	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint range of motion decreased (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010757431	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Influenza (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010757443	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010757445	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010757450	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Constipation (n/a - Unknown - );Malaise (n/a - Unknown - );Mental disorder (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Pain (n/a - Unknown - );Suicidal ideation (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757453	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METHYLPREDNISOLONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757454	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757457	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anxiety (n/a - Unknown - );Arrhythmia (n/a - Unknown - Other Medically Important Condition);Generalised anxiety disorder (n/a - Unknown - );Nervous system disorder (n/a - Unknown - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757570	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010757579	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Hot flush (n/a - Unknown - );Insomnia (n/a - Unknown - );Nausea (n/a - Unknown - );Otorrhoea (n/a - Unknown - );Pollakiuria (n/a - Unknown - );Secretion discharge (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010757595	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010757604	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010757619	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Myalgia (2d - Unknown - );Pain of skin (n/a - Unknown - );Pyrexia (2d - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010757621	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010757627	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Autoimmune haemolytic anaemia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chromaturia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010757628	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010757632	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sensitive skin (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010757639	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo positional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010757658	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovering/Resolving - Other Medically Important Condition);C-reactive protein increased (n/a - Unknown - );General physical health deterioration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Impaired work ability (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, COLECALCIFEROL, MAGNESIUM] (C - n/a - n/a - )|[GARLIC POWDER] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010757658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758053	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensitive skin (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010758059	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010758068	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Odynophagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sensitive skin (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010758071	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arterial thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cyanosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemorrhage subcutaneous (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemorrhagic diathesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Intermittent claudication (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - );Oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral arterial occlusive disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral artery occlusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Petechiae (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Skin discolouration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tenderness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis with thrombocytopenia syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - n/a])|ICOSAPENT ETHYL [ICOSAPENT ETHYL] (C - n/a - n/a - [n/a - 1800mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010758111	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Grip strength decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010758112	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010758125	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Unknown - Disabling, Other Medically Important Condition);Tinnitus (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010758126	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Sneezing (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758129	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (40min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758323	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010758395	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010758522	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010758551	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758728	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758796	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Headache (61d - Recovered/Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Blood pressure measurement - n/a - [n/a - 1{DF} - Oral])|[ATENOLOL, ATENOLOL HYDROCHLORIDE, ATENOLOL PH. EUR.] (C - Blood pressure measurement - n/a - [n/a - 1{DF} - Oral])|[HYDROCHLOROTHIAZIDE, LOSARTAN, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Blood pressure measurement - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010758908	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010758970	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758971	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758973	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758980	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758981	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010758982	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010758982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759255	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759272	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - );Feeling cold (n/a - Unknown - );Headache (n/a - Unknown - );Lymph node pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759277	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759278	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759282	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759287	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759375	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (24h - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010759384	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Recovered/Resolved With Sequelae - Disabling);Condition aggravated (n/a - Recovered/Resolved With Sequelae - Disabling);Deafness neurosensory (n/a - Recovered/Resolved With Sequelae - Disabling);Hypoacusis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010759413	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (2d - Unknown - Other Medically Important Condition);Diarrhoea (2d - Unknown - Other Medically Important Condition);Fatigue (2d - Unknown - Other Medically Important Condition);Malaise (2d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759421	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematemesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematochezia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemoglobin decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759424	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759425	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Malignant ascites (n/a - Unknown - Other Medically Important Condition);Neoplasm progression (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759428	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759429	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Parkinson's disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - Parkinson's disease - n/a - [n/a - n/a - Oral])|[ROPINIROLE] (C - Parkinson's disease - n/a - [n/a - n/a - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatic disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759436	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periorbital swelling (n/a - Recovering/Resolving - );Rash maculo-papular (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759439	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759441	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeding disorder (4530min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (4530min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (4530min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (4530min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (4530min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759443	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hepatic pain (2d - Recovered/Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[DEXLANSOPRAZOLE, LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 30mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759445	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Balance disorder (n/a - Unknown - Disabling);Dysarthria (n/a - Unknown - Disabling);Facial paralysis (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Unknown - Disabling);Thrombolysis (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010759447	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759448	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759450	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Antinuclear antibody positive (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling);Weight decreased (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - 75mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010759462	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759464	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Agranulocytosis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count decreased (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[BEPRIDIL, BEPRIDIL HYDROCHLORIDE] (S - Ventricular tachycardia - Drug withdrawn - [67d - 100mg - Oral])|[BUCILLAMINE] (S - Rheumatoid arthritis - Unknown - [n/a - n/a - Oral])	SPIRONOLACTONE [SPIRONOLACTONE] (C - n/a - n/a - [n/a - 25mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - 40mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 10mg - n/a])|[BUCILLAMINE] (C - n/a - n/a - [n/a - 200mg - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - 10mg - n/a])|[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - 60mg - n/a])|[DEXCHLORPHENIRAMINE, DEXCHLORPHENIRAMINE MALEATE] (C - n/a - n/a - [n/a - 2mg - n/a])|[ESOMEPRAZOLE, AMOXICILLIN, CLARITHROMYCIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - 10mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[GLUCOSE, GLUCOSE MONOHYDRATE, GLUCOSE, ANHYDROUS] (C - n/a - n/a - [n/a - 40mg - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 25mg - n/a])|[LOXOPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 8mg - n/a])|[SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759465	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - );Arthritis (n/a - Unknown - );Chest pain (n/a - Unknown - );Cough (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Dysstasia (n/a - Unknown - );Lip swelling (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Neck pain (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - );Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition);Rectal haemorrhage (n/a - Unknown - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - );Vein disorder (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759470	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759471	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Pain (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759475	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759476	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Gaze palsy (23235min - Recovered/Resolved - Other Medically Important Condition);Headache (19d - Recovered/Resolved - );Loss of consciousness (23235min - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759491	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Caused/Prolonged Hospitalisation);Angiogram pulmonary abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Ascites (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Atelectasis (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Castleman's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coagulopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Cytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased activity (n/a - Unknown - Caused/Prolonged Hospitalisation);Disseminated intravascular coagulation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Erythema (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Unknown - Caused/Prolonged Hospitalisation);Glycogen storage disease type V (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemorrhage subcutaneous (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemorrhagic diathesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiplegia (35d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatic function abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoalbuminaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);IIIrd nerve paralysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune system disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Megakaryocytes increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Monoplegia (35d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multi-organ disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Petechiae (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumothorax (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal infarct (33d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Reticuloendothelial dysfunction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Hyperthyroidism - n/a - [n/a - n/a - Oral])|[THIAMAZOLE] (C - Hyperthyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010759497	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DEXAMETHASONE [DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - 8mg - Oral])|[AZITHROMYCIN, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN HYDRATE] (C - n/a - n/a - [4d - 250mg - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759503	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MIRABEGRON [MIRABEGRON] (C - Prostatic disorder - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759504	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Immobile (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - );Thrombosis with thrombocytopenia syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759507	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759509	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Swollen tongue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759514	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Subarachnoid haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759515	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Medical induction of coma (n/a - Not Recovered/Not Resolved - Life Threatening);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010759536	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759539	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye irritation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensitive skin (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759543	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pleuritic pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759548	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759549	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interstitial lung disease (84h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung opacity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (15h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TRIAZOLAM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759551	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Insomnia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759552	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759555	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759560	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Migraine (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Off label use (n/a - Unknown - Other Medically Important Condition);Pulmonary congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory tract congestion (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Sarcoidosis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Major depression - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Sarcoidosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759562	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hyperthyroidism (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010759572	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Drug eruption (n/a - Unknown - );Erythema multiforme (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759582	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Muscle twitching (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Weight increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759597	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759608	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759611	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010759616	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Foot deformity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypertension (27d - Recovered/Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscle atrophy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010759638	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010759654	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Large intestine perforation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759666	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759679	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759698	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759700	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Induration (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Juvenile idiopathic arthritis (n/a - Unknown - Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nodule (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Sensitive skin (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759702	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759703	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759713	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - );Sensitive skin (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759734	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759738	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759739	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759740	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759741	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759790	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 36mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759791	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Faeces discoloured (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759804	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Retching (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010759884	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (237d - Recovered/Resolved - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Not applicable - [1d - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [1d - n/a - n/a])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010759909	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010759956	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pleurisy (57d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	COAPROVEL [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759969	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010759980	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Prinzmetal angina (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010759987	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759994	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010759996	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010759996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760003	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALENDRONATE SODIUM HYDRATE] (C - n/a - n/a - [n/a - 35mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - n/a])|[PREDNISOLONE, PREDNISOLONE ACETATE] (C - n/a - n/a - [n/a - 1.5{DF} - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760048	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760056	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760075	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760077	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (5d - Recovering/Resolving - );Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760083	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cytomegalovirus hepatitis (46d - Recovered/Resolved - Other Medically Important Condition);Cytomegalovirus infection (46d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010760084	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010760089	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760105	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760111	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760113	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010760131	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010760142	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pulmonary pain (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760145	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - );Balance disorder (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Dysstasia (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Neck pain (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - );Paralysis (n/a - Unknown - Other Medically Important Condition);Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - );Vein disorder (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Thyroid disorder - n/a - [n/a - .025mg - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - 2000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760161	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory distress (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760166	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Breast pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Joint stiffness (n/a - Not Recovered/Not Resolved - );Micturition urgency (n/a - Not Recovered/Not Resolved - );Middle insomnia (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pollakiuria (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN, PSEUDOEPHEDRINE] (C - n/a - n/a - [n/a - 800mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760174	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ANHYDROUS NALOXONE HYDROCHLORIDE, NALOXONE, NALOXONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[COCAINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010760177	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760214	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Hyperventilation (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010760215	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Meningitis (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760225	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010760315	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	COAPROVEL [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010760403	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010760502	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760522	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760591	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - Disabling);Gait disturbance (n/a - Recovered/Resolved - Disabling);Hyperhidrosis (n/a - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling);Restlessness (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAMETHASONE, BETAMETHASONE DIPROPIONATE, SALICYLIC ACID, BETAMETHASONE DIPROPIONATE, SALSALATE, BETAMETHASONE, SALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOMER, CARBOMER 980] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE DINITRATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - Restlessness - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL 4000] (C - n/a - n/a - [n/a - n/a - n/a])|[MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[OXAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL HYDROCHLORIDE] (C - Tremor - n/a - [n/a - n/a - n/a])|[QUETIAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010760749	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760758	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760768	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760771	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010760870	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - 75mg - n/a])|[AMLODIPINE] (C - n/a - Unknown - [n/a - 2.5mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010760870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761005	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Chills (0d - Recovered/Resolved - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (0d - Recovered/Resolved - Other Medically Important Condition);Tremor (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - 1{DF} - n/a])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761081	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Heart rate decreased (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761087	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness postural (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761094	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage subcutaneous (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761103	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Vertigo (6d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761145	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761163	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761167	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761168	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761171	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761177	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761180	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761185	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761186	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Pain in extremity (1wk - Recovered/Resolved - );Pyrexia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761190	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (2wk - Recovered/Resolved - );Lymphadenopathy (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761194	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pustule (2wk - Recovered/Resolved - );Rash (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761239	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Recovering/Resolving - Disabling);Dysarthria (n/a - Recovering/Resolving - Disabling);Muscular weakness (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010761240	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyslalia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761243	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HEPARIN, HEPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [2d - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SALINE, SODIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761253	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761254	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ageusia (n/a - Unknown - );Asthenia (n/a - Unknown - );Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Bell's palsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Brain fog (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - );Cognitive disorder (n/a - Unknown - );Constipation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Diplopia (n/a - Unknown - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyschromatopsia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Encephalitis brain stem (n/a - Unknown - Other Medically Important Condition);Eye movement disorder (n/a - Unknown - );Facial paralysis (n/a - Unknown - Disabling, Other Medically Important Condition);Faecaloma (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - );Gaze palsy (n/a - Unknown - Disabling, Other Medically Important Condition);Glossodynia (n/a - Unknown - );Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Hypoaesthesia oral (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Insomnia (n/a - Unknown - );Muscle disorder (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Optic neuritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Sleep apnoea syndrome (n/a - Unknown - );Tinnitus (n/a - Unknown - );Tongue coated (n/a - Unknown - );Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Urinary hesitation (n/a - Unknown - );Vertigo (n/a - Recovering/Resolving - );Visual field defect (n/a - Unknown - Disabling, Other Medically Important Condition);Vitreous floaters (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761256	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Dermatitis atopic (n/a - Recovering/Resolving - Other Medically Important Condition);Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Oedema (64h - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - Dermatitis atopic - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761257	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761262	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Nasopharyngitis (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010761263	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761265	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleuritic pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761267	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761270	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Illness (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010761326	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010761331	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[RANITIDINE, RANITIDINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761332	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Medulloblastoma (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - );Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination error (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761333	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition);Suspected COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010761334	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Appendicitis (154d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761337	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Bronchospasm (n/a - Unknown - );Cough (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Respiratory tract oedema (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761340	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Urinary incontinence (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761420	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010761555	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hypoaesthesia (4d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010761563	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Abdominal pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - );Weight decreased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761591	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral circulatory failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761667	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761668	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761676	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breath sounds (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sputum increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010761680	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761699	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761700	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761703	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761704	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761706	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761707	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761715	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761718	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761720	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761722	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761724	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761770	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Suffocation feeling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010761808	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761822	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Foetal exposure during pregnancy (n/a - Unknown - Congenital Anomaly);Heart disease congenital (n/a - Unknown - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010761835	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute kidney injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Iritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);SARS-CoV-2 test negative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761837	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myelopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[PHENOXYMETHYLPENICILLIN, PHENOXYMETHYLPENICILLIN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010761846	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761849	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010761883	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010761884	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Glucocorticoid deficiency (51d - Recovered/Resolved - Other Medically Important Condition);Hypophysitis (51d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010761890	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010761891	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010761892	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (34d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761901	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral sensory neuropathy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010761903	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (28d - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010761914	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761945	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010761953	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Muscle spasticity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Muscle twitching (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Presyncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761960	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010761991	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010761991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010762007	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010762012	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010762026	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010762035	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010762036	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Self-injurious ideation (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010762139	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pre-existing condition improved (n/a - Unknown - Other Medically Important Condition);Therapeutic response unexpected (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762207	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762209	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762211	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762218	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762220	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762230	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762233	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762237	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762241	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762242	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762243	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762245	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762246	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762247	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010762255	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762261	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762264	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762265	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762266	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762268	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762270	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762370	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010762418	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Disabling);Muscle spasms (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010762575	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug effect less than expected (n/a - Unknown - );Drug interaction (n/a - Unknown - );Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Speech disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[PROPIVERINE HYDROCHLORIDE] (I - Bladder irritation - Drug withdrawn - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010762585	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762586	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762587	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762589	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762598	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762602	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762603	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762605	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762614	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762622	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762632	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762633	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762642	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Mouth haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010762709	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure systolic increased (n/a - Recovering/Resolving - Life Threatening);Gait disturbance (n/a - Recovering/Resolving - Life Threatening);Gait inability (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Injection site pain (n/a - Recovering/Resolving - Life Threatening);Insomnia (n/a - Recovering/Resolving - Life Threatening);Muscle spasms (n/a - Not Recovered/Not Resolved - Life Threatening);Vertigo (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010762733	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010762748	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010762780	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Albumin CSF increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);CSF protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Daydreaming (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010762959	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762964	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762967	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762974	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762975	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762983	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762984	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010762996	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010762996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763002	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (148d - Recovering/Resolving - Disabling);Myalgia (148d - Recovering/Resolving - Disabling);Polymyalgia rheumatica (148d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010763017	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Accommodation disorder (n/a - Not Recovered/Not Resolved - );Eye disorder (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763019	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763021	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763027	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abnormal dreams (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763029	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperkalaemia (8d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763034	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010763039	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pancreatic enzymes increased (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763047	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Unknown - Other Medically Important Condition);Partial seizures (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763054	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Musculoskeletal chest pain (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010763065	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (80d - Recovered/Resolved - Other Medically Important Condition);Lung opacity (27d - Recovered/Resolved - );Lymphocyte count increased (65d - Recovered/Resolved - );Malaise (80d - Recovered/Resolved - );Pneumonia (65d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (80d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763072	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763085	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763092	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (48h - Recovering/Resolving - Other Medically Important Condition);Nausea (48h - Recovering/Resolving - Other Medically Important Condition);Sensation of foreign body (48h - Recovering/Resolving - Other Medically Important Condition);Vertigo (48h - Recovering/Resolving - Other Medically Important Condition);Vomiting (48h - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763093	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (14min - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Restlessness (35min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763094	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763096	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (1h - Recovered/Resolved - );Syncope (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763097	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (1d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763099	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010763101	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure diastolic decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure systolic increased (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763105	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Brain stem infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763106	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763123	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Body temperature abnormal (405h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (405h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Left ventricular dysfunction (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (405h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin T increased (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763137	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763146	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763150	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Occipital neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763154	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763164	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763166	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Costochondritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763170	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (14d - Recovered/Resolved - );Palpitations (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010763177	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drooling (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyskinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - Caused/Prolonged Hospitalisation);Ear discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye movement disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eyelid disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoacusis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Lagophthalmos (n/a - Unknown - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Physical deconditioning (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763188	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010763198	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Expired product administered (n/a - Unknown - );Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763200	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Mobility decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763207	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (0d - Recovered/Resolved - );Hypoaesthesia (n/a - Unknown - );Swelling of eyelid (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763220	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - );Aldolase increased (n/a - Unknown - );Amino acid level increased (n/a - Unknown - );Appetite disorder (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - );Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Autoimmune hepatitis (n/a - Unknown - Other Medically Important Condition);Bacterial infection (n/a - Unknown - );Blood albumin decreased (n/a - Unknown - );Blood alkaline phosphatase increased (n/a - Unknown - );Blood bilirubin increased (n/a - Unknown - );Blood calcium decreased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Haematocrit decreased (n/a - Unknown - );Haemoglobin decreased (n/a - Unknown - );Headache (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Hepatic enzyme increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interleukin level increased (n/a - Unknown - );Liver function test increased (n/a - Unknown - );Malaise (n/a - Unknown - );Mean platelet volume decreased (n/a - Unknown - );Muscle disorder (n/a - Unknown - );Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Myositis (n/a - Unknown - );Pain (1d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Platelet count increased (n/a - Unknown - );Procalcitonin increased (n/a - Unknown - );Protein total decreased (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Red blood cell count decreased (n/a - Unknown - );White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[PARACETAMOL, ACETYLSALICYLIC ACID, CAFFEINE] (C - Migraine - n/a - [n/a - n/a - n/a])|[SALICYLAMIDE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763223	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763226	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763227	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (5d - Recovered/Resolved - Other Medically Important Condition);Malaise (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763232	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763236	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Not Recovered/Not Resolved - Disabling);Interchange of vaccine products (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010763239	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763243	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lacunar infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cerebral infarction - n/a - [n/a - 75mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763244	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763245	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition);Trigeminal neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - .75mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 8mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763251	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763265	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb injury (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763267	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Eye swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Lip swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swollen tongue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763268	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763273	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Communication disorder (n/a - Unknown - );Glossoptosis (n/a - Unknown - );Hypokinesia (n/a - Unknown - );Hypophagia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Snoring (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Tachypnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - n/a])|FORXIGA [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - 5mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FLUVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[GALANTAMINE, GALANTAMINE HYDROBROMIDE] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - Oral])|[GLICLAZIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010763274	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763282	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Menstruation delayed (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ovarian disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763289	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763291	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Meningitis aseptic (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763295	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763369	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Insomnia (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763416	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nervous system disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - Unknown - [n/a - n/a - n/a])|[THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010763458	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Recovered/Resolved - );COVID-19 immunisation (n/a - Recovered/Resolved - );Constipation (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763459	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (10d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763489	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763490	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010763498	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Disabling);Injection site discomfort (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Not Recovered/Not Resolved - Disabling);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Disabling);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling);Product administered at inappropriate site (n/a - Not Recovered/Not Resolved - Disabling);Rotator cuff syndrome (n/a - Not Recovered/Not Resolved - Disabling);Tendon disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010763514	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763524	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coagulopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);White blood cell count decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763526	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763624	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763631	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763639	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763642	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763652	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763720	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763797	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010763827	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763829	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amenorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763884	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Child	No	Male	Dizziness (10min - Recovered/Resolved - );Vomiting (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010763886	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TECFIDERA 240 MG GASTRO-RESISTANT HARD CAPSULES [DIMETHYL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010763913	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (30d - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010763918	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (13d - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010763964	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Adrenal insufficiency (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Angioedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bone lesion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cushing's syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diabetes insipidus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug intolerance (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Humerus fracture (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Meningioma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mucosal hypertrophy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mumps (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rubella (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Varicella (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])|M-M-RVAXPRO [MEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED), MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS, MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS, MEASLES VIRUS EDMONSTON-ENDERS STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])|MENVEO [MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN, N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197, N. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED CRM197, N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197, MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN, NEISSERIA MENINGITIDIS GROUP C OLIGOSACCHARIDE, N. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED CRM197, N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197] (S - n/a - Not applicable - [n/a - n/a - n/a])|[truncated, see ICSR form for full text]	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010763964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764034	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764035	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764039	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764040	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764042	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764046	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764049	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764071	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Chavez, A.. Case of COVID-19 Vaccine Associated New Diagnosis Myasthenia Gravis. Journal of Primary Care &amp; Community Health. 2021;12:1-3. doi:10.1177/21501327211051933	65-85 Years	Not Specified	No	Male	Myasthenia gravis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764082	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Generalised oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Type IV hypersensitivity reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764092	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764100	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764103	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure systolic increased (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764114	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin papilloma (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010764118	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764139	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Cough (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Irritability (n/a - Unknown - );Myalgia (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pruritus (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764145	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Motion sickness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764146	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764150	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|RANOLAZINE [RANOLAZINE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764154	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Daydreaming (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry throat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypopnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sensation of foreign body (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat tightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tongue discolouration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tongue disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764155	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764173	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cardiovascular disorder (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of consciousness (16min - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - );Nervous system disorder (n/a - Unknown - );Somatic symptom disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764183	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Barrett's oesophagus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764190	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (39min - Recovered/Resolved - );Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Headache (39min - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BENZBROMARONE] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[DEXCHLORPHENIRAMINE MALEATE, BETAMETHASONE] (C - Food allergy - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[TAK 438] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764209	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764329	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764754	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[OMEPRAZOLE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764756	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764758	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764760	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764761	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Generalised anxiety disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [35d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764763	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Orchitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764765	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764766	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (27d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764771	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764784	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764788	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral artery thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764789	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Retinal artery occlusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764800	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune thrombocytopenia (80d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764807	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764809	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (6d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764812	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764816	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Antiphospholipid syndrome (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764817	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angiopathy (n/a - Not Recovered/Not Resolved - );Antiphospholipid antibodies positive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764820	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal artery thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Retinal vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764829	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cor pulmonale acute (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	AVASTIN [BEVACIZUMAB] (S - Glioblastoma - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])|IRINOTECAN [IRINOTECAN, IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE TRIHYDRATE] (S - Glioblastoma - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764830	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypohidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764842	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Fatal - Results in Death);Condition aggravated (n/a - Fatal - Results in Death);Lymphoma (n/a - Fatal - Results in Death);Pulmonary oedema (n/a - Fatal - Results in Death);Weight decreased (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010764845	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasticity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Visual acuity reduced (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010764849	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764851	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [22d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764857	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010764863	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764864	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764870	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - n/a])|REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [EVOLOCUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|TOUJEO [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, OLODATEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010764881	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764890	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pancytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764896	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010764901	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	RITUXIMAB [RITUXIMAB] (C - n/a - Not applicable - [1d - 400mg - Intravenous (not otherwise specified)])|[CYCLOPHOSPHAMIDE] (C - n/a - Not applicable - [1d - n/a - Intravenous (not otherwise specified)])|[DOXORUBICIN HYDROCHLORIDE] (C - n/a - Not applicable - [1d - n/a - Intravenous (not otherwise specified)])|[PREDNISOLONE] (C - n/a - Not applicable - [1d - 2mg/kg - Oral])|[VINCRISTINE SULFATE] (C - n/a - Not applicable - [1d - 2mg - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010764924	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764925	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010764956	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010764956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010765057	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765064	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (16d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (16d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010765081	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010765082	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010765089	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Physical deconditioning (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010765090	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dissociative disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010765092	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010765097	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010765098	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Respiratory disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765108	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	0-1 Month	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - );Neonatal disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - Transmammary])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Transmammary])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765119	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765123	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Adverse drug reaction (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[CEFACLOR, CEFACLOR MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXCARBAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010765168	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010765224	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010765236	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765293	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010765361	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765376	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765387	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765408	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765421	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765429	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Tendonitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765430	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765435	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765439	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [26d - .6mL - Intramuscular])	HULIO 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [ADALIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765440	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haemoptysis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[VALPROATE SEMISODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765463	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765464	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765502	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765503	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765504	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765505	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765508	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765525	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765544	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765552	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	HUMIRA 40 MG [ADALIMUMAB] (C - Colitis - n/a - [1d - n/a - n/a])|[COLECALCIFEROL] (C - Product used for unknown indication - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765553	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Influenza like illness - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765579	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ACARBOSE] (C - Product used for unknown indication - n/a - )|[ALTIZIDE, SPIRONOLACTONE] (C - Product used for unknown indication - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Product used for unknown indication - n/a - )|[GLIBENCLAMIDE] (C - Product used for unknown indication - n/a - )|[RAMIPRIL] (C - Product used for unknown indication - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765582	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765585	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Genital herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765603	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Bedridden (2d - Recovered/Resolved - );Decreased appetite (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Movement disorder (1d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765615	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765618	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765622	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765624	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765625	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765642	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Confusional state (12h - Recovering/Resolving - );Pyrexia (12h - Recovering/Resolving - );Seizure (12h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765659	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765666	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765669	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765673	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765685	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765686	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765690	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765691	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis bullous (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765694	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765711	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster reactivation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765732	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - Unknown - [n/a - 1000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765740	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (4h - Recovered/Resolved - );Malaise (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765752	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765753	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765769	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765806	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	BUDESONIDE [BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765808	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765817	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular - More in ICSR])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765831	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765833	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765834	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765835	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765836	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765837	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765839	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765846	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure diastolic increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765868	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Emotional disorder (n/a - Unknown - );Insomnia (n/a - Unknown - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765871	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765877	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (15d - Recovered/Resolved - );Headache (15d - Recovered/Resolved - );Palpitations (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765898	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765905	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Unknown - );Vaccination site inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765906	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765911	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amnesia (n/a - Unknown - );Apathy (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Flatulence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765916	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Respiratory depth decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765922	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pharyngeal paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765939	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765942	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Localised oedema (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010765955	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (7d - Recovered/Resolved - );Urticaria (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765961	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma muscle (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[OXAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765970	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010765971	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nocturnal dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010765971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010766011	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Psoriatic arthropathy - n/a - [7y - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [500d - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [69d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766016	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Brain fog (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Ear disorder (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766018	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010766041	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tenderness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	BUDESONIDE [BUDESONIDE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])|[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - Cellulitis - n/a - [11d - n/a - n/a])|[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - Localised infection - n/a - [8d - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766122	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766176	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766181	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010766257	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766258	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pruritus (12d - Recovered/Resolved With Sequelae - );Vaccination site cellulitis (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010766267	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010766277	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766293	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766324	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766356	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Mass (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766362	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766381	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766405	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Condition aggravated (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Hyperhidrosis (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010766417	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766418	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Productive cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766439	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766895	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010766925	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (112d - Recovering/Resolving - );Dyspnoea (112d - Recovering/Resolving - );Myalgia (112d - Recovering/Resolving - );Painful respiration (112d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010766925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010767032	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010767082	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (2d - Recovered/Resolved - );Transient ischaemic attack (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010767102	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767104	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Prostate cancer (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767105	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (43d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (43d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767113	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767119	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Muscle atrophy (n/a - Unknown - Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010767131	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767133	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Transient ischaemic attack (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767134	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767137	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767149	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - Sinusitis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767150	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Jaundice neonatal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767156	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767159	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767166	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010767167	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Pedersen, M.. Negative SARSCoV- 2 antibodies, T-cell response and virus neutralization following full vaccination in a renal transplant recipient: a call for vigilance.. Clinical Microbiology and Infection. 2021;27 (9):1371-1373	18-64 Years	Not Specified	No	Male	Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767173	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767175	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767178	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (6h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Muscle relaxant therapy - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure decreased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrointestinal pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767179	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767193	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (0d - Recovered/Resolved - );Syncope (2s - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767196	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Painful respiration (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767205	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (6485min - Recovered/Resolved - Other Medically Important Condition);Fall (6485min - Recovered/Resolved - Other Medically Important Condition);Haemorrhage (6485min - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (6485min - Recovered/Resolved - Other Medically Important Condition);Presyncope (6485min - Recovered/Resolved - Other Medically Important Condition);Wound (6485min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767206	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Pallor (n/a - Unknown - );Pyrexia (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767214	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010767220	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Pulse abnormal (n/a - Recovering/Resolving - );Shock symptom (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767227	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (1min - Recovered/Resolved - Other Medically Important Condition);Diplopia (1min - Recovered/Resolved - );Headache (1wk - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Migraine with aura (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767231	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767234	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (2d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Miliaria (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Respiration abnormal (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010767244	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767246	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767259	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - 5mg - Oral])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767266	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767268	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767290	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767293	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767324	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Unknown - );Headache (1d - Unknown - );Myalgia (1d - Unknown - );Pyrexia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767333	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Body temperature increased (n/a - Not Recovered/Not Resolved - );Brain fog (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Muscle fatigue (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - );Vaccination site discomfort (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010767345	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature abnormal (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767349	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - );Dizziness (n/a - Unknown - );Hemiparesis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Subcutaneous haematoma (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767384	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767441	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767445	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767449	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767465	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood bilirubin increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Unknown - );Eosinophil count increased (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Unknown - );Head discomfort (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Hyperacusis (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Mucosal hypertrophy (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Unknown - );Neck pain (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photophobia (n/a - Unknown - );Red blood cell sedimentation rate increased (n/a - Unknown - );Red cell distribution width increased (n/a - Not Recovered/Not Resolved - );Sinus bradycardia (n/a - Not Recovered/Not Resolved - );Urine abnormality (n/a - Recovered/Resolved - );White matter lesion (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010767488	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Incorrect route of product administration (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Speech disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767495	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767510	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767512	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767518	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767519	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767552	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767562	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (5d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010767628	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Foetal disorder (n/a - Fatal - Results in Death, Congenital Anomaly);Foetal exposure during pregnancy (n/a - Recovered/Resolved - Results in Death, Congenital Anomaly);Foetal growth restriction (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transplacental])	[NAPROXEN] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010767636	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erectile dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	[BENDROFLUMETHIAZIDE, POTASSIUM CHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010767656	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767668	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767705	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - );Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hemiparaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Swollen tongue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tongue discolouration (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010767718	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|METFORMIN HYDROCHLORIDE, CANAGLIFLOZIN [METFORMIN HYDROCHLORIDE, CANAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010767856	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010767929	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010767929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768209	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768273	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768275	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768283	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768310	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Furuncle (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768317	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	[HYDROXYCHLOROQUINE SULFATE] (C - Rheumatoid arthritis - n/a - [n/a - 400mg - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [114d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768443	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768452	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768453	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768455	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768460	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768461	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768472	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768503	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - );Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768538	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovered/Resolved With Sequelae - Disabling);Polymyalgia rheumatica (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010768544	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hallucination, auditory (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768550	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768557	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010768569	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Ventricular tachycardia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010768580	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye infarction (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010768599	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac fibrillation (19d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (19d - Recovered/Resolved - Other Medically Important Condition);Hypertension (19d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010768626	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Cardiac fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768649	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Parotitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|FLUAD TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza - Not applicable - [1d - 1{DF} - Intramuscular])	ICANDRA 50 MG/850 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - n/a - Unknown - )|VALSARTAN 160MG TABLET, AMLODIPINE 10MG TABLET, HYDROCHLOROTHIAZIDE 12.5MG TABLET  (C - n/a - Unknown - )|[ALLOPURINOL] (C - n/a - Unknown - )|[FOLIC ACID] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768658	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010768659	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768677	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Lymphoedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768755	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	CYMBALTA 60 MG HARD GASTRO-RESISTANT CAPSULES [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - Unknown - )|NOT AVAILABLE (C - n/a - Not applicable - )|NOT AVAILABLE (C - n/a - Unknown - )|PREGABALIN 50MG CAPSULE  (C - n/a - Unknown - )|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - Unknown - )|[FENTANYL] (C - n/a - Not applicable - )|[OMEPRAZOLE] (C - n/a - Not applicable - )|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768765	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	[METHYLPHENIDATE HYDROCHLORIDE] (C - Autism spectrum disorder - Dose not changed - [n/a - 54mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768774	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768776	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768778	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768781	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pleuropericarditis (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768788	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pleuropericarditis (17d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010768790	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pleuropericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768795	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tonsillar inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768806	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ETORICOXIB] (C - Sacral pain - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010768809	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768818	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768829	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute kidney injury (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Goodpasture's syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematuria (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nephritic syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary alveolar haemorrhage (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010768839	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ocular vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|FLUAD TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	NOT AVAILABLE (C - n/a - Unknown - )|[BROMAZEPAM] (C - n/a - Unknown - )|[SALBUTAMOL] (C - n/a - Unknown - )|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010768841	Spontaneous	2021-11-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Face oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768879	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (8d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010768947	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010768959	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010768972	Spontaneous	2021-11-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ALPHA-TOCOPHEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CUPRIC OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LUTEIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ZEAXANTHIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010768972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010734951	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735005	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735110	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735137	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735141	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735165	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735167	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735185	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735187	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735208	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735212	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735267	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735292	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735297	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010735298	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Dyspnoea (7d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735302	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735308	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735314	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735340	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735348	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site swelling (41d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735355	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735366	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735375	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - );Feeling hot (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - );Myalgia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735391	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735468	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735480	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - );Dyspnoea (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735517	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735522	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735991	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736015	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736022	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736035	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736043	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736047	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736053	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (1d - Recovered/Resolved - );Headache (2d - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736095	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736101	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Myalgia (8d - Not Recovered/Not Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736121	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736136	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736140	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736165	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736168	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736178	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Unknown - );Lymphadenopathy (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736181	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736183	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736196	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736204	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736211	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (2d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736221	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736225	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736230	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (21d - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tachycardia (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736236	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736240	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736352	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736363	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (7d - Not Recovered/Not Resolved - );Fatigue (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Pyrexia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736370	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736374	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736394	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736410	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (20d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736424	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (30d - Not Recovered/Not Resolved - );Headache (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736429	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736430	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (7d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736442	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736472	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736477	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site erythema (14d - Not Recovered/Not Resolved - );Injection site pain (14d - Not Recovered/Not Resolved - );Malaise (14d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736480	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736489	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736490	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736495	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736497	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736519	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736554	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736566	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736590	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736592	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736613	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736619	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (80d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736766	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736781	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (96d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736786	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736793	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736798	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737383	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Headache (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737450	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (66d - Not Recovered/Not Resolved - );Headache (66d - Recovering/Resolving - );Injection site pain (89d - Not Recovered/Not Resolved - );Malaise (66d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737456	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737459	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (93d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737470	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737475	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737478	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737480	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737488	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737489	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (34d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737490	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (4d - Recovering/Resolving - );Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737492	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737493	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (15d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737498	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737509	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737510	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737513	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737516	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Influenza (4d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737517	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737523	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737526	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Lymphadenopathy (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737531	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737534	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737535	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737679	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737691	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737698	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737701	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737702	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737706	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - );Fatigue (4d - Unknown - );Malaise (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737721	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Paraesthesia (94d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737726	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nausea (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737729	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737734	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737735	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737752	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737761	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737943	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Unknown - );Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737981	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737991	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738002	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Lymphadenopathy (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738003	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (64d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738021	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738029	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738035	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738036	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (63d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738037	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738039	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738047	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (38d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010738058	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738068	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738070	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738076	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738077	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738086	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738087	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738088	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (16d - Not Recovered/Not Resolved - );Tachycardia (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738091	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738095	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738096	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738098	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (23d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738099	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738102	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738110	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738115	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738128	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738129	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738149	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738157	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738167	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738192	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Unknown - );Headache (0d - Unknown - );Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738200	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738202	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738208	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Limb discomfort (1d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738215	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738217	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738219	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738222	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738227	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738229	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738230	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (32d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738232	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738239	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738243	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (19d - Not Recovered/Not Resolved - );Dyspnoea (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738245	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738254	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Vomiting (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738255	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738257	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (13d - Recovering/Resolving - );Rash (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738259	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (66d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738260	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (43d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738267	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738283	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738288	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738298	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738305	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738306	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Limb discomfort (5d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738309	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738313	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Myalgia (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738338	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738342	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738354	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738356	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738391	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Paraesthesia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738409	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738414	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738430	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738435	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738438	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Rash (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738441	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Feeling hot (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738456	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (n/a - Recovering/Resolving - );Vaccination site reaction (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738475	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (32d - Not Recovered/Not Resolved - );Limb discomfort (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738478	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738487	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738497	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (4d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (3d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738505	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (38d - Not Recovered/Not Resolved - );Headache (37d - Not Recovered/Not Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Limb discomfort (37d - Not Recovered/Not Resolved - );Myalgia (37d - Not Recovered/Not Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738510	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738514	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738526	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738532	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738535	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738537	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738540	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738541	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738544	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738550	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738554	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738555	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738561	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738564	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738565	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738567	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738568	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738571	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738574	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738575	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (52d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738576	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738659	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738662	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738664	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738665	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738666	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738667	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738670	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (11d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738674	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Malaise (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738677	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738682	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738689	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738698	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738699	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738701	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738703	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738704	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738709	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738711	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738713	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (44d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738714	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (14d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738719	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738721	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738724	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738729	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738731	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738734	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738744	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738751	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738752	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738757	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Recovering/Resolving - );Fatigue (8d - Recovering/Resolving - );Headache (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738758	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Unknown - );Myalgia (0d - Unknown - );Nausea (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738771	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738774	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738775	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738782	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738784	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738790	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738791	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Rash (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738799	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738800	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738801	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738802	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738805	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (63d - Recovering/Resolving - );Rash (48d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738812	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738814	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738818	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738820	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - );Dizziness (2d - Recovering/Resolving - );Fatigue (5d - Recovering/Resolving - );Feeling hot (3d - Recovering/Resolving - );Headache (6d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Paraesthesia (5d - Recovering/Resolving - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738824	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Influenza (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738826	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738832	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738833	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (87d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738834	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (36d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738837	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738848	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738852	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - );Feeling hot (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010738853	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738855	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738856	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (n/a - Recovered/Resolved - );Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738859	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738862	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738865	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738882	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738883	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738888	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738892	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738897	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738898	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738902	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738905	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Dizziness (5d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Influenza (6d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Limb discomfort (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738909	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738912	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738921	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738923	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738927	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738928	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738929	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738932	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738941	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovering/Resolving - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738942	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738943	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Influenza (5d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738944	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738945	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738948	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (8d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738956	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738965	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738970	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738980	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (38d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010738981	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738982	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738985	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738988	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (36d - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010738989	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738990	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738992	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Pyrexia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010738995	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010738995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739002	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739018	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739019	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739022	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739024	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739025	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739030	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739032	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739033	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739035	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739036	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (20d - Recovered/Resolved With Sequelae - );Dizziness (20d - Recovered/Resolved With Sequelae - );Dyspnoea (20d - Recovered/Resolved With Sequelae - );Fatigue (20d - Recovered/Resolved With Sequelae - );Headache (20d - Recovered/Resolved With Sequelae - );Malaise (20d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010739037	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739044	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (13d - Recovering/Resolving - );Tachycardia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739045	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739048	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (40d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739049	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739050	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (74d - Not Recovered/Not Resolved - );Limb discomfort (74d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739052	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (58d - Not Recovered/Not Resolved - );Malaise (58d - Not Recovered/Not Resolved - );Tachycardia (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739059	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Not Recovered/Not Resolved - );Influenza (11d - Recovering/Resolving - );Injection site pain (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739060	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739062	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Influenza (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739065	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739073	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739074	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739075	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739083	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739084	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739087	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739092	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739095	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739096	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739108	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739111	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739122	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739127	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739143	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739144	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739147	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (96d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739154	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739156	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739157	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (12d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739163	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739165	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Not Recovered/Not Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739169	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739179	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739183	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Recovering/Resolving - );Dyspnoea (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739184	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739191	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739193	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739201	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739205	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739211	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739212	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Seborrhoeic keratosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739215	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739216	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amyotrophy (n/a - Not Recovered/Not Resolved - );Mononeuritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739220	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739223	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739226	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pemphigoid (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739227	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abscess (66d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739231	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739232	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739254	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Faecaloma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739275	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Joint swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739285	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739290	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739292	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sinusitis (n/a - Not Recovered/Not Resolved - );Tension headache (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010739294	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739299	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyskinesia (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739301	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - );Visual acuity reduced transiently (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739304	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739309	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739369	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739370	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739373	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739374	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739381	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739385	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved With Sequelae - );Bone pain (n/a - Recovered/Resolved With Sequelae - );Diarrhoea (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - );Somnolence (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010739399	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739408	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739438	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysstasia (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Hyperaemia (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Thirst (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739503	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739536	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010739546	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tension headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739559	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010739618	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739664	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739668	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739687	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rhinitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010739693	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010739697	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Peripheral swelling (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010739705	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (82d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010739719	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Ischaemia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010739747	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739758	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LORAZEPAM] (C - Insomnia - n/a - [n/a - 1mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739766	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739782	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739789	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Brachial plexopathy (n/a - Recovering/Resolving - );Monoparesis (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739799	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739806	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hydrocele (n/a - Not Recovered/Not Resolved - );Orchitis noninfective (n/a - Not Recovered/Not Resolved - );Scrotal swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739819	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739829	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Loss of consciousness (n/a - Unknown - );Pallor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739854	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739877	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739880	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739897	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (7d - Recovered/Resolved - Other Medically Important Condition);Dilated cardiomyopathy (7d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (7d - Recovered/Resolved - Other Medically Important Condition);Orthopnoea (7d - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010739898	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010739902	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010739916	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010739925	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site joint pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739930	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010739933	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head injury (n/a - Recovered/Resolved - Other Medically Important Condition);Rectal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010739934	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved With Sequelae - );Enteritis (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010739942	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interstitial lung disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BICALUTAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010739947	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anorectal discomfort (n/a - Recovering/Resolving - );Dysuria (n/a - Recovering/Resolving - );Eyelid oedema (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739953	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010739957	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Flushing (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	GLYXAMBI [LINAGLIPTIN, EMPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Essential hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010739982	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010739983	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Ischaemia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010739989	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urinary tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010739992	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pleurisy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 15mg - Oral])|[EZETIMIBE, ROSUVASTATIN, EZETIMIBE, ROSUVASTATIN ZINC] (C - n/a - n/a - [n/a - 30mg - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010739995	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010739995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010740004	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740006	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovered/Resolved - );Dyspnoea (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Myositis (n/a - Not Recovered/Not Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010740007	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Recovering/Resolving - );Injection site swelling (1d - Recovering/Resolving - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740014	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740016	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Fatigue (1d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010740043	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740129	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE] (C - Neuropathy peripheral - n/a - [n/a - n/a - n/a])|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[SENNA ALEXANDRIAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740148	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740156	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740161	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin abnormal (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740163	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740164	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740165	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740166	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740168	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740169	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740404	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740405	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740406	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740407	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740414	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740415	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Unknown - );Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740417	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740422	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740423	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram ST segment depression (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740430	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010740432	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740435	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740441	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740451	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740454	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740456	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pleural effusion (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740459	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740467	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740469	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740470	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740471	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Hemianopia homonymous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740472	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperthyroidism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740475	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740477	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eating disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Ophthalmoplegia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740480	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740490	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740492	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740496	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hallucination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740510	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740511	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740513	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1wk - Recovered/Resolved - );Malaise (1wk - Recovered/Resolved - );Pyrexia (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740519	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740520	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740527	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740528	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Pharyngeal paraesthesia (n/a - Recovered/Resolved - );Swollen tongue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE, GLUCOSAMINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740531	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740533	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740535	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diverticulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740537	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740539	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740541	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Muscle fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740546	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740548	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Unknown - );Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition);Sensory disturbance (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740552	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740555	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740556	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740557	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740559	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740562	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pancreatitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740563	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Haematoma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010740566	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740567	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling of body temperature change (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740572	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740573	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740576	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740581	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Rhabdomyolysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740586	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (4d - Recovered/Resolved - Other Medically Important Condition);Muscle swelling (n/a - Unknown - Other Medically Important Condition);Viral infection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740631	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740634	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740639	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Chills (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740642	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740644	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740647	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740648	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010740651	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Viral myocarditis (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Other])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740652	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740654	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Brain fog (n/a - Unknown - Other Medically Important Condition);COVID-19 (35d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Drug ineffective (35d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010740661	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740679	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspepsia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010740680	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (1d - Recovered/Resolved - );Body temperature increased (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740756	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740758	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740761	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740768	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740775	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Brain fog (n/a - Unknown - Disabling);Dehydration (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010740778	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (24h - Recovered/Resolved - );Vaccination site pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010740779	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740780	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010740802	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010740802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010741121	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Throat tightness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010741121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010741216	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010741216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010741820	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (1d - Not Recovered/Not Resolved - );Vaccination failure (1d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010741820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010741860	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010741860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010741915	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY 30 MICROGRAMS/DOSE [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010741915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742030	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Hyperhidrosis (2d - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Polyuria (1d - Recovered/Resolved - );Thirst (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742053	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742054	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742222	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Condition aggravated (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742232	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010742287	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742297	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin abrasion (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742310	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742324	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LAMOTRIGINE] (C - Bipolar disorder relapse prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742330	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742334	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742340	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742343	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010742346	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paresis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010742350	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742362	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Ear pain (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010742363	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dry throat (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Poor quality sleep (n/a - Unknown - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742369	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Dry eye (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Hemiparesis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742373	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742384	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Disabling);Abdominal pain lower (7d - Recovered/Resolved With Sequelae - Disabling);Blepharitis (n/a - Recovered/Resolved - Disabling);Chest pain (n/a - Recovered/Resolved - Disabling);Diarrhoea (8d - Recovered/Resolved - Disabling);Diarrhoea haemorrhagic (7d - Recovered/Resolved - Disabling, Other Medically Important Condition);Eye pain (3d - Recovered/Resolved - Disabling);Gastrointestinal haemorrhage (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Disabling);Rectal haemorrhage (8d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010742389	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742404	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Recovered/Resolved - Other Medically Important Condition);Deafness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ear pain (n/a - Recovered/Resolved - );Facial pain (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in jaw (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Toothache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010742413	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nuchal rigidity (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742416	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742421	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742425	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742428	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742432	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742439	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742440	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742442	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742445	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742447	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742449	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - );Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742452	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742461	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742464	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742476	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742477	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742481	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742482	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pulmonary congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742485	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Dysphonia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Respiratory disorder (n/a - Unknown - );Throat tightness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742487	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742489	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericardial effusion (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742493	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742494	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Renal pain (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010742495	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYLEPHRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, XYLOMETAZOLINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742496	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sinus arrest (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742499	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742502	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742505	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742509	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742511	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Sneezing (n/a - Recovering/Resolving - );Throat irritation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FIASP [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742515	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742519	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742523	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - );Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742526	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742528	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742538	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742540	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Rash macular (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742548	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742551	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742553	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742556	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram PR shortened (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742563	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5h - Recovered/Resolved - );Fatigue (5h - Recovered/Resolved - );Pain in extremity (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742572	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eye swelling (n/a - Recovering/Resolving - );Eyelids pruritus (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742577	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742580	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742581	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved With Sequelae - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Intervertebral disc protrusion (n/a - Unknown - );Limb mass (n/a - Not Recovered/Not Resolved - );Post herpetic neuralgia (n/a - Not Recovered/Not Resolved - );Spinal column injury (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010742585	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742586	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742587	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742590	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742591	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742594	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742596	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis perforated (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742600	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma muscle (n/a - Unknown - Caused/Prolonged Hospitalisation);International normalised ratio increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Prothrombin time prolonged (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010742603	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742604	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742607	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742608	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742613	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742617	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010742621	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742623	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742624	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Demyelination (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742626	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuralgic amyotrophy (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010742627	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742629	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742630	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742631	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742632	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742635	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Diarrhoea haemorrhagic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742636	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742637	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742639	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Cardiac flutter (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - );Dyspnoea exertional (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - );Pleuritic pain (n/a - Recovered/Resolved - );Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742642	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742643	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742646	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742652	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742654	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[INDAPAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEXILETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOSAPRIDE, MOSAPRIDE CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010742656	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742664	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Lethargy (n/a - Unknown - );Myalgia (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Sleep paralysis (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742668	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Electrocardiogram abnormal (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Toothache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742669	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010742677	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742678	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Fibromyalgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Multiple sclerosis (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Trigeminal neuralgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742682	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742684	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742687	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742690	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010742693	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (35min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742695	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742698	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742700	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742702	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742703	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742704	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Contusion (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742708	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010742720	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oral mucosal roughening (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742724	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742740	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742969	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742970	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742971	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010742978	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742991	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010742996	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria chronic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010742996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743034	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Daydreaming (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hyporesponsive to stimuli (n/a - Recovered/Resolved - );Staring (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	AERIUS [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])|[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743066	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743161	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743168	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743172	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743175	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743183	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cyanosis (n/a - Recovered/Resolved - );Dysphagia (n/a - Recovered/Resolved - );Hallucination (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Hemiparesis (n/a - Recovering/Resolving - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[XYLOMETAZOLINE, XYLOMETAZOLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010743186	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743195	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral embolism (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CHOLESTEROLVERLAGER [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|HARTMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|NON SPECIFIED BLOEDDRUKMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743226	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DEXKETOPROFEN, IBUPROFEN, IBUPROFEN, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN PH. EUR., IBUPROFEN SODIUM, IBUPROFEN SODIUM DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743228	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743229	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743231	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Unresponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743232	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743235	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743237	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743242	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743245	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743249	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743250	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743255	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743260	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle tightness (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - n/a - n/a - [n/a - 40mg - n/a])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743261	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743262	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Atypical pneumonia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743264	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743269	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743270	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743272	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flank pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743303	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gout (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743309	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haematuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743311	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Photophobia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Vision blurred (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743319	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Lymphoma (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743326	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Limb discomfort (1d - Recovered/Resolved - );Migraine (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743327	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743330	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Internal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACONITE] (C - Dysuria - n/a - [n/a - n/a - Oral])|[GELATIN] (C - Dysuria - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743333	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743334	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743335	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743350	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Iritis (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743397	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743401	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743409	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743411	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743412	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743424	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743429	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743495	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743501	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010743600	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010743618	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743621	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (14d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743624	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743627	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743628	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743630	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743633	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010743634	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743636	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Fatigue (2d - Recovered/Resolved - );Limb discomfort (0d - Recovering/Resolving - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743638	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743647	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (22d - Not Recovered/Not Resolved - );Myalgia (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010743649	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (35d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743652	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743659	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743662	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743664	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743670	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743672	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743674	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (10d - Recovering/Resolving - );Influenza (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743677	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743678	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743679	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743691	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010743703	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoglycaemic unconsciousness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743718	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743727	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Vomiting (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743743	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Limb immobilisation (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743809	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743810	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743820	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743834	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743835	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743843	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cardiovascular insufficiency (n/a - Unknown - );Hypotension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743845	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743848	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lichen striatus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743858	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743860	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743862	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Middle insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743873	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743874	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Neurodermatitis (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743875	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Headache (7d - Recovered/Resolved - );Nausea (7d - Recovered/Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743877	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743879	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute sinusitis (n/a - Not Recovered/Not Resolved - );Headache (30d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010743887	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743888	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743893	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743894	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743895	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac disorder (n/a - Unknown - );Dizziness (n/a - Recovered/Resolved - );Ear pain (n/a - Unknown - );Headache (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743921	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743948	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010743962	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (30d - Not Recovered/Not Resolved - );Polymenorrhoea (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010743978	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010743981	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010743983	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010743988	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010743988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744008	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744035	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744038	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle ear inflammation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744070	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (3d - Recovering/Resolving - );Chest pain (3d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Nausea (3d - Recovering/Resolving - );Somnolence (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744071	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744081	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744084	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (17d - Not Recovered/Not Resolved - );Psoriatic arthropathy (17d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010744125	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Toothache (44d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010744141	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heart rate decreased (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744142	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (11d - Recovered/Resolved - );Pain (6d - Recovered/Resolved - );Tremor (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744151	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744164	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010744167	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Dysstasia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Monoplegia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Urinary incontinence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [1d - n/a - Unknown])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - 4{DF} - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010744181	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744196	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Unevaluable event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744221	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744226	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744254	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744262	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (25d - Not Recovered/Not Resolved - );Pain (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010744265	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (1d - Not Recovered/Not Resolved - );Oropharyngeal pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744267	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (5d - Recovering/Resolving - );Dyspnoea (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744270	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fibrin D dimer increased (4d - Unknown - );Pain in extremity (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744287	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744296	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744326	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperaesthesia (7d - Recovered/Resolved - );Pain (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744329	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744337	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematospermia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744339	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periorbital swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744362	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic vein thrombosis (35d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010744373	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (4d - Recovered/Resolved - );Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744391	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Inflammatory marker increased (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744400	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Unknown - );Diarrhoea (n/a - Unknown - );Fatigue (2d - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744408	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744419	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744433	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Neoplasm (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010744462	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010744464	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Diarrhoea (0d - Recovering/Resolving - );Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744466	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744467	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744468	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744471	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744475	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744479	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744481	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744483	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744499	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744504	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744507	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744520	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erysipelas (n/a - Recovered/Resolved - Other Medically Important Condition);Otitis externa (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010744536	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle tightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	UROREC [SILODOSIN] (C - Ill-defined disorder - n/a - [n/a - 8mg - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010744542	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744546	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Ejaculation failure (40d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010744547	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744555	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744559	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anal incontinence (n/a - Unknown - );Confusional state (n/a - Unknown - );Restlessness (n/a - Unknown - );Somnolence (n/a - Unknown - );Urinary incontinence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744562	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010744563	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744573	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Post herpetic neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744577	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (12d - Recovered/Resolved - );Pain (7d - Recovered/Resolved - );Tremor (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744596	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Hyperhidrosis (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744610	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744638	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744662	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (30d - Recovered/Resolved With Sequelae - );Injection site pain (30d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010744682	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744689	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (15d - Not Recovered/Not Resolved - );Hypoaesthesia (7d - Recovering/Resolving - );Paraesthesia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744698	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Vaccination site haematoma (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744729	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744730	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744731	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (6d - Recovering/Resolving - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744734	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744735	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010744738	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744740	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744747	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744749	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744777	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744779	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744783	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (16d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744784	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744787	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744789	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744790	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744796	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744800	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744801	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744826	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744835	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744836	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744842	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744852	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744910	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744917	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (6d - Not Recovered/Not Resolved - );Dizziness (9d - Not Recovered/Not Resolved - );Feeling hot (9d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Influenza (9d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (7d - Recovering/Resolving - );Lymphadenopathy (8d - Not Recovered/Not Resolved - );Malaise (9d - Recovering/Resolving - );Pyrexia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744918	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744932	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744933	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744934	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744935	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744960	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744968	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010744984	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010744989	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010744995	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010744996	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010744999	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010744999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010745000	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood glucose increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Excessive granulation tissue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - );Immobile (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Localised infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Non-24-hour sleep-wake disorder (24h - Recovered/Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Wound (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010745018	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745024	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745025	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745026	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745028	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745060	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (4d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745062	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Influenza (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745063	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745065	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745070	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (24d - Recovering/Resolving - );Paraesthesia (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745077	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745078	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - );Pyrexia (7d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745081	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745083	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745092	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010745106	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745110	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745118	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Injection site pain (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745121	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745123	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745124	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Lymphadenopathy (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745137	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745138	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745140	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745144	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovering/Resolving - );Dyspnoea (0d - Recovering/Resolving - );Injection site swelling (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745150	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745152	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Cough (1d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745157	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Not Recovered/Not Resolved - );Limb discomfort (0d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745158	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745174	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745177	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745194	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745201	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745202	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745204	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745207	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745208	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745210	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (31d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (20d - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745212	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745213	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745215	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (34d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745218	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745226	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745240	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745241	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (62d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745251	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745257	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (8d - Recovered/Resolved - );Feeling hot (15d - Not Recovered/Not Resolved - );Injection site pain (16d - Not Recovered/Not Resolved - );Tachycardia (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745259	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745267	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	[MEXAZOLAM] (C - Anxiety - n/a - [n/a - 1{DF} - Oral])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010745290	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745293	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745296	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745298	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Cough (6d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745301	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010745304	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745305	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745314	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010745324	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745327	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745328	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site erythema (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Vaccination site reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745329	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745330	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745334	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745336	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745339	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (40d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745340	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Fatigue (13d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (5d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745345	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745346	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745348	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745350	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745361	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745368	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745369	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745371	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745373	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745375	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745380	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745382	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745397	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745400	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745403	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (11d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010745405	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745409	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745410	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745414	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745418	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745421	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745450	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745460	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745462	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745464	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745519	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745525	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745526	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745528	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745541	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745544	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (2d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745547	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (6d - Recovering/Resolving - );Malaise (9d - Recovered/Resolved - );Myalgia (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745554	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745610	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745614	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745617	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745618	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745625	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745629	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Lymphadenopathy (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745630	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745635	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745640	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745654	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745657	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745663	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745670	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745675	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (13d - Not Recovered/Not Resolved - );Fatigue (13d - Not Recovered/Not Resolved - );Headache (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745676	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745679	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745731	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (17d - Not Recovered/Not Resolved - );Fatigue (14d - Not Recovered/Not Resolved - );Headache (18d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745735	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745739	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745742	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745750	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (5d - Recovered/Resolved - );Fatigue (46d - Unknown - );Limb discomfort (32d - Recovering/Resolving - );Myalgia (32d - Recovering/Resolving - );Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745777	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745779	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745781	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745782	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745783	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745785	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745795	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745797	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745800	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (6d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010745822	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745827	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (43d - Not Recovered/Not Resolved - );Limb discomfort (46d - Not Recovered/Not Resolved - );Myalgia (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745832	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Feeling hot (2d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745840	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010745842	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745843	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745862	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745863	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745869	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745872	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745873	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745875	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (16d - Not Recovered/Not Resolved - );Rash (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745877	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745878	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745886	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745924	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (8d - Recovering/Resolving - );Fatigue (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010745925	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745926	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745929	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745930	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Injection site scar (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010745936	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (0d - Unknown - );Hypoglycaemia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745941	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745984	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Hypertonia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745988	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745990	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745992	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745994	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745995	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745998	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010745999	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010745999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746001	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746002	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746003	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746006	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746028	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010746042	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Influenza (3d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746045	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746119	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010746185	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Idiopathic pulmonary fibrosis (n/a - Fatal - Results in Death);Pulmonary embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010746186	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (0d - Unknown - Caused/Prolonged Hospitalisation);Retrograde amnesia (0d - Unknown - Caused/Prolonged Hospitalisation);Syncope (0d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746188	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746195	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746198	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746199	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746201	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746208	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010746209	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746232	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746238	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746250	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010746253	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746255	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746270	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746272	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746281	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746282	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746289	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746291	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746311	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746312	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746313	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746315	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746319	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746323	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746326	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746328	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746329	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746332	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746337	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746338	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746339	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746342	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746343	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (12d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Disorganised speech (12d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (12d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Pneumonia aspiration (12d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010746345	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood glucose increased (n/a - Unknown - );Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746346	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746347	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746351	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746358	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746374	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746385	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746390	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746391	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746393	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746398	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746404	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746405	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746406	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746407	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746409	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746417	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746420	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746438	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746439	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746448	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746451	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746458	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746479	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746499	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746510	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746511	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746514	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746515	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746522	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Antiphospholipid syndrome (25d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746529	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010746585	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);VIth nerve paralysis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010746595	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746598	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010746606	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010746610	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746621	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010746628	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Not Recovered/Not Resolved - );Paraesthesia (28d - Not Recovered/Not Resolved - );Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010746647	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010746680	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arthralgia (47d - Not Recovered/Not Resolved - );Limb discomfort (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010746681	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746686	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (172d - Recovering/Resolving - );Fatigue (172d - Recovering/Resolving - );Injection site pain (172d - Recovering/Resolving - );Menstruation irregular (172d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010746687	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010746709	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Brain natriuretic peptide increased (7d - Not Recovered/Not Resolved - );Chills (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Pancytopenia (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - );Transaminases increased (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746714	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746733	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746745	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (91d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010746751	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010746832	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746929	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Sepsis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010746954	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010746955	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Recovered/Resolved - );Haematuria (13d - Recovered/Resolved - );Injection site pain (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010746962	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (6h - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010746962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747104	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747105	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747115	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747118	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747137	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747138	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (n/a - Unknown - );Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747148	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747164	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Anxiety (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	COPALIA [VALSARTAN, AMLODIPINE, VALSARTAN, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - )|[RISEDRONATE SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747351	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Subclavian vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|XARELTO 20 MG [RIVAROXABAN] (S - Atrial fibrillation - Drug withdrawn - [n/a - 20mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010747511	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747517	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747523	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747541	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747546	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747547	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747554	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (6d - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Pyrexia (6d - Recovered/Resolved With Sequelae - );Vasculitis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010747555	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010747557	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Flank pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747562	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Peripheral swelling (30min - Recovering/Resolving - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747565	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747567	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);Dyspnoea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010747568	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010747569	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010747571	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Death (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010747573	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Intestinal infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010747575	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (41d - Not Recovered/Not Resolved - );Insomnia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010747601	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010747618	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010747630	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747631	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatic pain (7d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Myalgia (6d - Recovered/Resolved - );Restlessness (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747633	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (1d - Unknown - );Paraesthesia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747649	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden cardiac death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010747676	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (141d - Recovering/Resolving - );Limb discomfort (141d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010747679	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - );Dyspnoea exertional (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010747681	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Peripheral vascular disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747771	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747776	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Application site swelling (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010747781	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747787	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747797	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747798	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747800	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010747830	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010747890	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010747935	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (5min - Unknown - Other Medically Important Condition);Syncope (5min - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intradermal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010747935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010748052	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [31d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010748060	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Syncope (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010748092	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin T increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010748221	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010748234	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010748359	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748361	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748365	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748369	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748377	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748395	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748398	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748406	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010748468	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Product used for unknown indication - Unknown - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010748471	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure fluctuation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - )|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - n/a - n/a - )|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - )|[PROPAFENONE, PROPAFENONE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010748521	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Aphasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Disorientation (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Femoral neck fracture (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Retrograde amnesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [84d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010748616	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (0d - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[TELMISARTAN] (C - Hypertension - n/a - [3y - 80mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748617	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010748697	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disability (n/a - Not Recovered/Not Resolved - Disabling);Sensory loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Walking disability (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010748728	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748739	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748743	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748745	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748755	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748805	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010748852	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010748852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749053	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749054	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fibromyalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010749057	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749060	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749062	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749063	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749064	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pneumothorax (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749068	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749069	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eosinophil count increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Nephrotic syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Physical deconditioning (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749074	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749075	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Recovering/Resolving - );Bradycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749076	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Macular oedema (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010749082	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749083	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - );Cardiac septal hypertrophy (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749084	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749089	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood test abnormal (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749095	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Unknown - );Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lip swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749096	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysstasia (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010749097	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Pharyngeal swelling (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749098	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749102	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749105	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Sweating fever (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749111	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (5h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CARBIMAZOLE] (C - Graves' disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749116	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749117	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749120	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Demyelination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749142	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010749153	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749156	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (9d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (9d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749159	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749168	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749170	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aortitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunoglobulin G4 related disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749175	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749184	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749185	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749187	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749190	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic reaction (560min - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (560min - Recovered/Resolved - Other Medically Important Condition);Eye pruritus (560min - Recovered/Resolved - Other Medically Important Condition);Ocular hyperaemia (560min - Recovered/Resolved - Other Medically Important Condition);Pruritus (560min - Recovered/Resolved - Other Medically Important Condition);Pyrexia (506min - Recovered/Resolved - );Rash (560min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749191	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Encephalitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749192	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - );IVth nerve paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749193	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749194	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749195	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749200	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749205	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749209	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Back pain (2d - Recovered/Resolved - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypotension - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Pulmonary embolism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749217	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749222	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749224	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749227	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Nephritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749232	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cholangitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatitis acute (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749240	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749241	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Gingival bleeding (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749246	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749247	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Memory impairment (n/a - Unknown - );Mental impairment (n/a - Unknown - Other Medically Important Condition);Taste disorder (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749248	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749255	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749266	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Antinuclear antibody positive (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - Other Medically Important Condition);Autoimmune haemolytic anaemia (n/a - Unknown - Other Medically Important Condition);Bacteraemia (n/a - Unknown - Other Medically Important Condition);Epstein-Barr viraemia (n/a - Unknown - );Haemophagocytic lymphohistiocytosis (n/a - Unknown - Other Medically Important Condition);Hepatomegaly (n/a - Unknown - );Hyperferritinaemia (n/a - Unknown - );Hypoxia (n/a - Recovering/Resolving - Other Medically Important Condition);Laboratory test abnormal (n/a - Unknown - );Pancytopenia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749271	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749279	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Unknown - );IVth nerve paralysis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	XELJANZ [TOFACITINIB, TOFACITINIB CITRATE] (C - Vitiligo - n/a - [n/a - 10mg - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 100ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749283	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749285	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749287	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage subcutaneous (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749303	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749304	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);IIIrd nerve paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749305	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749310	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749311	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain lower (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sensory disturbance (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749312	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749313	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Cognitive disorder (n/a - Unknown - );Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749315	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lethargy (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749317	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749319	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Magnetic resonance imaging abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749323	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749325	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749328	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749335	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachypnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749351	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749369	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dysstasia (n/a - Recovering/Resolving - );Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749370	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749375	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Arthritis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749377	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hepatic pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749378	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749381	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatic function abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Polymyalgia rheumatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[CELECOXIB] (C - n/a - n/a - [n/a - n/a - Oral])|[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[EXTRACT FROM INFLAMED RABBIT SKIN INOCULATED WITH VACCINIA VIRUS, NEUROTROPIN, SMALLPOX VACCINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749383	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Transient ischaemic attack (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749384	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dysuria (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749386	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Mobility decreased (n/a - Unknown - Disabling);Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010749389	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749395	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Arthritis - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Thyroid pain - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - Circulatory collapse - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749403	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749409	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749412	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (56d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Supraventricular tachycardia (56d - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (56d - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749414	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Supraventricular tachycardia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749418	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Kim, D.. A Case Report for Myopericarditis after BNT162b2 COVID-19 mRNA Vaccination in a Korean Young Male. Journal of Korean Medical Science. 2021;36 (39):e277. doi:10.3346/jkms.2021.36.e277	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749419	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749422	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749425	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling drunk (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749427	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749428	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749436	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749438	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Lymphadenitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749467	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749469	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749479	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749480	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749483	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749484	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749486	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749487	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749488	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749489	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749492	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749496	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749499	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749551	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CORTISONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749555	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749556	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Pain (n/a - Unknown - );Vaccination site nodule (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749559	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eczema (n/a - Unknown - );Skin plaque (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749560	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749564	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749569	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Prostatic specific antigen increased (1336h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 300mg - Oral])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - 32mg - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - 12.5mg - Oral])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749633	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749635	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749638	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749642	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010749646	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749647	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tenderness (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749651	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010749653	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749654	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749663	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Respiratory syncytial virus test positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749708	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010749709	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749712	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749714	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749727	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin disorder (3d - Recovered/Resolved - Life Threatening);Skin irritation (3d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010749744	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parapsoriasis (n/a - Unknown - );Pityriasis rosea (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749746	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749751	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Stress (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749753	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749755	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749885	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - Other Medically Important Condition);Dizziness (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749906	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749907	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010749908	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749912	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749915	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749917	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (2mo - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphatic disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749924	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749929	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Unknown - );Exercise tolerance decreased (n/a - Unknown - );Headache (n/a - Unknown - );Somnolence (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749930	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749931	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749936	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749938	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749950	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749962	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749963	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749964	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749970	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysstasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MECOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010749973	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749984	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (2d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749986	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Thrombosis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749988	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749989	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010749990	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749991	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal disorder (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Skin swelling (2d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010749996	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Confusional state (1d - Recovered/Resolved - );Disturbance in attention (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010749998	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (13d - Recovered/Resolved - Other Medically Important Condition);Dizziness (13d - Recovered/Resolved - Other Medically Important Condition);Gastritis (294h - Recovered/Resolved - Other Medically Important Condition);Headache (13d - Recovered/Resolved - Other Medically Important Condition);Nausea (11d - Recovered/Resolved - Other Medically Important Condition);VIIIth nerve injury (2d - Recovered/Resolved - Other Medically Important Condition);Vertigo (294h - Recovered/Resolved - Other Medically Important Condition);Vestibular neuronitis (294h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[PROCATEROL HYDROCHLORIDE, PROCATEROL HYDROCHLORIDE HYDRATE] (C - Asthma, Asthma-chronic obstructive pulmonary disease overlap syndrome - n/a - [n/a - n/a - Respiratory (inhalation)])|[THEOPHYLLINE] (C - Asthma, Asthma-chronic obstructive pulmonary disease overlap syndrome - n/a - [n/a - 1{DF} - Oral])|[TIOTROPIUM, OLODATEROL] (C - Asthma, Asthma-chronic obstructive pulmonary disease overlap syndrome - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010749998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750000	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Liver disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750005	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Localised oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750008	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Photosensitivity reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (S - n/a - Unknown - [n/a - 200mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750009	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Delusion (2d - Recovered/Resolved - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Restlessness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750015	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750017	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Retinal vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750106	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750137	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Recovering/Resolving - );Pulmonary thrombosis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [1d - n/a - Intramuscular])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - 20mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750138	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (0d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (48d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010750144	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750148	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiovascular disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory distress (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750217	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Muscular weakness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PANTOPRAZOLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750250	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750256	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750283	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750288	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750291	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750301	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750303	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750304	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Myocardial infarction (0d - Recovered/Resolved - Life Threatening, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010750306	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Bacterial infection (n/a - Unknown - );C-reactive protein decreased (n/a - Unknown - );Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Procalcitonin decreased (n/a - Unknown - );Pyrexia (33h - Recovered/Resolved - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ONGLYZA [SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[AMLODIPINE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[DABIGATRAN] (C - Cerebral artery embolism - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Cardiac failure chronic - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750330	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010750384	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain (n/a - Recovered/Resolved - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750385	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750394	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Papule (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750396	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750398	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750400	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750401	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750402	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750406	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750462	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Disabling);Feeling cold (n/a - Recovered/Resolved - Disabling);Loss of personal independence in daily activities (n/a - Unknown - Disabling);Nasopharyngitis (n/a - Recovered/Resolved - Disabling);Peripheral coldness (213d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010750465	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750466	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750487	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750540	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750589	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750592	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Incomplete course of vaccination (n/a - Unknown - );Urticaria chronic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750595	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Bekkali,  N.. Eczematiform eruption after Pfizer-BioNTech COVID-19 vaccine. Elsevier Masson s.r.l. 2021;76 (4):364-365. doi:10.1016/j.therap.2021.04.012	65-85 Years	Not Specified	No	Male	Eczema (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750676	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750684	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood glucose abnormal (46d - Not Recovered/Not Resolved - );Blood pressure fluctuation (46d - Not Recovered/Not Resolved - );Malaise (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010750686	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750689	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disorientation (17d - Recovering/Resolving - );Fatigue (17d - Recovering/Resolving - );Headache (17d - Recovering/Resolving - );Influenza (n/a - Unknown - );Limb discomfort (17d - Recovering/Resolving - );Pyrexia (17d - Recovering/Resolving - );Renal pain (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010750690	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750691	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Organising pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010750698	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (5d - Unknown - );Dyspnoea (5d - Unknown - );Tachycardia (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010750706	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750733	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Nasopharyngitis (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750749	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (26d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750752	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Respiratory failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010750772	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750780	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750788	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aortic thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750789	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Atrioventricular block (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750790	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fall (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - );Respiratory tract infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750792	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750793	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750797	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Polyneuropathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750803	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESBRIET [PIRFENIDONE] (C - Idiopathic pulmonary fibrosis - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750819	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradykinesia (n/a - Recovered/Resolved - );Hangover (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BICALUTAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTRADIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750823	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010750872	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thalamus haemorrhage (27d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ANGELICA ROOT, GLYCYRRHIZA GLABRA] (C - n/a - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750873	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Electrocardiogram abnormal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750883	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Basal cell carcinoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750900	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage subcutaneous (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mouth haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[SODIUM FERROUS CITRATE] (C - Anaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750905	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dysarthria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyskinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010750910	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750935	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750937	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750939	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750945	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750946	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscle haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010750974	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750975	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750976	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750978	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010750982	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010750982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010751000	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751002	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751011	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [56d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751018	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751022	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751033	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Incorrect dose administered (48h - Recovered/Resolved - );Vaccination site pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751041	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751042	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[METHADONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751045	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751047	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751065	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	Yes	Male	Vaccination failure (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751070	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751073	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751078	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (6mo - Recovered/Resolved - );Psoriatic arthropathy (6mo - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METHOTREXATE DISODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[NICARDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751079	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751080	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751081	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751082	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751093	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751101	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751108	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid oedema (n/a - Recovering/Resolving - );Rash maculo-papular (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751128	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751129	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751133	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751135	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751136	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751141	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751157	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751158	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751159	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751181	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751182	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751185	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - );Eczema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751186	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751187	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751196	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema (145d - Recovered/Resolved - );Urticaria (145d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [17d - 2{DF} - Intramuscular])|[AMOXICILLIN, AMOXICILLIN SODIUM, AMOXICILLIN TRIHYDRATE] (S - Tonsillitis - Drug withdrawn - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010751198	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysuria (n/a - Recovering/Resolving - );Influenza like illness (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751207	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751211	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751217	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Menstrual disorder (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751225	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751226	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751227	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Hypoaesthesia oral (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751230	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751231	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751236	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751238	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye disorder (45min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751247	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751248	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751262	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751265	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Menstrual disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751270	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vascular purpura (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751271	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751273	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751277	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751281	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751288	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751292	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751294	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751298	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (n/a - Recovered/Resolved - );Ophthalmic migraine (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [230d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751312	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751315	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751323	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (1wk - Recovered/Resolved - );Lymph node palpable (1wk - Recovered/Resolved - );Lymphadenitis (1wk - Recovered/Resolved - );Lymphadenopathy (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FENOFIBRATE] (C - n/a - n/a - [n/a - 160mg - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 125mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751331	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (2wk - Not Recovered/Not Resolved - );Nasopharyngitis (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751332	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751333	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751335	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751337	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo positional (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751342	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751348	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751349	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751352	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751353	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751358	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751361	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751691	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infection (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010751706	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Increased tendency to bruise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751711	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Flatulence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751718	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Acute disseminated encephalomyelitis (n/a - Unknown - Other Medically Important Condition);Multiple sclerosis (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])|HUMIRA [ADALIMUMAB] (S - Product used for unknown indication - Drug withdrawn - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010751735	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Depressed level of consciousness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010751761	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751791	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Infection (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010751819	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (14d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (14d - Recovered/Resolved - );Injection site swelling (14d - Recovered/Resolved - );Thyroxine increased (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751851	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (91d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HYDROCHLOROTHIAZIDE 12.5MG TABLET, ALISKIREN 150MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CLOMIPRAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751855	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010751881	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[COLESTYRAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Diverticulum - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010751882	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (1d - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010751884	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Typhoid fever (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010751885	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010751897	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (3d - Recovered/Resolved - Other Medically Important Condition);Chest pain (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Libido decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pleuritic pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Respiratory rate increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - Vitamin B12 deficiency - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010751898	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010751901	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Deafness (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vitreous floaters (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	INVEGA [PALIPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)] (C - n/a - n/a - [1d - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LITHIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010751906	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coronary artery disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coronary artery stenosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Road traffic accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010751939	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010751971	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Sciatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[PARACETAMOL, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010751971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752009	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (72h - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752079	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vein collapse (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMINO ACIDS] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752084	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (2d - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	AERIUS [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - 1{DF} - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - 2{DF} - n/a])|[BUDESONIDE, SALMETEROL] (C - Hypersensitivity - n/a - [n/a - 1{DF} - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 1{DF} - n/a])|[ROSUVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752118	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (4h - Unknown - );Dizziness (4h - Unknown - );Throat irritation (4h - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752141	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752142	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752144	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752148	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Somnolence (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752158	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752159	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - );Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Paresis (n/a - Not Recovered/Not Resolved - );Unresponsive to stimuli (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752163	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752167	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752168	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - 75mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010752240	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Premature ejaculation (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752245	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752252	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Right ventricular failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752280	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (167d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010752285	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6d - Recovered/Resolved With Sequelae - );Headache (6d - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Pyrexia (6d - Recovered/Resolved With Sequelae - );Vasculitis (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010752288	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752303	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752310	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752312	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Therapeutic response unexpected (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752313	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752315	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752316	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Panic attack (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752329	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752336	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752337	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752339	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lacrimation increased (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Barrett's oesophagus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752342	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (56d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752351	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OLMESARTAN MEDOXOMIL, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752381	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010752384	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature decreased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752385	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment depression (n/a - Recovering/Resolving - Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752387	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Product dose omission issue (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752392	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary incontinence (4d - Recovered/Resolved - Other Medically Important Condition);Urine output decreased (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752414	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 2{DF} - Intramuscular])	ARANESP 150 MICROGRAMS SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE [DARBEPOETIN ALFA] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[DRIED FERROUS SULFATE, FERROUS SULFATE, FERROUS SULFATE HYDRATE, FERROUS SULPHATE SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIPTORELIN PAMOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010752419	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tendon disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752429	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumothorax (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752437	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eosinophilic cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	[SOLIFENACIN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752442	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Hypertension (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752448	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752456	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752459	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Petit mal epilepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752462	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752465	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Giant cell arteritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752466	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE] (C - Myocarditis - Not applicable - [n/a - 2.5mg - Oral])|[RAMIPRIL] (C - Myocarditis - Not applicable - [n/a - 2.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752467	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752468	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752469	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Carotid artery dissection (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE] (C - Hypertension - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010752470	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752477	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752486	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752487	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebellar haematoma (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010752496	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752512	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hyperthyroidism (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010752515	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vertigo (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752519	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (4d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (4d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010752524	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752527	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chondrocalcinosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752532	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752553	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752570	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752571	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752574	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010752575	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752576	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752580	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (12h - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752581	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010752588	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Purpura (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752628	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (109d - Recovered/Resolved - Other Medically Important Condition);Impetigo (109d - Recovered/Resolved - Other Medically Important Condition);Parotitis (109d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010752633	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis reactive (n/a - Not Recovered/Not Resolved - Disabling);Dysstasia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010752637	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FINASTERIDE] (C - Androgenetic alopecia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752638	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752642	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Wheezing (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752646	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010752695	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010752706	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Childhood asthma (n/a - Not Recovered/Not Resolved - );Disease recurrence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752715	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752728	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Defaecation disorder (n/a - Not Recovered/Not Resolved - );Sensitive skin (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - n/a])|[PREDNISONE] (S - Polymyalgia rheumatica - Dose not changed - [n/a - n/a - n/a])	CHOLESTEROLVERLAGER [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|NON SPECIFIED BLOEDDRUKMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752733	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gastrointestinal haemorrhage (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|LEVETIRACETAM 250 MG - FILM-COATED TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010752763	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Photophobia (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (5d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010752779	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752816	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010752851	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Palpitations (n/a - Unknown - );Panic attack (n/a - Unknown - );Tachycardia (n/a - Not Recovered/Not Resolved - );Throat irritation (n/a - Unknown - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010752952	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thalamic infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010752980	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Heart rate decreased (0d - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010752980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753060	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (16h - Recovered/Resolved - );Myalgia (5h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753137	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Fall (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753172	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753177	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753179	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concussion (n/a - Unknown - Other Medically Important Condition);Face injury (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Fracture (n/a - Unknown - Other Medically Important Condition);Joint dislocation (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pain in jaw (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition);Skin laceration (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition);Trismus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753195	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753240	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753242	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753310	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753416	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753424	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753429	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753459	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010753496	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Exercise tolerance decreased (3h - Recovered/Resolved - );Palpitations (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010753549	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Dehydration (n/a - Unknown - );Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperventilation (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753587	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Atrial fibrillation (8d - Recovered/Resolved - Disabling, Other Medically Important Condition);Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Platelet count decreased (n/a - Unknown - );Vaccination site erythema (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site rash (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 5mg - Oral - More in ICSR])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - 10mg - Oral - More in ICSR])|[OMEPRAZOLE] (C - Barrett's oesophagus, Gastrooesophageal reflux disease - n/a - [n/a - 40mg - Oral - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010753596	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753640	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753664	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753667	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Emotional disorder (1d - Recovered/Resolved - Other Medically Important Condition);Emotional distress (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753696	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753721	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010753724	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010753741	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753750	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753752	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753754	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010753758	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Rash erythematous (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - );Skin lesion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ADAPALENE] (C - Acne - n/a - [212d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753778	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Exposure to SARS-CoV-2 (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753798	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753813	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753826	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753832	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753867	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eructation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pollakiuria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753882	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Crystal arthropathy (n/a - Recovering/Resolving - );Dizziness (17970min - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753885	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CINNARIZINE] (C - Ataxia, Nausea - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUNARIZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLMITRIPTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010753906	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Catarrh (3d - Recovered/Resolved - Other Medically Important Condition);Depression (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753913	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010753965	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010753982	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (3wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010753990	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (8h - Recovered/Resolved - );Oropharyngeal discomfort (8h - Recovered/Resolved - );Oropharyngeal pain (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010753990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754007	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster reactivation (n/a - Recovered/Resolved - Other Medically Important Condition);Migraine (n/a - Unknown - );Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[PRAVASTATIN SODIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754009	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (0d - Recovered/Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (7d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (2h - Recovered/Resolved - );Sarcoidosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754045	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (48h - Recovered/Resolved - );Asthenia (48h - Recovered/Resolved - );Diarrhoea (48h - Recovered/Resolved - );Feeding disorder (48h - Recovered/Resolved - );Malaise (48h - Recovered/Resolved - );Vomiting (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754046	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754053	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754201	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);COVID-19 (n/a - Unknown - );Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754242	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754256	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754269	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (4790min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (4730min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (4760min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lethargy (5330min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (4790min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754347	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754375	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754386	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754433	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754608	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754609	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754616	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Depressed mood (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754617	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Leukopenia (182d - Recovered/Resolved - );Lymphopenia (182d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010754618	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Embolic stroke (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754620	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	SYNJARDY 12.5 MG/1,000 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - Product used for unknown indication - Not applicable - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Transient ischaemic attack - Not applicable - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Gout - Not applicable - [n/a - n/a - Oral])|[CIPROFLOXACIN] (C - Otitis externa - Not applicable - [n/a - n/a - Other])|[EZETIMIBE, ROSUVASTATIN] (C - Myocardial ischaemia - Not applicable - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE] (C - Myocardial ischaemia - Not applicable - [n/a - n/a - Oral])|[PANTOPRAZOLE] (C - Myocardial ischaemia - Not applicable - [n/a - n/a - Oral])|[PARACETAMOL] (C - Arthrodesis - Not applicable - [n/a - n/a - Oral])|[SOLIFENACIN SUCCINATE] (C - Benign prostatic hyperplasia - Not applicable - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - Benign prostatic hyperplasia - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754632	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754665	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])|[MERCAPTOPURINE] (S - Hepatic cirrhosis - Unknown - [n/a - 50mg - n/a])	NOT AVAILABLE (C - n/a - Not applicable - )|NOT AVAILABLE (C - n/a - Unknown - )|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Unknown - )|[SPIRONOLACTONE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010754673	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010754674	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754676	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - Diabetes mellitus - Dose not changed - [n/a - 5mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - Dose not changed - [n/a - 100mg - Oral])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)] (C - Prophylaxis - Dose not changed - [1d - .5mL - Intramuscular])|[ESOMEPRAZOLE] (C - n/a - Dose not changed - [n/a - 20mg - Oral])|[KETAZOLAM] (C - n/a - Dose not changed - [n/a - 15mg - Oral])|[MANIDIPINE DIHYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 10mg - Oral])|[METAMIZOLE MAGNESIUM] (C - n/a - Dose not changed - [n/a - 575mg - Oral])|[MIRTAZAPINE] (C - n/a - Dose not changed - [n/a - 30mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - Hypertension - Dose increased - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754677	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010754678	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)] (S - Influenza immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010754696	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754698	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754711	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754712	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754721	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754722	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemoglobin decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (30s - Recovering/Resolving - Caused/Prolonged Hospitalisation);Unresponsive to stimuli (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754784	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Foetal exposure during pregnancy (n/a - Recovered/Resolved - Results in Death, Congenital Anomaly);Foetal malformation (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010754868	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010754919	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Ear discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Laryngeal dyskinesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754927	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Hyperglycaemia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Dose not changed - [n/a - n/a - Intramuscular])	TOUJEO SOLOSTAR 300 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - Subcutaneous])|ZOMARIST 50 MG/850 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Acute myocardial infarction - Dose not changed - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Cardiovascular event prophylaxis - Dose not changed - [n/a - n/a - Oral])|[CAFFEINE CITRATE, GLYCERYL TRINITRATE] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - Sublingual])|[FENTANYL] (C - Pain - Dose not changed - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Prophylaxis against gastrointestinal ulcer - Dose not changed - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - Dose not changed - [n/a - n/a - Oral])|[TORASEMIDE] (C - Angina unstable - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754945	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754958	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754959	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754965	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754979	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[CALCIFEDIOL] (C - Osteopenia - Dose not changed - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Rhinitis - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010754983	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754987	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010754988	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])|[B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010754988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755009	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755012	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010755030	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (2h - Recovered/Resolved - );Chest discomfort (2h - Recovered/Resolved - );Dyspnoea (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010755056	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755058	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	No	Male	Gastroenteritis Escherichia coli (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Maternal exposure during breast feeding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755073	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755080	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010755094	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flushing (1h - Recovered/Resolved - );Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755109	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755112	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755121	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755122	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755130	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755172	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755237	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755261	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal loss of weight (n/a - Unknown - Caused/Prolonged Hospitalisation);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010755265	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010755276	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010755305	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaemia (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Leukocytosis (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010755358	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010755366	Spontaneous	2021-11-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Brain injury (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Renal failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010755410	Spontaneous	2021-11-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010755410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010717968	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010717982	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718002	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Polymerase chain reaction positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718012	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Administration site reaction (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718013	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718014	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718019	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myositis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718021	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Apathy (n/a - Recovered/Resolved - );Confusional state (n/a - Recovered/Resolved - );Depression (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Autoimmune hepatitis - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718178	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718187	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010718191	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010718196	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Intervertebral disc protrusion (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718209	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718252	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010718264	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010719814	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (61d - Recovered/Resolved - );Fatigue (61d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010719818	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720000	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Autonomic dysreflexia (n/a - Recovering/Resolving - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Recovering/Resolving - Other Medically Important Condition);Physical deconditioning (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BILASTINE] (C - n/a - n/a - [n/a - n/a - Oral])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720014	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720015	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Photopsia (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720016	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Embolic stroke (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BEZAFIBRATE] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[TELMISARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720020	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720025	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720044	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720056	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720061	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Ear discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010720093	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720121	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720124	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720132	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neck pain (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - n/a - [n/a - 1{DF} - Intramuscular])	KARVEA [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720142	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lip oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010720149	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720156	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720184	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010720192	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Axillary pain (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720197	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720200	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720204	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720208	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720212	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720217	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720218	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (13d - Recovered/Resolved - );Fatigue (13d - Recovered/Resolved - );Insomnia (13d - Recovered/Resolved - );Vomiting (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720220	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720224	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Prostatitis (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010720246	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720248	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720258	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720261	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720279	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720299	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Injection site oedema (n/a - Unknown - );Injection site pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720322	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Raynaud's phenomenon (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720331	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720343	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[PYRIDOSTIGMINE, PYRIDOSTIGMINE BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720350	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Flushing (n/a - Not Recovered/Not Resolved - );Joint warmth (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID, ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, ACETYLSALICYLIC ACID, MAGNESIUM HYDROXIDE, ALGELDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL PH. EUR., CHLORTALIDONE PH. EUR., ATENOLOL, CHLORTALIDONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720424	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720429	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720443	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720563	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (230h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lung infiltration (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (230h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pleurisy (230h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (230h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary infarction (230h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720564	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Frequent bowel movements (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720565	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010720685	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720701	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010720702	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720704	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010720716	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010720720	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010720950	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720952	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Liquid product physical issue (n/a - Unknown - );Muscular weakness (1d - Recovered/Resolved - );Product colour issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720958	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Hypotonia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010720976	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Diplegia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Movement disorder (n/a - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720981	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010720985	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010720986	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Fatigue (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pollakiuria (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vomiting (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - 1.25mg - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 4mg - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010720995	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Respiratory disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010720995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010721005	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721011	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010721136	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010721282	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Breast swelling (n/a - Recovering/Resolving - );Gynaecomastia (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721285	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721328	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (6d - Recovered/Resolved - );Dry skin (n/a - Not Recovered/Not Resolved - );Fatigue (14d - Recovered/Resolved - );Nasal congestion (n/a - Unknown - );Paraesthesia (n/a - Recovering/Resolving - );Pruritus (n/a - Not Recovered/Not Resolved - );Respiratory symptom (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721446	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Immunisation - Not applicable - [1d - n/a - Parenteral])	[BUDESONIDE, BUDESONIDE, MICRONISED] (C - n/a - Dose not changed - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010721495	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleurisy (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010721522	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved With Sequelae - );Fatigue (1d - Recovered/Resolved With Sequelae - );Myalgia (1d - Recovered/Resolved With Sequelae - );Somnolence (1d - Recovered/Resolved With Sequelae - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010721525	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Incorrect route of product administration (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721542	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721547	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure fluctuation (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010721557	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721562	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721565	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Scar pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721566	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Insomnia (52h - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ENALAPRIL, ENALAPRIL MALEATE] (C - Blood pressure measurement - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721568	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Deafness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dysgeusia (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Toothache (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010721574	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (8h - Recovering/Resolving - );Back pain (8h - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (8h - Recovering/Resolving - );Pyrexia (8h - Recovered/Resolved - );Vomiting (8h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORPHENAMINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROMETHAZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721586	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Immunisation reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE OXIDE] (C - Diarrhoea - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721587	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Joint range of motion decreased (n/a - Unknown - );Neck pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721588	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010721603	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ear haemorrhage (4d - Recovered/Resolved - Other Medically Important Condition);Epistaxis (21d - Recovered/Resolved - Other Medically Important Condition);Eye haemorrhage (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010721781	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aggression (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Irritability (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721877	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - );Paraesthesia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010721943	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Lymphadenopathy (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010721974	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010721982	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010721985	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial flutter (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - )|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010721985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010722038	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Unknown - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722057	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010722090	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Dyspepsia (n/a - Recovering/Resolving - Disabling);Exercise tolerance decreased (n/a - Recovering/Resolving - Disabling);Extrasystoles (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Fear of disease (n/a - Recovering/Resolving - Disabling);Loss of personal independence in daily activities (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myocarditis (n/a - Recovering/Resolving - Disabling);Sleep disorder (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010722144	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - );Syncope (5min - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010722280	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Nuchal rigidity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722537	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010722538	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (3mo - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE, CIPROFLOXACIN LACTATE] (C - n/a - n/a - )|[DEXTRIFERRON] (C - n/a - n/a - [n/a - 1000mg - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 4mg - n/a])|[POTASSIUM HYDROGEN CARBONATE, CITRIC ACID ANHYDROUS, POTASSIUM CITRATE, POTASSIUM HYDROGEN CARBONATE, POTASSIUM CITRATE PH. EUR., CITRIC ACID, POTASSIUM HYDROGEN CARBONATE, POTASSIUM CITRATE, CITRIC ACID] (C - n/a - n/a - [n/a - 40mg - n/a])|[PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010722542	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site warmth (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722555	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722557	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722560	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722571	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722574	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Incorrect product formulation administered (n/a - Unknown - );Liquid product physical issue (n/a - Unknown - );Muscular weakness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722591	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722615	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722619	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722621	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Idiopathic urticaria (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722627	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722630	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disturbance in attention (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Muscle tightness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010722633	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722639	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (5d - Recovered/Resolved - Disabling, Other Medically Important Condition);Nausea (6d - Recovered/Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010722640	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722642	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - );Cough (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Recovered/Resolved - );Oedema genital (n/a - Recovered/Resolved - );Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Skin discolouration (n/a - Recovering/Resolving - );Swelling face (n/a - Recovered/Resolved - );Swollen tongue (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722645	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722652	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722659	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash erythematous (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722665	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722673	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722679	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722683	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722688	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722701	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema of eyelid (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Eye swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lacrimation increased (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722706	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Dizziness (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010722711	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010722713	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (10s - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010722720	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722724	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Monoplegia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010722733	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010722741	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010722744	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Sudden hearing loss (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	GANFORT [TIMOLOL MALEATE, BIMATOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010722755	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010722796	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMYLASE, LIPASE, PROTEASE, AMYLASE, LIPASE, PROTEASE, PANCREAS POWDER, PANCREAS POWDER FROM PORCINE, PANCREAS POWDER FROM PORCINE, AMYLASE, LIPASE, PROTEASE, PANCREATIN, PANCREATIN, AMYLASE, LIPASE, PROTEASE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722801	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - 20mg - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, COLECALCIFEROL CONCENTRATE (OILY FORM)] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 50mg - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010722904	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids thrombosed (n/a - Unknown - Life Threatening);Proctalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[CANDESARTAN CILEXETIL] (C - Hypertension - Dose not changed - [n/a - 8mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010722904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010723005	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Diarrhoea (10d - Recovered/Resolved - );Fatigue (12d - Recovered/Resolved - );Influenza (8d - Recovering/Resolving - );Myalgia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723007	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (n/a - Unknown - );Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723026	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Feeling of body temperature change (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723027	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cardiovascular disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010723031	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723036	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723041	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovered/Resolved - );Hypoaesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723045	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cutaneous vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010723046	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (5d - Not Recovered/Not Resolved - );Mobility decreased (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723080	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723103	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (3d - Recovered/Resolved - );Eye pain (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Stupor (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010723250	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PYRIDOSTIGMINE] (C - Muscular weakness - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010723381	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Asthenia (13min - Recovered/Resolved - Life Threatening);Chest pain (13min - Recovered/Resolved - Life Threatening);Hypotension (n/a - Recovered/Resolved - Life Threatening);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening);Malaise (n/a - Unknown - Life Threatening);Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010723562	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haematoma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010723562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010724051	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[TELMISARTAN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724169	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724219	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lip swelling (n/a - Recovering/Resolving - );Oedema peripheral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE] (C - n/a - n/a - [n/a - n/a - Oral])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[BETAHISTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724259	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724260	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724266	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724271	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Anxiety (n/a - Recovering/Resolving - );Apathy (n/a - Recovering/Resolving - Other Medically Important Condition);Aphasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arrhythmia (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - );Chills (n/a - Unknown - );Cognitive disorder (n/a - Unknown - );Contusion (n/a - Unknown - );Depressed level of consciousness (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysphagia (n/a - Unknown - );Dysphonia (n/a - Unknown - );Dyspnoea (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Exercise tolerance decreased (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - );Feeling of body temperature change (n/a - Unknown - );Gilbert's syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation);Head discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - );Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - );Hypotension (n/a - Unknown - );Insomnia (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Joint instability (n/a - Unknown - );Judgement impaired (n/a - Unknown - );Lethargy (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Memory impairment (n/a - Unknown - );Muscle discomfort (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Muscle spasms (4d - Recovered/Resolved - Other Medically Important Condition);Muscle spasticity (n/a - Unknown - );Muscle strain (n/a - Unknown - );Muscle twitching (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Myalgia (4d - Recovered/Resolved - Other Medically Important Condition);Myopathy (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - );Night sweats (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Panic disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - );Pharyngitis (n/a - Unknown - );Photophobia (n/a - Unknown - );Platypnoea (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Polyneuropathy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Injection - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - Dose increased - [1d - n/a - Oral])|[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[PYRIDOXINE] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[RIBOFLAVIN] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[THIAMINE NITRATE] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010724305	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Chills (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724310	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - Disabling);Hypoacusis (n/a - Recovered/Resolved With Sequelae - Disabling);Neurosensory hypoacusis (n/a - Recovered/Resolved With Sequelae - Disabling);Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010724428	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Mental fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010724459	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Unknown - );Peripheral artery thrombosis (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724462	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724466	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724520	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved - );Flushing (n/a - Recovered/Resolved - );Lymphadenitis (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - )|[PERINDOPRIL TERT-BUTYLAMINE, AMLODIPINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724523	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010724535	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010724546	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Dizziness (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Illness (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Platelet count decreased (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724548	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLCYSTEINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724582	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724587	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724589	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724605	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Neck pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724610	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724617	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Recovered/Resolved - );Local reaction (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724633	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Headache (n/a - Unknown - );Swollen tongue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724642	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Multiple sclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - 100mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 15mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - 160mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010724650	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Movement disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724654	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoacusis (17d - Not Recovered/Not Resolved - );Paraesthesia (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724657	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724659	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood urine present (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Petechiae (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010724671	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010724695	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dyspnoea (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Polyserositis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinary tract infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010724697	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	B-cell lymphoma (n/a - Fatal - Results in Death);Testis cancer (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010724703	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010724711	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bacterial sepsis (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HALOPERIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[MELPERONE, MELPERONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEMANTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIAPRIDE, TIAPRIDE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010724716	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cutaneous sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cytomegalovirus infection reactivation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 150mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - 2.5mg - Oral])|[CICLOSPORIN] (C - Renal transplant - n/a - [n/a - 125mg - Oral])|[DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 180mg - Oral])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 2.5mg - Oral])|[MYCOPHENOLATE SODIUM, MYCOPHENOLIC ACID] (C - Renal transplant - n/a - [n/a - 1080mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724720	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Virologic failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ATRIPLA [EMTRICITABINE, EFAVIRENZ, TENOFOVIR DISOPROXIL, EMTRICITABINE, EFAVIRENZ, TENOFOVIR DISOPROXIL FUMARATE] (C - HIV infection - n/a - [13y - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724725	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse drug reaction (n/a - Recovered/Resolved - );Gait disturbance (n/a - Recovered/Resolved - );Head discomfort (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010724729	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724789	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724806	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 2.5mg - n/a])|HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 10mg - n/a])|[BISOPROLOL FUMARATE] (C - Angina pectoris - n/a - [n/a - 2.5mg - n/a])|[DIGOXIN, DIGOXIN PH. EUR.] (C - Atrial fibrillation - n/a - [n/a - 62.5mg - n/a])|[DUTASTERIDE] (C - Prostatic disorder - n/a - [n/a - .5mg - n/a])|[FUROSEMIDE] (C - Fluid retention - n/a - [n/a - 40mg - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatic disorder - n/a - [n/a - 400ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010724818	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010724887	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Stress (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724888	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724893	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cognitive linguistic deficit (n/a - Unknown - Disabling, Other Medically Important Condition);Contusion (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Coordination abnormal (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Grip strength decreased (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Neurological symptom (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010724894	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724895	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724900	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724903	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain of skin (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724905	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Other Medically Important Condition);Cough (3d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (3d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sneezing (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724906	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724943	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724944	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual field defect (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724946	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724948	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angioedema (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[CODEINE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724950	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (0d - Recovered/Resolved - Other Medically Important Condition);Arrhythmia (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (0d - Recovered/Resolved - Other Medically Important Condition);Hypertension (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (0d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 80mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[NICORANDIL] (C - n/a - n/a - [n/a - 20mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724955	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010724958	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (10d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Sciatica (10d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Sleep disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010724967	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperthyroidism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBIMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724968	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010724969	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 15mg - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 5mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010724969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725017	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product use issue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	[HUMAN COAGULATION FACTOR VII] (C - Factor VII deficiency - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010725088	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FORXIGA 5 MG FILM-COATED TABLETS [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|GREPID 75 MG FILM-COATED TABLETS [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|IRBESARTAN 75 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PROCORALAN 5 MG FILM-COATED TABLETS [IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|TOUJEO SOLOSTAR [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725105	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725109	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Mouth haemorrhage (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010725111	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725117	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725119	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Eye pain (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Groin pain (n/a - Unknown - );Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Vomiting projectile (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725121	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALFUZOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725124	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Chronic kidney disease - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[QUININE BISULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725125	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epicondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725128	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010725175	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010725189	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Hypokinesia (n/a - Not Recovered/Not Resolved - );Impaired work ability (2d - Recovered/Resolved - );Infection (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725210	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aplastic anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Contusion (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pancytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010725213	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Recovered/Resolved - Other Medically Important Condition);Disorientation (n/a - Recovered/Resolved - Other Medically Important Condition);Transient ischaemic attack (3h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725252	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725259	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725260	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pustule (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725272	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	EXFORGE [VALSARTAN, AMLODIPINE, VALSARTAN, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725323	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010725354	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725357	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725360	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725371	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725372	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725374	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725377	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Suicidal ideation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725380	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovered/Resolved - );Swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725381	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Hypersomnia (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paralysis (2h - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725382	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725400	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725406	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725412	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amenorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725417	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling);Myocarditis (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010725480	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Disease recurrence (n/a - Unknown - Life Threatening);Feeling hot (1wk - Recovered/Resolved - Life Threatening);Heart rate increased (n/a - Recovering/Resolving - Life Threatening);Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010725489	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010725532	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725539	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725543	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725547	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725576	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	RILUZOLE [RILUZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|TRESIBA [INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725604	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Fatal - Results in Death);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010725656	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725659	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725683	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725755	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725763	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010725770	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Posterior reversible encephalopathy syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Psoriasis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash pruritic (n/a - Unknown - Caused/Prolonged Hospitalisation);Seborrhoeic dermatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010725772	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Electrocardiogram abnormal (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725791	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725796	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725805	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725829	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010725863	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010725866	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725876	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725880	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010725897	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Medical induction of coma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010725902	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - );Blood creatine phosphokinase MB increased (n/a - Unknown - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Unknown - Other Medically Important Condition);Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Coronary artery stenosis (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - );Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Oedema peripheral (n/a - Unknown - );Pallor (n/a - Unknown - );Ventricular fibrillation (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|SILODOSIN [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ETIZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEMANTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010725903	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010725912	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (6mo - Recovered/Resolved - );Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - );Nystagmus (1mo - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010725912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726005	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726009	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726011	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726029	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Mental disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Phlebitis (n/a - Unknown - Disabling);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition);Vascular pain (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010726030	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726031	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 treatment - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE] (S - n/a - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE, PARACETAMOL, CODEINE PHOSPHATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726034	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726035	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood cholesterol abnormal (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Oedema peripheral (158h - Recovered/Resolved - );Rash (158h - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );White blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	VALDOXAN [AGOMELATINE] (C - Depression - n/a - [n/a - n/a - Oral])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010726036	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis allergic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Swelling face (16d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010726108	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726154	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726157	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726159	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726163	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726165	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726166	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Feeling hot (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726168	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chalazion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726171	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726173	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );White blood cell count increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726174	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, FOLIC ACID, NICOTINAMIDE, POTASSIUM CHLORIDE, LACTOBACILLUS GASSERI, CALCIUM, CHROMIC CHLORIDE, IRON, MAGNESIUM, MANGANESE, PHOSPHORUS, MOLYBDENUM, BIFIDOBACTERIUM LONGUM, BIFIDOBACTERIUM SPP.] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SELENIUM, SODIUM SELENITE PENTAHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726280	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726283	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010726284	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010726290	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac ventricular thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010726341	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726364	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infection (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726368	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - );Vaccination site rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726373	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010726390	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Autoantibody positive (n/a - Unknown - Other Medically Important Condition);Blood immunoglobulin G increased (n/a - Unknown - Other Medically Important Condition);Impaired work ability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Movement disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726391	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726392	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726397	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726400	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726410	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure abnormal (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726418	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Plantar erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726419	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726424	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726428	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726432	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersomnia (n/a - Unknown - );Hypoaesthesia (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )|[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726447	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infection (11d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726453	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726472	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (15d - Recovered/Resolved - );Headache (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726477	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726480	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726483	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726485	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (2mo - Recovered/Resolved - );Alopecia (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726488	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726490	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726494	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Exercise tolerance decreased (n/a - Unknown - );Inflammation (n/a - Unknown - );Myositis (n/a - Recovering/Resolving - );Periostitis (n/a - Recovering/Resolving - );Tendonitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[BETULA VERRUCOSA POLLEN] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[DESLORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726512	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726524	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726536	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726552	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LYMECYCLINE] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726553	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726665	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726673	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM DIHYDRATE] (C - n/a - n/a - [n/a - 40mg - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726678	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726691	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Subdural haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726694	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726696	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010726698	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726706	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726707	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726711	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bursitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726714	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726741	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Unknown - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010726746	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (3d - Recovered/Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726779	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010726801	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726807	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Maximum heart rate (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Nasal dryness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726810	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Taste disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726879	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726897	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010726899	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010726924	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Body temperature decreased (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010726924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010727044	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010727067	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727074	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727079	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatinine increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727083	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727085	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Unknown - );Neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727105	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ear pain (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727112	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727167	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727218	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [80d - 2{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010727220	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010727224	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727225	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727231	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727241	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727269	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (14d - Recovered/Resolved - Other Medically Important Condition);Fall (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (14d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727272	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727283	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727284	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727289	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [33d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727292	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	CSF oligoclonal band present (n/a - Unknown - Other Medically Important Condition);Myelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727308	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cardiac failure (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Septic shock (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727314	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal artery occlusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727316	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral ischaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727326	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ZOLMITRIPTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727341	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Phlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727344	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pancreatitis acute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727345	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal obstruction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727352	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727354	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727356	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727362	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727363	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute pulmonary oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Acute respiratory failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727365	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epstein-Barr virus infection (n/a - Recovering/Resolving - Other Medically Important Condition);Tonsillitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727366	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010727368	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727369	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tongue oedema (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727372	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727378	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727388	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [41d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727391	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727394	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727400	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727402	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727403	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral artery thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727413	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Recovered/Resolved - Other Medically Important Condition);Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727426	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727428	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727454	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paroxysmal arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727463	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727465	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727471	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727617	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Photosensitivity reaction (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [77d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727641	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727643	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (12h - Recovered/Resolved - );Injected limb mobility decreased (12h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - );Neck pain (12h - Recovered/Resolved - );Pain in extremity (12h - Recovered/Resolved - );Paraesthesia (1h - Recovered/Resolved - );Paraesthesia oral (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727693	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Herpes zoster (n/a - Unknown - );Neuralgia (n/a - Recovered/Resolved - );Oral herpes (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])|SHINGRIX [RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, STIMULON, MONOPHOSPHORYL LIPID A] (S - Prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727773	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727779	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727780	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727786	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Cold sweat (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010727798	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling hot (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematemesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727814	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010727821	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727825	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727830	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727832	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hepatic enzyme increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727838	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727842	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727844	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 200mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Hypercholesterolaemia - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727846	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727851	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727857	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727872	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727883	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727884	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727886	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727888	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pH increased (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727890	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727892	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Influenza (5d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[HEPATITIS A VACCINE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727893	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727916	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Unknown - );Abdominal pain upper (n/a - Unknown - );Anxiety (n/a - Unknown - );Dysuria (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Neck pain (n/a - Unknown - );Off label use (n/a - Unknown - );Rash pruritic (n/a - Not Recovered/Not Resolved - );Urinary retention (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])|[BUPRENORPHINE] (S - Drug withdrawal maintenance therapy - Dose not changed - [n/a - 24mg - Subcutaneous])	BUPRENORPHINE [BUPRENORPHINE] (C - Drug withdrawal maintenance therapy - n/a - [n/a - 2mg - Sublingual])|[EPIRUBICIN] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727929	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Portal vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010727930	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727939	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Bipolar disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010727973	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1wk - Recovered/Resolved - );Cough (n/a - Recovering/Resolving - );Eye disorder (n/a - Recovered/Resolved - );Nodule (n/a - Recovering/Resolving - );Ocular hyperaemia (n/a - Recovered/Resolved - );Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Blood disorder - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727978	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Genital herpes simplex (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010727982	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (1d - Fatal - Results in Death);General physical health deterioration (7d - Fatal - Results in Death);Pneumonia (5d - Fatal - Results in Death);Pyrexia (6d - Fatal - Results in Death);Rales (6d - Fatal - Results in Death);Urinary tract infection (5d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010727988	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727989	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727991	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Constipation (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010727994	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727996	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Mental impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010727998	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010727998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728041	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728047	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Infection (n/a - Recovered/Resolved - );Ocular hyperaemia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728048	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (1d - Recovered/Resolved - );Seizure (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728053	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gingivitis (n/a - Recovering/Resolving - );Immunisation reaction (5d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728069	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728075	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728076	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periostitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728078	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728080	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rotator cuff syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728083	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728092	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728100	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728113	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (1d - Recovered/Resolved - );Condition aggravated (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728149	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728150	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728155	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728160	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728161	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728175	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728181	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728182	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728215	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Post-acute COVID-19 syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728217	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728249	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - );Dizziness (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728264	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728270	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728275	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hyperthyroidism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728282	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Libido disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728298	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pruritus (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728299	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2wk - Recovered/Resolved - );Dyspnoea (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728308	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728309	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728312	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood urine present (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[D,L-LYSINE ACETYLSALICYLATE] (S - n/a - n/a - [n/a - n/a - Oral])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728322	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728343	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728345	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728347	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728348	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [22d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728357	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728384	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hyperthermia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728385	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728388	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728389	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728391	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (15d - Recovering/Resolving - );Trigeminal neuralgia (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728407	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728415	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip oedema (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728418	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728438	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728441	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728448	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728456	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728457	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Photophobia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728461	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728464	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast discomfort (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728467	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728506	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728531	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Vaccination failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010728539	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728547	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - );Hypothyroidism (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728553	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728567	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Depressed mood (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Not Recovered/Not Resolved - );Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728613	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728615	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ocular discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728616	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Emphysema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728619	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aggression (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728623	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728624	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Stomatitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728628	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728675	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728684	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728694	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728734	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Atrial fibrillation (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiovascular disorder (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENTRESTO 49 MG/51 MG [VALSARTAN, SACUBITRIL] (C - n/a - Unknown - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Unknown - [n/a - n/a - n/a])|XARELTO 15 MG [RIVAROXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[OTILONIUM BROMIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010728742	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemoglobin abnormal (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Other Medically Important Condition);White blood cell count abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[CORTISONE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[HYDROXYCARBAMIDE] (S - Product used for unknown indication - Unknown - [n/a - 2000mg - Oral])|[RUXOLITINIB] (S - Myelofibrosis - Drug withdrawn - [n/a - 40mg - Oral])	[ACETYLSALICYLIC ACID] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[ALLOPURINOL] (C - Liver disorder, Renal disorder, Spleen disorder - Unknown - [n/a - n/a - Unknown])|[ASCORBIC ACID, FOLIC ACID, NICOTINAMIDE, ASCORBIC ACID, RETINOL] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[CALCIUM CARBONATE, CALCIUM CARBONATE PH. EUR.] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[CYANOCOBALAMIN, VITAMIN B12] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[FAMOTIDINE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[IBUPROFEN, NAPROXEN, NAPROXEN SODIUM] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[RANITIDINE, RANITIDINE HYDROCHLORIDE] (C - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728787	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (5min - Recovered/Resolved - );Hypotension (5min - Recovered/Resolved - );Oxygen saturation decreased (5min - Recovered/Resolved - );Syncope (5min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010728788	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010728799	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Herpes zoster (n/a - Recovered/Resolved With Sequelae - );Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010728810	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010728815	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010728821	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010728884	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010728976	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010728976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729001	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Unknown - );Tongue blistering (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729055	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Extensive swelling of vaccinated limb (2d - Recovered/Resolved - );Injection site lymphadenopathy (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729059	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abnormal loss of weight (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Movement disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscle atrophy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010729084	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (S - Hypertension - n/a - [n/a - n/a - Oral])|[FELODIPINE] (S - Hypertension - n/a - [n/a - n/a - Oral])|[FEXOFENADINE HYDROCHLORIDE] (S - Hypersensitivity - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729103	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010729105	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729114	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010729115	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729143	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (23d - Recovered/Resolved - );Balance disorder (23d - Recovered/Resolved - );Disturbance in attention (23d - Recovered/Resolved - );Dizziness (23d - Recovered/Resolved - );Fatigue (23d - Recovered/Resolved - );Feeling abnormal (23d - Recovered/Resolved - );Mental impairment (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729144	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010729190	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID, AMOXICILLIN, POTASSIUM CLAVULANATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUSIDIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729195	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010729196	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010729206	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pollakiuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729210	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729212	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729223	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Syncope (50min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010729277	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010729351	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (1d - Recovered/Resolved - );Colitis ulcerative (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729449	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729451	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729459	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729481	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729482	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010729485	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729489	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - );SARS-CoV-2 test positive (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ARIPIPRAZOLE] (C - Psychotic disorder - Dose not changed - [n/a - 1{DF} - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE HEMIFUMARATE] (C - Psychotic disorder - Dose not changed - [n/a - n/a - n/a])|[SODIUM VALPROATE] (C - n/a - Dose not changed - [n/a - 4{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729492	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729494	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729508	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729509	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729520	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729522	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729538	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729548	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Recovering/Resolving - );Erythema of eyelid (n/a - Recovering/Resolving - );Eyelid irritation (n/a - Recovering/Resolving - );Oral discomfort (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - );Tongue discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729550	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729556	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729565	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729569	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729570	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Raynaud's phenomenon (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729571	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	No adverse event (25d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010729585	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Breast pain (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010729598	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729600	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alanine aminotransferase increased (n/a - Recovered/Resolved - );Aspartate aminotransferase increased (n/a - Recovered/Resolved - );Hepatic enzyme increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729601	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apathy (54d - Recovering/Resolving - );Chills (54d - Recovering/Resolving - );Disturbance in attention (54d - Recovering/Resolving - );Dizziness (54d - Recovering/Resolving - );Fatigue (54d - Recovering/Resolving - );Pyrexia (54d - Recovering/Resolving - );Restlessness (54d - Recovering/Resolving - );Somnolence (54d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010729620	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (21d - Recovered/Resolved - );Pain in extremity (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010729623	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010729626	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729639	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729651	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729683	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729712	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729713	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010729756	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729772	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (5d - Recovering/Resolving - );Pyrexia (4d - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729775	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729780	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010729784	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729785	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Not Recovered/Not Resolved - );Palpitations (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729799	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Initial insomnia (n/a - Recovered/Resolved With Sequelae - );Middle insomnia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010729829	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (35d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729839	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (25d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010729850	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (7d - Recovered/Resolved - );Diarrhoea (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729859	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729861	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729865	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Epilepsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010729871	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729877	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010729883	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729890	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729896	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729918	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729921	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010729928	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Haematochezia (1d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010729934	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vasculitis (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010729935	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729946	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovered/Resolved - );Haemorrhagic diathesis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010729954	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Varicella (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010729984	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729996	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (13d - Recovering/Resolving - );Herpes zoster (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010729998	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure systolic decreased (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010729998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730019	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (1d - Recovered/Resolved - );Heavy menstrual bleeding (1d - Recovered/Resolved - );Menstrual disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730024	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730040	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730053	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (10d - Recovering/Resolving - );Muscle twitching (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730054	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Chills (n/a - Unknown - );Confusional state (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Disorientation (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypophagia (n/a - Unknown - );Irritability (n/a - Unknown - );Lymphoma (n/a - Unknown - Other Medically Important Condition);Parkinsonian gait (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Speech disorder (n/a - Unknown - );Tremor (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730064	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster infection neurological (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730116	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Soft tissue swelling (n/a - Not Recovered/Not Resolved - );Type IV hypersensitivity reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730137	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhage subcutaneous (41d - Not Recovered/Not Resolved - Other Medically Important Condition);Penile haemorrhage (41d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730145	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730152	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730159	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thyroiditis subacute (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730163	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest discomfort (8d - Recovered/Resolved - );Dyspnoea (8d - Recovered/Resolved - );Tonsillitis (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730167	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730170	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Dehydration (n/a - Unknown - Other Medically Important Condition);Disorientation (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypophagia (n/a - Unknown - Other Medically Important Condition);Irritability (n/a - Unknown - Other Medically Important Condition);Muscle rupture (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Parkinsonian gait (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Speech disorder (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730173	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Herpes zoster (10d - Not Recovered/Not Resolved - );Post herpetic neuralgia (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730191	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730192	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730210	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Toothache (40d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730221	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (61d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730225	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730227	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune-mediated lung disease (n/a - Not Recovered/Not Resolved - );Lung infiltration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730229	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type IV hypersensitivity reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730230	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (16d - Not Recovered/Not Resolved - Other Medically Important Condition);Bradycardia (16d - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730233	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphoedema (28d - Recovered/Resolved - );Peripheral swelling (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730234	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Bursitis (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730244	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010730251	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010730254	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Balance disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730262	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730267	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Type IV hypersensitivity reaction (n/a - Not Recovered/Not Resolved - );Vaccination site eczema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730271	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation of wound (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730288	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730300	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Unknown - );Flushing (n/a - Unknown - );Skin burning sensation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730302	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (3d - Not Recovered/Not Resolved - );Anosmia (3d - Not Recovered/Not Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (4d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Myalgia (2d - Unknown - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730304	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730309	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730313	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730319	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730320	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010730327	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hyperhidrosis (2d - Unknown - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730331	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Cardiovascular disorder (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730342	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730350	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rheumatoid arthritis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010730359	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (2d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730373	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (21d - Recovered/Resolved With Sequelae - );Tinnitus (21d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010730386	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730387	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spinal pain (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730389	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Heart rate increased (4d - Unknown - );Tinnitus (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730393	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730398	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730413	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Stockholm syndrome (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730418	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling of eyelid (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730420	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (71d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730430	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (46d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730431	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Orthostatic hypotension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730448	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010730463	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730465	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Crying (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730483	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Scar pain (n/a - Recovering/Resolving - );Toothache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730486	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Urine flow decreased - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Urine output decreased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010730491	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Fatigue (8d - Recovered/Resolved - );Heart rate increased (0d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Taste disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730501	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	No adverse event (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730507	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730515	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730521	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730526	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730528	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Unknown - );Vaccination site reaction (30d - Recovered/Resolved - );Visual field defect (1d - Recovered/Resolved - );Visual impairment (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730531	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730539	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730542	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Petechiae (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730545	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (41d - Not Recovered/Not Resolved - );Fatigue (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730567	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory level abnormal (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730580	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - );Gait disturbance (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Pulmonary pain (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010730581	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730591	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal behaviour (1d - Not Recovered/Not Resolved - );Euphoric mood (1d - Not Recovered/Not Resolved - );Mania (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730597	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730606	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730607	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730625	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Encephalopathy (8d - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (8d - Recovered/Resolved - );Somnolence (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730627	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Temperature regulation disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730636	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730645	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730646	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730648	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730650	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Haematoma (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730659	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730673	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730699	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730703	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	IIIrd nerve paresis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730717	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (5d - Recovered/Resolved With Sequelae - );Muscle spasms (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010730742	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchospasm (5d - Recovered/Resolved - );Hypersensitivity (5d - Recovered/Resolved - );Urticaria (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730743	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730744	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730747	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730765	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyskinesia (3d - Recovering/Resolving - );Muscle twitching (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730772	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (3303d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730779	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (21d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730786	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (33d - Recovered/Resolved - Other Medically Important Condition);Bundle branch block left (33d - Recovered/Resolved - );Cardiac failure (33d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730789	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730791	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (12d - Recovered/Resolved - );Pain (7d - Recovered/Resolved - );Tremor (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730792	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730794	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730795	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type I hypersensitivity (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010730796	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type 1 diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010730797	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Weight bearing difficulty (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730798	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010730799	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Basilar artery occlusion (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebellar stroke (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness postural (n/a - Recovered/Resolved - Other Medically Important Condition);Vertebral artery occlusion (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010730803	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster oticus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730806	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatoid arthritis (14d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010730810	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (12d - Not Recovered/Not Resolved - );Sudden hearing loss (12d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730812	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiovascular disorder (n/a - Unknown - );Palatal disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730815	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (7d - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730834	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (4d - Not Recovered/Not Resolved - );Fatigue (5d - Recovering/Resolving - );Myalgia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730836	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010730837	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730852	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730870	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730885	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010730907	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Oral herpes (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730913	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730918	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spondylitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730928	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parotitis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730948	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual acuity reduced (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730950	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730968	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010730972	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute lymphocytic leukaemia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010730978	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematochezia (1d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010730985	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010730985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731016	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vein occlusion (0d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010731019	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (16d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731028	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	No adverse event (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731040	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731062	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Recovered/Resolved - );Fatigue (42d - Not Recovered/Not Resolved - );Headache (41d - Not Recovered/Not Resolved - );Malaise (43d - Not Recovered/Not Resolved - );Nausea (29d - Not Recovered/Not Resolved - );Night sweats (2d - Not Recovered/Not Resolved - );Paraesthesia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731064	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731073	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Odynophagia (3d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Tonsillar hypertrophy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731075	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (26d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010731076	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Prostatic specific antigen increased (57d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731087	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (12d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731092	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731093	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731095	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731110	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (1d - Recovering/Resolving - );Blood urine present (1d - Recovering/Resolving - );Urethral pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731111	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731126	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731129	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731132	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Homosexuality (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731139	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731140	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731154	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731183	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Vomiting (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731199	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731203	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (3d - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731205	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blepharospasm (6d - Not Recovered/Not Resolved - );Muscle twitching (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731208	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|ETANERCEPT 50 MG - SOLUTION FOR INJECTION  (C - Arthritis - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - Arthritis - n/a - )|NOT AVAILABLE (C - Hypertension - n/a - [n/a - n/a - n/a])|VORTIOXETINE 10MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731231	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (7d - Recovered/Resolved - );Paraesthesia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731234	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (54d - Recovered/Resolved - );Vaccination site joint movement impairment (54d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731235	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ataxia (n/a - Not Recovered/Not Resolved - );Depression suicidal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Encephalopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertensive crisis (78d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731239	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eye contusion (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731252	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Apathy (21d - Recovering/Resolving - );Fatigue (21d - Recovering/Resolving - );Histamine intolerance (22d - Recovering/Resolving - );Malaise (21d - Recovering/Resolving - );Motion sickness (21d - Recovering/Resolving - );Thinking abnormal (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731260	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ascites (n/a - Unknown - Other Medically Important Condition);Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Polyserositis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[HUMAN IMMUNOGLOBULIN G, HUMAN NORMAL IMMUNOGLOBULIN] (C - Antibody test abnormal - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010731270	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731274	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731281	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731282	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epididymitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731295	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Malaise (24h - Recovered/Resolved - );Vaccination site pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731296	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (16d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (16d - Recovered/Resolved - Other Medically Important Condition);Rotator cuff syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731311	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Peripheral nerve injury (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731315	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatoid arthritis (14d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731316	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (35d - Not Recovered/Not Resolved - );Arthralgia (35d - Not Recovered/Not Resolved - );Chest pain (35d - Not Recovered/Not Resolved - );Eructation (35d - Not Recovered/Not Resolved - );Fatigue (35d - Not Recovered/Not Resolved - );Neck pain (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731319	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731323	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731329	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (6d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731340	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Lividity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731359	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731365	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Throat irritation (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731366	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731367	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731377	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731384	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urinary hesitation (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731389	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731403	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Blood pressure increased (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731444	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731446	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731452	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731480	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731493	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Malaise (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731500	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731501	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731507	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (3d - Recovering/Resolving - );Feeling hot (3d - Recovering/Resolving - );Headache (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731509	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731517	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731519	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Lymphoedema (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731536	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Influenza (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731568	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Anxiety (14d - Recovering/Resolving - );Asthenia (14d - Recovering/Resolving - );Dizziness (14d - Recovering/Resolving - );Dyspnoea (n/a - Unknown - );Feeling abnormal (14d - Recovering/Resolving - );Heart rate increased (14d - Recovering/Resolving - );Hypertension (14d - Recovering/Resolving - );Malaise (14d - Recovering/Resolving - );Nausea (14d - Recovering/Resolving - );Palpitations (14d - Recovering/Resolving - );Panic attack (14d - Recovering/Resolving - );Tremor (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731596	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731607	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731617	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731625	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731627	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingivitis (2d - Recovered/Resolved With Sequelae - );Hypersensitivity (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010731631	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731632	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731636	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (7d - Recovered/Resolved - );Dyspnoea (7d - Recovered/Resolved - );Myocarditis (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731637	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731639	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731641	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Unknown - );Nasal discomfort (1d - Unknown - );Oropharyngeal pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731648	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovered/Resolved With Sequelae - );Rhinorrhoea (2d - Recovered/Resolved With Sequelae - );Sneezing (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010731654	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intelligence increased (78d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731659	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731661	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731662	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731664	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731669	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (5d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731670	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731674	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Feeling cold (0d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Mouth injury (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731681	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Euphoric mood (1d - Recovered/Resolved - );Mania (1d - Recovered/Resolved - );Mental disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731694	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731701	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731703	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731706	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731709	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731714	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Eyelid oedema (4d - Recovering/Resolving - );Lymphadenopathy (4d - Recovering/Resolving - );Vaccination site joint pain (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731721	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Increased insulin requirement (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731725	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Trigeminal neuralgia (91d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010731727	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731730	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (5d - Recovering/Resolving - );Dyskinesia (1d - Recovered/Resolved - );Tachycardia (5d - Recovering/Resolving - );Trismus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731737	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (35d - Not Recovered/Not Resolved - );Myalgia (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731740	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (16d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731743	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731744	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731748	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemihypoaesthesia (0d - Recovering/Resolving - Other Medically Important Condition);Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731750	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Circulatory collapse (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731756	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Dermatitis allergic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731767	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LYRICA 75 MG CAPSULES [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731771	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nausea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731787	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731794	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731810	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Petechiae (10d - Recovering/Resolving - );Pruritus (10d - Recovering/Resolving - );Rash (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731823	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (1d - Unknown - );Injection site pain (1d - Unknown - );Malaise (1d - Unknown - );Noninfective gingivitis (0d - Unknown - );Toothache (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731826	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731837	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovering/Resolving - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731843	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731848	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthropod bite (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731849	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731852	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731868	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arterial disorder (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010731869	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain lower (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Uterine pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731876	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tenosynovitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731879	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731880	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731881	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731885	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731917	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (26d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731921	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731923	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731944	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Balance disorder (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010731945	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731954	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010731957	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731967	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731969	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug-induced liver injury (11d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010731981	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010731983	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling face (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010731983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732014	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (32d - Recovering/Resolving - );Influenza (32d - Recovering/Resolving - );Limb discomfort (32d - Recovering/Resolving - );Malaise (32d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Vomiting (25d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732022	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Myalgia (0d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732030	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732037	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Postmenopausal haemorrhage (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732050	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732054	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732065	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732069	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732070	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732073	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732075	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732087	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732101	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732103	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732107	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732111	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732123	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732126	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Uveitis (0d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010732128	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732131	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732133	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732134	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732144	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (4d - Recovering/Resolving - );Fatigue (11d - Recovering/Resolving - );Limb discomfort (9d - Recovered/Resolved - );Myalgia (7d - Recovering/Resolving - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732146	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732151	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (26d - Not Recovered/Not Resolved - );Visual impairment (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732155	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (2d - Not Recovered/Not Resolved - );Angina pectoris (2d - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (2d - Not Recovered/Not Resolved - );Constipation (2d - Not Recovered/Not Resolved - );Feeling cold (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732156	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732160	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732163	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732166	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (34d - Recovered/Resolved - );Tourette's disorder (34d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010732167	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (27d - Not Recovered/Not Resolved - );Tachycardia (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732174	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (2d - Unknown - );Chills (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732175	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732190	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732191	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732197	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732198	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (1d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732211	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732215	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Feeling abnormal (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010732219	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Sinusitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732220	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovering/Resolving - );Hyperhidrosis (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732223	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovered/Resolved With Sequelae - );Abnormal faeces (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010732241	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732242	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732244	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovering/Resolving - );Dyspnoea (9d - Recovering/Resolving - );Feeling hot (9d - Recovering/Resolving - );Headache (9d - Not Recovered/Not Resolved - );Myalgia (10d - Not Recovered/Not Resolved - );Pyrexia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732261	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster reactivation (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732268	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732274	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732279	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732310	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Penile erythema (n/a - Not Recovered/Not Resolved - );Penile oedema (n/a - Not Recovered/Not Resolved - );Penile swelling (n/a - Not Recovered/Not Resolved - );Scrotal swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732333	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010732351	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732403	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (3d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732424	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732435	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732436	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732442	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732444	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732450	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732452	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (32d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732469	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732471	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[GLUCOSE, ANHYDROUS, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM CITRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM CITRATE, GLUCOSE] (C - Gastroenteritis - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732472	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal infarct (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010732477	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732480	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732484	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732485	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - Product used for unknown indication - Not applicable - [n/a - n/a - Oral])|[CLOPIDOGREL] (C - Angina pectoris - Not applicable - [n/a - n/a - Oral])|[ESCITALOPRAM] (C - Persistent depressive disorder - Not applicable - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Acute myocardial infarction - Not applicable - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - Product used for unknown indication - Not applicable - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - Acute myocardial infarction - Not applicable - [n/a - n/a - Oral])|[RAMIPRIL, ACETYLSALICYLIC ACID, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Acute myocardial infarction - Not applicable - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Acute myocardial infarction - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732486	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	[LEVOTHYROXINE SODIUM] (C - Autoimmune thyroiditis - Dose not changed - [n/a - n/a - n/a])|[PITAVASTATIN] (C - Type IIa hyperlipidaemia - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732533	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry eye (17d - Recovered/Resolved - );Ocular hyperaemia (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732542	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732560	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732571	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732621	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (0d - Recovered/Resolved - );Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732625	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732627	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732633	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Taste disorder (26d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732637	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732638	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732639	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732660	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (19d - Recovered/Resolved - );Chest pain (19d - Recovered/Resolved - );Feeding disorder (n/a - Unknown - );Headache (19d - Recovered/Resolved - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Nausea (19d - Recovered/Resolved - );Product administered at inappropriate site (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732672	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732675	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (64d - Recovered/Resolved - );Dizziness (72d - Recovering/Resolving - );Fatigue (74d - Not Recovered/Not Resolved - );Influenza (6d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Malaise (74d - Not Recovered/Not Resolved - );Nausea (11d - Recovered/Resolved - );Tachycardia (72d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732677	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732684	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732689	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (26d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010732693	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732696	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732709	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732711	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732715	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coagulopathy (n/a - Recovered/Resolved With Sequelae - );Lymphadenopathy (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010732716	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732724	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732725	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732726	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure decreased (n/a - Unknown - );Circulatory collapse (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Unknown - );Prothrombin time shortened (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732728	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (2d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymph node pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732745	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732748	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arterial disorder (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010732749	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732774	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (76d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732782	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732830	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732831	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (8d - Not Recovered/Not Resolved - );Influenza (8d - Not Recovered/Not Resolved - );Pyrexia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732839	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732848	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732854	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732857	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (32d - Not Recovered/Not Resolved - );Paraesthesia (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732859	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732869	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732871	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732878	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732891	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Influenza (2d - Recovering/Resolving - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732893	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732904	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732907	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010732913	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732919	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - );Rash (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732928	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732929	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010732931	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (7d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732934	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732937	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732941	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732944	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732952	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Blood pressure decreased (n/a - Unknown - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732961	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732968	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010732973	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010732985	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010732991	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010732991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733001	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733002	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733009	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733016	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733020	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (35d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733025	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733027	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733028	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733034	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neurodermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733044	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (7d - Not Recovered/Not Resolved - );Dizziness (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733048	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733050	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (2d - Recovered/Resolved - );Renal pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733057	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733061	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733062	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (4d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733083	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733084	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733088	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733090	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733092	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010733095	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733098	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733099	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733101	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733106	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733108	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (26d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733120	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733145	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733165	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733170	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733173	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733174	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733183	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (15d - Not Recovered/Not Resolved - );Myalgia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733185	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733187	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733188	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovering/Resolving - );Injection site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733189	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733197	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Cough (3d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733213	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Influenza (0d - Recovered/Resolved - );Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733214	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site swelling (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733215	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (2d - Unknown - );Headache (1d - Not Recovered/Not Resolved - );Tinnitus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733220	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733223	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (50d - Not Recovered/Not Resolved - );Trigeminal neuralgia (50d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733224	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733231	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733232	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733236	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (48d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733238	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (61d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733243	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Paraesthesia (70d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733247	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733249	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733252	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733253	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733266	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733273	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733274	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733277	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733282	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733284	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733285	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Unknown - );Abdominal rigidity (n/a - Unknown - );Dizziness (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733288	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733301	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Lip oedema (1d - Recovered/Resolved - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A)] (S - Influenza immunisation - Not applicable - [1d - .5mL - Intramuscular])	[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - Dose not changed - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733302	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctival haemorrhage (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733315	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombotic thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733333	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Phlebitis superficial (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010733344	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010733353	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733354	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733356	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733357	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (14d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733358	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (34d - Recovering/Resolving - );Feeling hot (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010733367	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733368	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Localised infection (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733369	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733372	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Dizziness (5d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (5d - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733375	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733399	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Influenza (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733402	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733411	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733425	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Headache (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733429	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733430	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733461	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (19d - Not Recovered/Not Resolved - );Dyspnoea (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733464	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733471	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733472	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733479	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Incorrect dosage administered (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733482	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Petechiae (40d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010733486	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (15d - Recovering/Resolving - );Headache (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733496	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling face (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733499	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733503	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733504	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733505	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733506	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733509	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733517	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733518	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733520	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Headache (10d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Malaise (9d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733528	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733529	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733533	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733539	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypotonia (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733541	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733550	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733560	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Lymphadenopathy (4d - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733564	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733567	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Contusion (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733568	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733580	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovering/Resolving - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733582	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Feeling hot (5d - Not Recovered/Not Resolved - );Injection site erythema (4d - Recovered/Resolved - );Malaise (5d - Not Recovered/Not Resolved - );Nausea (2d - Recovered/Resolved - );Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733585	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733587	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733588	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733589	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Not Recovered/Not Resolved - );Tachycardia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733593	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733598	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733600	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733607	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733608	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733632	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733643	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733650	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733653	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733663	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733691	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733726	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733730	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733734	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733739	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site erythema (n/a - Unknown - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733747	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (1h - Recovered/Resolved - );Pain in extremity (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733752	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733753	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733755	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733762	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (8d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733763	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (0d - Not Recovered/Not Resolved - );Feeling hot (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733768	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733774	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733775	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733782	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733783	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733788	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733789	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733794	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733808	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733812	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733816	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733819	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733828	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733835	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733841	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733850	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733851	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733854	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733855	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733859	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733862	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733864	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733868	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733871	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733876	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Unknown - );Influenza (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733877	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Recovered/Resolved - );Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733893	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733896	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733904	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733908	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733910	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733914	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733919	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733920	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Myalgia (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733921	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010733929	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733930	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010733941	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733948	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733955	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733956	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010733959	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733984	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010733999	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010733999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734000	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734004	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734007	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (25d - Not Recovered/Not Resolved - );Headache (26d - Not Recovered/Not Resolved - );Injection site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734020	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734027	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734038	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734042	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734047	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Eczema (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734049	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734050	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734054	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734055	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoxia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010734056	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734062	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734067	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010734074	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (16d - Not Recovered/Not Resolved - );Restlessness (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734081	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (1d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734082	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (22d - Not Recovered/Not Resolved - );Eye pruritus (22d - Not Recovered/Not Resolved - );Fatigue (22d - Not Recovered/Not Resolved - );Influenza (22d - Not Recovered/Not Resolved - );Nasal congestion (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734084	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734089	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (5d - Recovering/Resolving - );Rash (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734094	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734114	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734121	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734126	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (10d - Not Recovered/Not Resolved - );Pyrexia (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734127	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (4d - Not Recovered/Not Resolved - );Limb discomfort (3d - Recovered/Resolved - );Rash (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734135	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734136	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734141	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734143	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734148	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734154	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (80d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010734157	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734161	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734163	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734167	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734193	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010734202	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734216	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (46d - Not Recovered/Not Resolved - );Depressed mood (46d - Not Recovered/Not Resolved - );Disturbance in attention (46d - Not Recovered/Not Resolved - );Fatigue (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734224	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734227	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734233	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (22d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010734242	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734243	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734256	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734268	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734288	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734292	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (1d - Not Recovered/Not Resolved - );Dizziness (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734293	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734303	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010734307	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734308	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734327	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734331	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site swelling (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734333	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734335	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734336	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Dyspnoea (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Nausea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734339	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Malaise (4d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734340	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734342	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734349	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734350	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734360	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Headache (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734364	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Myalgia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734365	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734366	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734373	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734378	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734379	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734381	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - );Vaccination site reaction (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734385	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734388	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734391	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Feeling hot (4d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734395	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734399	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734401	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734404	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (20d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734406	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734419	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734422	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734423	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734431	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734432	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734442	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734445	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734458	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734463	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734465	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734466	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734471	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (37d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734493	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734498	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734502	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734503	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734507	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (5d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734508	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734509	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734511	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734515	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734524	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734528	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734535	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734537	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734545	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734548	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovering/Resolving - );Headache (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734552	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734555	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734566	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734567	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734568	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734570	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (61d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734571	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (17d - Recovering/Resolving - );Fatigue (17d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Tachycardia (24d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734572	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Eye discharge (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734576	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Influenza (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734579	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734588	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (41d - Not Recovered/Not Resolved - );Malaise (43d - Not Recovered/Not Resolved - );Tachycardia (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734598	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734601	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734602	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734604	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734609	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734618	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734626	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734639	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734643	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Fatigue (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734645	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734649	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (33d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734653	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Fatigue (3d - Recovering/Resolving - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734658	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734674	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734688	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734691	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734711	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734716	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Feeling hot (2d - Unknown - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734717	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734718	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734722	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734723	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734728	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Cough (0d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734733	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734739	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734745	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734750	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734757	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Malaise (0d - Recovering/Resolving - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734760	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734767	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734770	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734774	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734778	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734780	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734782	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734792	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734797	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734813	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734814	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734817	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734843	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (8d - Not Recovered/Not Resolved - );Dizziness (8d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Palpitations (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734845	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (90d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734855	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (7d - Not Recovered/Not Resolved - );Paraesthesia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734861	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Dizziness (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734863	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (4d - Not Recovered/Not Resolved - );Dysphagia (4d - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Oropharyngeal pain (4d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734869	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (8d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Gait disturbance (8d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734870	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Dyspnoea (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Nausea (6d - Not Recovered/Not Resolved - );Yawning (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010734875	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734878	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734880	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (4d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734886	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734887	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734891	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (105d - Not Recovered/Not Resolved - );Flank pain (105d - Not Recovered/Not Resolved - );Hyperhidrosis (105d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734895	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734904	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734905	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (86d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010734908	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734914	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734917	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734927	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734928	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734930	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734939	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734942	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734954	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734959	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734964	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734965	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010734969	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734978	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Erythema (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734980	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734990	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010734993	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (27d - Recovered/Resolved - );Influenza (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010734993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735003	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735015	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010735020	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735031	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735032	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735033	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735045	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735047	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735067	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved With Sequelae - );Headache (0d - Recovered/Resolved With Sequelae - );Pyrexia (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010735080	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735082	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735084	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735085	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010735095	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735099	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735104	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735105	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735106	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735112	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Not Recovered/Not Resolved - );Dizziness (0d - Not Recovered/Not Resolved - );Dyspnoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Feeling hot (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735123	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735126	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site swelling (2d - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735130	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735132	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010735135	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735155	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735177	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735181	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735182	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735200	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735202	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (24d - Recovering/Resolving - );Paraesthesia (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735206	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735210	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735214	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735222	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735236	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Cough (4d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735241	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735244	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735251	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735257	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010735261	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735271	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Rash (57d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735278	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735289	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735293	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Limb discomfort (0d - Not Recovered/Not Resolved - );Malaise (1d - Recovering/Resolving - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735309	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (5d - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735310	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735313	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Cough (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Feeling hot (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735336	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735359	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735360	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735367	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735388	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735402	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735404	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Feeling hot (8d - Not Recovered/Not Resolved - );Rash (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735412	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (48h - Recovered/Resolved - );Lymph node pain (48h - Recovered/Resolved - );Pyrexia (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735418	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735426	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735437	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735452	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735454	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735458	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735462	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Fatigue (2d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735482	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735483	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (45d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735484	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735489	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (17d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735501	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735503	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735504	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735515	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735518	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (65d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735524	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735525	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735527	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735530	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735533	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735544	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735563	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735566	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735568	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735583	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735592	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735598	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Nausea (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735603	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735612	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Nausea (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735621	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735627	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735628	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735629	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735636	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735637	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735639	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735641	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735642	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735656	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735663	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735668	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735673	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735677	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735700	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735721	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735723	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735725	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (62d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735729	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735740	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735743	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735744	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (47d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735748	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Vomiting (181d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735749	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735751	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735756	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735763	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735764	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (62d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735783	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735784	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735792	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735798	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735809	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735812	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735819	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735849	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735855	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735856	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735857	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735859	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735865	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (14d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735870	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735878	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735880	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735908	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (6d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010735915	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735935	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735937	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735941	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735945	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735950	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735960	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735969	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735975	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735979	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010735983	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (36d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010735997	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010735997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736001	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736011	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736013	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (20d - Recovering/Resolving - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736023	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736032	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736039	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736040	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736056	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Unknown - );Headache (0d - Unknown - );Influenza (0d - Unknown - );Injection site pain (1d - Unknown - );Limb discomfort (1d - Unknown - );Malaise (1d - Unknown - );Pyrexia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736082	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (32d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010736087	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Dyspnoea (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736088	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736100	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736102	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736104	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736105	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736106	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myalgia (82d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010736122	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736126	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736127	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736130	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736150	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736174	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736199	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (24d - Not Recovered/Not Resolved - );Myalgia (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736206	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736218	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (37d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736234	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (6d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736235	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736247	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736248	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736254	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736258	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Limb discomfort (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736260	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (39d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010736261	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736263	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736265	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736271	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Injection site erythema (2d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - );Vomiting (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736281	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Injection site pain (4d - Recovering/Resolving - );Injection site swelling (3d - Recovering/Resolving - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736289	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (0d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736293	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736294	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736297	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (54d - Not Recovered/Not Resolved - );Fatigue (54d - Not Recovered/Not Resolved - );Feeling hot (54d - Not Recovered/Not Resolved - );Headache (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736304	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736305	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736306	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cough (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Myalgia (6d - Not Recovered/Not Resolved - );Tachycardia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736309	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736315	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Not Recovered/Not Resolved - );Tachycardia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736318	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (2d - Recovered/Resolved - );Headache (4d - Recovering/Resolving - );Injection site swelling (2d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736335	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736338	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736340	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (25d - Not Recovered/Not Resolved - );Influenza (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736351	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Unknown - );Fatigue (5d - Unknown - );Headache (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736355	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736365	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736367	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736376	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (6d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736393	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (34d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736398	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736400	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (0d - Unknown - );Feeling hot (2d - Unknown - );Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Injection site swelling (1d - Recovered/Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Pyrexia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736407	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736413	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736419	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736422	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736447	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736459	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736469	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736474	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736494	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736501	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736503	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736517	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736520	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site erythema (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736528	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736531	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (28d - Recovered/Resolved - );Fatigue (28d - Recovered/Resolved - );Influenza like illness (28d - Recovered/Resolved - );Vaccination site pain (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736532	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736535	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736538	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (62d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736540	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (46d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010736542	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736545	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Cough (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736548	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736558	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (57d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736567	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736573	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (3d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010736579	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736591	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736597	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736626	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736632	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736640	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (14d - Recovering/Resolving - );Dyspnoea (39d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Paraesthesia (36d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736661	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736667	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736682	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (4d - Not Recovered/Not Resolved - );Influenza (4d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Nausea (4d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736683	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010736693	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736696	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Malaise (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736697	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736699	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736709	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736720	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736722	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736723	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736726	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736747	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovering/Resolving - );Limb discomfort (18d - Unknown - );Myalgia (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736760	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736765	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736777	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736792	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736799	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736801	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736805	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736818	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736820	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736832	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736833	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736837	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736844	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736847	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (6d - Recovering/Resolving - );Myalgia (5d - Recovering/Resolving - );Vaccination site reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736851	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736855	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736856	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736863	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736873	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736875	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736877	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736880	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736883	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736885	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Headache (2d - Recovering/Resolving - );Injection site erythema (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Injection site swelling (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736891	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736902	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010736903	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Unknown - );Injection site swelling (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736904	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736907	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736909	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736917	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736924	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736925	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736933	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736935	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736937	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736938	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736941	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736945	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736946	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736953	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736963	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010736965	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736968	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (11d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736972	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736974	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736977	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736981	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736987	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736989	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010736991	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010736991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737004	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737012	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737018	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737031	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737040	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737043	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (23d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737048	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737051	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737052	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737065	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (39d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737066	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737075	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (71d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737077	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737078	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737080	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737083	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737090	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737108	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737115	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737136	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737146	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737161	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737165	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737167	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737181	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737201	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737204	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737240	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Neoplasm malignant (n/a - Unknown - Other Medically Important Condition);Neoplasm recurrence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010737260	Spontaneous	2021-11-23 00:00:00	Healthcare Professional	European Economic Area	Gardellini, A.. Severe immune thrombocytopenia after COVID-19 vaccination: Report of four cases and review of the literature. Blood Cells, Molecules, and Diseases. 2021;92:10.1016/j.bcmd.2021.102615. doi:10.1016/j.bcmd.2021.102615	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010737264	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737268	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737269	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737271	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737277	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Paraesthesia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737278	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737279	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arrhythmia (70d - Not Recovered/Not Resolved - );Tachycardia (70d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737287	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737300	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737302	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737305	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737309	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737310	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737315	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (4d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Vaccination site reaction (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737325	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737327	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (2d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737328	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737330	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737331	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (2d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737333	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arrhythmia (70d - Not Recovered/Not Resolved - );Tachycardia (70d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737335	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737337	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Myalgia (3d - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737349	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737350	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737356	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737357	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737364	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737365	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737368	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737388	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737390	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737393	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737395	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737397	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737401	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737407	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737424	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (28d - Recovered/Resolved With Sequelae - );Limb discomfort (27d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737428	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (6d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737434	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737443	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Feeling hot (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737445	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737446	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737527	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Incomplete course of vaccination (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010737555	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling hot (19d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737565	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (11d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737567	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737568	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737569	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737570	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737575	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (14d - Recovering/Resolving - );Dyspnoea (29d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737585	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737596	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737600	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737601	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737608	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737611	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737613	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737618	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737620	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737623	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737633	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Not Recovered/Not Resolved - );Rash (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737637	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737648	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737652	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737667	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737760	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737768	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737770	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737776	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737779	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737781	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Malaise (2d - Recovering/Resolving - );Nausea (3d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737786	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737788	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737792	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737794	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737803	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737809	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Dizziness (0d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (2d - Not Recovered/Not Resolved - );Injection site erythema (3d - Not Recovered/Not Resolved - );Injection site pain (3d - Not Recovered/Not Resolved - );Injection site swelling (2d - Not Recovered/Not Resolved - );Myalgia (2d - Recovering/Resolving - );Pyrexia (2d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737818	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737823	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737829	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737832	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737834	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737835	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737839	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737842	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737847	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737853	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737856	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (0d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737858	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (97d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737860	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (17d - Not Recovered/Not Resolved - );Malaise (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737877	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (7d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737883	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737887	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737889	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737908	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737911	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737912	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737918	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Lymphadenopathy (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737921	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737922	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737923	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737928	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010737939	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737942	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737948	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737950	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737954	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737956	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737958	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010737960	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737966	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (35d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010737972	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010737975	Spontaneous	2021-11-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (61d - Not Recovered/Not Resolved - );Fatigue (69d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Malaise (69d - Not Recovered/Not Resolved - );Tachycardia (69d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010737975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010706531	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site abscess (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site mass (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site warmth (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706542	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706584	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Sciatica (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706598	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706603	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706743	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of libido (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706746	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706750	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706762	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Joint instability (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706763	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706776	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706788	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Bradycardia (1d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Confusional state (0d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pallor (0d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706795	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	GANFORT [TIMOLOL MALEATE, BIMATOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706797	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010706801	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706804	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010706805	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706904	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706910	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706912	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Emphysema (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706916	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706917	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (4d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706922	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling drunk (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706926	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Brain oedema (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Death (n/a - Fatal - Results in Death);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Disseminated intravascular coagulation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Escherichia infection (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Escherichia sepsis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hepatic failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sopor (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Systemic bacterial infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707090	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707094	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Concomitant disease progression (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707100	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (461h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (461h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Lacunar infarction (461h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])|JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (S - n/a - Unknown - [n/a - 50mg - Oral])|[AMLODIPINE BESILATE] (S - n/a - Unknown - [n/a - 5mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010707102	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Increased upper airway secretion (n/a - Unknown - );Influenza (2d - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Muscle spasms (n/a - Unknown - );Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010707109	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010707113	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eye disorder (n/a - Unknown - Other Medically Important Condition);Intraocular pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010707115	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707124	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010707128	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707134	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (n/a - Not Recovered/Not Resolved - );Muscle rupture (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010707135	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707174	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010707211	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death);Cardiac failure acute (n/a - Fatal - Results in Death);Cardiogenic shock (n/a - Fatal - Results in Death);Coronary artery thrombosis (n/a - Fatal - Results in Death);Pulmonary oedema (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707215	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (3d - Recovered/Resolved - Other Medically Important Condition);Limb discomfort (3d - Recovered/Resolved - Other Medically Important Condition);Neck pain (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010707225	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707340	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707358	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010707417	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Aphasia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010707422	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Petechiae (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis allergic - n/a - [n/a - n/a - Nasal])|MELATONIN [MELATONIN] (C - Insomnia - n/a - [n/a - n/a - Oral])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010707507	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Pneumonia (18d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (26d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707511	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Life Threatening);Ventricular fibrillation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010707512	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010707525	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010707541	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PRASUGREL [PRASUGREL] (C - n/a - n/a - [n/a - n/a - Oral])|[ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ASCORBIC ACID, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[BUSPIRONE] (C - n/a - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - Oral])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ISOSORBIDE DINITRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010707542	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	ENTYVIO [VEDOLIZUMAB] (C - Colitis ulcerative - n/a - [n/a - 1{DF} - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010707545	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (5h - Recovered/Resolved - );Syncope (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707549	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707558	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707562	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death);Respiratory disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010707563	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling abnormal (n/a - Unknown - );Palpitations (n/a - Unknown - );Panic attack (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707564	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707565	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707631	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010707665	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Nephrolithiasis, Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707674	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - );Decreased appetite (5d - Recovered/Resolved - );Diarrhoea (5d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707679	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707697	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707713	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (24d - Recovered/Resolved - );Chest pain (24d - Recovered/Resolved - );Cold sweat (1d - Recovered/Resolved - );Dyspnoea (24d - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010707718	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707731	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010707761	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707783	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (4d - Recovered/Resolved - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010707784	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[SALBUTAMOL] (C - Asthma - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707795	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707798	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood pressure decreased (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707824	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Neck pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707830	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010707831	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707943	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Motion sickness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707955	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (30min - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707973	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nasopharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707981	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Salivary gland enlargement (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707992	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010707998	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1mo - Recovered/Resolved - );Painful respiration (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010707998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708000	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - )|[FELODIPINE, FELODIPINE PH. EUR.] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708020	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708023	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708051	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708056	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - );Chest pain (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010708071	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708076	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LYMECYCLINE] (C - Folliculitis - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010708127	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010708134	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708213	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema nodosum (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010708449	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010708542	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal loss of weight (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Depression (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Extrasystoles (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Myositis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010708552	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708557	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708585	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708828	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Rheumatic disorder (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010708840	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling of body temperature change (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Heart rate variability decreased (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Poor quality sleep (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[TESTOSTERONE UNDECANOATE] (C - n/a - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010708846	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010708922	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - );Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010708928	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chills (6h - Recovered/Resolved - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Myalgia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010708931	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - );Pustule (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010708940	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010708953	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cyanosis (n/a - Unknown - );Delirium (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Disseminated intravascular coagulation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Embolism (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Erythema (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Haemorrhage subcutaneous (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Petechiae (n/a - Unknown - );Pleural effusion (n/a - Unknown - );Purpura (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Thrombosis with thrombocytopenia syndrome (n/a - Fatal - Results in Death);White blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - Atrial fibrillation - n/a - [n/a - 30mg - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010708970	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary congestion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010708975	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010708988	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Eye inflammation (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Unknown - );Trigeminal neuritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010708991	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);COVID-19 (n/a - Unknown - Life Threatening, Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Sensory disturbance (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010708994	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (10d - Recovered/Resolved - Other Medically Important Condition);Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Skin reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALFACALCIDOL] (C - Renal disorder - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE] (C - Renal disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010708994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709025	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac dysfunction (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary oedema (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010709044	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709050	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709063	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Axial spondyloarthritis (n/a - Unknown - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Gait inability (n/a - Not Recovered/Not Resolved - Disabling);Mobility decreased (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pollakiuria (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010709064	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Parapsoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pustule (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709065	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac ventricular thrombosis (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Embolism (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Encephalopathy (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hemianopia (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Monoplegia (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombosis with thrombocytopenia syndrome (16d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709069	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Other Medically Important Condition);Autoimmune haemolytic anaemia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Cardiac arrest (n/a - Unknown - Other Medically Important Condition);Circulatory collapse (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Cerebral infarction - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CASSIA] (C - n/a - n/a - [n/a - n/a - n/a])|[EPINASTINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SENNA ALEXANDRINA LEAF] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010709074	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Gingival discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gingival pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Noninfective gingivitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oral herpes (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [1d - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Raynaud's phenomenon - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Obsessive-compulsive disorder - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A, PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT), PNEUMOCOCCAL VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709076	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Cervinek, L.. Pacient leceny agonisty trombopoetinoveho receptoru a vakcinaci proti SARS-CoV-2. HEMATOZPRAVODAJ. 2021;(Podzim 2021) Cervinek, L.. Patient treated with thrombopoietin receptor agonists vaccinated against SARS-CoV-2. HEMATOZPRAVODAJ. 2021;(Autumn 2021)	18-64 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709085	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709132	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709141	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NON SPECIFIED INHALATION [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709192	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BUPRENORPHINE [BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709194	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709215	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLECALCIFEROL] (C - Immunology test, Vitamin D decreased - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Immunology test - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709221	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Mood altered (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site discomfort (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	AERIUS [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BUDESONIDE, SALMETEROL] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709222	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthma (n/a - Unknown - );Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709224	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709305	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709455	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709467	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Body temperature increased (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site dysaesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709470	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709476	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Not Recovered/Not Resolved - );Cough (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Pyrexia (3d - Not Recovered/Not Resolved - );Sneezing (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709482	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (2d - Recovering/Resolving - );Chills (2d - Recovering/Resolving - );Dizziness (2d - Recovering/Resolving - );Dysphagia (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Oropharyngeal pain (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709506	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal dreams (2d - Not Recovered/Not Resolved - );Blood immunoglobulin E increased (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Night sweats (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709510	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709512	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Micturition urgency (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709516	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood immunoglobulin E (21d - Unknown - );Blood pressure decreased (21d - Unknown - );Dyspnoea (n/a - Unknown - );Palpitations (21d - Unknown - );Syncope (21d - Unknown - );Tachycardia (21d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010709540	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709543	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709544	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709545	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Recovered/Resolved - );Heart rate decreased (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010709550	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709551	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709553	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (7d - Recovered/Resolved - );Limb discomfort (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709554	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Unknown - );Rash (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010709559	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709580	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cutaneous vasculitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709582	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709584	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (19d - Not Recovered/Not Resolved - );Headache (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709592	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709612	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709628	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010709637	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709640	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Panic attack (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Suicidal ideation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709643	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709708	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (17d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (17d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - Not applicable - )|XARELTO [RIVAROXABAN] (C - n/a - Not applicable - )|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709777	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010709801	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - );Puncture site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010709809	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Chills (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Malaise (0d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709818	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010709819	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010709820	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (3min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709842	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010709854	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010709922	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010709935	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[VENLAFAXINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010709979	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010709979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010710258	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ear discomfort (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Motor dysfunction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010710261	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic dissection (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010710263	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Orthostatic hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010710264	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010710266	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (11d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010710269	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710273	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Pallor (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[MESTRANOL, NORETHISTERONE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710276	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Fatal - Results in Death);Asthenia (n/a - Fatal - Results in Death);Balance disorder (n/a - Fatal - Results in Death);Cognitive disorder (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Dysstasia (n/a - Fatal - Results in Death);Fall (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Hypertension (n/a - Fatal - Results in Death);Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Intestinal obstruction (n/a - Fatal - Results in Death);Large intestinal obstruction (n/a - Fatal - Results in Death);Muscular weakness (n/a - Fatal - Results in Death);Off label use (n/a - Fatal - Results in Death);Respiratory rate increased (n/a - Fatal - Results in Death);Syncope (n/a - Fatal - Results in Death, Other Medically Important Condition);Tachycardia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010710280	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Febrile convulsion (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710295	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010710333	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010710336	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710338	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Unknown - Other Medically Important Condition);Dysstasia (n/a - Unknown - );Mobility decreased (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RITUXIMAB [RITUXIMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - 850mg - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710339	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710360	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010710417	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anger (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Initial insomnia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010710747	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphostasis (n/a - Recovering/Resolving - );Oedema (n/a - Unknown - );Oedema peripheral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010710845	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ejaculation failure (n/a - Not Recovered/Not Resolved - );Rash (n/a - Recovering/Resolving - );Spermatozoa abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010710902	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010710916	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010710925	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010710982	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010710982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010711191	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Graves' disease (n/a - Unknown - Other Medically Important Condition);Hyperthyroidism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010711196	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Dizziness (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711200	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Dysgeusia (2d - Recovered/Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Injection site pain (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010711225	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010711230	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711236	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Night sweats (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711250	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711252	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Respiratory symptom (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010711263	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Local reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711271	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Paraesthesia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711281	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (5d - Not Recovered/Not Resolved - );Myalgia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711299	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (4d - Recovered/Resolved - );Cold sweat (n/a - Unknown - );Dizziness (4d - Recovered/Resolved - );Dyspnoea (19d - Recovered/Resolved With Sequelae - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010711308	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Lividity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711313	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Petechiae (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010711314	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010711317	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - );Night sweats (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711321	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspnoea (n/a - Fatal - Results in Death);Pulmonary embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010711454	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (7d - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010711519	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparaesthesia (7d - Recovered/Resolved - );Hypoaesthesia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TECFIDERA [DIMETHYL FUMARATE] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711522	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Life Threatening);Pulmonary pain (n/a - Not Recovered/Not Resolved - Life Threatening);Rash macular (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010711575	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node palpable (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711604	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711658	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Purpura (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711665	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (80d - Recovered/Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010711673	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711681	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (72h - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711769	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Peripheral coldness (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010711991	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Petechiae (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010711991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712319	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Dehydration (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate irregular (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010712322	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010712325	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010712493	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010712513	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010712515	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010712540	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712541	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010712545	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010712553	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiovascular disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Thinking abnormal (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010712555	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712556	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010712563	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (7d - Recovered/Resolved - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712600	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - Unknown - [n/a - n/a - n/a])|XARELTO [RIVAROXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010712605	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 100mg - n/a])|[AMANTADINE SULFATE] (C - n/a - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - Oral])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - n/a - [n/a - 62.5mg - n/a])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - 2.5mg - Oral])|[FUROSEMIDE] (C - Hypertension - n/a - [n/a - 40mg - Oral])|[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[SPIRONOLACTONE] (C - Cardiac failure - n/a - [n/a - 25mg - Oral])|[TRIMETAZIDINE DIHYDROCHLORIDE] (C - Cardiac failure congestive - n/a - [n/a - 35mg - n/a])|[WARFARIN SODIUM] (C - Atrial fibrillation, Atrial flutter - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010712608	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010712611	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010712616	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010712617	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712618	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712653	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010712655	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712736	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphoma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pain in extremity (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010712737	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bedridden (n/a - Recovered/Resolved - );Immunisation (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010712740	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anosmia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712752	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010712754	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010712758	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010712762	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010712766	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Yamada, G.. Basic knowledge of prophylaxis for influenza and novel coronavirus(Vaccination and prophylactic administration of drug). INFECTION CONREOL. 2021;30(11):1104	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712769	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712770	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haemoglobin decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Platelet count decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010712773	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Other Medically Important Condition);Myalgia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010712837	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute leukaemia (n/a - Fatal - Results in Death);Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure congestive (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight increased (n/a - Unknown - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PREGABALIN [PREGABALIN] (C - Neuralgia - n/a - [n/a - n/a - Oral])|XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[ATORVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - Cardiac failure chronic - n/a - [n/a - n/a - Oral])|[ELDECALCITOL] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[LIMAPROST ALFADEX] (C - Lumbar spinal stenosis - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[MECOBALAMIN] (C - Neuropathy peripheral - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[REBAMIPIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SILODOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010712919	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALGELDRATE, TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN, TICK-BORNE ENCEPHALITIS VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010712926	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BIFONAZOLE, CLOTRIMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010712973	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010712978	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010712980	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010712980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010713021	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aneurysm (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010713031	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Eye swelling (26d - Not Recovered/Not Resolved - );Lip swelling (26d - Not Recovered/Not Resolved - );Rash (26d - Not Recovered/Not Resolved - );Urticaria (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010713033	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (30d - Not Recovered/Not Resolved - );Fatigue (29d - Not Recovered/Not Resolved - );Headache (29d - Not Recovered/Not Resolved - );Herpes zoster (25d - Not Recovered/Not Resolved - );Myalgia (32d - Not Recovered/Not Resolved - );Pain (32d - Not Recovered/Not Resolved - );Rash (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713035	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (1d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713041	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - );Vaccination site movement impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713043	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site movement impairment (75d - Not Recovered/Not Resolved - );Myalgia (75d - Not Recovered/Not Resolved - );Vaccination site pain (75d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010713063	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713077	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Not Recovered/Not Resolved - );Atrial fibrillation (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713081	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Rash (n/a - Unknown - );Sensory level abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713109	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Fatigue (5d - Unknown - );Visual impairment (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713122	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Dehydration (6d - Recovering/Resolving - );Dry mouth (6d - Recovering/Resolving - );Feeling hot (2d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713124	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713141	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713146	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713150	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713156	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Venous pressure jugular increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713163	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (12d - Not Recovered/Not Resolved - );Headache (12d - Not Recovered/Not Resolved - );Insomnia (12d - Not Recovered/Not Resolved - );Rash macular (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713177	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713250	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713262	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes virus infection (6d - Recovered/Resolved - );Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713272	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (13d - Recovered/Resolved With Sequelae - );Arrhythmia (14d - Recovered/Resolved With Sequelae - );Dyspnoea (14d - Recovered/Resolved With Sequelae - );Fatigue (14d - Recovered/Resolved With Sequelae - );Feeling hot (14d - Recovered/Resolved With Sequelae - );Headache (6d - Recovering/Resolving - );Limb discomfort (14d - Recovered/Resolved With Sequelae - );Myalgia (13d - Recovered/Resolved With Sequelae - );Nausea (3d - Recovering/Resolving - );Tachycardia (14d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010713299	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Limb discomfort (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713302	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713305	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713308	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713312	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713340	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Cough (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713351	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713353	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (4d - Recovering/Resolving - );Malaise (4d - Recovering/Resolving - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713354	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713357	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713359	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713376	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010713392	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713395	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713398	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site erythema (4d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713400	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713402	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713414	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713415	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713418	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713429	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Unknown - );Dizziness (3d - Unknown - );Fatigue (8d - Unknown - );Headache (8d - Unknown - );Malaise (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713434	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Unknown - );Dizziness (1d - Unknown - );Dyspnoea (1d - Unknown - );Fatigue (1d - Unknown - );Headache (1d - Unknown - );Influenza (1d - Unknown - );Injection site pain (1d - Unknown - );Nausea (1d - Unknown - );Tachycardia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713435	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713438	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713440	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713441	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713449	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713460	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713463	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713467	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713468	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713472	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713474	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713476	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713477	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713478	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713480	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713494	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovering/Resolving - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713509	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713511	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713521	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713526	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713529	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Fatigue (5d - Not Recovered/Not Resolved - );Feeling hot (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - );Vomiting (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713531	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713534	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arrhythmia (1d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713549	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713551	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713556	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713558	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713562	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bedridden (8d - Recovered/Resolved - );Chills (8d - Recovered/Resolved - );Hypotension (8d - Recovered/Resolved - );Peripheral vascular disorder (8d - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713571	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713572	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Unknown - );Malaise (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713574	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010713578	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713580	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovered/Resolved - );Fatigue (8d - Recovering/Resolving - );Headache (5d - Recovered/Resolved - );Influenza (5d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (5d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713583	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dizziness (8d - Unknown - );Injection site pain (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713587	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713599	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713614	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713622	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (13d - Recovering/Resolving - );Rhinorrhoea (13d - Recovering/Resolving - );Throat irritation (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713629	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010713639	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713644	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713660	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713661	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Not Recovered/Not Resolved - );Myalgia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713666	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713678	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713680	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713682	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713701	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010713716	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713758	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713762	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713769	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (5d - Recovering/Resolving - );Influenza (5d - Recovering/Resolving - );Limb discomfort (5d - Recovering/Resolving - );Pyrexia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713793	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Peripheral coldness (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713799	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (36d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010713810	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713812	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (86d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010713852	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713858	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713859	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713873	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713877	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010713885	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713888	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713893	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713894	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010713896	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010713897	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713906	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010713909	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010713921	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010713921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714045	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714067	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Hypothermia (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Induration (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition);Toothache (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010714075	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (0d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Vaccination site movement impairment (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714129	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714184	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714192	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714193	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site bruising (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site paraesthesia (15min - Recovered/Resolved - );Injection site pruritus (1d - Recovered/Resolved - );Injection site reaction (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714252	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714253	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Unknown - );Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (3d - Recovered/Resolved - );Decreased appetite (n/a - Unknown - );Dizziness (3d - Recovered/Resolved - );Fatigue (n/a - Unknown - );Joint effusion (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Metastatic neoplasm (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - );Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010714256	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714266	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714277	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Listless (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (79h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714287	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Rhinorrhoea (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010714290	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714294	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Contusion (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714322	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Infectious mononucleosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714345	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714377	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714379	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714382	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714400	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Application site reaction (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714403	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714433	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714460	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714473	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010714474	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ageusia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );Sinusitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714493	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Unknown - );Rash maculo-papular (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714499	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714506	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714508	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714517	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714518	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Joint range of motion decreased (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714521	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster reactivation (4wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714526	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714532	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [92d - 1{DF} - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714538	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714569	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714572	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714576	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Not Recovered/Not Resolved - );Influenza like illness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714580	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714587	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714588	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[MIANSERIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714589	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714593	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714599	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714636	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714647	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714653	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714664	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovered/Resolved - );Sinus tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714665	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714676	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714698	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714702	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714706	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714770	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714886	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714909	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010714936	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[NEBIVOLOL] (C - Hypertension - Not applicable - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714947	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Urticaria (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714957	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus inadequate control (15d - Not Recovered/Not Resolved - );Hyperglycaemia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714958	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714962	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714964	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010714965	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714968	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[CLOMIPRAMINE] (C - n/a - n/a - )|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714975	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714989	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714993	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010714996	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (380min - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - Life Threatening);Loss of consciousness (3min - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Pulse abnormal (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010714997	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010714997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715003	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010715005	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Spinal pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715010	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Fatal - Results in Death);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Face oedema (7d - Recovered/Resolved - Other Medically Important Condition);Hypoxia (n/a - Fatal - Results in Death, Other Medically Important Condition);Oedema peripheral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010715012	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Allergic respiratory symptom (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715013	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010715016	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715019	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (4d - Recovered/Resolved - );Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715025	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate abnormal (n/a - Unknown - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - 75mg - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Hyperglycaemia - n/a - [n/a - 850mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715030	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715038	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715043	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715044	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715049	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715051	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Transaminases increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715053	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715056	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[DESLORATADINE] (C - n/a - Unknown - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715059	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715071	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pulmonary pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715098	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715102	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715107	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (3mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715121	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715122	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715127	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715130	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint stiffness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715132	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715138	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Influenza (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rhinitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715145	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010715153	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715158	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715182	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradycardia (6h - Recovered/Resolved - );Chest pain (6h - Recovered/Resolved - );Hypoaesthesia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715191	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715215	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715216	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715217	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715222	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715224	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (9d - Recovered/Resolved - );Pyrexia (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715225	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingivitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715231	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715235	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715249	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715250	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715258	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715264	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715271	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715272	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715274	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715282	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715305	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Basilar artery thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition);COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition);Chest pain (n/a - Unknown - );Coronary artery occlusion (n/a - Fatal - Results in Death, Other Medically Important Condition);Cough (n/a - Unknown - );Dizziness (n/a - Unknown - );Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition);Nausea (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pulmonary congestion (n/a - Unknown - Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROMETHAZINE, PROMETHAZINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010715314	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715343	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Energy increased (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - );Tension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[IGNATIA AMARA D 6, CORYDALIS FORMOSA D3, CICUTA VIROSA D8, GAULTHERIAE AETHEROLEUM D4, SUMBULUS MOSCHATUS D3, STAPHISAGRIA D4, HYOSCYAMUS NIGER D6, ASA FOETIDA D3, AVENA SATIVA MOTHER TINCTURE, VALERIANA OFFICINALIS DIL. D3, SUMBUL D6, IGNATIA AMARA D3, AVENA SATIVA TM, NUX VOMICA D3, CICUTA VIROSA D6, HYOSCYAMUS NIGER D1, STAPHISAGRIA D4, VALERIANA OFFICINALIS D2, MATRICARIA RECUTITA D3, ASA FOETIDA D6, SUMBUL D6, IGNATIA AMARA D3, AVENA SATIVA TM, NUX VOMICA D3, CICUTA VIROSA D6, HYOSCYAMUS NIGER D1, VALERIANA OFFICINALIS D2, DELPHINIUM STAPHISAGRIA D4, MATRICARIA RECUTITA D3, ASA FOETIDA D6] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715449	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Pruritus (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[BACLOFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE FUROATE, VILANTEROL TRIFENATATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715488	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Injection site haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010715489	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Dizziness (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gait inability (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (105h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Movement disorder (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715522	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715546	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715553	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715558	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715575	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715611	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715621	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010715633	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010715653	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pleurisy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715685	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Spinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715698	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dysphonia (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - 15mmol - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715802	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715865	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood creatine phosphokinase increased (3d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (3d - Recovered/Resolved - Other Medically Important Condition);Palpitations (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010715913	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Nausea (24h - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	DUOTRAV [TIMOLOL, TRAVOPROST] (C - Ocular hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715914	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715923	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Purpura (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715932	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715936	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertensive crisis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715939	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715942	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Foetal death (n/a - Fatal - Results in Death);Hydrocephalus (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010715944	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010715952	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010715956	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Macular oedema (n/a - Unknown - Other Medically Important Condition);Ocular vascular disorder (n/a - Not Recovered/Not Resolved - Disabling);Retinal vein occlusion (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010715971	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010715974	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010715975	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010715975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010716023	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716040	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Seronegative arthritis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716042	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716048	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716058	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716069	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal colic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	RELVAR ELLIPTA 184 MICROGRAMS/22 MICROGRAMS [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - Dose not changed - [n/a - 1{DF} - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716076	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010716090	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood folate decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716104	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Post-acute COVID-19 syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Postural orthostatic tachycardia syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716112	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eczema (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716135	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716145	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatosplenomegaly (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716156	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716160	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716186	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010716229	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - );Back pain (n/a - Unknown - );Rhabdomyolysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716265	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Macular oedema (n/a - Not Recovered/Not Resolved - Disabling);Retinal vascular thrombosis (n/a - Not Recovered/Not Resolved - Disabling);Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010716384	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysstasia (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle tightness (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METHOTREXATE] (C - n/a - n/a - [n/a - 6mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716412	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral disorder (n/a - Unknown - Other Medically Important Condition);Death (n/a - Fatal - Results in Death);Delusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Hallucination, visual (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of control of legs (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010716437	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716443	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010716505	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (6h - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Nightmare (6h - Recovered/Resolved - );Pyrexia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716509	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716511	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Parkinson's disease (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUDROCORTISONE ACETATE] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[MIDODRINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716517	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse event following immunisation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010716522	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - Disabling);Pleurisy (n/a - Recovered/Resolved With Sequelae - Disabling);Pulmonary pain (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010716530	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010716578	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthritis infective (n/a - Unknown - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Unknown - );Swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[KETAMINE] (C - Hip arthroplasty - n/a - [n/a - n/a - n/a])|[METHADONE] (C - Hip arthroplasty - n/a - [n/a - n/a - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (C - Hip arthroplasty - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716595	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010716622	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Renal failure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010716696	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Dysstasia (n/a - Unknown - );Fatigue (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Hyperhidrosis (0d - Recovered/Resolved - );Injection site pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010716711	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disorientation (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Recovering/Resolving - );Gait disturbance (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mental fatigue (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - );Nystagmus (n/a - Unknown - );Palpitations (n/a - Unknown - );Performance status decreased (n/a - Recovering/Resolving - );Tremor (n/a - Unknown - );Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vestibular neuronitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FIASP [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716714	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site erythema (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716731	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010716735	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010716736	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site joint movement impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010716741	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute respiratory failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Miller Fisher syndrome (n/a - Fatal - Results in Death, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition);Type 2 diabetes mellitus (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010716755	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716775	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Product use issue (n/a - Unknown - )	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716777	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (24h - Unknown - );Nausea (24h - Unknown - );Pain (24h - Unknown - );Vomiting (24h - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716808	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716858	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Fatal - Results in Death);Hemiparesis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010716864	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Leukocytosis (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010716874	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ZOPICLONE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010716909	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716944	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716953	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010716957	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010716957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717036	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717068	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Coordination abnormal (0d - Recovered/Resolved - Disabling, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (0d - Recovered/Resolved - Disabling, Other Medically Important Condition);Hyperphagia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Mobility decreased (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Neuralgia (0d - Recovered/Resolved - Disabling, Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010717081	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717086	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac death (n/a - Fatal - Results in Death, Other Medically Important Condition);Decreased appetite (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010717105	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Meningism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717108	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010717128	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Yamada, G.. Basic knowledge of prophylaxis for influenza and novel coronavirus(Vaccination and prophylactic administration of drug). INFECTION CONREOL. 2021;30(11):1104	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717204	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Feeling cold (n/a - Unknown - );Headache (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717215	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Disabling);Affect lability (n/a - Unknown - Disabling);Chest pain (n/a - Unknown - Disabling);Chronic gastritis (n/a - Unknown - Disabling);Constipation (3d - Recovered/Resolved - Disabling);Delirium (n/a - Unknown - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Disabling);Disturbance in attention (n/a - Unknown - Disabling);Feeling hot (n/a - Unknown - Disabling);Increased appetite (n/a - Unknown - Disabling);Muscle twitching (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Parasomnia (n/a - Unknown - Disabling);Pollakiuria (n/a - Unknown - Disabling);Postural orthostatic tachycardia syndrome (n/a - Recovered/Resolved With Sequelae - Disabling);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Thirst (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010717217	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010717223	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (252h - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (252h - Recovered/Resolved - Other Medically Important Condition);Urticaria (252h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010717225	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717240	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717278	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (5wk - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (10s - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010717291	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Drug hypersensitivity (0d - Recovered/Resolved - );Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|KIOVIG 100 MG/ML SOLUTION FOR INFUSION [HUMAN NORMAL IMMUNOGLOBULIN] (S - Product used for unknown indication - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717308	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717341	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Thrombophlebitis (4wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010717442	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717478	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010717519	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717520	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717522	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Drug ineffective (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717550	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010717591	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010717612	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Transient ischaemic attack (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[BIOFLAVONOIDS, DIOSMIN, BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - Unknown - [n/a - n/a - n/a])|[PIRACETAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010717618	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Myositis (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PAROXETINE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010717674	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Ear pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010717715	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Minocha, P.. Recurrence of Acute Myocarditis Temporally Associated with Receipt of the mRNA Coronavirus Disease 2019 (COVID-19) Vaccine in a Male Adolescent.. Journal of Pediatrics. 2021;238:321-323. doi:10.1016/j.jpeds.2021.06.035	12-17 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010717742	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717743	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Ambati, S.. Acute myopericarditis after covid-19 vaccine in teenagers. Case Reports in Cardiology. 2021;10.1155/2021/8268755. doi:10.1155/2021/8268755	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010717748	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Ambati, S.. Acute myopericarditis after covid-19 vaccine in teenagers. Case Reports in Cardiology. 2021;10.1155/2021/8268755. doi:10.1155/2021/8268755	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010717748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010718275	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	EXFORGE 5 MG/160 MG FILM-COATED TABLETS [VALSARTAN, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|RIVAROXABAN 15MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010718301	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010718466	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Hyperglycaemia - n/a - [n/a - 850mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010718674	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (12h - Recovered/Resolved - );Pyrexia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718704	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cutaneous vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Raynaud's phenomenon (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010718712	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010718872	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Menstruation irregular (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718920	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010718924	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening);Chest discomfort (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID, MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - 75mg - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 1g - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010718924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010719030	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine with aura (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719033	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719040	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719041	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719044	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719075	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Incorrect dose administered (n/a - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719085	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periorbital haematoma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	[LEVOMEPROMAZINE] (C - Irritability - Dose not changed - [n/a - n/a - Unknown])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Irritability - Dose not changed - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719102	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010719121	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719126	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010719135	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010719136	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719143	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719144	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719147	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719157	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719158	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Breast pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Groin pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010719163	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Recovered/Resolved With Sequelae - );Varicose vein (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010719166	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719171	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719173	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719175	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719176	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719181	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psychotic disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	[RISPERIDONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010719193	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Incorrect dose administered (n/a - Unknown - );No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719221	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010719232	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Panic attack (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010719239	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac ventricular thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010719371	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010719412	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010719456	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010719544	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - 10mg - Oral])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - 1g - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010719615	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	Non European Economic Area	Grome, H.. Fatal Multisystem Infl ammatory Syndrome in Adult after SARS-CoV-2 Natural Infection and COVID-19 Vaccination. Emerging Infectious Diseases. 2021;27 (11):2914-2918. doi:10.3201/eid2711.211612	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Multisystem inflammatory syndrome in adults (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010719712	Spontaneous	2021-11-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (4d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010719741	Spontaneous	2021-11-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - Other Medically Important Condition);Chills (4d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (4d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (4d - Recovered/Resolved - Other Medically Important Condition);Dizziness (4d - Recovered/Resolved - Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - Other Medically Important Condition);Headache (4d - Recovered/Resolved - Other Medically Important Condition);Myalgia (4d - Recovered/Resolved - Other Medically Important Condition);Nausea (4d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination site induration (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination site oedema (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination site warmth (4d - Recovered/Resolved - Other Medically Important Condition);Vomiting (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010719741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705438	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705446	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS 2.5 MG FILM-COATED TABLETS [APIXABAN] (C - Thrombosis prophylaxis - n/a - [n/a - 2.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705449	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010705458	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705464	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705474	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705478	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705531	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010705546	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705553	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	International normalised ratio increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - n/a - Dose not changed - [n/a - 50mg - Oral])|ULTIBRO BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER HARD CAPSULES [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - n/a - Dose not changed - [n/a - 1{DF} - Respiratory (inhalation)])|[ACENOCOUMAROL] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - Dose not changed - [n/a - 150mg - Oral])|[BISOPROLOL FUMARATE] (C - n/a - Dose not changed - [n/a - 2.5mg - Oral])|[ENOXAPARIN SODIUM] (C - n/a - Dose not changed - [n/a - 60mg - Subcutaneous])|[ESOMEPRAZOLE] (C - n/a - Dose not changed - [n/a - 20mg - Oral])|[FUROSEMIDE] (C - n/a - Dose not changed - [n/a - 80mg - Oral])|[QUETIAPINE] (C - n/a - Dose not changed - [n/a - 25mg - Oral])|[SIMVASTATIN, EZETIMIBE] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010705571	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705575	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705584	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - );Musculoskeletal pain (14d - Recovered/Resolved - );Rhinitis (4d - Recovered/Resolved - );Vaccination failure (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705596	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705598	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705600	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705606	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705614	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705620	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705621	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705671	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705675	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705681	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705683	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705687	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705692	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705694	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Body temperature increased (7d - Recovered/Resolved - );Ear pain (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705697	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (12min - Recovered/Resolved - );Pyrexia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705702	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (6h - Recovered/Resolved - );Nausea (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705705	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705707	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705710	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705719	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705725	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (3d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Hypertension (3d - Recovering/Resolving - );Influenza like illness (3d - Recovering/Resolving - );Puncture site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705729	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (11d - Recovered/Resolved - );Diarrhoea (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705747	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Papule (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010705757	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705770	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705775	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Food allergy (3mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMISULPRIDE] (C - n/a - n/a - [3y - 120mg - Oral])|[FLUVOXAMINE HYDROGENMALEATE, FLUVOXAMINE MALEATE] (C - n/a - n/a - [3y - 50mg - Oral])|[VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [3mo - 75mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705793	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705801	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705807	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705835	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705845	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Dose increased - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705846	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705871	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705882	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705889	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - Atopy - n/a - [n/a - n/a - n/a])|[TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010705897	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (15d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (15d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705905	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemoptysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010705911	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Arthralgia (1d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Productive cough (n/a - Not Recovered/Not Resolved - );Pulmonary pain (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010705915	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (8d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (8d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705926	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705927	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705928	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin discolouration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705935	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Recovering/Resolving - Other Medically Important Condition);Disease recurrence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);IgA nephropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Renal impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010705936	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705939	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Varicose vein (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705944	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705948	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705950	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - );Nervousness (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705953	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010705955	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Neoplasm malignant (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705963	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Transplant rejection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705964	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010705966	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010705969	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010705976	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705977	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal sounds abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Somnolence (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705984	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Breast disorder (n/a - Unknown - Disabling);Breast enlargement (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Lymphadenopathy (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010705997	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Baicus, C.. Hyper-inflammation after COVID-19 mARN vaccination: at the crossroads of multisystem inflammatory disease and adult-onset Still&apos;s disease. Does terminology matter?. ROM. J. INTERN. MED. 2021;0:1-7. doi:10.2478/rjim-2021-0035	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Unknown - Other Medically Important Condition);Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - );Cytokine storm (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dysphagia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);General physical health deterioration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemophagocytic lymphohistiocytosis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Hepatic cytolysis (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - );Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammatory marker increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Leukocytosis (n/a - Unknown - );Lymphopenia (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial necrosis (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neutrophilia (n/a - Unknown - );Odynophagia (n/a - Unknown - );Oropharyngeal candidiasis (n/a - Unknown - Other Medically Important Condition);Oropharyngeal erythema (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pleurisy (n/a - Unknown - Caused/Prolonged Hospitalisation);Proteinuria (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Rash macular (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Still's disease (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transaminases increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010706010	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706011	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (30d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706021	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706023	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706025	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Urinary tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706032	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Sensory loss (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010706044	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );Back pain (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - );Dysgeusia (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706045	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Amyotrophic lateral sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706047	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706055	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706060	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Illness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Migraine (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706061	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back disorder (n/a - Unknown - );Dysstasia (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Impaired ability to use machinery (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Sciatica (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010706062	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ocular vascular disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema (n/a - Recovered/Resolved - );Orbital haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photopsia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706063	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[ETORICOXIB] (C - Pain - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706104	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706148	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphthous ulcer (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706159	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (4d - Recovered/Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706162	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706172	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706189	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010706231	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Erectile dysfunction (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706236	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706242	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706247	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706278	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706291	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Mouth ulceration (n/a - Not Recovered/Not Resolved - );Oral herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - [3y - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [3y - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [832d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706302	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706315	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706341	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706344	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706346	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Depressed mood (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706352	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Skin discolouration (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706356	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706363	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706383	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706384	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706390	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vestibular neuronitis (29d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010706391	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gout (5d - Recovered/Resolved - );Joint swelling (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706393	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706397	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706399	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706406	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706410	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706411	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706419	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706420	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706425	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706431	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706432	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706435	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706440	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706446	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706448	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706454	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706469	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706474	Spontaneous	2021-11-21 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010706478	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Groin pain (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010706489	Spontaneous	2021-11-21 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Sedation (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010706489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701184	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[NOT AVAILABLE] (S - Multiple fractures - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701421	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (25min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010701433	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - n/a - n/a - [n/a - 30mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 500mg - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701437	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701441	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701456	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701473	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Injection site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701478	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701484	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701494	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701495	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701496	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Disabling);Loss of consciousness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010701511	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pericarditis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010701515	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010701525	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone density decreased (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Polymyositis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010701526	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sense of oppression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701530	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Life Threatening);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Hot flush (n/a - Not Recovered/Not Resolved - Life Threatening);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010701537	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701538	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701629	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701631	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701637	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701859	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site induration (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701878	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701899	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Mobility decreased (n/a - Unknown - );Myalgia (9d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010701900	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701906	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701911	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (12h - Recovered/Resolved - );Fatigue (12h - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (12h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701912	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (4d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702937	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702946	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702950	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (36h - Recovered/Resolved - );Malaise (36h - Recovered/Resolved - );Myalgia (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702956	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702966	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site discomfort (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702968	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702969	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702971	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702979	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702991	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702992	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (5d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010702995	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703031	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Epistaxis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703048	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703059	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Life Threatening);Subdural haematoma (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010703067	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|IMMUNOTHERAPIE (IMMUUNTHERAPIE) [NOT AVAILABLE] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010703071	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (11d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703074	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vestibular neuronitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703076	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703080	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[CHLORTALIDONE] (S - n/a - Dose not changed - [n/a - n/a - n/a])|[NOT AVAILABLE] (S - n/a - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010703089	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703090	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[HALOPERIDOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703102	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703107	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703341	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703350	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703365	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial asymmetry (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	TRAJENTA [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010703379	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Oedema (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703390	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703415	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovering/Resolving - );Palatal oedema (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703429	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug hypersensitivity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703451	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703634	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctivitis (8d - Recovered/Resolved - );Oral herpes (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703750	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010703751	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010703753	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Blood pressure increased (n/a - Fatal - Results in Death);Cardiac arrest (n/a - Fatal - Results in Death);Diverticulitis (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Nausea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 25mg - Oral])|[METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - 100mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 40mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - 5mg - Oral])|[VALPROIC ACID, SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - 900mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010703756	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epilepsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[TOPIRAMATE] (C - Epilepsy - n/a - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010703773	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010703777	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertensive crisis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010703778	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	BINOCRIT [EPOETIN ALFA] (C - n/a - n/a - [n/a - 10000k[iU] - Intramuscular])|ENVARSUS 0.75 MG PROLONGED-RELEASE TABLETS [TACROLIMUS] (C - n/a - n/a - [n/a - 4mg - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100ug - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 1.25mg - Oral])|[CALCITRIOL] (C - n/a - n/a - [n/a - .25mg - Oral])|[CALCITRIOL] (C - n/a - n/a - [n/a - .25ug - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 10000k[iU] - Oral])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 25mg - Oral])|[MYCOPHENOLIC ACID] (C - Transplant rejection - n/a - [n/a - 360mg - Oral])|[OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - 1000mg - Oral])|[OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - 1000mg - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 25mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - .5{DF} - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[VALGANCICLOVIR] (C - Antiviral treatment - n/a - [n/a - 450mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010703790	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010703792	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010703794	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010703811	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Paraesthesia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010703819	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010703821	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral artery occlusion (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010703823	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Quadrantanopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010703903	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703921	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/FLORIDA/4/2006-LIKE STRAIN, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/SOUTH AUSTRALIA/55/2014 STRAIN, A/SWITZERLAND/9715293/2013 (H3N2) - LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/WISCONSIN/67/2005 (H3N2), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN, B/MALAYSIA/2506/2004 - LIKE STRAIN, B/BEIJING/184/93-LIKE STRAIN (B/YAMANASHI/166/98), A/SYDNEY/5/97 (H3N2)-LIKE STRAIN (A/SYDNEY/5/97 REASS. RESVIR 13), A/BEIJING/262/95 (H1N1) - LIKE STRAIN (A/BEIJING/262/95 REASS. X-127), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NIB-65), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/02/2012, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, IVR-175), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (S - Influenza immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703926	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010703927	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010703942	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Deep vein thrombosis - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703957	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Breast oedema (n/a - Not Recovered/Not Resolved - );Nipple pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703958	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703961	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010703995	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Lymphoma (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010703995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010704003	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704014	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010704258	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NON SPECIFIED OORDRUPPELS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010704316	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010704344	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704444	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (0d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010704474	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704484	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704488	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pemphigus (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	NOT AVAILABLE (C - n/a - n/a - )|[METHYLPREDNISOLONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704519	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704522	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704570	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704606	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704670	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704671	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704673	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704703	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (2d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704712	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - n/a - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|ZARZIO 30 MU/0.5 ML [FILGRASTIM] (C - n/a - n/a - [n/a - n/a - n/a])|[EPOETIN ALFA] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704722	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - );Chills (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704723	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704738	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704750	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Flatulence (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704839	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704841	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704842	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704843	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704844	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704845	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704846	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704848	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704850	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704852	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704857	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704886	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pneumonia (2wk - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010704888	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704891	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704907	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (8h - Recovered/Resolved - );Injection site inflammation (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CHLORAMPHENICOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704910	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704912	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010704915	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010704941	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704943	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704944	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704947	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704948	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704953	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704955	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704957	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704961	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704968	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704969	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704970	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704972	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010704998	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010704998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705004	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705009	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705010	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705013	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705014	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705018	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705051	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705052	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705055	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705056	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705057	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705061	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705090	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010705102	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705140	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLSALAZINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010705151	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705154	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Conjunctival haemorrhage (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010705341	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010705382	Spontaneous	2021-11-20 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010705401	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010705409	Spontaneous	2021-11-20 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010705409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010690514	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired healing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690641	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690644	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690645	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690646	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Vertigo (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690651	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690652	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690751	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[LEVOTHYROXINE SODIUM] (C - Thyroid mass - n/a - [n/a - 50ug - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690765	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - );Sense of oppression (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690769	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Impetigo (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690822	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (34d - Recovered/Resolved - );Hemiparesis (34d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[HYDROCHLOROTHIAZIDE, NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010690987	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690998	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Hypotension (n/a - Unknown - );Loss of consciousness (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010691002	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumonitis (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691005	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691006	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved With Sequelae - );Syncope (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010691026	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010691034	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Recovered/Resolved With Sequelae - );Arthralgia (n/a - Recovered/Resolved With Sequelae - );Lip oedema (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010691037	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Productive cough (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691055	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Ear pain (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691059	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Disabling);Back injury (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010691066	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691077	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010691084	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010691100	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691104	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010691105	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (79d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691117	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691134	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010691136	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Band sensation (6d - Recovered/Resolved - );Burning sensation (6d - Recovered/Resolved - );Dermatitis bullous (6d - Recovered/Resolved - );Erythema (6d - Recovered/Resolved - );Pruritus (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691137	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertensive crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691139	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bradycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010691146	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010691154	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691157	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis acneiform (7d - Recovered/Resolved - );Folliculitis (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691162	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691163	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691166	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691167	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691169	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010691177	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Dermatitis (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspepsia (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010691189	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691222	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691253	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Hot flush (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691256	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691259	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691274	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening);Pain in extremity (n/a - Recovering/Resolving - Life Threatening);Peripheral swelling (n/a - Recovering/Resolving - Life Threatening);Pulmonary microemboli (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010691282	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010691298	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691299	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010691304	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovered/Resolved - Other Medically Important Condition);Anosmia (n/a - Recovered/Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Tachypnoea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691314	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691369	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691411	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (12d - Recovered/Resolved - );Lymphadenopathy (12d - Recovered/Resolved - );Pain (12d - Recovered/Resolved - );Pyrexia (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	PRITOR 80 MG TABLETS [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[BARNIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691450	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691453	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death);Intracranial aneurysm (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LACIDIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEGA-3-ACID ETHYL ESTERS 90 WITH A SPECIFIC COMPOSITION FOR EPA AND DHA NOT LOWER THAN 85%.] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RIFAXIMIN] (C - Diverticulitis - n/a - [n/a - n/a - n/a])|[TICLOPIDINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010691456	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Dysphagia (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Vertigo (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010691465	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010691476	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691478	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691520	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691571	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1mo - Not Recovered/Not Resolved - );Myalgia (3mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010691764	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010691777	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691791	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Unknown - Other Medically Important Condition);Bone pain (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691798	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691816	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691817	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral circulatory failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691818	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691824	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691825	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691828	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Other Medically Important Condition);Internal haemorrhage (n/a - Unknown - Other Medically Important Condition);Nephrolithiasis (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691830	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691831	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691832	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691834	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691848	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Blood immunoglobulin E increased (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - );Lip swelling (19h - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - );Paraesthesia oral (19h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CANDESARTAN] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[DABIGATRAN] (C - Atrial fibrillation - n/a - [n/a - 220mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010691865	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010691870	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Emotional disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010691875	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010691884	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Ocular discomfort (n/a - Not Recovered/Not Resolved - Disabling);Photophobia (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010691884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010692095	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM] (C - Arthritis - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692096	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692097	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM] (C - Decreased activity - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692098	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[BACILLUS COAGULANS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Prostatic operation - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692102	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - n/a])|HUMAN NORMAL IMMUNOGLOBULIN [HUMAN NORMAL IMMUNOGLOBULIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[HYDROCHLOROTHIAZIDE, LOSARTAN] (C - n/a - n/a - [n/a - 100mg - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692172	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692182	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010692184	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Thyroid pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692191	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DEXAMETHASONE [DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TRIPTORELIN ACETATE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692202	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Candida infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692205	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692273	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Respiratory tract infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692280	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692292	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Erectile dysfunction (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - );Palpitations (n/a - Unknown - );SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692457	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010692458	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010692473	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[DYDROGESTERONE, ESTRADIOL, DYDROGESTERONE, ESTRADIOL HEMIHYDRATE, ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Menopause - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692474	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692479	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010692490	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Breast pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692493	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692503	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (1d - Recovered/Resolved - Other Medically Important Condition);Dysarthria (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692504	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspepsia (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mouth breathing (2d - Recovered/Resolved - Other Medically Important Condition);Nasal congestion (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692508	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PREDNISOLONE, PREDNISOLONE SODIUM PHOSPHATE] (C - Myalgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692509	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Dysgeusia (2d - Recovered/Resolved - Other Medically Important Condition);Feeling of body temperature change (3d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692516	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness postural (2d - Recovered/Resolved - Other Medically Important Condition);Feeling drunk (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692556	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010692568	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Illusion (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling);Vomiting (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010692572	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692578	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692581	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Drug effect less than expected (n/a - Unknown - );Myasthenia gravis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010692582	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dehydration (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692594	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [8y - n/a - n/a])|JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [8y - n/a - n/a])|TRULICITY [DULAGLUTIDE] (C - n/a - n/a - [5y - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [8y - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [8y - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [2y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010692601	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010692676	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010692691	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010692767	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acne (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin hypertrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692821	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010692845	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692848	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692853	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypertension (61d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010692854	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692861	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692882	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692890	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epistaxis (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010692912	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial flutter (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010692914	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010692915	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Life Threatening);Nightmare (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010692917	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010692944	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3h - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Loss of consciousness (3h - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010692974	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692975	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692976	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Memory impairment (n/a - Recovering/Resolving - Other Medically Important Condition);Mental fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692988	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010692989	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010692989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693024	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693030	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693031	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693033	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693035	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Osteonecrosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693095	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - )|[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )|[PREDNISOLONE] (C - n/a - n/a - )|[SODIUM IBANDRONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693123	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (13d - Fatal - Results in Death, Other Medically Important Condition);Lung neoplasm malignant (13d - Fatal - Results in Death, Other Medically Important Condition);Paralysis (13d - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ARIPIPRAZOLE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE HYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - 1{DF} - Respiratory (inhalation)])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - .5{DF} - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PITAVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010693167	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693212	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mobility decreased (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693282	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693286	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010693291	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (15d - Recovered/Resolved - );Pruritus (15d - Recovered/Resolved - );Rash pruritic (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010693294	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010693307	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010693320	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematuria (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nephropathy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[ACETYLSALICYLIC ACID] (C - Essential thrombocythaemia - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693364	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010693630	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tendon injury (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693635	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010693658	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693678	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693682	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693698	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693701	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693703	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693709	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Retinal detachment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693718	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693720	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Contusion (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693724	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693728	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693730	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010693745	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693746	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling abnormal (n/a - Unknown - );Malaise (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010693747	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MORPHINE SULFATE, MORPHINE SULPHATE BP] (C - Neck pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693748	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693750	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693753	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness neurosensory (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010693770	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Influenza like illness (3d - Unknown - );Vaccination site discomfort (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693772	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693777	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010693786	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010693881	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693889	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	DOCETAXEL [DOCETAXEL] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693899	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010693903	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral nerve paresis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010693941	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (4d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010693989	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010693989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010694165	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010694166	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694171	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphoedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010694184	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (7d - Not Recovered/Not Resolved - );Dyspnoea (7d - Not Recovered/Not Resolved - );Paraesthesia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010694194	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (2d - Recovering/Resolving - );Urticaria (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694196	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694222	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal discomfort (41d - Recovered/Resolved - );Chills (41d - Recovered/Resolved - );Head discomfort (41d - Recovered/Resolved - );Hypoaesthesia (41d - Recovered/Resolved - );Nausea (41d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010694223	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (2d - Recovered/Resolved - );Cardiac discomfort (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010694226	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (4d - Not Recovered/Not Resolved - );Lymphadenopathy (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694233	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (10d - Recovering/Resolving - );Fatigue (10d - Recovering/Resolving - );Hot flush (10d - Recovering/Resolving - );Influenza like illness (10d - Recovering/Resolving - );Pain in extremity (10d - Recovering/Resolving - );Palpitations (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010694234	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010694236	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694250	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (12h - Recovered/Resolved - );Dizziness (12h - Recovered/Resolved - );Fatigue (12h - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010694252	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010694255	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - );Epstein-Barr virus infection reactivation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sepsis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010694258	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010694262	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694263	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010694266	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694272	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (48d - Not Recovered/Not Resolved - );Injection site erythema (48d - Not Recovered/Not Resolved - );Polymenorrhoea (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010694273	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (1d - Recovered/Resolved - );Local reaction (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694297	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (25d - Not Recovered/Not Resolved - );Fatigue (25d - Not Recovered/Not Resolved - );Headache (25d - Not Recovered/Not Resolved - );Hemianaesthesia (n/a - Recovered/Resolved With Sequelae - );Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - );Muscular weakness (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010694301	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694303	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hepatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010694307	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694318	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694319	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694353	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash maculo-papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010694359	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010694394	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010694409	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alanine aminotransferase increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010694410	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010694416	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010694508	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010694542	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gait inability (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010694567	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis reactive (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010694584	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute sinusitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dermatitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Eosinophilic pneumonia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypereosinophilic syndrome (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Impaired work ability (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pneumococcal infection (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);SARS-CoV-2 test negative (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [88d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE PH. EUR.] (C - n/a - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010694600	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Macular degeneration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010694665	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010694723	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (7d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	BRIVIACT [BRIVARACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|FYCOMPA [PERAMPANEL] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYTOIN, PHENYTOIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010694835	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Body temperature increased (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694920	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (20d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (20d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (20d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010694923	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (4d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010694993	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010694994	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010694999	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010694999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010695000	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010695056	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute polyneuropathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ataxia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Burning sensation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Leukoencephalopathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Motor dysfunction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myositis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Polyneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Quadriplegia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE, CIPROFLOXACIN, HYDROCORTISONE] (C - Urinary tract disorder - n/a - [n/a - n/a - Oral])|[DICLOFENAC DIETHYLAMINE, DICLOFENAC SODIUM, DICLOFENAC SODIUM, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - 50mg - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[TAMOXIFEN CITRATE, TAMSULOSIN HYDROCHLORIDE] (C - Urinary tract disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010695181	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Painful respiration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695218	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - );Myalgia (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695246	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695254	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DEXAMETHASONE [DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE] (C - Plasma cell myeloma - n/a - [n/a - n/a - n/a])|LENALIDOMIDE [LENALIDOMIDE] (C - Plasma cell myeloma - n/a - [n/a - n/a - n/a])|[ACICLOVIR, ACICLOVIR SODIUM] (C - Plasma cell myeloma - n/a - [n/a - n/a - n/a])|[CO-TRIMOXAZOLE, SULFAMETHOXAZOLE, TRIMETHOPRIM, TRIMETHOPRIM BP, SULFAMETHOXAZOLE BP] (C - Plasma cell myeloma - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Plasma cell myeloma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695258	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695266	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (4d - Recovered/Resolved - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Breast pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695268	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ADALIMUMAB [ADALIMUMAB] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695270	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Disabling);Hyperhidrosis (n/a - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (n/a - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010695271	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695275	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Limb injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010695375	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Melanocytic naevus (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010695384	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Spondylolisthesis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010695386	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (5d - Recovered/Resolved - Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - );Pain (5d - Recovered/Resolved - Other Medically Important Condition);Upper respiratory tract congestion (5d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695389	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diplopia (n/a - Unknown - );Ulcerative keratitis (n/a - Unknown - Other Medically Important Condition);VIth nerve paralysis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010695392	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Eye disorder (n/a - Unknown - );Fall (n/a - Unknown - );Hypopnoea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Respiration abnormal (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010695396	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - );Seizure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Shock (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[NADOLOL] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010695434	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010695467	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac dysfunction (n/a - Recovering/Resolving - Life Threatening);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010695488	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Portal vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010695491	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Central nervous system vasculitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010695497	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (18d - Not Recovered/Not Resolved - );Vaccination site movement impairment (18d - Not Recovered/Not Resolved - );Vaccination site pain (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695499	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695517	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695525	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695527	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (5d - Not Recovered/Not Resolved - );Chest pain (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Panic attack (5d - Not Recovered/Not Resolved - );Tachycardia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695536	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695542	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (4d - Not Recovered/Not Resolved - );Influenza like illness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695551	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (41d - Not Recovered/Not Resolved - );Influenza like illness (41d - Not Recovered/Not Resolved - );Local reaction (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010695555	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovered/Resolved - );Dyspnoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695588	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010695597	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695602	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved With Sequelae - );Tinnitus (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010695610	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (0d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695634	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved With Sequelae - );Tinnitus (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010695641	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695647	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Not Recovered/Not Resolved - );Vaccination site movement impairment (0d - Not Recovered/Not Resolved - );Vaccination site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695648	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (11d - Recovering/Resolving - );Limb discomfort (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695671	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (4d - Recovered/Resolved With Sequelae - );Injection site pain (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010695685	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695688	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695700	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010695940	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010695941	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010695944	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010695976	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Painful erection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Spontaneous penile erection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[THYROID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010695976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696076	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696098	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696112	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Poor quality sleep (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE OXIDE] (C - Diarrhoea - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696114	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (4mo - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol increased - n/a - [n/a - 40mg - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - 1{DF} - n/a])|[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696122	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	TRULICITY [DULAGLUTIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696149	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	XARELTO [RIVAROXABAN] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[EPLERENONE] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[RAMIPRIL] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010696235	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (5d - Fatal - Results in Death);Hypotension (5d - Fatal - Results in Death);Pyrexia (5d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 500mg - Oral - More in ICSR])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - 100mg - Intramuscular - More in ICSR])|[TAMOXIFEN CITRATE, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010696266	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010696328	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696351	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	XARELTO [RIVAROXABAN] (C - Atrial fibrillation - Dose not changed - [n/a - 1{DF} - n/a])|[ALLOPURINOL] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE, AMILORIDE, HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE DIHYDRATE, HYDROCHLOROTHIAZIDE, ANHYDROUS AMILORIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - .5{DF} - n/a])|[AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - .5{DF} - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, TULIP] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[DORZOLAMIDE HYDROCHLORIDE, TIMOLOL, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE, DORZOLAMIDE, TIMOLOL] (C - n/a - Dose not changed - [n/a - 2[drp] - n/a])|[DRY EXTRACT OF GINKGO BILOBA LEAVES (35-67:1), EXTRACTION SOLVENT: ACETONE 60% ( M / M), GINKGO BILOBA, GINKGO BILOBA EXTRACT, GINKGO BILOBA LEAF EXTRACT] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])|[PIRACETAM] (C - n/a - Dose not changed - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696447	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	REVOLADE [ELTROMBOPAG] (C - n/a - Unknown - )|RITUXIMAB [RITUXIMAB] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010696478	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - );Sensory loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696604	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696609	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696618	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010696620	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696656	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (6d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tendon rupture (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696660	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Hangover (n/a - Unknown - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Eye disorder prophylaxis - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696675	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Epilepsy (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Movement disorder (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696683	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Illness (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010696684	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Illness (n/a - Unknown - );Tunnel vision (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696686	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696731	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010696747	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	CSF immunoglobulin increased (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010696764	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696770	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dry mouth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010696775	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Bronchospasm (4d - Recovered/Resolved - Other Medically Important Condition);Cough (5d - Recovered/Resolved - );Myalgia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010696783	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Anaemia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010696791	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Retinal detachment (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696842	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (37d - Recovered/Resolved - Other Medically Important Condition);Immunisation (37d - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010696883	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Loss of consciousness (1min - Recovered/Resolved - );Muscle spasms (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010696914	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sinus arrest (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696915	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010696927	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696938	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Lymph node pain (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696940	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (1d - Unknown - );Cough (1d - Unknown - );Fatigue (1d - Unknown - );Headache (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696967	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010696978	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (7d - Recovering/Resolving - );Dizziness (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010696985	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010696985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697001	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursa disorder (n/a - Not Recovered/Not Resolved - );Eczema (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Lip dry (n/a - Not Recovered/Not Resolved - );Oral herpes (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697007	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697084	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mental impairment (12d - Recovered/Resolved - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010697116	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dermatitis allergic (2h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (2h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Flushing (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lip swelling (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Skin reaction (2h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swelling face (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697160	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Male	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697169	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[DIHYDROCODEINE TARTRATE, PARACETAMOL, PARACETAMOL BP, DIHYDROCODEINE TARTRATE BP, PARACETAMOL, DIHYDROCODEINE TARTRATE BP] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[LACIDIPINE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697170	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Herpes zoster oticus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697190	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Apathy (1d - Recovering/Resolving - );Back pain (1d - Recovering/Resolving - );Decreased interest (1d - Recovering/Resolving - );Depressed mood (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APROVEL 300 MG [IRBESARTAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[SPIRONOLACTONE, SPIRONOLACTONE BP] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697243	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Diplopia (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697273	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Gout (n/a - Unknown - );Movement disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697275	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697278	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Erythema (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Hot flush (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Peripheral coldness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010697281	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697305	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYTOIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697372	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010697391	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Urticaria (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[LORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])|[LOSARTAN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697410	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010697417	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pyrexia (2d - Recovered/Resolved - );Urinary tract infection (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697418	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697449	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Gout (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010697452	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697534	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697538	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [22d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697555	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697556	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697559	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (10d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697566	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697603	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Creutzfeldt-Jakob disease (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010697605	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697609	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010697612	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697620	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697621	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Skin haemorrhage (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010697689	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis reactive (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697741	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697771	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697776	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697786	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010697806	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697829	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	IMBRUVICA 140 MG HARD CAPSULES [IBRUTINIB] (C - n/a - n/a - )|[VALACICLOVIR] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697874	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010697881	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697892	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697909	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebellar stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697911	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697912	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697913	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697915	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697928	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010697935	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697936	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697939	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [29d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697942	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697944	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (1wk - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697947	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697948	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697949	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010697952	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010697965	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN EMBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010697979	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010697992	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Recovering/Resolving - );Tachycardia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010697992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010698006	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010698013	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010698055	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010698101	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010698122	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010698123	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [22d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698133	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010698170	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dehydration (690min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (690min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (690min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010698172	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death, Other Medically Important Condition);Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [44mo - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [1254d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010698195	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral swelling (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010698196	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (1d - Recovered/Resolved - );Chest discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698223	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Dysphagia (n/a - Unknown - Other Medically Important Condition);Electrophoresis abnormal (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunoglobulins abnormal (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Unknown - Other Medically Important Condition);Lymphoma (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLOBETASONE BUTYRATE] (C - T-cell lymphoma - n/a - [n/a - n/a - Topical])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010698225	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye discharge (n/a - Not Recovered/Not Resolved - );Photopsia (n/a - Not Recovered/Not Resolved - Disabling);Visual acuity reduced (n/a - Not Recovered/Not Resolved - Disabling);Visual field defect (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling);Vitreous floaters (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010698226	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypersensitivity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010698288	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010698304	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698318	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698326	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Groin pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010698329	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Nightmare (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698336	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010698339	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (10h - Recovered/Resolved - );Pain (10h - Recovered/Resolved - );Pain in extremity (10h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698342	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010698414	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (2d - Recovered/Resolved - );Dizziness (30min - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - );Nausea (30min - Recovered/Resolved - );Pain in extremity (10min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010698417	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE] (C - n/a - n/a - [n/a - 10mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010698488	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010698504	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Erythema multiforme (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (1d - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Pustule (n/a - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010698633	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698637	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698638	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (5d - Recovered/Resolved - );Chills (2.5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698651	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698670	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698671	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698674	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010698681	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3wk - Recovered/Resolved - );Joint swelling (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698686	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	DOVATO 50 MG/300 MG FILM-COATED TABLETS [LAMIVUDINE, DOLUTEGRAVIR] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698699	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010698704	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [39d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698707	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - );Testicular pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	KALETRA (80 MG + 20 MG)/ML ORAL SOLUTION [LOPINAVIR, RITONAVIR] (C - n/a - n/a - [n/a - n/a - n/a])|TRUVADA [EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698710	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698717	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010698728	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovering/Resolving - );Depression (n/a - Recovering/Resolving - );Diarrhoea (9d - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698739	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698748	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698749	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698750	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698758	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698785	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698786	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - )|[ROSUVASTATIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698816	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Vaccination site pain (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010698817	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010698826	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698857	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010698862	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[NICARDIPINE HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698873	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovered/Resolved - );Hypoaesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698881	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698893	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	ENBREL 50 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [ETANERCEPT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698895	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698898	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698899	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698914	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010698922	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698932	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698937	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698940	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal stiffness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698941	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698943	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698946	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Convulsions local (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[BROMAZEPAM] (C - Anxiety - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Mental disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010698949	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698952	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4wk - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698954	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (6wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	CLOPIDOGREL MYLAN 75 MG FILM-COATED TABLETS [CLOPIDOGREL, CLOPIDOGREL HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SOTALOL HYDROCHLORIDE] (C - Arrhythmia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698959	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698963	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698967	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (12d - Not Recovered/Not Resolved - );Hyperhidrosis (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698970	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (4d - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698974	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (2d - Recovering/Resolving - );Spinal pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010698992	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010698999	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010698999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699008	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Hypotension (1h - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699009	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[FENOFIBRATE] (C - Hypertriglyceridaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699015	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699017	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699019	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[LOSARTAN POTASSIUM] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699022	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699033	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Dizziness (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010699035	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699040	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699041	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699051	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699052	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[OMEPRAZOLE] (C - Product used for unknown indication - Drug withdrawn - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699054	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699055	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699076	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699083	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699106	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699114	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699120	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (13d - Not Recovered/Not Resolved - );Pruritus (15d - Not Recovered/Not Resolved - );Rash (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699123	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699124	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699133	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699134	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699139	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699144	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699146	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (4d - Recovered/Resolved - );Gastrointestinal disorder (4d - Recovered/Resolved - );Respiratory disorder (4d - Recovered/Resolved - );Testicular pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699176	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699183	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699223	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved With Sequelae - );Blood pressure increased (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - );Epistaxis (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Migraine (n/a - Recovered/Resolved With Sequelae - );Mouth swelling (n/a - Recovered/Resolved With Sequelae - );Pharyngeal swelling (n/a - Recovered/Resolved With Sequelae - );Pruritus (n/a - Recovered/Resolved With Sequelae - );Vision blurred (n/a - Recovered/Resolved With Sequelae - );Vomiting (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010699228	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699230	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699242	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699244	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Vertigo (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699245	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699253	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699269	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699270	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Conjunctivitis (n/a - Recovered/Resolved - );Herpes simplex (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699292	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster reactivation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699293	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crohn's disease (12d - Recovered/Resolved - );Disease recurrence (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	[BUDESONIDE, BUDESONIDE, MICRONISED] (C - n/a - n/a - [n/a - n/a - n/a])|[KETAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699327	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699340	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699342	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699344	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699456	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute generalised exanthematous pustulosis (19d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699468	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699503	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Anaemia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood glucose fluctuation (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Urinary retention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JENTADUETO [METFORMIN HYDROCHLORIDE, LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[CALCIUM, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM HYDROBROMIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[DIOSMIN] (C - n/a - n/a - [n/a - 500mg - n/a])|[METOCLOPRAMIDE HYDROCHLORIDE, PARACETAMOL, PARACETAMOL, PARACETAMOL, METOCLOPRAMIDE HYDROCHLORIDE ANHYDROUS] (C - n/a - n/a - [n/a - 500mg - n/a])|[NADROPARIN, NADROPARIN CALCIUM] (C - Anticoagulant therapy - n/a - [n/a - 4mL - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010699539	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Mobility decreased (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CHLORAMPHENICOL] (C - Cataract operation - n/a - [21d - n/a - n/a])|[FINASTERIDE] (C - Prostate examination - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - Cataract operation - n/a - [27d - n/a - n/a])|[SODIUM CHLORIDE] (C - Cataract operation - n/a - [21d - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010699566	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Arthralgia (2d - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699586	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BETAMETHASONE VALERATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOBETASOL PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOMENTHOL, COAL TAR SOLUTION, MENTHOL, COAL TAR] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010699604	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Erythema (40min - Recovered/Resolved - Other Medically Important Condition);Facial paresis (40min - Recovered/Resolved - Other Medically Important Condition);Hemiparesis (40min - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (40min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010699606	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased insulin requirement (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Emotional distress (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - n/a - n/a - )|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010699637	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Heart rate irregular (n/a - Not Recovered/Not Resolved - Disabling);Hypercoagulation (n/a - Not Recovered/Not Resolved - Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Gastrointestinal disorder - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010699695	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - );Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010699752	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - [n/a - 40mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699770	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Flushing (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gastritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010699790	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Central nervous system inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010699802	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699861	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699862	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699895	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010699918	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010699975	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010699977	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010699977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010700016	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysstasia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Unresponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010700024	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (2d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010700073	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700099	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700103	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Sciatica (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, RAMIPRIL, RAMIPRIL] (C - Product prescribing issue - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010700197	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700202	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cholecystitis infective (n/a - Unknown - Other Medically Important Condition);Cholelithiasis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Constipation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral artery aneurysm (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal aneurysm (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [98d - n/a - n/a])|[LANSOPRAZOLE] (C - Eructation - n/a - [7d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010700211	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700218	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypokinesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nervous system disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010700237	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010700268	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Deafness bilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ear discomfort (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010700269	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010700273	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700290	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700316	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Costochondritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010700330	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Disabling, Other Medically Important Condition);Blood pressure fluctuation (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Ear discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010700427	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010700428	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700482	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Neuropathy peripheral (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700492	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700495	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700498	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700544	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700546	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700670	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010700782	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010700835	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Decreased appetite (n/a - Unknown - );Depressed mood (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010700867	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Mouth ulceration (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Petechiae (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010700895	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700930	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700933	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Metastases to liver (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	APIDRA [INSULIN GLULISINE] (C - n/a - n/a - [n/a - n/a - n/a])|SYNJARDY [METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|TOUJEO [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|TRULICITY [DULAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010700947	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Left ventricular hypertrophy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010700989	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010700989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701017	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701032	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701087	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701109	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Physical deconditioning (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701139	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Skin mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701153	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701158	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701172	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701228	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Diarrhoea haemorrhagic (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701357	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Child	Yes	Male	Exposure via breast milk (n/a - Not Recovered/Not Resolved - );Rash (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701380	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701417	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701425	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701641	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Post procedural haematuria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701646	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])|KEPPRA 1000 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - Epilepsy - Dose not changed - [n/a - 1000mg - Oral])|KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - Epilepsy - Dose not changed - [n/a - 500mg - Oral])|NOT AVAILABLE (C - Epilepsy - Dose not changed - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701651	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701663	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701669	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701689	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701699	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010701700	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Balance disorder (n/a - Unknown - );Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010701701	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701727	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute abdomen (2d - Fatal - Results in Death);Diarrhoea (2d - Fatal - Results in Death);Vomiting (2d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Not applicable - )|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Not applicable - )|[ACETYLSALICYLIC ACID] (C - n/a - Not applicable - )|[AMILORIDE, HYDROCHLOROTHIAZIDE] (C - n/a - Not applicable - )|[LEVOTHYROXINE SODIUM] (C - n/a - Not applicable - )|[OLANZAPINE] (C - n/a - Not applicable - )|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - Not applicable - )|[TAPENTADOL] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010701745	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701749	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701751	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701758	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701759	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701763	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701766	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (15d - Recovered/Resolved - );Vaccination site lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701778	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Malaise (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701783	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina bullosa haemorrhagica (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010701796	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site inflammation (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701804	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010701809	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [2d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701819	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010701822	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701823	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701833	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701835	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701836	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010701849	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010701970	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010701970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702013	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702111	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702379	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Ulnar neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010702405	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702409	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702412	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702417	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702420	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702425	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702435	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702437	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702463	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702464	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anxiety (n/a - Unknown - );Hypomenorrhoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ETHINYLESTRADIOL, LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702517	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702521	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010702537	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702544	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cholecystitis infective (n/a - Unknown - Other Medically Important Condition);Cholelithiasis (n/a - Unknown - );Constipation (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Peripheral artery aneurysm (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Pyrexia (n/a - Unknown - );Renal aneurysm (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Eructation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010702560	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic dissection (n/a - Recovered/Resolved - Life Threatening);Vasculitis (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010702564	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702566	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010702579	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702584	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702603	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Accidental overdose (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Otorrhoea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Somnolence (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702631	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702682	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Pulse volume decreased (0d - Recovered/Resolved - );Shock (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010702710	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010702733	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010702772	Spontaneous	2021-11-19 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702793	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acne (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702864	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010702895	Spontaneous	2021-11-19 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	General physical health deterioration (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010702895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678868	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678872	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678919	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (4d - Recovered/Resolved - );Sense of oppression (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678977	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679010	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010679015	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679058	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Maculopathy (n/a - Not Recovered/Not Resolved - );Nail discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679059	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Oropharyngeal discomfort (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679060	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010679062	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Phlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679063	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679089	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679093	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679100	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679113	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679116	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679141	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679152	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010679159	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemophagocytic lymphohistiocytosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010679163	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anger (n/a - Not Recovered/Not Resolved - Life Threatening);Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Life Threatening);Pain (n/a - Not Recovered/Not Resolved - Life Threatening);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010679180	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679182	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679183	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679192	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679200	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679208	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Axillary pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022, IVR-238), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED] (C - Influenza immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679232	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679276	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Transaminases increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679315	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (218d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010679321	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679332	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site rash (2d - Recovered/Resolved - );Vaccination site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679339	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010679341	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - );Dizziness (n/a - Unknown - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010679360	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679362	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hyperpyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679377	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010679405	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Optic neuritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Photosensitivity reaction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010679423	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - );Asthenia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679425	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679433	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679435	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679437	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679472	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Erectile dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Liver tenderness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tendon pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010679478	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679479	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MINOXIDIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010679487	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679489	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010679501	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Gait disturbance (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679728	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Electrocardiogram repolarisation abnormality (n/a - Unknown - Other Medically Important Condition);Sinus arrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010679737	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Inflammatory marker increased (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010679741	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010679754	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Giant cell arteritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010679765	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010679767	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [7d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010679785	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010679797	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010679817	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010679821	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010679827	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (1d - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Vomiting (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Polymyalgia rheumatica - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010679831	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010679979	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010679979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680010	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Jaundice (68d - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010680012	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Unknown - );Eye haemorrhage (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - );Visual impairment (n/a - Unknown - );Vitreous disorder (n/a - Unknown - );Vitreous haze (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680018	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Head injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680021	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Hydrocephalus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680023	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DALTEPARIN] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680027	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680043	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bacteraemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypercoagulation (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680075	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry throat (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680136	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680137	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Generalised tonic-clonic seizure (7d - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680139	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680142	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Irregular breathing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680159	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680168	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pneumothorax (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680171	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680251	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680492	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (1h - Recovered/Resolved - );Sensory loss (n/a - Recovering/Resolving - );Vaccination site hypoaesthesia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680497	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Generalised tonic-clonic seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oculogyric crisis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680498	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680506	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dry eye (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680510	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Immobile (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680516	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680522	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Skin laceration (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680525	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal distension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysmenorrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Endometriosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heavy menstrual bleeding (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680526	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Nerve injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Neuropathy peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680527	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680631	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010680634	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680635	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680636	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Insomnia (2d - Recovered/Resolved - Other Medically Important Condition);Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680656	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680661	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010680663	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Oedema peripheral (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680673	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680891	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1wk - Recovered/Resolved - Other Medically Important Condition);Chest pain (1wk - Recovered/Resolved - );Ear discomfort (1wk - Recovered/Resolved - );Emotional disorder (1wk - Recovered/Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Injection site pain (1wk - Recovered/Resolved - );Ocular hyperaemia (n/a - Not Recovered/Not Resolved - );Peripheral coldness (1wk - Recovered/Resolved - );Productive cough (1wk - Recovered/Resolved - );Tinnitus (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - )|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - )|[METOPROLOL TARTRATE] (C - n/a - n/a - )|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010680892	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site reaction (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010680896	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute respiratory distress syndrome (n/a - Recovering/Resolving - Life Threatening);COVID-19 (n/a - Recovering/Resolving - Life Threatening);Dependence on respirator (1mo - Recovered/Resolved - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Post-acute COVID-19 syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Recovering/Resolving - Life Threatening);Vaccination failure (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010680896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010681127	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010681147	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010681159	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681161	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681165	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681166	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681169	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681173	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681176	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681177	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Testicular pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010681184	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681188	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010681253	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (25d - Not Recovered/Not Resolved - );Paraesthesia (25d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[METOPROLOL TARTRATE] (C - n/a - Not applicable - )|[RAMIPRIL] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010681326	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (63d - Not Recovered/Not Resolved - );Paraesthesia (63d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010681334	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blindness (7min - Recovered/Resolved - );Dizziness (7min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010681336	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010681352	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010681424	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681426	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681442	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Disabling);Dermatitis exfoliative generalised (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010681652	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Ventricular extrasystoles (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681690	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681691	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Sick leave (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010681692	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681693	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681698	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010681873	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	AVAMYS 27.5 MICROGRAMS/SPRAY NASAL SPRAY SUSPENSION [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010681904	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain (n/a - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [84d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010681912	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperventilation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010681953	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010681953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682010	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (20d - Not Recovered/Not Resolved - );Asthenia (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Vision blurred (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682034	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682036	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Unknown - );Arthralgia (n/a - Unknown - );Palindromic rheumatism (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682037	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);COVID-19 immunisation (n/a - Unknown - );Fatigue (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Vaccine breakthrough infection (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - [n/a - n/a - n/a])|[EMTRICITABINE, TENOFOVIR DISOPROXIL] (C - Prophylaxis against HIV infection - n/a - [n/a - 1{DF} - Oral])|[FINASTERIDE] (C - Alopecia - n/a - [n/a - 1.25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682038	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute respiratory distress syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Organising pneumonia (24d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	ARAVA [LEFLUNOMIDE] (S - Psoriatic arthropathy - n/a - [n/a - n/a - Oral])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|MULTAQ [DRONEDARONE] (S - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[METHYLPREDNISOLONE] (S - Hyperthyroidism - n/a - [n/a - 8mg - Oral])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010682047	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682186	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (21d - Not Recovered/Not Resolved - );Tachycardia (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682190	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Sensitive skin (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682199	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682216	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoclonal B-cell lymphocytosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682235	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (47d - Not Recovered/Not Resolved - );Dyspnoea (48d - Not Recovered/Not Resolved - );Fatigue (61d - Not Recovered/Not Resolved - );Gait inability (47d - Not Recovered/Not Resolved - );Malaise (63d - Not Recovered/Not Resolved - );Tachycardia (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682256	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682258	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site movement impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682261	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (42d - Not Recovered/Not Resolved - );Rash (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682263	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682264	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682265	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Recovering/Resolving - );Dizziness (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682266	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - );Toothache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682280	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (47d - Not Recovered/Not Resolved - );Dyspnoea (48d - Not Recovered/Not Resolved - );Fatigue (61d - Not Recovered/Not Resolved - );Gait inability (47d - Not Recovered/Not Resolved - );Malaise (63d - Not Recovered/Not Resolved - );Tachycardia (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682285	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682293	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682300	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682321	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (87d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010682346	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682352	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Application site pain (n/a - Recovered/Resolved - );Blepharospasm (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682371	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Renal artery stent placement (n/a - Recovered/Resolved With Sequelae - Life Threatening);Renal artery thrombosis (n/a - Recovered/Resolved With Sequelae - Life Threatening);Renal failure (n/a - Recovered/Resolved With Sequelae - Life Threatening);Renal infarct (n/a - Recovered/Resolved With Sequelae - Life Threatening);Subclavian artery occlusion (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010682417	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Fluid retention (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pleural effusion (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010682497	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682498	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (3d - Recovered/Resolved - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682518	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Hypertension (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682536	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682546	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010682547	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Renal pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682562	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eczema (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site erythema (1d - Recovered/Resolved - );Pain (n/a - Recovering/Resolving - );Pruritus genital (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010682577	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[BUMETANIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[LACTULOSE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[QUETIAPINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682603	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia totalis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010682626	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010682640	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - Disabling);Ear infection (n/a - Recovering/Resolving - Disabling);Headache (4d - Recovered/Resolved - Disabling);Hypoacusis (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling);Tinnitus (n/a - Recovering/Resolving - Disabling);Vaccination site pain (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010682656	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010682668	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010682680	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed mood (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682684	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682688	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site pain (n/a - Recovered/Resolved - );Circulatory collapse (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682743	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010682838	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epithelioid sarcoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Neoplasm (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition);Vitamin D deficiency (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682842	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - Other Medically Important Condition);Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682845	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Epistaxis (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Illness (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682858	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myalgia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010682861	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682864	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010682869	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Tension headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682873	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Dehydration (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dry skin (n/a - Unknown - Caused/Prolonged Hospitalisation);Movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Skin exfoliation (n/a - Unknown - Caused/Prolonged Hospitalisation);Xeroderma (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010682878	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[DICLOFENAC DIETHYLAMINE, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - 5mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010682885	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010682891	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682894	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Ear infection (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Ear inflammation (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hypoacusis (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010682895	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682903	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (85d - Recovered/Resolved - );Facial paralysis (85d - Recovered/Resolved - Other Medically Important Condition);Herpes zoster oticus (85d - Recovered/Resolved - Other Medically Important Condition);Herpes zoster reactivation (n/a - Recovered/Resolved - );Malaise (70d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Trigeminal palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Varicella zoster virus infection (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682908	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682910	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682911	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Unknown - Disabling, Other Medically Important Condition);Depressed mood (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Sputum increased (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010682919	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682922	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682938	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010682948	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Bipolar I disorder - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682959	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682967	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682968	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010682971	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Atrioventricular block (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Atrioventricular block second degree (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus bradycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010682981	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682988	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010682991	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Idiopathic intracranial hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Papilloedema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010682991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010683004	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - Other Medically Important Condition);Malaise (4d - Recovered/Resolved - Other Medically Important Condition);Pain (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683011	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Euphoric mood (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683024	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dermatitis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SOTALOL, SOTALOL HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683028	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683033	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Tachycardia foetal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683058	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683066	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683082	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683084	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Hot flush (1d - Recovered/Resolved - );Immunisation (n/a - Unknown - );Increased viscosity of upper respiratory secretion (n/a - Recovering/Resolving - );Interchange of vaccine products (n/a - Unknown - );Lethargy (0d - Recovered/Resolved - );Middle insomnia (n/a - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Off label use (n/a - Unknown - );Productive cough (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683107	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (35h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683110	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683114	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683117	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010683118	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683126	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Poor quality sleep (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683138	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (270min - Recovered/Resolved - );Ocular discomfort (15min - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - );Vertigo (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683142	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Drug ineffective (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (18d - Recovered/Resolved - Disabling, Other Medically Important Condition);Illness (6d - Recovered/Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Mental fatigue (120d - Recovered/Resolved - Disabling, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Sinus headache (115d - Recovered/Resolved - Disabling, Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010683150	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (1d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683151	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683238	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683371	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial asymmetry (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683560	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683564	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683567	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010683718	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Macular degeneration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010683760	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Unknown - );Oropharyngeal pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683761	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683762	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchospasm (4d - Recovering/Resolving - );Lip swelling (4d - Recovering/Resolving - );Rash (4d - Recovering/Resolving - );Swelling face (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010683775	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (48d - Not Recovered/Not Resolved - );Hypoaesthesia (48d - Not Recovered/Not Resolved - );Injection site joint pain (48d - Not Recovered/Not Resolved - );Insomnia (48d - Not Recovered/Not Resolved - );Joint swelling (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010683795	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Sleep disorder (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683806	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (1d - Recovered/Resolved - );Hypoaesthesia (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Local reaction (2d - Recovered/Resolved - );Sensory disturbance (0d - Recovered/Resolved - );Vaccination site induration (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683807	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site erythema (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683859	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysgeusia (26d - Not Recovered/Not Resolved - );Malaise (16d - Recovering/Resolving - );Menstrual disorder (16d - Recovering/Resolving - );Oedema (16d - Recovering/Resolving - );Palpitations (25d - Not Recovered/Not Resolved - );Panic attack (25d - Not Recovered/Not Resolved - );Sensory disturbance (25d - Not Recovered/Not Resolved - );Tachycardia (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010683861	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Not Recovered/Not Resolved - );Chills (n/a - Unknown - );Decreased appetite (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (5d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Hyperhidrosis (5d - Not Recovered/Not Resolved - );Somnolence (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683862	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683870	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Influenza (n/a - Unknown - );Injection site pain (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683874	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683890	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683893	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Abdominal distension (3d - Unknown - );Decreased appetite (3d - Unknown - );Diarrhoea (3d - Unknown - );Malaise (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683894	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683896	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hyperhidrosis (8d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Paresis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010683897	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Lip discolouration (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683899	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (21d - Recovered/Resolved With Sequelae - );Vaccination site movement impairment (21d - Recovered/Resolved With Sequelae - );Vaccination site pain (21d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010683906	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (0d - Recovered/Resolved - );Peripheral swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683908	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (26d - Recovered/Resolved With Sequelae - );Limb discomfort (26d - Recovered/Resolved With Sequelae - );Weight bearing difficulty (26d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010683913	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Body temperature increased (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypotonia (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683929	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coagulopathy (n/a - Unknown - Other Medically Important Condition);Haematoma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010683948	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683950	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683952	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bladder cancer recurrent (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010683975	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (3d - Not Recovered/Not Resolved - );Dizziness (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Gait disturbance (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010683994	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Not Recovered/Not Resolved - );Rash macular (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010683994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684012	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684019	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684020	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Not Recovered/Not Resolved - );Gastrointestinal sounds abnormal (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Thirst (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684021	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684023	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hand dermatitis (100d - Not Recovered/Not Resolved - );Rash (100d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010684053	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684057	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684060	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684095	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - )|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684230	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684333	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684362	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amenorrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684364	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684382	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684386	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684427	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684428	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684430	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684431	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684432	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Application site pain (n/a - Recovered/Resolved - );Dermatitis allergic (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010684433	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684435	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684484	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [187d - n/a - Oral])|[TIZANIDINE, TIZANIDINE HYDROCHLORIDE] (C - Muscle twitching - n/a - [n/a - n/a - Oral])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Neuralgia - n/a - [181d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010684524	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling hot (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684556	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - );Insomnia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010684560	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Joint stiffness (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684587	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010684594	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010684696	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness bilateral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [1d - n/a - Parenteral])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684745	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684759	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684767	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684769	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684771	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Speech disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010684782	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Cardiac disorder (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	IFIRMASTA [IRBESARTAN, IRBESARTAN HYDROCHLORIDE] (C - n/a - n/a - )|XARELTO [RIVAROXABAN] (C - n/a - Drug withdrawn - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - Drug withdrawn - [n/a - n/a - Oral])|[PROPAFENONE, PROPAFENONE HYDROCHLORIDE] (C - n/a - Drug withdrawn - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684839	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684841	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back disorder (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684842	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684856	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pallor (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral coldness (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	EDOXABAN [EDOXABAN] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - Palpitations - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684864	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010684876	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684879	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dehydration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684881	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684900	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Euphoric mood (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Mydriasis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684904	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENAZEPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LABETALOL, LABETALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010684909	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010684913	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune haemolytic anaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Jaundice (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LINAGLIPTIN [LINAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684974	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neutrophilia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Fatal - Results in Death, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FORTISIP [CARBOHYDRATES NOS, FATS NOS, MINERALS NOS, PROTEIN, VITAMINS NOS] (C - Pancreatic failure - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMYLASE, LIPASE, PROTEASE, PANCREALIPASE, PANCREAS POWDER, PANCREAS POWDER FROM PORCINE, PANCREATIN, PANCREATIN BP] (C - Pancreatic failure - n/a - [n/a - n/a - n/a])|[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (C - Pancreatic failure - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Pancreatic failure - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010684986	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010684990	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010684990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685001	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature fluctuation (4d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease recurrence (7d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nocturia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Urinary tract infection (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685002	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685018	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685139	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	APIDRA [INSULIN GLULISINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|LANTUS [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685251	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685253	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010685257	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeding disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685263	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010685265	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685299	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Secretion discharge (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010685303	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - Liver transplant - n/a - [n/a - n/a - n/a])|[TACROLIMUS] (C - Liver transplant - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010685310	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685313	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Unknown - );Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (2d - Recovered/Resolved - Other Medically Important Condition);Coordination abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysphagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Eye pruritus (n/a - Unknown - );Faeces soft (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Groin pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mastication disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Micturition disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - );Myalgia (n/a - Unknown - );Neck pain (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Shock (n/a - Recovered/Resolved - Other Medically Important Condition);Testicular pain (n/a - Unknown - );Throat tightness (n/a - Recovered/Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010685316	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685452	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010685453	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (2d - Recovered/Resolved - Other Medically Important Condition);Ophthalmic vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010685488	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Malaise (1d - Recovered/Resolved - Disabling);Seizure (1d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010685497	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovering/Resolving - );Rash (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010685499	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (40d - Not Recovered/Not Resolved - );Myositis (40d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010685506	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rheumatoid bursitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685507	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685530	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685537	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010685543	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685568	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010685573	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exfoliative rash (15d - Recovering/Resolving - );Rash (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685621	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685623	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685624	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685633	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685637	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685660	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Back pain (n/a - Recovered/Resolved With Sequelae - Disabling);Cardiac discomfort (n/a - Recovered/Resolved With Sequelae - Disabling);Erythema (n/a - Recovered/Resolved With Sequelae - Disabling);Gait disturbance (n/a - Recovered/Resolved With Sequelae - Disabling);Head discomfort (n/a - Recovered/Resolved With Sequelae - Disabling);Hyperaesthesia (n/a - Recovered/Resolved With Sequelae - Disabling);Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Disabling);Insomnia (n/a - Recovered/Resolved With Sequelae - Disabling);Limb mass (n/a - Recovered/Resolved With Sequelae - Disabling);Muscle tightness (n/a - Recovered/Resolved With Sequelae - Disabling);Pain (n/a - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling);Pyrexia (n/a - Recovered/Resolved With Sequelae - Disabling);Vaccination site pain (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010685694	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685698	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nasal discomfort (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinalgia (7d - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685701	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Product use issue (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010685703	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010685710	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mobility decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010685711	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Magnetic resonance imaging - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Magnetic resonance imaging - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685768	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Sinus congestion (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Tremor (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010685771	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010685825	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010685826	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010685885	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010685891	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010685896	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Monoplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010685935	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685937	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010685947	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bladder catheter permanent (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac disorder (n/a - Fatal - Results in Death);General physical health deterioration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Incontinence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lung disorder (n/a - Fatal - Results in Death);Movement disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - )|[DIGITOXIN] (C - n/a - n/a - )|[FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE, FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - )|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - )|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - )|[PHENPROCOUMON] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - )|[SPIRONOLACTONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010685995	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010685995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010686014	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686110	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010686115	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Abdominal distension (n/a - Recovered/Resolved - );Alanine aminotransferase increased (n/a - Recovering/Resolving - );Arrhythmia (n/a - Unknown - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Recovering/Resolving - );Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Brain natriuretic peptide increased (n/a - Unknown - );Cardiac failure (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiothoracic ratio increased (n/a - Unknown - );Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pleural effusion (n/a - Recovered/Resolved - );Tachycardia (n/a - Unknown - );Weight increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010686121	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - );Dyspnoea (14min - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010686122	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Other Medically Important Condition);Confusional state (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Incoherent (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686131	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Impaired work ability (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686205	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686217	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (5d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (24h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (24h - Recovered/Resolved - Other Medically Important Condition);Vomiting (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686220	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Grip strength decreased (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686224	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686282	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686289	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686300	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686304	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686361	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Disease progression (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLCHICINE] (C - Pericarditis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010686395	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal heart rate decreased (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Umbilical cord abnormality (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686396	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010686398	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Movement disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010686466	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686477	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cognitive disorder (n/a - Unknown - );Condition aggravated (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686480	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686481	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash vesicular (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686482	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eyelid oedema (n/a - Recovering/Resolving - );Face oedema (n/a - Recovering/Resolving - );Hypersensitivity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686483	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686484	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686488	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686489	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686495	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual acuity reduced transiently (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686500	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686515	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Paraesthesia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686526	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Accidental overdose (1d - Recovered/Resolved - );Asthenia (1d - Recovered/Resolved - );Circumstance or information capable of leading to medication error (1d - Recovered/Resolved - );Product preparation error (1d - Recovered/Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686529	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686530	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686531	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686532	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686533	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686534	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pruritus (10h - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686537	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686540	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686541	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686545	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Vaccination site oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686550	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Rhinitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686551	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686557	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1wk - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686571	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain upper (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686577	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	REMICADE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION [INFLIXIMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686579	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686582	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686584	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686587	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ocular discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686600	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nausea (2h - Recovered/Resolved - );Presyncope (2h - Recovered/Resolved - );Vomiting (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686601	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Presyncope (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686604	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686611	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686613	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686624	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686625	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site inflammation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686631	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686633	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686634	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686637	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686647	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Torticollis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686655	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686660	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[RISPERIDONE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[VALPROATE SEMISODIUM] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686662	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686666	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686668	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (50d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010686674	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686676	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash maculo-papular (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686678	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686683	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686684	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686689	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686690	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686692	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle tightness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686694	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686698	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686703	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B)] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686707	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 1.25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686709	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686710	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686716	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Sleep disorder (1mo - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686719	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Flank pain (6h - Recovered/Resolved - );Headache (6h - Recovered/Resolved - );Lymphadenopathy (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686721	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Hypertension (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686722	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686727	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686728	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686729	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686733	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686734	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686883	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686900	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010686911	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010686918	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multisystem inflammatory syndrome in adults (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010686918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010687113	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687124	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Unknown - );Injection site vesicles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687160	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (226d - Not Recovered/Not Resolved - );Fatigue (226d - Not Recovered/Not Resolved - );Insomnia (226d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010687181	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687184	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthropathy (n/a - Unknown - Disabling);Chondrocalcinosis (n/a - Unknown - Disabling);Erythema (n/a - Recovering/Resolving - Disabling);Induration (n/a - Unknown - Disabling);Inflammation (n/a - Recovering/Resolving - Disabling);Oedema (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Peripheral swelling (n/a - Recovering/Resolving - Disabling);Rheumatoid arthritis (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PIOGLITAZONE [PIOGLITAZONE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LISINOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010687304	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687306	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (6d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	UROREC 8 MG HARD CAPSULES [SILODOSIN] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[DIOSMECTITE] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[METOPROLOL SUCCINATE, FELODIPINE] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[MOXONIDINE] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[PRAVASTATIN SODIUM] (C - n/a - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687311	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thyroiditis subacute (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687312	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Meningitis viral (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687313	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687315	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaemia (3mo - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010687331	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687337	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (4wk - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687345	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010687353	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Granulomatosis with polyangiitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687367	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687372	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Life Threatening);Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010687374	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687378	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687379	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral paralysis (1mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687380	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687392	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis reactive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Tonsillitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687398	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal inflammation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[OMEPRAZOLE] (S - Abdominal pain upper - Not applicable - [12d - 20mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687404	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cutaneous vasculitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687406	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - );Platelet count decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687413	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Haematemesis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [39d - 1{DF} - Intramuscular])|ELIQUIS [APIXABAN] (S - Atrial fibrillation - Drug withdrawn - [33d - 5mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010687415	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Graves' disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [32d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687416	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pleuropericarditis (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687423	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687429	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Haematoma (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010687434	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687488	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovering/Resolving - );Arrhythmia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010687490	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (11d - Recovered/Resolved - );Myalgia (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687493	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687502	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687545	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687656	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Lip swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLOBETASONE BUTYRATE] (C - n/a - n/a - [n/a - n/a - Topical])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687665	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Supraventricular extrasystoles (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687744	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - );Feeling hot (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - );Pallor (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Tearfulness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010687751	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Musculoskeletal disorder (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010687758	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687849	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010687854	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (7wk - Recovered/Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687858	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Skin infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010687871	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tongue coated (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ANHYDROUS METHYLDOPA, METHYLDOPA, METHYLDOPA SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687876	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687878	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010687917	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Disabling);Intervertebral disc protrusion (n/a - Recovering/Resolving - Disabling);Malaise (1d - Recovered/Resolved - Disabling);Myalgia (n/a - Unknown - Disabling);Vaccination site pain (3d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010687928	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood blister (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687930	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CARBAMAZEPINE] (C - n/a - n/a - [n/a - 200mg - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687942	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687944	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010687945	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010687949	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687955	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Injected limb mobility decreased (n/a - Unknown - );Injection site joint pain (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687964	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687966	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010687967	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010687967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688024	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010688027	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apraxia (n/a - Unknown - );Areflexia (n/a - Unknown - );Communication disorder (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Mobility decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688030	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688064	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (95h - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010688072	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cyanosis (770min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Discomfort (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (245min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (795min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (245min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Somnolence (815min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688075	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PREGABALIN [PREGABALIN] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[BUPRENORPHINE] (C - Pain - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Anaemia - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010688265	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010688280	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation);Burning sensation (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac flutter (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Head discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Panic attack (n/a - Unknown - Caused/Prolonged Hospitalisation);Poisoning (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688367	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010688432	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688437	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010688452	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site abscess (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site induration (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site pruritus (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688455	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010688549	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Small fibre neuropathy (137d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010688555	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (71d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688562	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010688570	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688578	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688579	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovering/Resolving - );Influenza (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688593	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688644	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Foetal death (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Foetal exposure during pregnancy (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Foetal hypokinesia (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transplacental])	HYDROXOCOBALAMIN [HYDROXOCOBALAMIN] (C - n/a - n/a - [1d - 1{DF} - n/a])|[VITAMINS NOS] (C - n/a - n/a - [30d - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010688678	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010688698	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);False positive investigation result (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010688702	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010688705	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688722	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688736	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyneuropathy (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Raynaud's phenomenon (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Trigeminal neuralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010688880	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (5d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010688892	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Radiculopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010688895	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688899	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Psoriasis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PHENPROCOUMON] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010688987	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vestibular disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010688989	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia bacterial (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonitis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Reaction to excipient (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010688998	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010688998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689015	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gait disturbance (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689072	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689090	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Blood alkaline phosphatase increased (n/a - Unknown - );Blood bilirubin increased (n/a - Unknown - );Blood creatine phosphokinase increased (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Blood lactate dehydrogenase increased (n/a - Unknown - );Blood potassium increased (n/a - Unknown - );Blood urea increased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebrovascular disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Unknown - );Coronary artery disease (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Eosinophil count decreased (n/a - Unknown - );Gamma-glutamyltransferase increased (n/a - Unknown - );Glomerular filtration rate decreased (n/a - Unknown - );Haematocrit decreased (n/a - Unknown - );Haemoglobin decreased (n/a - Unknown - );Hemianopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);High density lipoprotein decreased (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphocyte count abnormal (n/a - Unknown - );Neutrophil count increased (n/a - Unknown - );Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Platelet count increased (n/a - Unknown - );Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Polyserositis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Red blood cell count decreased (n/a - Unknown - );Rheumatoid factor increased (n/a - Unknown - );Sensory loss (n/a - Not Recovered/Not Resolved - );White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689092	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689100	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vein occlusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010689148	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Immunodeficiency (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Unknown])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Unknown])	[CARVEDILOL] (C - n/a - Dose not changed - [n/a - n/a - Unknown])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689194	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Delirium (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SALBUTAMOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689305	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site reaction (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689354	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689392	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689394	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Near death experience (n/a - Unknown - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010689413	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Unknown - Disabling);Fatigue (1d - Recovered/Resolved - Disabling);Headache (3d - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Myalgia (2d - Recovered/Resolved - Disabling);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling);Pain (n/a - Unknown - Disabling);Palpitations (n/a - Unknown - Disabling);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Disabling);Syncope (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (13d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010689458	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689465	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689478	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689485	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689597	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OTEZLA [APREMILAST] (C - Psoriatic arthropathy - n/a - [n/a - 60mg - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689600	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation delayed (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689624	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689630	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - Other Medically Important Condition);Erythema (3d - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689650	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689653	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - );Vaccination site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689656	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689661	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689666	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Vaccination site inflammation (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689667	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689746	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Menstruation irregular (n/a - Recovering/Resolving - );Polymenorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689755	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Vertigo positional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Vestibular neuronitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	JARDIANCE [EMPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|OZEMPIC [SEMAGLUTIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE MONOHYDRATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypometabolism - n/a - [n/a - n/a - Oral])|[CINNARIZINE] (C - Dizziness - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Heart rate irregular - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689783	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689785	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689786	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689790	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - Dose not changed - [n/a - 1{DF} - Respiratory (inhalation)])|[RIVAROXABAN] (C - Atrial fibrillation - Drug withdrawn - [2551d - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010689793	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689795	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatic cirrhosis (43d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Portal vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689798	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689802	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689814	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Demyelinating polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular - More in ICSR])|FLUAD TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), SQUALENE, INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/DARWIN/6/2021, IVR-227), CITRIC ACID] (S - n/a - Not applicable - [1d - 1{DF} - Unknown])	NOT AVAILABLE (C - n/a - Unknown - )|XERISTAR 60 MG HARD GASTRO-RESISTANT CAPSULES [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 60mg - n/a])|[BIPERIDEN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 4mg - n/a])|[PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - Unknown - )|[RABEPRAZOLE SODIUM] (C - n/a - Unknown - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689816	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689825	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689828	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|FLUAD TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	NOT AVAILABLE (C - n/a - Unknown - )|[CITICOLINE, CITICOLINE SODIUM] (C - n/a - Unknown - )|[DICLOFENAC SODIUM] (C - n/a - Unknown - )|[FINASTERIDE] (C - n/a - Unknown - )|[LEVOTHYROXINE SODIUM] (C - n/a - Unknown - )|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - )|[OMEPRAZOLE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689832	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010689837	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010689838	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Vaccination site inflammation (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689859	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689865	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689867	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689871	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010689912	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye infarction (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010689914	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arterial occlusive disease (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Eye infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010689920	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689925	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Polyneuropathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689945	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010689952	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010689976	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Injection site hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010689978	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010689978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010690049	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010690054	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Stress (n/a - Unknown - );Weight decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010690126	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Folliculitis (n/a - Unknown - Other Medically Important Condition);Petechiae (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OLANZAPINE [OLANZAPINE] (C - n/a - n/a - [n/a - 10mg - n/a - More in ICSR])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - 184mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - 5mg - n/a - More in ICSR])|[BECLOMETASONE] (C - n/a - n/a - [n/a - 50mg - n/a - More in ICSR])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - 30mg - n/a])|[MORPHINE SULFATE, MORPHINE SULPHATE BP] (C - n/a - n/a - [n/a - 10mg - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[VALPROIC ACID] (C - n/a - n/a - [n/a - 250mg - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010690175	Spontaneous	2021-11-18 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010690239	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pacemaker syndrome (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010690400	Spontaneous	2021-11-18 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010690400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010663821	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (23d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (15d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - );Streptococcal infection (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010665535	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HYDROCHLOROTHIAZIDE 12.5 MG, TELMISARTAN 80 MG  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665557	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (34h - Recovered/Resolved - );Headache (34h - Recovered/Resolved - );Hyperhidrosis (34h - Recovered/Resolved - );Nausea (34h - Recovered/Resolved - );Pain in extremity (34h - Recovered/Resolved - );Pyrexia (34h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	LYTOXIN [NOT AVAILABLE] (C - Hyperthyroidism - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665702	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665713	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Skin exfoliation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665736	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - .3mL - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665744	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665746	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665747	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665749	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665750	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665752	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665763	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665806	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665859	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Back pain (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Head discomfort (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665867	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Somnolence (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010665904	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665905	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665968	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665973	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	RANEXA [RANOLAZINE] (C - Arrhythmia - n/a - [n/a - 750mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])|[METOPROLOL TARTRATE, METOPROLOL TARTRATE BP] (C - Arrhythmia - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666008	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666039	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666046	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666085	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chromaturia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - Autism spectrum disorder - n/a - [n/a - n/a - n/a])|[LEVOMEPROMAZINE, LEVOMEPROMAZINE EMBONATE, LEVOMEPROMAZINE HYDROCHLORIDE, LEVOMEPROMAZINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - Autism spectrum disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666168	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Rash pustular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666189	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema multiforme (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666190	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666216	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vein disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666254	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666256	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666257	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperthermia (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666258	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666259	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphonia (n/a - Not Recovered/Not Resolved - Life Threatening);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Life Threatening);Pharyngeal neoplasm (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010666265	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666275	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Gait disturbance (n/a - Not Recovered/Not Resolved - Life Threatening);Haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	NOVONORM 2 MG TABLETS [REPAGLINIDE] (C - n/a - n/a - [n/a - 6mg - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 150mg - Oral])|[INDAPAMIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010666277	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Throat tightness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010666284	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Face oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lip oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666297	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interstitial lung disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666299	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (14d - Recovered/Resolved - Other Medically Important Condition);Erectile dysfunction (14d - Recovered/Resolved - Other Medically Important Condition);Injection site pain (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666306	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666307	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666310	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666313	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (10d - Recovered/Resolved - );Oropharyngeal pain (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666322	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Capillary disorder (85d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010666323	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010666332	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666354	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666379	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoparesis (3d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	[NEBIVOLOL] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[VALSARTAN] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666398	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved With Sequelae - );Chronic gastritis (n/a - Recovered/Resolved With Sequelae - );Gastrooesophageal reflux disease (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010666405	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010666410	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666411	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666412	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666413	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Cough (3d - Recovered/Resolved - );Nasopharyngitis (3d - Recovered/Resolved - );Pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666416	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - );Pneumonitis (n/a - Not Recovered/Not Resolved - );Tonsillar inflammation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010666418	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010666422	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666437	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thyroiditis subacute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666442	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Amnesia (0d - Recovered/Resolved - );Blood pressure increased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666465	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphadenopathy (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666516	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666531	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666532	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666537	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	COSENTYX 150 MG POWDER FOR SOLUTION FOR INJECTION [SECUKINUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666562	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ear pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666566	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010666567	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug eruption (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Kaposi's sarcoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	ENTECAVIR [ENTECAVIR] (C - Hepatitis B - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666569	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (n/a - Recovered/Resolved - );Proteinuria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Myalgia - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010666571	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666573	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute respiratory distress syndrome (n/a - Recovering/Resolving - Life Threatening);Pneumonia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010666579	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666615	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Catarrh (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Insomnia (2d - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - );Oropharyngeal pain (n/a - Recovering/Resolving - Disabling);Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - Prophylaxis - Not applicable - [1d - 1{DF} - Parenteral])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Prophylaxis - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010666859	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tonsillar hypertrophy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666865	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Arthropathy (n/a - Unknown - );Asthenia (n/a - Unknown - );Blood cholesterol increased (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Gait inability (n/a - Unknown - );General physical health deterioration (n/a - Unknown - );Joint range of motion decreased (n/a - Unknown - );Pain (n/a - Unknown - );Tendonitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666866	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (1d - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666871	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (n/a - Unknown - );Erectile dysfunction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666888	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666896	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666903	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Lacunar infarction - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Lacunar infarction - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depressed mood - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010666912	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666916	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666919	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lyme disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666923	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cervical vertebral fracture (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fall (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Immunisation - n/a - [1d - n/a - n/a])...	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010666931	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Apathy (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Breath odour (n/a - Unknown - Other Medically Important Condition);Fluid intake reduced (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nightmare (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666934	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666949	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010666950	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666965	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Nervousness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666967	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breath sounds abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Cardiac disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory tract congestion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010666970	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010666970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010667150	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Unknown - Disabling);Orchitis (67d - Recovered/Resolved - Disabling);Pain (n/a - Recovering/Resolving - Disabling);Testis discomfort (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010667160	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667170	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667175	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010667185	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667189	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired quality of life (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667191	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667195	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Arthritis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Cervical spinal stenosis (n/a - Unknown - Disabling, Other Medically Important Condition);Eczema (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Enthesopathy (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Gait inability (n/a - Unknown - Disabling, Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Disabling, Other Medically Important Condition);Movement disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Unknown - Disabling, Other Medically Important Condition);Myelopathy (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Osteoporotic fracture (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Psychotic disorder (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Rheumatic disorder (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Tri-iodothyronine decreased (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - 400mg - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Tinnitus - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - 60mg - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METHOTREXATE SODIUM] (C - n/a - n/a - [n/a - 15mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 1000mg - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010667196	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac murmur (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667197	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667198	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667200	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphonia (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Eye colour change (n/a - Recovered/Resolved - Other Medically Important Condition);Head lag (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tearfulness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|IVABRADINE HYDROCHLORIDE [IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE TARTRATE, PARACETAMOL, PARACETAMOL BP, DIHYDROCODEINE TARTRATE BP, PARACETAMOL, DIHYDROCODEINE TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667208	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Colitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667212	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ageusia (n/a - Unknown - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667215	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 500mg - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010667220	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anosmia (n/a - Recovered/Resolved - Other Medically Important Condition);Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667223	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abnormal loss of weight (n/a - Recovered/Resolved - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nervousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667224	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667236	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667240	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenderness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667241	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667249	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667251	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010667277	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667282	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Migraine (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667316	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010667338	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667438	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Irritability (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667439	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Irritability (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667570	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - )|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - )|[METOPROLOL, METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - )|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010667572	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	VITAMINBJØRNER JUNGEL [BIOTIN, CYANOCOBALAMINE, FOLIC ACID, NICOTINAMIDE, VITAMIN A, VITAMIN B6, VITAMIN C, VITAMIN E, VITAMINE D3] (C - n/a - n/a - )|[IBUPROFEN] (C - Pain, Pyrexia - n/a - [2d - n/a - n/a])|[PARACETAMOL] (C - Pain, Pyrexia - n/a - [2d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667604	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010667634	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )|[ASCORBIC ACID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667654	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (10h - Recovering/Resolving - );Pyrexia (20h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010667669	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Hypertension (n/a - Unknown - );Malaise (n/a - Unknown - );Myocardial necrosis marker increased (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Tachycardia paroxysmal (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE, PERINDOPRIL TOSILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010667876	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010667876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668016	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668249	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668257	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668267	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Limb discomfort (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010668362	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668421	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (n/a - Recovered/Resolved - );Blood pressure decreased (n/a - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010668516	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668518	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668523	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668525	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668529	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668552	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart valve incompetence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Left ventricular hypertrophy (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sinus tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ventricular extrasystoles (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CYCLOPHOSPHAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - Steroid therapy - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668569	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668583	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Feeding disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668585	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668590	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668609	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Life Threatening);Pneumonia (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668617	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Blood pressure systolic decreased (n/a - Recovering/Resolving - Other Medically Important Condition);C-reactive protein increased (n/a - Unknown - );Heart rate increased (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668624	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Aortic aneurysm rupture (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668640	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668648	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010668649	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arteriosclerosis (n/a - Fatal - Results in Death);Cardiovascular disorder (n/a - Fatal - Results in Death);Enterocolitis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Intestinal perforation (n/a - Fatal - Results in Death);Peritonitis (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vasculitis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668652	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Dysgeusia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668654	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye movement disorder (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tenderness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tremor (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - n/a - n/a - [n/a - n/a - n/a])|[HEPATITIS A VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668660	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Apnoea (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Fatal - Results in Death);Oropharyngeal pain (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668690	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668693	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668696	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Anti-neutrophil cytoplasmic antibody positive vasculitis (n/a - Fatal - Results in Death, Other Medically Important Condition);Asthenia (n/a - Unknown - );Oxygen saturation decreased (n/a - Unknown - );Pulmonary alveolar haemorrhage (n/a - Unknown - Other Medically Important Condition);Renal failure (n/a - Unknown - Other Medically Important Condition);Slow speech (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668699	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria chronic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668708	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (1d - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010668711	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cyanosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668717	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Balance disorder (n/a - Unknown - Disabling);Chest pain (n/a - Recovering/Resolving - Disabling);Decreased appetite (n/a - Unknown - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Recovered/Resolved - Disabling);Malaise (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Unknown - Disabling);Rash (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - Adverse drug reaction - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Abdominal pain upper - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010668719	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668732	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry skin (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668733	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Systolic hypertension (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TELMISARTAN [TELMISARTAN] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|TICAGRELOR [TICAGRELOR] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Scintillating scotoma - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastric ulcer - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Abdominal discomfort - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Cholecystostomy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668741	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668744	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010668748	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010668749	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668750	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010668755	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - 500mg - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668760	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (20min - Recovered/Resolved - );Immunisation (n/a - Unknown - );Lymphadenopathy (2d - Recovered/Resolved - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668764	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668771	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CANAGLIFLOZIN [CANAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668775	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling);Anxiety (n/a - Not Recovered/Not Resolved - Disabling);COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Disabling);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Fear (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010668784	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (118d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (118d - Recovered/Resolved - );Hypotension (118d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668793	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Abdominal pain (n/a - Unknown - );Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Bronchospasm (n/a - Unknown - );Chills (0d - Recovered/Resolved - Disabling, Other Medically Important Condition);Cough (n/a - Unknown - );Dyspepsia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dysphonia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Feeding disorder (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Frequent bowel movements (n/a - Unknown - Disabling, Other Medically Important Condition);Haematemesis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Haemoptysis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Hypotension (n/a - Unknown - );Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Painful respiration (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pulmonary congestion (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Respiratory distress (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - );Upper respiratory tract inflammation (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010668800	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668803	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668804	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668808	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668809	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668811	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flank pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nephrolithiasis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668828	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute endocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);C-reactive protein increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Epstein-Barr virus antibody positive (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Red blood cell sedimentation rate increased (n/a - Not Recovered/Not Resolved - );Streptococcus test positive (n/a - Unknown - );Upper respiratory tract infection (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, LISINOPRIL, LISINOPRIL DIHYDRATE, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [752d - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety, Depression - n/a - [n/a - n/a - Oral])|[TRAZODONE HYDROCHLORIDE] (C - Insomnia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668836	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysuria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haematuria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668839	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - );Pain (n/a - Unknown - );Palpitations (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668842	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668843	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668845	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668852	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668858	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668864	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668865	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Panic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668870	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668874	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait inability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010668876	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Heart rate variability decreased (n/a - Not Recovered/Not Resolved - Disabling);Joint noise (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010668925	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668926	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668939	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gastroenteritis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668940	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668946	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668953	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668956	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668957	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668962	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Nodule (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668963	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668967	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dehydration (n/a - Unknown - );Gastroenteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668968	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668979	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010668985	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood immunoglobulin E increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010668986	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (0d - Recovered/Resolved - Other Medically Important Condition);Cardiac discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668988	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010668990	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010668997	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010668997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010669001	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Sinus tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010669002	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Gastroenteritis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010669005	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Brain natriuretic peptide increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hepatic function abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial necrosis marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Sepsis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669006	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669010	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dermatochalasis (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669012	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669015	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Genital herpes (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669016	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010669019	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood potassium decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669020	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Perichondritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669023	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669026	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010669034	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669099	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	GALVUS 50 MG [VILDAGLIPTIN] (C - n/a - n/a - )|[ALLOPURINOL] (C - n/a - n/a - )|[ATORVASTATIN] (C - n/a - n/a - )|[BEZAFIBRATE] (C - n/a - n/a - )|[CARVEDILOL] (C - n/a - n/a - )|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010669107	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010669143	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Parosmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669192	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669230	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Tonsillitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LITHIUM] (C - Mania - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669235	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669351	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669360	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Atrial flutter (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669423	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669424	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669524	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Extrasystoles (5d - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010669622	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010669629	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010669664	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (55min - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010669669	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669674	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010669691	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Cold sweat (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010669734	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Decreased appetite (1d - Recovered/Resolved - );Ear pain (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Oropharyngeal pain (0d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669735	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010669789	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic dissection (n/a - Recovered/Resolved With Sequelae - Life Threatening);Vasculitis (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010669800	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic dissection (n/a - Recovered/Resolved - Life Threatening);Vasculitis (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BUDESONIDE, BUDESONIDE, MICRONISED] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010669818	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphoedema (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010669822	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669950	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010669961	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010669989	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Quadriplegia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010669989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010670028	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Diplopia (n/a - Unknown - );Fatigue (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010670055	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paratracheal lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pulmonary oedema (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [ADALIMUMAB] (S - n/a - n/a - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010670061	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastroenteritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Kawasaki's disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Tonsillitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010670073	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670078	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung infiltration (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocardial ischaemia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010670083	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - 10mg - Oral])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - 1g - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010670100	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chromaturia (2d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Retching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urine abnormality (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670213	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670242	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010670248	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670249	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670257	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010670369	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (37d - Recovered/Resolved - Disabling);Back pain (37d - Recovered/Resolved - Disabling);Chills (37d - Recovered/Resolved - Disabling);Dyspnoea (37d - Recovered/Resolved - Disabling);Fatigue (37d - Recovered/Resolved - Disabling);Feeling cold (37d - Recovered/Resolved - Disabling);Headache (37d - Recovered/Resolved - Disabling);Influenza like illness (37d - Recovered/Resolved - Disabling);Muscle spasms (37d - Recovered/Resolved - Disabling);Myalgia (37d - Recovered/Resolved - Disabling);Neck pain (37d - Recovered/Resolved - Disabling);Pain (37d - Recovered/Resolved - Disabling);Pain in extremity (37d - Recovered/Resolved - Disabling);Paraesthesia (37d - Recovered/Resolved - Disabling);Pyrexia (37d - Recovered/Resolved - Disabling);Renal pain (37d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010670462	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670698	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670699	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670700	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670701	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphasia (n/a - Recovering/Resolving - Disabling);Basal ganglia haemorrhage (n/a - Recovering/Resolving - Disabling);Cerebral infarction (n/a - Recovering/Resolving - Disabling);Hemiparesis (n/a - Recovering/Resolving - Disabling);Pneumonia aspiration (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010670704	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670707	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670708	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670709	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670711	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670715	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670719	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010670739	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (8d - Recovered/Resolved - );Anosmia (8d - Recovered/Resolved - );COVID-19 (8d - Recovered/Resolved - );Cough (8d - Recovered/Resolved - );Malaise (8d - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010670856	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - Unknown - [n/a - n/a - n/a])|[CLONAZEPAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[ENOXAPARIN SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[LORAZEPAM, LORMETAZEPAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010670998	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (19d - Unknown - Other Medically Important Condition);Balance disorder (32d - Unknown - );Disturbance in attention (62d - Unknown - );Malaise (32d - Recovered/Resolved - );Myositis (8d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010670998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010671039	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010671044	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010671047	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010671092	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671186	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Activated partial thromboplastin time prolonged (n/a - Unknown - Other Medically Important Condition);Amylase decreased (n/a - Unknown - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Unknown - Other Medically Important Condition);Blood albumin abnormal (n/a - Unknown - Other Medically Important Condition);Blood alkaline phosphatase increased (n/a - Unknown - Other Medically Important Condition);Blood calcium decreased (n/a - Unknown - Other Medically Important Condition);Blood cholesterol decreased (n/a - Unknown - Other Medically Important Condition);Blood creatine phosphokinase decreased (n/a - Unknown - Other Medically Important Condition);Blood lactic acid increased (n/a - Unknown - Other Medically Important Condition);Blood pressure immeasurable (140min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood pressure systolic decreased (n/a - Unknown - Other Medically Important Condition);Blood sodium decreased (n/a - Unknown - Other Medically Important Condition);Blood uric acid increased (n/a - Unknown - Other Medically Important Condition);C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Chest discomfort (140min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Disease recurrence (140min - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (140min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ejection fraction decreased (n/a - Unknown - Other Medically Important Condition);Haemoglobin decreased (n/a - Unknown - );Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Intentional product use issue (n/a - Unknown - );Movement disorder (n/a - Unknown - );N-terminal prohormone brain natriuretic peptide increased (n/a - Unknown - Other Medically Important Condition);Pleural effusion (n/a - Unknown - Other Medically Important Condition);Protein total decreased (n/a - Unknown - Other Medically Important Condition);Prothrombin time ratio increased (n/a - Unknown - Other Medically Important Condition);Respiratory rate increased (n/a - Unknown - Other Medically Important Condition);Shock (140min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus node dysfunction (140min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|ELIQUIS [APIXABAN] (S - Sinus node dysfunction - Unknown - [n/a - n/a - Oral])	[FUROSEMIDE] (C - Hypertension - Dose not changed - [n/a - n/a - Oral])|[MIGLITOL] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - Dose not changed - [n/a - n/a - Oral])|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - Sinus node dysfunction - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671227	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral vein thrombosis (30d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010671228	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Alopecia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671233	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Myocardial infarction (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671238	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arteriosclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671244	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671254	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myopericarditis (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671259	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death);Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010671260	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010671261	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671265	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671266	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Activated partial thromboplastin time shortened (n/a - Unknown - );Fibrin D dimer increased (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671270	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphasia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671272	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bladder disorder (n/a - Not Recovered/Not Resolved - );Urinary tract infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671273	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010671358	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671368	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671534	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671536	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671639	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671652	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671674	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010671675	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010671901	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Pain in extremity (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010671954	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010671955	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010671955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672013	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010672104	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Cerebral venous sinus thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Disorientation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Neurological infection (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672127	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010672160	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - n/a - Unknown])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Prophylaxis - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672197	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672201	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - Pain - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[MORPHINE SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])|[RIBOFLAVIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672203	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood potassium decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672205	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation);Underdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672208	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672214	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672215	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672219	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672220	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672227	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Disorientation (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - );Peripheral coldness (n/a - Unknown - Other Medically Important Condition);Pollakiuria (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 4000[iU] - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LACTOBACILLUS ACIDOPHILUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672228	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);White blood cell count decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672244	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Productive cough (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672248	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672251	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (0d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672253	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dermatitis allergic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672256	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672259	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672261	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sciatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [26d - n/a - n/a])|[DIAZEPAM] (C - Back pain - n/a - [4d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672262	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672269	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672273	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (5d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672277	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672278	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (18d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672284	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Delirium (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition);Urinary incontinence (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672285	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - );Palpitations (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672286	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672290	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672292	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Burkitt's lymphoma stage I (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672294	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Carditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672309	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672314	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672317	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Cardiac disorder (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672321	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672322	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672329	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672330	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (0d - Recovered/Resolved - Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Unknown - );Myalgia (0d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672333	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672334	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672336	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672447	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010672488	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672489	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672491	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672492	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672530	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010672531	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672533	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovered/Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672537	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672546	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Nasopharyngitis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672553	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672557	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672562	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Fatal - Results in Death);Hypopnoea (n/a - Fatal - Results in Death);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672566	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672580	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung disorder (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672581	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure acute (261h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (308h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (308h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[INDOMETACIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN ASPART, INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010672588	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672594	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - );Inflammatory marker increased (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010672611	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Motor dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Skin laceration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672624	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Induration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672625	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Febrile neutropenia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|TISAGENLECLEUCEL [TISAGENLECLEUCEL] (S - Non-Hodgkin's lymphoma refractory - Unknown - [n/a - n/a - Intravenous (not otherwise specified)])|TOCILIZUMAB [TOCILIZUMAB] (S - Non-Hodgkin's lymphoma refractory - Unknown - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672626	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dehydration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeding disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672636	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672645	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672648	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672650	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672661	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672665	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Joint stiffness (n/a - Not Recovered/Not Resolved - );Lyme disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672671	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skin discolouration (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672686	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Immunisation (n/a - Unknown - );Myalgia (2d - Recovered/Resolved - );Off label use (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010672691	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Ileus (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672696	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Contusion (n/a - Unknown - );Depressed level of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Subdural haematoma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|SILODOSIN [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ANGELICA ROOT, GLYCYRRHIZA GLABRA, YOKUKANSAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BETHANECHOL CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TRICHLORMETHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010672706	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Deep vein thrombosis (19d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - );Platelet count increased (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pneumonitis (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[PHLEUM PRATENSE, PHLEUM PRATENSE (225), PHLEUM PRATENSE POLLEN EXTRACT, TIMOTHY GRASS POLLEN EXTRACT] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010672711	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672730	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Faeces discoloured (n/a - Unknown - Other Medically Important Condition);Urine output decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672738	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition);Cardiac hypertrophy (n/a - Unknown - );Dilated cardiomyopathy (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Intestinal fibrosis (n/a - Unknown - );Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation);Parvovirus B19 infection (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Ventricular dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672744	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672746	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Brain fog (n/a - Unknown - );Cognitive disorder (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Mental impairment (n/a - Unknown - Other Medically Important Condition);Neurological symptom (n/a - Unknown - );Vertigo (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672751	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoxia (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672762	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672798	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010672799	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ADAPALENE, BENZOYL PEROXIDE] (C - Acne - n/a - [n/a - 1{DF} - Cutaneous])|[LYMECYCLINE] (C - Acne - n/a - [n/a - 300mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672842	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (3mo - Recovered/Resolved - );Brain fog (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Dizziness (2mo - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Impaired work ability (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Nausea (3mo - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Peripheral swelling (6d - Recovered/Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ISOTRETINOIN] (C - Acne - n/a - [219d - 20mg - n/a])|[POTASSIUM CHLORIDE, AMMONIUM CHLORIDE, CALCIUM GLUCONATE, POTASSIUM CITRATE] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010672883	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010672888	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );Carditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672890	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dry mouth (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Eating disorder (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Unknown - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Oral pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Suffocation feeling (n/a - Not Recovered/Not Resolved - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Tongue coated (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672941	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - Life Threatening);Depressed level of consciousness (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Heart rate decreased (0d - Recovered/Resolved - Life Threatening);Nausea (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010672944	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672949	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672954	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - n/a])|FESOTERODINE [FESOTERODINE] (C - n/a - n/a - [n/a - 8mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 80mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - 1000mg - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010672958	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Jaundice (9d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672959	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010672969	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Fatal - Results in Death, Other Medically Important Condition);Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[ISOSORBIDE DINITRATE] (C - Angina pectoris - n/a - [n/a - n/a - Transdermal])|[NIFEDIPINE] (C - Angina pectoris - n/a - [n/a - 80mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010672974	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis perforated (n/a - Recovered/Resolved - Other Medically Important Condition);Complicated appendicitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010672989	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMYLASE, LIPASE, PROTEASE, PANCREALIPASE, PANCREAS POWDER, PANCREATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, ZINC, CALCIUM, COPPER, IRON, MAGNESIUM, MANGANESE, PYRIDOXINE HYDROCHLORIDE, RETINOL, ALPHATOCOPHEROL ACETATE, MOLYBDENUM, ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, ZINC, VITAMIN B6, CALCIUM, COPPER, IRON, MAGNESIUM, MANGANESE, PHOSPHORUS, RETINOL, MOLYBDENUM, DL-ALPHA TOCOPHEROL ACETATE, VITAMIN B12, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, FOLIC ACID, NICOTINAMIDE, PHYTOMENADIONE, RIBOFLAVIN, THIAMINE, PHOSPHOROUS ACID, ZINC, VITAMIN B6, CALCIUM, CHROMIUM, COPPER, IODINE, IRON, MAGNESIUM, MANGANESE, PANTOTHENIC ACID, SELENIUM, RETINOL, ALPHA-TOCOPHEROL, MOLYBDENUM, FLUORINE, VITAMIN B12, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE, ZINC, VITAMIN B6, CALCIUM, COPPER, IRON, MAGNESIUM, MANGANESE, PANTOTHENIC ACID, PHOSPHORUS, RETINOL, ALPHA-TOCOPHEROL, MOLYBDENUM, VITAMIN B12, POTASSIUM ASCORBATE] (C - n/a - n/a - [n/a - n/a - n/a])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010672989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673008	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673012	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673024	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673028	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673038	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010673040	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673042	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673044	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Intermenstrual bleeding (n/a - Unknown - );Polymenorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673046	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac failure chronic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenosynovitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673063	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (4wk - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010673069	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombophlebitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673129	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673140	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (1d - Recovered/Resolved - );Diarrhoea (4d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Febrile convulsion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673212	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Roseola (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673213	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673217	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Oral pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673220	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673226	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673346	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug-induced liver injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Liver disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673350	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Completed suicide (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[GLIBENCLAMIDE] (C - n/a - n/a - [n/a - 1.25mg - Oral])|[SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010673352	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673356	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tinnitus (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673362	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Poor quality sleep (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010673364	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Embolism (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673365	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase MB increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673428	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673429	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673430	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Feeling cold (n/a - Unknown - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673441	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673472	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Haematemesis (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pancreatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - 4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673512	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010673519	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010673557	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPROSARTAN, EPROSARTAN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673568	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (7d - Not Recovered/Not Resolved - );Chest discomfort (12d - Not Recovered/Not Resolved - );Chest pain (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Paraesthesia (7d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010673595	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (1d - Recovered/Resolved - );Chills (3wk - Recovered/Resolved - );Eczema weeping (4d - Recovered/Resolved - );International normalised ratio decreased (1wk - Recovered/Resolved - Other Medically Important Condition);Papule (4d - Recovered/Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rash macular (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[PHENPROCOUMON] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673600	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673602	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (2d - Recovering/Resolving - Disabling);Headache (2d - Recovering/Resolving - Disabling);Pyrexia (2d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010673636	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - Dose not changed - [n/a - 1{DF} - Oral])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673732	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertension (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673742	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage intracranial (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673753	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673755	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alcohol intolerance (n/a - Recovering/Resolving - );Blood pressure fluctuation (n/a - Recovered/Resolved - Other Medically Important Condition);Bronchospasm (n/a - Recovering/Resolving - );Condition aggravated (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Depressed level of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Dermatitis atopic (n/a - Recovering/Resolving - );Dermatitis contact (n/a - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fat intolerance (n/a - Recovering/Resolving - );Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Parosmia (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Pyrexia (1wk - Recovered/Resolved - );Rash (n/a - Unknown - );Rash erythematous (n/a - Recovered/Resolved - Other Medically Important Condition);Respiratory distress (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory tract oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Shock (n/a - Recovering/Resolving - Other Medically Important Condition);Skin lesion (3wk - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - );Use of accessory respiratory muscles (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Vaccination site urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMILORIDE HYDROCHLORIDE, CHLORTALIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010673823	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010673830	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673841	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010673848	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ear haemorrhage (n/a - Recovered/Resolved - );Epistaxis (n/a - Recovered/Resolved - );Faeces discoloured (3wk - Unknown - );Fatigue (n/a - Recovered/Resolved - );General physical health deterioration (n/a - Unknown - );Haematoma (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pulmonary pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Skin discolouration (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Coronary arterial stent insertion - n/a - [n/a - 75mg - Oral])|[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Diaphragmatic hernia, Gastric ulcer - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010673885	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (0d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673888	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cognitive disorder (n/a - Fatal - Results in Death);Creutzfeldt-Jakob disease (n/a - Fatal - Results in Death);Dysarthria (n/a - Fatal - Results in Death);Gait disturbance (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - Product used for unknown indication - Dose not changed - [n/a - 40mg - n/a])|[PRAVASTATIN SODIUM] (C - Product used for unknown indication - Dose not changed - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010673932	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (3d - Recovered/Resolved - );Paraesthesia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010673937	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Tsaldari,N.. Abducens Nerve Paralysis after SARS-CoV-2 Vaccination. 54TH PANHELLENIC OPHTHALMOLOGICAL CONGRESS. 2021;148	65-85 Years	Not Specified	No	Male	VIth nerve paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010673939	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Incorrect route of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Other])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673950	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673956	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Tinnitus (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010673963	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Back pain (2d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673966	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673967	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673970	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010673973	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drooling (n/a - Recovered/Resolved - Other Medically Important Condition);Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010673973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674032	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Overdose (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674043	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthropathy (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010674157	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674158	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674163	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE HYDROCHLORIDE] (C - Neuralgia - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674189	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Physical deconditioning (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674194	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspepsia (4d - Recovered/Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674197	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Fatal - Results in Death);Drowning (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010674255	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cyanosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674292	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Blood glucose increased (n/a - Unknown - );Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Cerebral artery stenosis (n/a - Recovering/Resolving - Other Medically Important Condition);Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Haematocrit decreased (n/a - Unknown - );High density lipoprotein decreased (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Supraventricular extrasystoles (n/a - Unknown - );Tachycardia (n/a - Unknown - );Taste disorder (n/a - Unknown - );Ventricular extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Subcutaneous])|[CANDESARTAN] (S - Hypertension - Drug withdrawn - [n/a - 8mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010674313	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674314	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674362	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Blister (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Unknown - );Dry skin (n/a - Unknown - );Emotional distress (n/a - Unknown - );Erythema (n/a - Unknown - );Joint swelling (n/a - Recovering/Resolving - );Mass (n/a - Unknown - );Pain (n/a - Unknown - );Pemphigoid (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - );Pruritus (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - );Sunburn (n/a - Unknown - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674406	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010674415	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674416	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674418	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood potassium decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674431	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674438	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674463	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Oropharyngeal blistering (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674489	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674495	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674497	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Painful respiration (n/a - Unknown - Other Medically Important Condition);Pulmonary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674498	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674553	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Colitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Varices oesophageal (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674593	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tendon pain (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674597	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (113d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Atrial fibrillation (113d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674628	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674673	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674676	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674695	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Renal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010674717	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674719	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674721	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674790	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674791	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Back pain (1wk - Recovered/Resolved - );Chest pain (1wk - Recovered/Resolved - );Depressed mood (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Spinal pain (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INDAPAMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - Polymyalgia rheumatica - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674899	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Respiration abnormal (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010674921	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - );Skin burning sensation (n/a - Recovering/Resolving - );Vaccination site oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674925	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FLUDROCORTISONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010674934	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010674941	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674945	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010674948	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674949	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Skin exfoliation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [212d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674954	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674960	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674964	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010674966	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010674970	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Albumin urine present (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood urine present (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);IgA nephropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[RAMIPRIL] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674974	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010674975	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Endolymphatic hydrops (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoacusis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010674987	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010674987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675003	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675011	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675018	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675020	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675045	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (40min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675052	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site swelling (8d - Recovered/Resolved - );Vaccination site warmth (20min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675057	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675058	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675065	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675067	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthmatic crisis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675070	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675071	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675074	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675075	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ACARBOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FENOFIBRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675077	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - );Visual impairment (3min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675104	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Foetal malformation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010675110	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675115	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary pain (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675118	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675126	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675133	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (n/a - Recovering/Resolving - Other Medically Important Condition);Ocular myasthenia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675159	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Albumin urine present (n/a - Not Recovered/Not Resolved - );Creatinine urine increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675162	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675172	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agitation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood thyroid stimulating hormone decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675175	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675180	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neurological symptom (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675210	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675217	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site haematoma (11d - Recovered/Resolved - );Injection site inflammation (11d - Recovered/Resolved - );Injection site pain (11d - Recovered/Resolved - );Injection site pruritus (11d - Recovered/Resolved - );Injection site swelling (11d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Skin disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675235	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675246	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010675255	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675300	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675306	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675308	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675314	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675332	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [173d - 3{DF} - Intramuscular])|TRUXIMA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION [RITUXIMAB] (S - Rheumatoid arthritis - Not applicable - [n/a - 1g - Intravenous drip])|[PREDNISONE] (S - Rheumatoid arthritis - Drug withdrawn - [128d - 7mg - Oral])	[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - Mineral supplementation - n/a - [n/a - 1{DF} - Oral])|[COLECALCIFEROL] (C - Vitamin supplementation - n/a - [n/a - 1{DF} - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - 40mg - Oral])|[POTASSIUM CHLORIDE] (C - Mineral supplementation - n/a - [n/a - 1800mg - Oral])|[RISEDRONATE MONOSODIUM, RISEDRONATE SODIUM] (C - Osteoporosis - n/a - [n/a - 35mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675349	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Intestinal ischaemia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010675358	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675363	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675365	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675371	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675374	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675389	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675390	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675391	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675410	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675412	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SILODOSIN [SILODOSIN] (C - Benign prostatic hyperplasia - Dose increased - [n/a - 8mg - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - Dose not changed - [n/a - 20mg - Oral])|[PYGEUM AFRICANUM, PYGEUM AFRICANUM EXTRACT] (C - Benign prostatic hyperplasia - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675420	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Graves' disease (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675421	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Sinus tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675422	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675432	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675433	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675438	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675439	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo positional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675450	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Influenza like illness (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675453	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675455	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Influenza like illness (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675457	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VEDOLIZUMAB [VEDOLIZUMAB] (C - Enterocolitis haemorrhagic - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675460	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diabetes mellitus inadequate control (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675467	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hyperglycaemia (1h - Recovered/Resolved - );Presyncope (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675470	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SEEBRI BREEZHALER 44 MICROGRAMS INHALATION POWDER HARD CAPSULES [GLYCOPYRRONIUM BROMIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - Nasal])|[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - 1{DF} - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675477	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Rhinitis (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	KIVEXA 600 MG/300 MG FILM-COATED TABLETS [ABACAVIR SULFATE, LAMIVUDINE, ABACAVIR, LAMIVUDINE] (C - HIV infection - n/a - [n/a - 1{DF} - Oral])|VIRAMUNE 400 MG PROLONGED-RELEASE TABLETS [NEVIRAPINE] (C - HIV infection - n/a - [n/a - 400mg - Oral])|[ROSUVASTATIN] (C - Blood cholesterol - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675486	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (36h - Recovering/Resolving - );Lymphadenopathy (12h - Recovering/Resolving - );Vaccination site reaction (12h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[SALBUTAMOL SULFATE] (C - Product used for unknown indication - n/a - [n/a - 100ug - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675487	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675491	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675494	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675495	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pemphigoid (2mo - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675496	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675501	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675504	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675506	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675508	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675511	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Recovering/Resolving - Other Medically Important Condition);Hypertension (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675524	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675553	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675565	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675572	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675581	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675582	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675588	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pneumothorax (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675589	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675608	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675619	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675625	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675627	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675632	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Glomerulonephritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675645	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675651	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Neck pain (3wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675660	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (7h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675702	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Multisystem inflammatory syndrome in children (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675708	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint noise (n/a - Not Recovered/Not Resolved - );Tendonitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675709	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Purpura (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675714	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Respiratory distress (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675728	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hallucination, visual (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675732	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (1mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [30d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675754	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675759	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675774	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675784	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675817	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Generalised oedema (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Motor dysfunction (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Unknown - Other Medically Important Condition);Sjogren's syndrome (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010675823	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry throat (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010675857	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ALFUZOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, HYDROXOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675873	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - );Fear of death (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010675876	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (153d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Atrial fibrillation (55d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial fibrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (152d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CURCUMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010675895	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010675924	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ROSUVASTATIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675952	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[BROMAZEPAM] (C - Depression - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010675957	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010675957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010676054	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Nausea (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010676076	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676095	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010676098	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	RANEXA [RANOLAZINE] (C - n/a - n/a - )|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - )|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - )|[GALANTAMINE, GALANTAMINE HYDROBROMIDE] (C - n/a - n/a - )|[GLYCERYL TRINITRATE] (C - n/a - n/a - )|[INSULIN, INSULIN HUMAN] (C - n/a - n/a - )|[LANSOPRAZOLE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010676115	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676117	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676137	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysstasia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676370	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676371	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676374	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gout (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (S - Arrhythmia - Dose not changed - [n/a - 5mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676382	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676402	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Incorrect route of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676416	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE, PERINDOPRIL ARGININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676483	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676486	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Fallot's tetralogy (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[DALTEPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010676515	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Overdose (n/a - Unknown - );Visual acuity reduced (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676520	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010676590	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Endocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nocturia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL, LISINOPRIL ANHYDROUS, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENPROCOUMON] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676598	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lower respiratory tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Oedema peripheral (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Upper gastrointestinal haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DABIGATRAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [461d - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Gout - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [4116d - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676604	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676607	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010676612	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676680	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation);Eczema (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676727	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010676825	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Hypokalaemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypomagnesaemia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (2min - Recovered/Resolved - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676840	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676861	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010676875	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2[arb'U] - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010676877	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010676937	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010676937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677000	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677010	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (55d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	PLEGRIDY [PEGINTERFERON BETA-1A] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010677033	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (12h - Recovered/Resolved - );Chills (12h - Recovered/Resolved - );Dizziness (12h - Recovered/Resolved - );Hypokinesia (12h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - );Pyrexia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [5s - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677061	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Unknown - );Interstitial lung disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pancreatitis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pulmonary fibrosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010677075	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Colon cancer (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Neoplasm malignant (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010677076	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (6d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010677168	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acrochordon (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash macular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010677189	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010677216	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Pain in extremity (5h - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677217	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010677232	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Life Threatening);Cardiac disorder (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Embolism (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening);Malaise (n/a - Unknown - Life Threatening);Off label use (n/a - Unknown - Life Threatening);Presyncope (n/a - Unknown - Life Threatening);Pulmonary embolism (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010677233	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010677345	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Injection site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677364	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	[CORTISONE] (C - n/a - n/a - [n/a - 50mg - n/a])|[FLUDROCORTISONE] (C - n/a - n/a - [n/a - .2mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677378	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Eye pain (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Not Recovered/Not Resolved - Disabling);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (3d - Recovered/Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010677386	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Nail bed bleeding (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677421	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677450	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Puncture site pain (n/a - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677464	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677478	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	GREPID 75 MG FILM-COATED TABLETS [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])|[AMOXICILLIN, CLARITHROMYCIN, PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677557	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677560	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677562	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677564	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677589	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Cough (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677590	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Throat clearing (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[BETAMETHASONE VALERATE, FUSIDIC ACID, BETAMETHASONE VALERATE, FUSIDIC ACID HEMIHYDRATE, BETAMETHASONE, ANHYDROUS FUSIDIC ACID, BETAMETHASONE, FUSIDIC ACID HEMIHYDRATE, BETAMETHASONE, FUSIDIC ACID PH. EUR., FUSIDIC ACID HEMIHYDRATE, BETAMETHASONE VALERATE (PH. EUR.), FUSIDIC ACID, BETAMETHASONE] (C - Skin disorder - n/a - [n/a - n/a - Cutaneous])|[BETAMETHASONE, BETAMETHASONE VALERATE] (C - Skin disorder - n/a - [n/a - n/a - Cutaneous])|[CLOBETASOL PROPIONATE] (C - Skin disorder - n/a - [n/a - n/a - Cutaneous])|[ECONAZOLE NITRATE, TRIAMCINOLONE ACETONIDE] (C - Skin disorder - n/a - [n/a - n/a - Cutaneous])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Urticaria - n/a - [n/a - n/a - Oral])|[KETOCONAZOLE, KETOCONAZOLE PH. EUR.] (C - Dandruff - n/a - [n/a - n/a - Cutaneous])|[MOMETASONE FUROATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[SILDENAFIL, SILDENAFIL CITRATE] (C - Erectile dysfunction - n/a - [n/a - n/a - Oral])|[TADALAFIL] (C - Erectile dysfunction - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677591	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstruation delayed (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010677592	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677618	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [9d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010677634	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site inflammation (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677659	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677660	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677663	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677679	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677681	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Otitis media (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010677687	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677714	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677728	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677732	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677740	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677756	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (9d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Multisystem inflammatory syndrome (5d - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010677774	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677783	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677790	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sexual dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010677799	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677806	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010677813	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677814	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (124d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010677837	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677847	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677848	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])|FLUCELVAX TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010677858	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677889	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug interaction (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|GLIVEC [IMATINIB, IMATINIB MESILATE] (I - Gastrointestinal stromal tumour - Unknown - [n/a - 400mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677931	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677935	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Irregular breathing (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Sputum discoloured (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Status epilepticus (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	LEVETIRACETAM ACCORD [LEVETIRACETAM] (C - Epilepsy congenital - n/a - [n/a - 1{DF} - n/a])|[TOPIRAMATE] (C - Epilepsy - n/a - [n/a - 1{DF} - n/a])|[TOPIRAMATE] (C - Epilepsy - n/a - [n/a - 25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010677943	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arthralgia (98d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Arthritis reactive (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Eyelid ptosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677944	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677972	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677982	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Endocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling hot (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010677987	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - );Swelling of eyelid (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010677987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678084	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678176	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010678199	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Cerebral infarction (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010678222	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (1d - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678273	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678279	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Increased tendency to bruise (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678292	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Epistaxis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678293	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Periarthritis (n/a - Recovering/Resolving - );Plantar fasciitis (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678297	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mobility decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010678307	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast pain (30s - Recovered/Resolved - );Chills (4d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[TETANUS VACCINES] (S - Tetanus immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010678311	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678323	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLCYSTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678343	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678387	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010678404	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010678473	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[TOLTERODINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010678486	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678496	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678522	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema nodosum (3wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010678538	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Electrocardiogram abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Left ventricular hypertrophy (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678544	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010678557	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010678620	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010678641	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678674	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678682	Spontaneous	2021-11-17 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678704	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010678710	Spontaneous	2021-11-17 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [22d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010678710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652594	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652595	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652597	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dementia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010652607	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652611	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652623	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (7d - Recovered/Resolved - );Nausea (7d - Recovered/Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652626	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cutaneous T-cell lymphoma (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010652631	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010652634	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - );Confusional state (6d - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652635	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Hypertonia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652640	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria physical (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652649	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Not Recovered/Not Resolved - );Muscle discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010652657	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010652664	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abortion spontaneous (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652668	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652672	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Skin papilloma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652678	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652679	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dry skin (31d - Recovered/Resolved - );Hypoaesthesia (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010652680	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652689	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Colitis microscopic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652693	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652695	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash pustular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652696	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Herpes zoster (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652697	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652701	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652715	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652724	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Circulatory collapse (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652734	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010652739	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652741	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652747	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652751	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (4d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652752	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652758	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010652760	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652764	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652767	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652769	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apathy (7d - Recovered/Resolved - );Decreased appetite (7d - Recovered/Resolved - );Tachycardia (7d - Recovered/Resolved - );Visual field defect (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652772	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aortic dissection (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010652783	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652787	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652788	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652792	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Status epilepticus (12d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010652797	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652805	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652808	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652809	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652810	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010652813	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neurodermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652849	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Muscular weakness (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652850	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oral herpes (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010652861	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652893	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis allergic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652903	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652942	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])|[A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/60/2008, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008, B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURCH/16/2010, B/BRISBANE/60/2008-LIKE VIRUS, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26), A/DARWIN/9/2021 (H3N2) - LIKE STRAIN (A/DARWIN/6/2021, IVR-227), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED] (S - Influenza immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652982	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hypersomnia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652996	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010652997	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653000	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - Oral])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - Oral])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653022	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653023	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653026	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653029	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Endocarditis bacterial (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Injection site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653031	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653047	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653048	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653049	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653064	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653069	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Oral papilloma (n/a - Unknown - Other Medically Important Condition);Phimosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653074	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (9d - Recovered/Resolved - );Lymphadenopathy (9d - Recovered/Resolved - );Sciatica (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653104	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653110	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Panic disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Somnolence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653112	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653113	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Disabling);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010653114	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653117	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653119	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010653123	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010653125	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653126	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010653129	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010653154	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Oropharyngeal pain (n/a - Fatal - Results in Death);Syncope (n/a - Fatal - Results in Death);Tinnitus (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010653166	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Obstructive airways disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	TRIMBOW 87 MICROGRAMS/5 MICROGRAMS/9 MICROGRAMS PRESSURISED INHALATION, SOLUTION [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653170	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653171	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening);Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653178	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653184	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hallucination (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Skin odour abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Urine odour abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653187	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653207	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Life Threatening);Pneumonitis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653214	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653216	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653221	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (20d - Recovered/Resolved - );Pyrexia (20d - Recovered/Resolved - );Vaccination failure (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACENOCOUMAROL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653227	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653230	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653231	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (2d - Recovered/Resolved - );Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653249	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653250	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653251	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653252	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653255	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Embolism (n/a - Unknown - Life Threatening);Thrombosis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010653256	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653257	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (1d - Recovered/Resolved - Other Medically Important Condition);Facial paresis (1d - Recovered/Resolved - Other Medically Important Condition);Pruritus (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653259	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653260	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653261	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653262	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653271	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sputum abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tooth socket haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653272	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Constipation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyponatraemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653281	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac index (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Left ventricular dysfunction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653290	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - Other Medically Important Condition);Anosmia (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653295	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653303	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653338	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653342	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653347	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653348	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653351	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653363	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose reduced - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653371	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (3d - Recovered/Resolved - );Urticaria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653384	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653386	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653390	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653392	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653395	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653397	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653398	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])|FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653423	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry eye (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653424	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Rhinitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653462	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653470	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653483	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653487	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653490	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653497	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653504	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653526	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoparesis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653570	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Gingival bleeding (n/a - Unknown - );Haematochezia (n/a - Unknown - );Headache (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653571	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone pain (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653594	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653606	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspepsia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653607	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653609	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653613	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010653622	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653637	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Ventricular fibrillation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653646	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653656	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653664	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Renal pain (n/a - Unknown - );Skin burning sensation (n/a - Unknown - );Vaccination site pruritus (n/a - Unknown - );Vision blurred (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Major depression - n/a - [n/a - 10[drp] - Oral])|[CLONAZEPAM] (C - Panic attack - n/a - [n/a - 30[drp] - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653667	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010653682	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653701	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653702	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653885	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653897	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653899	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (4d - Recovered/Resolved - Other Medically Important Condition);Viral infection (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653902	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pleurisy (n/a - Recovered/Resolved - );Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653915	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653928	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653929	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash vesicular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Infectious mononucleosis - n/a - [14d - n/a - n/a])|[BENZYDAMINE] (C - Infectious mononucleosis - n/a - [4d - n/a - n/a])|[PARACETAMOL] (C - Infectious mononucleosis - n/a - [14d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653942	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Photopsia (1d - Recovered/Resolved - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653949	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653950	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pityriasis rosea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653951	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010653955	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Hypersomnia (n/a - Unknown - );Libido decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010653959	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653961	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653966	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653972	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Parosmia (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Compression fracture - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Compression fracture - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010653974	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653975	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sinus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653982	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hepatic function abnormal (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653984	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653986	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Brain fog (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );Cerebral disorder (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Unknown - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Unknown - );Pulmonary pain (n/a - Unknown - );Vision blurred (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS ESTRADIOL, ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Hysterectomy - n/a - [n/a - n/a - n/a])|[CLOBAZAM] (C - Anxiety - n/a - [n/a - 10mg - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010653990	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653993	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010653995	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010653995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654018	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Oropharyngeal pain (4d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654223	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Gait disturbance (n/a - Unknown - Disabling);Hyperaesthesia (n/a - Unknown - Disabling);Insomnia (n/a - Unknown - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010654231	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654235	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654237	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CODEINE] (C - Pain - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654242	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cellulitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dermatitis bullous (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654243	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654244	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654249	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010654250	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ZOSTAVAX [VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED), VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS] (C - Herpes zoster - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthritis - n/a - [n/a - n/a - n/a])|[SOLIFENACIN] (C - Bladder disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654251	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654260	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654265	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654407	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cardiac arrest (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Recovered/Resolved - );Coronary artery thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Dehydration (n/a - Recovered/Resolved - );Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010654439	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654442	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal stiffness (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654459	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654466	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654469	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654474	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [3d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010654484	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Eye pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654489	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654492	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disturbance in attention (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Thinking abnormal (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010654497	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654498	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654501	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swollen tongue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Arrhythmia supraventricular - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654504	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654506	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - );Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654514	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654519	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Connective tissue disorder (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Mediastinal disorder (n/a - Unknown - );Musculoskeletal disorder (n/a - Unknown - );Respiratory disorder (n/a - Unknown - );Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654521	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654523	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep deficit (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654526	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Rash erythematous (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654791	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[BETULA VERRUCOSA] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010654796	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010654816	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010654830	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - );Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010654838	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010654862	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654863	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654868	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Unknown - Caused/Prolonged Hospitalisation);Neuromuscular pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654869	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Throat irritation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654871	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pustule (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010654886	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010654888	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Hypokinesia (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654892	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654893	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Exposure to extreme temperature (1d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654899	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dermatitis acneiform (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654901	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654902	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010654905	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654913	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654920	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654926	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010654945	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010654983	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010654983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655019	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655024	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010655025	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010655028	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Feeling abnormal (n/a - Unknown - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Lacunar infarction - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Lacunar infarction - n/a - [n/a - n/a - n/a])|[HYDROXYCHLOROQUINE] (C - Rheumatoid arthritis - n/a - [n/a - 400mg - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depressed mood - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010655029	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655034	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655035	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Obsessive thoughts (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010655039	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chromaturia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhabdomyolysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655044	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655046	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - );Peripheral coldness (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010655049	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Delirium (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655052	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010655054	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655056	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Injection related reaction (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010655060	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Impaired work ability (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Mental disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pyrexia (30h - Recovered/Resolved - Disabling, Other Medically Important Condition);Vaccination site discolouration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010655252	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspepsia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[COLCHICINE] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655277	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655278	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655279	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655280	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655376	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injection site pain (2d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010655514	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010655517	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010655520	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NON SPECIFIED BLOEDDRUKMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010655552	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (1d - Recovering/Resolving - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010655752	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Allergy to arthropod bite (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Cough (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [78d - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010655803	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655808	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010655820	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site movement impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655838	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (3d - Unknown - Life Threatening, Other Medically Important Condition);Heart rate increased (3d - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[BIOFLAVONOIDS, DIOSMIN, BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, FLAVONOIDS EXTRACTED FROM RUTACAE (AURANTIAE), MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - Unknown - [n/a - n/a - n/a])|[INDAPAMIDE, PERINDOPRIL, INDAPAMIDE, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010655849	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Circulatory collapse (n/a - Fatal - Results in Death);Resuscitation (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010655853	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010655885	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010655914	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal disorder (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site joint pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010655962	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening);Cough (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Lymphadenopathy (n/a - Recovering/Resolving - Life Threatening);Myalgia (n/a - Recovering/Resolving - Life Threatening);Oropharyngeal pain (n/a - Recovering/Resolving - Life Threatening);Pyrexia (n/a - Recovering/Resolving - Life Threatening);Rhinitis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010655993	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial discomfort (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010655993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656013	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Dyskinesia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010656027	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656068	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656071	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	DUOTRAV [TIMOLOL, TRAVOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[AMOXICILLIN] (C - n/a - n/a - [10d - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656106	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site abscess (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010656115	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - );Confusional state (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[L-SERINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656118	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nasopharyngitis (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - );Rhinitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DULACIA INOPIFLORA WOOD] (C - n/a - n/a - [n/a - n/a - n/a])|[FENUGREEK] (C - n/a - n/a - [n/a - n/a - n/a])|[PIPERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PYRIDOXINE HYDROCHLORIDE, VITAMIN B6] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656130	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[WARFARIN SODIUM] (C - Cardiac disorder - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656139	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010656167	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656168	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656172	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656192	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dilated cardiomyopathy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - 3mg - n/a])|[PARACETAMOL] (C - Back pain, Headache, Pain - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010656195	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Disorientation (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Mydriasis (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656209	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BIKTARVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - n/a - n/a - [n/a - 500mg - Oral])|ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - 10mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656228	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Myalgia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656230	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dental caries (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyskinesia (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Eating disorder (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Joint abscess (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (27d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sepsis (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656236	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656241	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carotid artery thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mental impairment (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Monoplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Unknown - );Paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Unknown - );Venous thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656244	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood pH increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Immunisation - n/a - [1d - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656253	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (3d - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Rash (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656257	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erectile dysfunction (n/a - Unknown - Other Medically Important Condition);Libido decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656359	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Life Threatening);Facial paresis (n/a - Not Recovered/Not Resolved - Life Threatening);Haematoma (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010656360	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656374	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Not Specified	Anomalous pulmonary venous connection (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Atrial septal defect (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Congenital great vessel anomaly (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Death neonatal (n/a - Fatal - Results in Death, Congenital Anomaly, Other Medically Important Condition);Foetal exposure during pregnancy (n/a - Recovered/Resolved - Congenital Anomaly, Other Medically Important Condition);Heterotaxia (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Multiple congenital abnormalities (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Ventricular hypoplasia (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Ventricular septal defect (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (S - Anxiety - Dose not changed - [n/a - 50mg - Transplacental])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (S - n/a - Not applicable - [n/a - 50mg - Oral])	[FOLIC ACID] (C - Product used for unknown indication - Unknown - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010656465	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Malaise (n/a - Unknown - );Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010656566	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656575	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010656637	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cyanosis (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656638	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure diastolic decreased (15min - Recovered/Resolved - );Bradycardia (15min - Recovered/Resolved - Other Medically Important Condition);Cold sweat (15min - Recovered/Resolved - );Depressed level of consciousness (15min - Recovered/Resolved - Other Medically Important Condition);Dizziness (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656640	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656643	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BRINZOLAMIDE [BRINZOLAMIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)] (C - Immunisation - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656653	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656667	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Left ventricular hypertrophy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010656671	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656675	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656682	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656684	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BRIVARACETAM [BRIVARACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])|ESLICARBAZEPINE ACETATE [ESLICARBAZEPINE ACETATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|ZONISAMIDE [ZONISAMIDE] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656693	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (20min - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010656701	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradyphrenia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Daydreaming (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656702	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ataxia (n/a - Recovered/Resolved - Other Medically Important Condition);Balance disorder (1d - Recovered/Resolved - Other Medically Important Condition);Enuresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BRINZOLAMIDE [BRINZOLAMIDE] (C - Glaucoma - n/a - [n/a - n/a - n/a])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[ALENDRONIC ACID] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[ERGOCALCIFEROL] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Prophylaxis - n/a - [1d - n/a - n/a])|[LANSOPRAZOLE] (C - Oesophagitis - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Respiratory symptom - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[TIMOLOL, TIMOLOL MALEATE] (C - Glaucoma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656705	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010656708	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656721	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Choking (n/a - Unknown - Caused/Prolonged Hospitalisation);Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656723	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010656775	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Life Threatening, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Unknown - Life Threatening, Other Medically Important Condition);Discomfort (6d - Recovered/Resolved - );Syncope (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010656780	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Fall (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010656866	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amaurosis (3h - Recovered/Resolved - Other Medically Important Condition);Symptom recurrence (3h - Recovered/Resolved - Other Medically Important Condition);Vision blurred (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010656898	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ABILIFY 15 MG TABLETS [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656966	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010656979	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010656979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010657015	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010657020	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657131	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Movement disorder (3d - Recovered/Resolved - );Night sweats (n/a - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Skin odour abnormal (9d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657133	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (14d - Recovered/Resolved - );Rash (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657138	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye inflammation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010657157	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (42d - Not Recovered/Not Resolved - );Chest pain (42d - Not Recovered/Not Resolved - );Muscle atrophy (42d - Not Recovered/Not Resolved - );Paraesthesia (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010657159	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Influenza (2d - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Rash (36d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010657161	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010657196	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Alopecia (58d - Not Recovered/Not Resolved - );Rash (58d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010657201	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (36d - Recovered/Resolved With Sequelae - );Hyperhidrosis (36d - Recovered/Resolved With Sequelae - );Weight bearing difficulty (36d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010657207	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657210	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Cyanosis (0d - Recovered/Resolved - );Feeling hot (0d - Recovering/Resolving - );Hallucination (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657282	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypotonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Incontinence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657373	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657396	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Tremor (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010657437	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657444	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657449	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657456	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657459	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657491	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657519	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657529	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657540	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657544	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657550	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657552	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657574	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657623	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (7d - Recovered/Resolved - );Hypoaesthesia (61d - Recovered/Resolved - );Lymphadenopathy (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010657647	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Recovered/Resolved - );Hallucination (2d - Recovered/Resolved - );Influenza like illness (2d - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Puncture site pain (n/a - Recovered/Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657678	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657680	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657682	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010657752	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Osteomyelitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657756	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (11h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657757	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pneumothorax (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657759	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - );Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657761	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Optic neuritis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657762	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657764	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657765	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657767	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - );Muscular weakness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657771	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010657773	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657774	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010657826	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657827	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657834	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657837	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657842	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (1mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010657849	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bruxism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle tightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Toothache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657853	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657854	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657863	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Metamorphopsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657865	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657871	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010657880	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Loss of consciousness (30s - Recovered/Resolved - Other Medically Important Condition);Pallor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MESTRANOL, NORETHISTERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010657954	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010657959	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lung disorder (n/a - Unknown - );Pneumonia (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010657965	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myasthenia gravis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010657979	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (2d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - );Respiration abnormal (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010657979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010658042	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658049	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658053	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658062	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NON SPECIFIED CREME [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658065	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood testosterone decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010658070	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658120	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658122	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658324	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658369	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658372	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658379	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (0d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658387	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658389	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (0d - Not Recovered/Not Resolved - );Hot flush (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658399	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658412	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (13d - Recovering/Resolving - );Palpitations (13d - Recovering/Resolving - );Tachycardia (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010658416	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010658424	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658429	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Influenza (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658447	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658449	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658468	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658469	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thalamic infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010658498	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658500	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658507	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658509	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658518	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658521	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658712	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658717	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658723	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658725	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3mo - Not Recovered/Not Resolved - );Asthenia (3mo - Not Recovered/Not Resolved - );Depression (3mo - Not Recovered/Not Resolved - );Dizziness (3mo - Not Recovered/Not Resolved - );Hypoaesthesia (3mo - Not Recovered/Not Resolved - );Paraesthesia (3mo - Not Recovered/Not Resolved - );Peripheral coldness (3mo - Not Recovered/Not Resolved - );Visual impairment (3mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658779	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658781	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658867	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658889	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010658894	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Varicella (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010658896	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010658896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659120	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Abdominal pain (n/a - Not Recovered/Not Resolved - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659242	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659245	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659246	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659256	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Recovered/Resolved - );Body temperature increased (n/a - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659294	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659322	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659329	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659334	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010659341	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659356	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myositis (n/a - Unknown - Caused/Prolonged Hospitalisation);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659357	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pancreatitis (27d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010659358	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659364	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Haematochezia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659366	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659368	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659369	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoglycaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMALOG [INSULIN LISPRO] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659382	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blepharospasm (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010659454	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Psoriasis (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659478	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic inflammatory demyelinating polyradiculoneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659480	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010659483	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Erythema (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhinorrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659495	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659514	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659517	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (2wk - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659526	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Wrong product administered (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])|[HALOPERIDOL] (C - n/a - n/a - [n/a - 100mg - Intramuscular])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659532	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659543	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659559	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac disorder (n/a - Unknown - );Gait inability (n/a - Unknown - );Palpitations (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659562	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659564	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Bradycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659567	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Death (n/a - Fatal - Results in Death);Discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypersomnia (n/a - Unknown - );Illness (n/a - Unknown - );Pneumonia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Respiration abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010659575	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Coordination abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659582	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659595	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659598	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthma (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659604	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Hypertension (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Inflammatory bowel disease - n/a - [n/a - n/a - n/a])|INFLIXIMAB [INFLIXIMAB] (C - Inflammatory bowel disease - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659606	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pneumonitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659608	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Injection related reaction (1d - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659615	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659621	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epilepsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659622	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659636	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659694	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010659787	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	APROVEL [IRBESARTAN] (C - n/a - n/a - )|COAPROVEL [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - )|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE HYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010659866	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659870	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010659882	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (0d - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010659884	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovered/Resolved With Sequelae - Life Threatening);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Life Threatening);Hypersensitivity (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010659933	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659938	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood urine present (n/a - Not Recovered/Not Resolved - );Laboratory test abnormal (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659947	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659950	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010659980	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (4d - Recovered/Resolved - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010659980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010660057	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovered/Resolved - Disabling);Chest pain (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Heart rate increased (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (3d - Recovered/Resolved - Disabling);Tinnitus (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010660099	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010660109	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (2d - Recovered/Resolved - );Blepharospasm (2d - Recovered/Resolved - );Blood lactic acid increased (4770min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (101h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (2d - Recovered/Resolved - );Oropharyngeal erythema (2d - Recovered/Resolved - );Palpitations (4770min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peripheral circulatory failure (4770min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (101h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660110	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Coordination abnormal (n/a - Unknown - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Joint swelling (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Restless legs syndrome (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PRALUENT [ALIROCUMAB] (C - Hypercholesterolaemia - n/a - [138d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010660120	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhage (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660136	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Vidula, M.. Myocarditis and Other Cardiovascular Complications of the mRNA-Based COVID-19 Vaccines. Cureus. 2021;13 (6):e15576. doi:10.7759/cureus.15576	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660144	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010660185	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Breast pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Flank pain (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660188	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient global amnesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010660192	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cervicobrachial syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010660194	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (n/a - Recovered/Resolved - );Dysarthria (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010660195	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Diarrhoea (22d - Recovered/Resolved - );Enteritis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010660196	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Fall (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010660197	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660206	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Periorbital irritation (n/a - Unknown - );Skin reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010660289	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660292	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660322	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Therapeutic response unexpected (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660349	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660350	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660353	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660354	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660357	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660359	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660414	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypokinesia (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660418	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660420	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Alanine aminotransferase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Aspartate aminotransferase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660428	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660472	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bell's palsy (31d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010660506	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ALFACALCIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[MANIDIPINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010660534	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[ALLOPURINOL] (C - n/a - n/a - )|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE HYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 150ug - Oral])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660590	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660611	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Osteoarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sciatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660612	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dry eye (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Head discomfort (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010660614	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660617	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chest pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dizziness (n/a - Unknown - );Hepatitis (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Palpitations (n/a - Unknown - );Sinus tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660625	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESTRADIOL, ESTRADIOL HEMIHYDRATE, ESTRADIOL, NORETHISTERONE, NORETHISTERONE ACETATE, NORETHISTERONE ACETATE, ESTRADIOL, NORETHISTERONE ACETATE, ESTRADIOL HEMIHYDRATE] (C - Menopause - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660629	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Facial paresis (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660632	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Abu-rumaileh, M.. COVID-19 vaccine and hyperosmolar hyperglycaemic state. Cureus. 2021;13 (3):e14125. doi:10.7759/cureus.14125	18-64 Years	Not Specified	No	Male	Hyperglycaemic hyperosmolar nonketotic syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660648	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Conjunctivitis (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Eye discharge (n/a - Recovering/Resolving - );Eye oedema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	[PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - Hypertension - Dose not changed - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660672	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660733	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood lactic acid increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pyruvic acid increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Papilloedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual field defect (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Antidepressant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660801	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Fall (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010660913	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010660990	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660991	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010660992	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010660992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661016	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010661024	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661213	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Drug ineffective (15d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	[B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - n/a - Not applicable - [0d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010661251	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661258	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661260	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blindness transient (12750min - Recovered/Resolved - Other Medically Important Condition);Dizziness (12750min - Recovered/Resolved - );Hyperhidrosis (12750min - Recovered/Resolved - );Pallor (12750min - Recovered/Resolved - );Tinnitus (12750min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661261	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (n/a - Unknown - Other Medically Important Condition);Lung opacity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661442	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dehydration (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661443	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661444	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661445	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (25h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (25h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (25h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swelling face (25h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661452	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661453	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661527	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glaucoma (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Retinal vascular occlusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661530	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (7d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (7d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661533	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661535	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661537	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661584	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661589	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin I increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661690	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010661702	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1mo - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661713	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	CSF test abnormal (n/a - Not Recovered/Not Resolved - );Dysaesthesia (n/a - Not Recovered/Not Resolved - );Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010661720	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amyotrophic lateral sclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Amyotrophic lateral sclerosis gene carrier (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Familial amyotrophic lateral sclerosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661728	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphasia (n/a - Recovering/Resolving - );Dysarthria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010661755	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute motor axonal neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);CSF cell count abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Radiculopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661779	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Right ventricular failure (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010661784	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010661825	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cerebral haemorrhage (36d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661860	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661870	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661875	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661876	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Unknown - );Gamma-glutamyltransferase increased (n/a - Unknown - );Hepatic function abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Liver function test abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661945	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010661962	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010661972	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010661976	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010661982	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010661983	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rectal haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010661985	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haemorrhagic stroke (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (S - Myocardial ischaemia - Drug withdrawn - [n/a - 1{DF} - Oral])	ADENURIC [FEBUXOSTAT] (C - n/a - n/a - )|[BISOPROLOL FUMARATE] (C - n/a - n/a - )|[METFORMIN EMBONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010661990	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pulmonary oedema (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010661992	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010661996	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010661996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662004	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662011	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662013	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662016	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662019	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662021	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010662033	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral ischaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662035	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac tamponade (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662039	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662041	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662050	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662051	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662064	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662067	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Sinus bradycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662106	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010662110	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Recovered/Resolved - );Musculoskeletal stiffness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662111	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysgeusia (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662112	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662113	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662114	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662115	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site erythema (2d - Recovered/Resolved - );Vaccination site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662118	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662119	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662127	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Affective disorder (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Vaccination site joint movement impairment (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662138	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662142	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662148	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662149	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662151	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urinary tract infection (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662156	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662167	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Non-cardiac chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662170	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662171	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662182	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Tinnitus - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662193	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3wk - Recovered/Resolved - );Influenza like illness (15d - Recovered/Resolved - );Pain in extremity (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662196	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662201	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662206	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662211	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear infection (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662219	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seborrhoeic dermatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662222	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Pain in jaw (n/a - Not Recovered/Not Resolved - );Pulpitis dental (n/a - Not Recovered/Not Resolved - );Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662226	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662231	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662262	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662266	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662270	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662280	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662288	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Fall (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662315	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662319	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662321	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - Hypertension - Dose not changed - [n/a - n/a - n/a])|EUCREAS 50 MG/1000 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662327	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662342	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diffuse large B-cell lymphoma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662364	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662375	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662379	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662411	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662414	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [31d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010662432	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662438	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Adolescent	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662448	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662455	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Choking (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662458	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (3wk - Recovered/Resolved - );Dyspnoea (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662461	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662465	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662512	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662526	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMETICONE, PHLOROGLUCINOL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662529	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662530	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Recovered/Resolved - );Dysuria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662549	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (n/a - Recovered/Resolved - );Visual field defect (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662550	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662551	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662552	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662567	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662575	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662586	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662591	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral arterial occlusive disease (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662593	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010662634	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thyroiditis subacute (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - )|[GLICLAZIDE] (C - n/a - n/a - )|[METFORMIN EMBONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662744	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662754	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatocellular carcinoma (73d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010662836	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010662884	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Monoparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	VELMETIA [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010662896	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662904	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Brain oedema (n/a - Unknown - Caused/Prolonged Hospitalisation);Subarachnoid haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010662907	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662923	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010662990	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (4d - Recovering/Resolving - );Fatigue (4d - Recovering/Resolving - );Malaise (4d - Recovering/Resolving - );Myalgia (4d - Recovering/Resolving - );Nausea (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010662990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663052	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysstasia (45min - Unknown - );Hypoaesthesia (45min - Recovered/Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Malaise (45min - Not Recovered/Not Resolved - );Skin tightness (45min - Recovered/Resolved - );Trismus (45min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010663182	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Cardiac discomfort (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010663186	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663195	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663203	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Sensitive skin (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663208	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blister (n/a - Not Recovered/Not Resolved - Disabling);Chills (18h - Recovered/Resolved - Disabling);Influenza like illness (n/a - Unknown - );Lethargy (n/a - Unknown - );Mental fatigue (18h - Recovered/Resolved - Disabling);Pain (18h - Recovered/Resolved - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (18h - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010663209	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663239	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663240	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (7d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain (7d - Recovered/Resolved - );Pain in extremity (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663243	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Hemiparaesthesia (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pollakiuria (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010663266	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010663267	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Malaise (4d - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663295	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Movement disorder (n/a - Unknown - );Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663301	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Impaired work ability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Not Recovered/Not Resolved - Life Threatening);Loss of personal independence in daily activities (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sinus bradycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010663329	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blister (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal disorder (n/a - Unknown - );Pruritus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663419	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Disabling);Musculoskeletal pain (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010663421	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood creatine phosphokinase increased (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);General physical health deterioration (n/a - Recovered/Resolved - Other Medically Important Condition);Hospitalisation (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1wk - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (1wk - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663428	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Colitis microscopic (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Normochromic anaemia (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663469	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspepsia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663529	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663533	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010663539	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663540	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010663569	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663576	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure diastolic decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663578	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Colitis ischaemic (n/a - Unknown - Other Medically Important Condition);Fat necrosis (n/a - Unknown - Other Medically Important Condition);Mesenteric vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010663583	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663592	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010663599	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663628	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition);Overdose (n/a - Unknown - Other Medically Important Condition);Pruritus (3h - Recovered/Resolved - Other Medically Important Condition);Swelling of eyelid (510min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663638	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663687	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Drug ineffective (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663697	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663725	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010663733	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Hyperhidrosis (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Shock (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010663734	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663740	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663758	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Application site reaction (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling of body temperature change (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663762	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663776	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663806	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663883	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Application site swelling (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663887	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663907	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Oedema (n/a - Recovered/Resolved - );Personality disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010663922	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Dose not changed - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010663946	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010663962	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (3mo - Recovering/Resolving - Disabling, Other Medically Important Condition);Vision blurred (3mo - Recovering/Resolving - Disabling, Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010663962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010664004	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (40min - Recovered/Resolved - Other Medically Important Condition);Erythema (40min - Recovered/Resolved - Other Medically Important Condition);Pruritus (40min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664132	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664147	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664149	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664152	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664169	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664176	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (14d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010664213	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Discomfort (n/a - Recovering/Resolving - );Eye pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Restlessness (n/a - Recovering/Resolving - );Sinusitis (n/a - Recovering/Resolving - );Throat irritation (n/a - Recovering/Resolving - );Toothache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664216	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature fluctuation (14d - Recovered/Resolved - );Dry mouth (11d - Recovered/Resolved - );Dyspnoea (11d - Recovered/Resolved - );Feeling abnormal (11d - Recovered/Resolved - );Hepatitis chronic active (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertensive heart disease (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (11d - Recovered/Resolved - );Thirst (11d - Recovered/Resolved - );Throat tightness (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664305	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010664309	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664310	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Lymphadenitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664311	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthma (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664313	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Altered state of consciousness (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664332	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood immunoglobulin E increased (n/a - Recovering/Resolving - Other Medically Important Condition);Eczema (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Unknown - );Scrub typhus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010664399	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovered/Resolved - );Gastritis (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010664460	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (7d - Recovered/Resolved - );Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664542	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664568	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood triglycerides increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood uric acid increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664589	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Food aversion (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664662	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation delayed (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664810	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664819	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute respiratory failure (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664829	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664830	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site mass (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664838	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664842	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664843	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664845	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664856	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664858	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664865	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664870	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664872	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664873	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664874	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Muscle contracture (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664878	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664892	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - );Vaccination failure (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664898	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664912	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovering/Resolving - );Vaccination site lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664918	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664924	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664926	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664935	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disorientation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary incontinence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown - More in ICSR])|FLUAD TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	NOT AVAILABLE (C - n/a - Unknown - )|TOVANOR BREEZHALER 44 MICROGRAMS INHALATION POWDER HARD CAPSULES [GLYCOPYRRONIUM BROMIDE] (C - n/a - Unknown - )|[BISOPROLOL FUMARATE] (C - n/a - Unknown - )|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - Unknown - )|[FUROSEMIDE] (C - n/a - Unknown - )|[LEVETIRACETAM] (C - n/a - Unknown - )|[PARACETAMOL] (C - n/a - Unknown - )|[RAMIPRIL, ACETYLSALICYLIC ACID, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - Unknown - )|[SPIRONOLACTONE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010664949	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664959	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664962	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664965	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010664972	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664976	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010664994	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010664994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665004	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665008	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665014	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665019	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010665024	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010665076	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Lung infiltration (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010665086	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Unknown - Other Medically Important Condition);Blood pressure increased (1d - Recovered/Resolved - Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010665133	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010665148	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dermatitis psoriasiform (n/a - Unknown - );Psoriasis (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665158	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010665159	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cutaneous vasculitis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665169	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665185	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - );Loss of libido (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665188	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010665209	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010665245	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Recovered/Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010665268	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010665282	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010665301	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665309	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010665311	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Unknown - );Application site swelling (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665313	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665342	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal discomfort (n/a - Unknown - Other Medically Important Condition);Trigeminal neuralgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010665347	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665355	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina unstable (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010665356	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010665360	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (3h - Recovered/Resolved - );Tachycardia (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010665363	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - );Skin irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[METHADONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665375	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665388	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010665391	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665394	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665397	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Visual impairment (13d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010665424	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010665435	Spontaneous	2021-11-16 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Pericarditis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010665441	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010665469	Spontaneous	2021-11-16 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010665469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641271	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Testicular pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010641278	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Life Threatening);Chest discomfort (n/a - Unknown - Life Threatening);Chest pain (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010641280	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010641283	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010641287	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010641325	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (52d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010641330	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641657	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Alopecia (n/a - Not Recovered/Not Resolved - Disabling);Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Hypothyroidism (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010641670	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (24d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (24d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010641687	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Epistaxis (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ADAPALENE, BENZOYL PEROXIDE] (C - Acne - n/a - [n/a - n/a - Topical])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641715	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Pain (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [15d - 75mg - Oral])|[FINASTERIDE] (C - Alopecia - n/a - [15d - 1mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641750	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010641763	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010641765	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641771	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Glossoptosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010641774	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Meniscus injury (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010641780	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641781	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010641784	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Erythema (1d - Recovered/Resolved - );Flushing (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Migraine (1d - Recovered/Resolved - );Pharyngeal swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[KETOPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641789	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Acne (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Acne cystic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641797	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Tenderness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641807	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (4d - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010641809	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010641810	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010641819	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Angioedema (n/a - Recovered/Resolved - Other Medically Important Condition);Enlarged uvula (n/a - Recovered/Resolved - );Eye swelling (n/a - Recovered/Resolved - );Lip swelling (n/a - Recovered/Resolved - );Pharyngeal swelling (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Speech disorder (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010641822	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641831	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Tendon pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641838	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Muranaka, M.. A Case of Elderly Dementia Where Multiorgan Disorders Were Noted Following COVID-19 Vaccination. The 32nd Tohoku Regional Meeting of the Japan Geriatrics Society. 2021;32nd	65-85 Years	Not Specified	No	Male	Abnormal behaviour (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Alanine aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Aspartate aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood urea increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hepatic function abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Multi-organ disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010641864	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Kidney transplant rejection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010641869	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641870	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641882	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Menstruation irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641888	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous floaters (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYL L-CARNITINE, ACETYLCARNITINE HYDROCHLORIDE, CARNITINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010642173	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642178	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642182	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure fluctuation (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Confusional state (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Nausea (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	[CAPTOPRIL] (C - n/a - n/a - )|[NEBIVOLOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010642358	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642361	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Compartment syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphangiopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sepsis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010642595	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010642599	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - );Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010642606	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood glucose increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	[GLICLAZIDE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010642611	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010642628	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain fog (n/a - Recovered/Resolved With Sequelae - Disabling);Ear discomfort (n/a - Recovered/Resolved With Sequelae - Disabling);Headache (n/a - Recovered/Resolved With Sequelae - Disabling);Hypoacusis (n/a - Recovered/Resolved With Sequelae - Disabling);Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010642740	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010642745	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Unknown - Life Threatening, Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010642782	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (37d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010642797	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642800	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642803	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642809	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642812	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642816	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642817	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642849	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Disturbance in attention (n/a - Recovered/Resolved With Sequelae - Disabling);Sleep disorder (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010642923	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010642989	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642990	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010642998	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010642998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643000	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643002	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643029	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643130	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Constipation (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition);Oedema peripheral (n/a - Unknown - );Spinal claudication (n/a - Unknown - );Weight increased (n/a - Unknown - )	TAFAMIDIS [TAFAMIDIS] (S - n/a - Unknown - [n/a - 61mg - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643135	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Axillary pain (2d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643140	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643144	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643156	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643161	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010643166	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Syncope (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010643168	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Flushing (n/a - Recovered/Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Wheezing (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643176	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epithelioid sarcoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neoplasm (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition);Vitamin D deficiency (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643197	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643213	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Influenza (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643215	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010643267	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Small fibre neuropathy (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - 75mg - Oral])|[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - Oral])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Hyperlipidaemia - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643276	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010643281	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Sensitive skin (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010643282	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiopulmonary failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010643285	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mental fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643305	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Carditis (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Ventricular extrasystoles (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Ventricular extrasystoles - n/a - [n/a - 2.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643309	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Poor quality sleep (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643324	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643325	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643326	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643329	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010643334	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643337	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643338	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010643347	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oxygen saturation decreased (30min - Recovered/Resolved - Other Medically Important Condition);Throat irritation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BILASTINE] (C - Rhinitis allergic - n/a - [n/a - n/a - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OLOPATADINE HYDROCHLORIDE] (C - Conjunctivitis allergic - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643359	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643375	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic shock (525min - Recovered/Resolved - Other Medically Important Condition);Lip oedema (525min - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (525min - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643384	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperpyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Liver injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010643395	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Premature baby (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643397	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643463	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - Seasonal allergy - Unknown - [n/a - n/a - n/a])|[SODIUM CROMOGLICATE] (C - Seasonal allergy - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643482	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010643499	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abscess (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010643503	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Herpes zoster (1wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643627	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643632	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643633	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643638	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (3d - Recovered/Resolved - );Gait disturbance (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643689	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643719	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643721	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643735	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (3d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643744	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643766	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643769	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643770	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643773	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643782	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG [APIXABAN] (C - Deep vein thrombosis - n/a - [n/a - 2{DF} - n/a])|[BROMAZEPAM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[HYDROCHLOROTHIAZIDE, TRIAMTERENE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - .5{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010643783	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - );Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010643784	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010643792	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643793	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643795	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643836	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );Dry mouth (n/a - Not Recovered/Not Resolved - );Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643841	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DESLORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[LEVOCABASTINE HYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643926	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643932	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac fibrillation (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Dysgeusia (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COLECALCIFEROL, CYANOCOBALAMIN, ERGOCALCIFEROL, RETINOL ACETATE, ERGOCALCIFEROL, TOCOPHERYL ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643935	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643938	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tenderness (2d - Recovered/Resolved - );Vaccination site movement impairment (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643939	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010643941	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010643945	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	BETA GLUCAN [NOT AVAILABLE] (C - n/a - n/a - )|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[METFORMIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[MINERALS NOS] (C - n/a - n/a - )|[NALOXONE, OXYCODONE, OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE] (C - Pain - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010643945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644008	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Skin haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010644036	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	FIASP 100 UNITS/ML [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644103	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644141	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010644143	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Apnoea (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Head discomfort (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Irregular breathing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010644147	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644226	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (20d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (20d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010644322	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COAPROVEL [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - )|[FORMOTEROL, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )|[THEOPHYLLINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010644357	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (2wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010644361	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune hepatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hepatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010644366	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Abdominal hernia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010644367	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010644393	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010644396	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Malaise (14d - Not Recovered/Not Resolved - );Vitreous haemorrhage (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010644402	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644415	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (51d - Not Recovered/Not Resolved - );Polyarthritis (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010644430	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (0d - Not Recovered/Not Resolved - );Somnolence (0d - Not Recovered/Not Resolved - );Vaccination site reaction (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644433	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (2d - Recovering/Resolving - );Spinal pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644439	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Unknown - );Hyperhidrosis (0d - Unknown - );Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644440	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644452	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Faeces soft (n/a - Unknown - );Fatigue (2d - Unknown - );Feeling hot (1d - Unknown - );Headache (0d - Recovered/Resolved - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644477	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644496	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	PROLIA [DENOSUMAB] (C - n/a - n/a - )|[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - )|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010644510	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haematemesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|[INFLUENZA VIRUS] (S - Prophylaxis - Not applicable - [1d - n/a - Unknown])	[ACETYLSALICYLIC ACID] (C - Product used for unknown indication - Dose not changed - [n/a - 75mg - Unknown])|[AMITRIPTYLINE HYDROCHLORIDE] (C - Product used for unknown indication - Dose not changed - [n/a - 30mg - Unknown])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])|[BACLOFEN] (C - Product used for unknown indication - Dose not changed - [n/a - 40mg - Unknown])|[BISOPROLOL FUMARATE] (C - Product used for unknown indication - Dose not changed - [n/a - 7.5mg - Unknown])|[COLECALCIFEROL] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])|[ERYTHROPOIETIN] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Unknown])|[GABAPENTIN] (C - Product used for unknown indication - Dose not changed - [n/a - 600mg - Unknown])|[OMEPRAZOLE] (C - Product used for unknown indication - Dose not changed - [n/a - 20mg - Unknown])|[SENNA ALEXANDRIAN] (C - Product used for unknown indication - Dose not changed - [n/a - 7.5mg - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010644515	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010644548	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010644615	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ROSUVASTATIN CALCIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010644617	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Flatulence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644618	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644673	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Flatulence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644690	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (6d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (6d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Not applicable - [n/a - 40mg - Oral])|PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - n/a - Not applicable - [n/a - 75mg - Oral])|[ALLOPURINOL] (C - n/a - Not applicable - )|[FERRIC HYDROXIDE POLYMALTOSE COMPLEX, IRON] (C - n/a - Not applicable - )|[RAMIPRIL] (C - n/a - Not applicable - )|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Not applicable - )|[SPIRONOLACTONE] (C - n/a - Not applicable - [n/a - 12.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010644765	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010644782	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - Other Medically Important Condition);Haematoma (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010644819	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010644849	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis exfoliative generalised (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010644871	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vertebrobasilar stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010644913	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CALCIUM, CALCIUM CARBONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010644930	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010644930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010645041	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645042	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645045	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645052	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster reactivation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	XOTERNA BREEZHALER [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (C - n/a - n/a - )|[ENALAPRIL MALEATE, NITRENDIPINE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010645110	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645111	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645112	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010645122	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (2h - Recovered/Resolved - );Hypertension (4h - Recovered/Resolved - );Influenza like illness (12h - Recovered/Resolved - );Peripheral coldness (2h - Recovered/Resolved - );Tremor (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010645220	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645230	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Injection site swelling (n/a - Unknown - );Myalgia (n/a - Unknown - );Vaccination site joint movement impairment (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645286	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010645310	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645363	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - );Herpes zoster (n/a - Unknown - );Hyperaesthesia (n/a - Unknown - );Incorrect route of product administration (n/a - Unknown - );Pain (n/a - Unknown - );Post herpetic neuralgia (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Intramuscular])|SHINGRIX [RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, STIMULON, MONOPHOSPHORYL LIPID A] (S - Prophylaxis - Not applicable - [n/a - n/a - Subcutaneous])	APIXABAN [APIXABAN] (C - Product used for unknown indication - Unknown - [n/a - 5mg - n/a])|COMIRNATY [TOZINAMERAN] (C - Product used for unknown indication - Unknown - [n/a - n/a - Intramuscular])|[AMIODARONE HYDROCHLORIDE] (C - Product used for unknown indication - Unknown - [n/a - 200mg - n/a])|[AMLODIPINE BESILATE] (C - Product used for unknown indication - Unknown - [n/a - 6935mg - n/a])|[EPLERENONE] (C - Product used for unknown indication - Unknown - [n/a - 25mg - n/a])|[GABAPENTIN] (C - Product used for unknown indication - Unknown - [n/a - 900mg - n/a])|[HYDROCHLOROTHIAZIDE] (C - Product used for unknown indication - Unknown - [n/a - 25mg - n/a])|[LIDOCAINE, LIDOCAINE HYDROCHLORIDE] (C - Product used for unknown indication - Unknown - [n/a - 700mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - Product used for unknown indication - Unknown - [n/a - 500mg - n/a])|[MIRTAZAPINE] (C - Product used for unknown indication - Unknown - [n/a - 30mg - n/a])|[PRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Product used for unknown indication - Unknown - [n/a - .5mg - n/a])|[TORASEMIDE] (C - Product used for unknown indication - Unknown - [n/a - 10mg - n/a])|[VALSARTAN] (C - Product used for unknown indication - Unknown - [n/a - 160mg - n/a])|[ZOPICLONE] (C - Product used for unknown indication - Unknown - [n/a - 7.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010645388	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dysphagia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Swelling face (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010645435	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645480	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010645488	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010645494	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Rhinorrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - 20mg - n/a])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - 25mg - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645523	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (18d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	EDOXABAN [EDOXABAN] (C - n/a - Not applicable - [n/a - 30mg - Oral])|[ATORVASTATIN] (C - n/a - Not applicable - [n/a - 20mg - Oral])|[METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 50mg - Oral])|[PANTOPRAZOLE] (C - n/a - Not applicable - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010645551	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010645583	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645633	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645642	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645655	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site movement impairment (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010645679	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - Oral])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 16mg - Oral])|[DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - Oral])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[SERTRALINE] (C - n/a - n/a - [n/a - 100mg - Oral])|[SERTRALINE] (C - n/a - n/a - [n/a - 50mg - Oral])|[SERTRALINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010645693	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (13d - Recovered/Resolved - );Vaccination failure (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645719	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010645725	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010645774	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Cardiac failure chronic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010645780	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645802	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645818	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Induration (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645829	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Carditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010645833	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (11d - Recovering/Resolving - );Seborrhoeic dermatitis (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645839	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010645849	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010645851	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (4d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010645856	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010645887	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010645898	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010645987	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 50mg - Oral])|[RAMIPRIL] (C - n/a - Not applicable - [n/a - 2.5mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Not applicable - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010645987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646045	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646062	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010646098	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovering/Resolving - );Vaccination failure (12d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646151	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646155	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646165	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646166	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646167	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646192	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (4d - Recovering/Resolving - );Vaccination failure (4d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646213	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646225	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646233	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac hypertrophy (n/a - Unknown - );Fatigue (n/a - Unknown - );General physical health deterioration (n/a - Unknown - );Headache (n/a - Unknown - );Hyperaesthesia (n/a - Unknown - );Oversensing (n/a - Unknown - );Pain (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646259	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ENBREL 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [ETANERCEPT] (C - Ankylosing spondylitis - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646294	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in jaw (2d - Recovered/Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - Intramuscular])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646383	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646386	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646389	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646392	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646393	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646401	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646403	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646406	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646440	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Blood pressure decreased (2mo - Recovered/Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness postural (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (1mo - Recovered/Resolved - );Heart rate increased (2mo - Recovered/Resolved - );Hiccups (1mo - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Physical disability (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010646528	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646533	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646536	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Premature baby (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646540	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (1d - Recovering/Resolving - Other Medically Important Condition);Hearing disability (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646576	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac dysfunction (535h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (535h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (535h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (535h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646580	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646617	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646618	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - Other Medically Important Condition);Rash (3d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646625	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Life Threatening);Blood pressure decreased (n/a - Unknown - Life Threatening);Hyperhidrosis (n/a - Unknown - Life Threatening);Nausea (n/a - Unknown - Life Threatening);Shock (n/a - Unknown - Life Threatening);Vomiting (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010646631	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (0d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646633	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646641	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac dysfunction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646650	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646651	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (n/a - Unknown - );Cardiac disorder (n/a - Unknown - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Muscle tone disorder (n/a - Unknown - );Renal impairment (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646661	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646697	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Other Medically Important Condition);Labyrinthitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646736	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site induration (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646739	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (n/a - Recovering/Resolving - );Respiratory arrest (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010646771	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646780	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646785	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646787	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Monoplegia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1) V REASS. X - 179 A, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/NANCHANG 933/95 (H3N2), A/BAYERN/7/95 (H1N1) - LIKE STRAIN (A/JOHANNESBURG/82/96), B/BEIJING/184/93-LIKE STRAIN (B/HARBIN/7/94), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/CALIFORNIA/7/2004 (H3N2) - LIKE STRAIN (A/NEW YORK/55/2004 REASS. NYMC X-157), B/SHANGHAI/361/2002 - LIKE STRAIN (B/JIANGSU/10/2003), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/BRISBANE/60/2008, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/MASSACHUSETTS/2/2012 -DERIVED STRAIN USED (NYMC BX-51B), A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H1N1), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN A (H3N2), INFLUENZA VIRUS INACTIVATED SURFACE ANTIGEN STRAIN B] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010646793	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema multiforme (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[ACETIC ACID, GLACIAL, DEXAMETHASONE SODIUM PHOSPHATE PH. EUR., NEOMYCIN SULPHATE PH. EUR., NEOMYCIN SULFATE, DEXAMETHASONE, ACETIC ACID, GLACIAL, NEOMYCIN SULFATE, DEXAMETHASONE, GLACIAL ACETIC ACID BP] (C - n/a - n/a - [n/a - 3{DF} - Auricular (otic)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646803	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - );Decreased immune responsiveness (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Glossodynia (1wk - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - );Oropharyngeal pain (1wk - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rheumatic disorder (n/a - Unknown - Other Medically Important Condition);Tonsillar hypertrophy (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646807	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646832	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (1wk - Recovered/Resolved - );Pain in extremity (2wk - Recovered/Resolved - );Pyrexia (2wk - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rheumatic disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646833	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646840	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646841	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Oral herpes (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Poor quality sleep (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010646843	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Life Threatening);Abdominal pain upper (n/a - Unknown - Life Threatening);Chest discomfort (n/a - Unknown - Life Threatening);Chest pain (n/a - Unknown - Life Threatening);Toothache (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010646848	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646858	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646864	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646866	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Sudden hearing loss (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646875	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Head banging (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotonia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal stiffness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Postictal state (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (37d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tongue biting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646879	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010646884	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[DESVENLAFAXINE, DESVENLAFAXINE SUCCINATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646918	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dermatitis allergic (30min - Recovered/Resolved - Other Medically Important Condition);Erythema (30min - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - );Hypertension (n/a - Unknown - );Panic attack (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[DESLORATADINE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646948	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646950	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010646952	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010646957	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010646958	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaesthesia oral (n/a - Not Recovered/Not Resolved - );Angina pectoris (n/a - Not Recovered/Not Resolved - );Blood pressure abnormal (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dysaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Panic attack (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010646962	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye inflammation (n/a - Recovered/Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - )|[ALLOPURINOL] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[CICLOSPORIN] (C - n/a - n/a - )|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - )|[PERINDOPRIL ARGININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010646990	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010646990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647143	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flank pain (12d - Not Recovered/Not Resolved - );Myalgia (12d - Not Recovered/Not Resolved - );Pain in extremity (12d - Not Recovered/Not Resolved - );Spider vein (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647149	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovered/Resolved - );Nasopharyngitis (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647151	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site joint pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647153	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010647154	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010647157	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647191	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647193	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nodule (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647201	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Radiculopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010647272	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Impaired driving ability (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647300	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Haemoptysis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010647342	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemoglobin increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010647346	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647351	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647353	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Chest pain (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Nasopharyngitis (3d - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647357	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647375	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (13d - Recovered/Resolved - );Vaccination failure (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647398	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647505	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010647565	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647574	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647575	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647579	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rhinorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647584	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010647585	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010647611	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coordination abnormal (n/a - Not Recovered/Not Resolved - Disabling);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Gait inability (n/a - Not Recovered/Not Resolved - Disabling);Movement disorder (n/a - Not Recovered/Not Resolved - Disabling);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010647620	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647624	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010647632	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647648	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (16d - Recovered/Resolved - );Vaccination failure (16d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647759	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (6d - Recovered/Resolved - );Vaccination failure (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647760	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (7wk - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647780	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Hypopnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Pulse abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tongue biting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010647792	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paralysis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010647857	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral nerve paresis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010647863	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647877	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Foreign body (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pulmonary congestion (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TETANUS VACCINES] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647951	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647952	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010647963	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Wound (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010647986	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Photosensitivity reaction (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUENZ TETRA [A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE STRAIN (A/HAWAII/66/2019, MEDI 326775), A/HONG KONG/2671/2019 (H3N2) - LIKE STRAIN (A/HONG KONG/2671/2019, MEDI 325078), B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, MEDI 306444), B/WASHINGTON/02/2019 - LIKE STRAIN (B/WASHINGTON/02/2019, MEDI 323797), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, MEDI 237514), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, MEDI 228029), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/BOLIVIA/559/2013, MEDI 255962), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/NEW CALEDONIA/71/2014, MEDI 263122), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/MICHIGAN/45/2015 (H1N1)PDM09 - LIKE STRAIN (A/SLOVENIA/2903/2015, MEDI 279432), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, MEDI 291690), B/COLORADO/06/2017-LIKE STRAIN (B/COLORADO/06/2017, MEDI 293454)] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010647991	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - Caused/Prolonged Hospitalisation);Motor neurone disease (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle atrophy (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle contractions involuntary (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Walking disability (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010647991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648007	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral mucosal blistering (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648041	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648070	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648104	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648114	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (9d - Recovered/Resolved - );Vaccination failure (9d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648164	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648167	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010648242	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chorea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648243	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Genital erythema (n/a - Not Recovered/Not Resolved - );Immunisation reaction (27d - Recovered/Resolved - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010648245	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (62d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648258	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648259	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648266	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648267	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648269	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648270	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agranulocytosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|OCREVUS [OCRELIZUMAB] (S - Multiple sclerosis - Not applicable - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648275	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Presyncope (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648285	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648286	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648292	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Haematuria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648302	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648309	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648311	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (5d - Recovered/Resolved - );Application site swelling (3d - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648337	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (17d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648339	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (42d - Recovered/Resolved - );Vertigo (6wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010648341	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Schwannoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - n/a - n/a - )|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010648346	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648373	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010648375	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lip oedema (1h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648381	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[METHADONE HYDROCHLORIDE] (C - Withdrawal syndrome - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010648382	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear infection (7d - Recovered/Resolved - );Influenza like illness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648384	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648385	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling);Somnolence (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010648389	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648397	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648405	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (13d - Recovered/Resolved - );Erythema (13d - Recovered/Resolved - );Gastrointestinal disorder (13d - Recovered/Resolved - );Middle insomnia (13d - Recovered/Resolved - );Neck pain (13d - Recovered/Resolved - );Swelling face (13d - Recovered/Resolved - );Tongue coated (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648409	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site haemorrhage (n/a - Recovered/Resolved - );Petechiae (82d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648412	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648415	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Purpura (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648417	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648418	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dermatitis allergic (n/a - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648425	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648428	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Haemorrhagic stroke (1d - Fatal - Results in Death);Thrombocytopenia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[AMOXICILLIN, AMOXICILLIN SODIUM, AMOXICILLIN TRIHYDRATE] (S - Bronchitis - Drug withdrawn - [7d - 1g - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010648430	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648436	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1.5mo - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648443	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dehydration (n/a - Recovering/Resolving - Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648447	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648449	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648459	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648474	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648483	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Acute myocardial infarction (82d - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010648486	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648509	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2wk - Recovered/Resolved - );Migraine (2wk - Recovered/Resolved - Other Medically Important Condition);Visual impairment (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648512	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immune thrombocytopenia (155d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010648513	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648527	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648555	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648556	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648566	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [48d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648568	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - );Scab (n/a - Recovering/Resolving - );Skin burning sensation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648590	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010648593	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	CYMBALTA 60 MG HARD GASTRO-RESISTANT CAPSULES [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - Product used for unknown indication - Not applicable - [n/a - n/a - Oral])|[KETOPROFEN] (C - Product used for unknown indication - Not applicable - [n/a - n/a - Oral])|[PARACETAMOL, OPIUM, PREPARED] (C - Product used for unknown indication - Not applicable - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648607	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (24h - Recovered/Resolved - );Limb discomfort (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648611	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [61d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648614	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648620	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648622	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648624	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648645	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648661	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Poor quality sleep (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648663	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648674	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648675	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ocular discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648685	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2h - Recovered/Resolved - );Dyspnoea (2h - Recovered/Resolved - );Muscular weakness (2h - Recovered/Resolved - );Rhinorrhoea (2h - Recovered/Resolved - );Urticaria (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648686	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648702	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648704	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648710	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pruritus genital (n/a - Not Recovered/Not Resolved - );Skin odour abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	EXFORGE [VALSARTAN, AMLODIPINE, VALSARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|VELMETIA 50 MG/1000 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[BILASTINE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648714	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648715	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Sudden death (1d - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Type 2 diabetes mellitus - n/a - )|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - 20mg - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - 300mg - n/a])|[CHONDROITIN SULFATE SODIUM] (C - Arthralgia - n/a - )|[D,L-LYSINE ACETYLSALICYLATE] (C - Ischaemic heart disease prophylaxis - n/a - )|[GLICLAZIDE] (C - Type 2 diabetes mellitus - n/a - )|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - )|[ROSUVASTATIN] (C - Ischaemic heart disease prophylaxis - n/a - )|[SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - 25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010648734	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648741	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010648743	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Affective disorder (n/a - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648752	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648754	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648755	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648757	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010648760	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648775	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Hyperthermia (3h - Recovered/Resolved - Other Medically Important Condition);Immunisation reaction (3wk - Recovered/Resolved - Other Medically Important Condition);Malaise (3wk - Recovered/Resolved - Other Medically Important Condition);Motor dysfunction (3wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648776	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pollakiuria (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648785	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648786	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648795	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010648799	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648804	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010648810	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648824	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648835	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (4d - Recovered/Resolved - );Injection site hypoaesthesia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648853	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010648854	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010648855	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urinary tract infection (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648862	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648864	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Oesophageal pain (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648871	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648881	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Extrasystoles (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648888	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010648902	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Sudden death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - Dose not changed - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Thyroidectomy - Dose not changed - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010648973	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Unknown - );Head discomfort (n/a - Not Recovered/Not Resolved - );Impaired work ability (n/a - Unknown - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648989	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010648994	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010648994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649121	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (2h - Recovered/Resolved - );Hypertension (2h - Recovered/Resolved - Other Medically Important Condition);Palpitations (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[AMINOPHYLLINE] (S - Asthma - n/a - [n/a - 10mL - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010649144	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (n/a - Unknown - Life Threatening);Blood creatine phosphokinase increased (n/a - Unknown - Life Threatening);Brain natriuretic peptide increased (n/a - Unknown - Life Threatening);Cardiac arrest (n/a - Unknown - Life Threatening);Troponin increased (n/a - Unknown - Life Threatening);Ventricular fibrillation (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010649147	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649167	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649169	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649188	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	[ATORVASTATIN] (C - n/a - n/a - )|[CHLORTALIDONE] (C - n/a - n/a - )|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010649205	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neurosarcoidosis (n/a - Not Recovered/Not Resolved - Disabling);Optic neuritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010649212	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649216	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649226	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Large intestine perforation (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010649227	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649234	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling);Parosmia (n/a - Not Recovered/Not Resolved - Disabling);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling);Weight decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010649235	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chronic lymphocytic leukaemia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010649291	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649314	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649315	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649316	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649317	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649347	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649369	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blister (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Unknown - );Rash erythematous (n/a - Unknown - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010649373	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649375	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hot flush (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649380	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pyrexia (22h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649427	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649491	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010649495	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649506	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649507	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Child	Yes	Male	Diarrhoea (n/a - Unknown - );Exposure via breast milk (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649512	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (7h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649526	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649539	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010649542	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649546	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [ADALIMUMAB] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010649637	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Ophthalmoplegia (n/a - Recovered/Resolved - Other Medically Important Condition);Orbital myositis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010649694	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010649703	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure diastolic increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649714	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010649750	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (1mo - Unknown - Other Medically Important Condition);Suspected COVID-19 (1mo - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649757	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Decreased immune responsiveness (n/a - Unknown - Other Medically Important Condition);Depressed mood (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (46d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Skin disorder (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Viral infection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010649772	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010649797	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010649844	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649910	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - );Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [1d - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Raynaud's phenomenon - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Obsessive-compulsive disorder - n/a - [n/a - n/a - n/a])|[PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A, PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT), PNEUMOCOCCAL VACCINE] (C - n/a - n/a - [1d - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010649913	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (1h - Recovered/Resolved - );Pain in extremity (1h - Recovered/Resolved - );Paraesthesia (1h - Recovered/Resolved - );Peripheral coldness (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010649960	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010649969	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Mood swings (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010649969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010650112	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (7d - Recovered/Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010650237	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Subacute hepatic failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010650383	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650393	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650405	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650407	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010650409	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - );Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Shock (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010650503	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650504	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650509	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650511	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyskinesia (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650526	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650554	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Bradycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cyanosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Fall (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation);Head banging (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Head injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypopnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010650591	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650640	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650645	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650704	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (56d - Recovering/Resolving - Other Medically Important Condition);Myocarditis (56d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010650727	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650737	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010650748	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovering/Resolving - );Fall (n/a - Unknown - );Head discomfort (n/a - Unknown - );Seizure (n/a - Unknown - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010650751	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010650757	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Unknown])|[B/PHUKET/3073/2013-LIKE STRAIN, A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186)] (S - n/a - Not applicable - [n/a - n/a - Unknown])	[OMEPRAZOLE] (C - n/a - Dose not changed - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010650973	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010650977	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inflammation (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010650996	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebellar artery occlusion (n/a - Unknown - Life Threatening);Cerebral infarction (n/a - Unknown - Life Threatening);Decreased appetite (n/a - Unknown - Life Threatening);Gait disturbance (n/a - Unknown - Life Threatening);Lethargy (n/a - Unknown - Life Threatening);Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010650996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010651001	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651014	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Musculoskeletal stiffness (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Anaphylactic reaction - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010651065	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651080	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651215	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Malaise (3d - Recovered/Resolved - );Off label use (n/a - Unknown - );Pyrexia (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651228	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651246	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651306	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651339	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Delirium (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651358	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Unknown - Other Medically Important Condition);Cough (11d - Recovered/Resolved - Other Medically Important Condition);Epistaxis (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Productive cough (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (11d - Recovered/Resolved - Other Medically Important Condition);Sinus pain (n/a - Recovering/Resolving - Other Medically Important Condition);Sneezing (11d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651365	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651526	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010651555	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010651624	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Syncope (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010651678	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010651731	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Hip fracture (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651742	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651744	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651765	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651798	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651809	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Face oedema (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651824	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Confusional state (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651865	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651902	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010651911	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651919	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010651931	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010651977	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010651977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652068	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2mo - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652071	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652072	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652090	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652095	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652143	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652159	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010652198	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010652207	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010652301	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Recovering/Resolving - Other Medically Important Condition);Otitis media (n/a - Recovering/Resolving - );Pyrexia (95d - Recovered/Resolved - );Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010652320	Spontaneous	2021-11-15 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angiopathy (n/a - Fatal - Results in Death);Cardiovascular disorder (n/a - Fatal - Results in Death);Chest discomfort (n/a - Fatal - Results in Death);Condition aggravated (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010652337	Spontaneous	2021-11-15 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010652337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010640598	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640599	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640601	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640602	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640608	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640609	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640610	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640625	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640630	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (2d - Recovered/Resolved - );Oropharyngeal pain (8d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640654	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640671	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010640687	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640692	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640703	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640721	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (2d - Recovered/Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640759	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010640839	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010640856	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640860	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Hyperpyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640863	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[TETANUS VACCINES] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640867	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640874	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia oral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640876	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Extrasystoles (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640884	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (20min - Recovered/Resolved - );Dizziness (20min - Recovered/Resolved - );Pallor (20min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640891	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	Yes	Male	Pyrexia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640914	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640921	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640923	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640935	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640942	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640954	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Injection site pain (3d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (19d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640965	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Type I hypersensitivity (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640967	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Incontinence (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMITRIPTYLINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - Oral])|[LOMERIZINE HYDROCHLORIDE] (C - Migraine - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010640968	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010640983	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640985	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (80d - Recovered/Resolved - );Erythema multiforme (n/a - Recovering/Resolving - Other Medically Important Condition);Haemorrhage subcutaneous (n/a - Recovering/Resolving - Other Medically Important Condition);Internal haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Venous thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])|[WARFARIN, WARFARIN SODIUM] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010640986	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (5535min - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (2655min - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tremor (2655min - Recovered/Resolved - );Vaccination site pain (2655min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ISOPHANE INSULIN [ISOPHANE INSULIN] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|[INSULIN HUMAN ISOPHANE, INSULIN HUMAN] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010640991	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Hyporesponsive to stimuli (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010640996	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (4d - Recovered/Resolved - );Pain (4905min - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010641034	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641038	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Thirst (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641054	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641057	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641068	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (39d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010641070	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641087	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641090	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641100	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641121	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641132	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010641170	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010641173	Spontaneous	2021-11-14 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lip swelling (n/a - Unknown - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (n/a - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010641187	Spontaneous	2021-11-14 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear infection (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ANTIBIOTICA [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010641187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637884	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637894	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Injection site pain (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637930	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637938	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637976	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (0d - Recovered/Resolved - );Injury (0d - Recovered/Resolved - );Urticaria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637979	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637980	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash erythematous (0d - Recovered/Resolved - );Urticaria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638012	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638015	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Gait disturbance (1d - Recovered/Resolved - );Hypokinesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Influenza immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638022	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638024	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638026	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638031	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - );Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638097	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638127	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638141	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638142	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sinusitis (n/a - Not Recovered/Not Resolved - );Tracheitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638179	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Burning mouth syndrome (n/a - Unknown - );Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638180	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638183	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638253	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Injection site pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638255	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/AUSTRIA/1359417/2021 HAEMAGGLUTININ ANTIGEN, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), INFLUENZA VIRUS B/MICHIGAN/01/2021, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022, IVR-238), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022, IVR-238), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS A/DARWIN/9/2021 SAN-010 (H3N2), B/AUSTRIA/1359417/2021 LIKE STRAIN-(B/MICHIGAN/01/2021, WILD TYPE), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED, B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), INFLUENZA VIRUS B/MICHIGAN/01/2021, INFLUENZA VIRUS A/DARWIN/9/2021 IVR-228 (H3N2), INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED] (C - Influenza immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010638256	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638260	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Encephalomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638261	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhoids thrombosed (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010638270	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (6d - Recovered/Resolved - );Vertigo positional (6d - Recovered/Resolved - );Vomiting (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638301	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638312	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (1d - Recovered/Resolved - Other Medically Important Condition);Dyspepsia (1d - Recovered/Resolved - Other Medically Important Condition);Hypotension (1d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010638320	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010638321	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010638324	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemoptysis (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ADVAGRAF 0.5 MG PROLONGED-RELEASE HARD CAPSULES [TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])|CELLCEPT 1 G/5 ML POWDER FOR ORAL SUSPENSION [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])|LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOFENOPRIL CALCIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010638327	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638337	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010638380	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638384	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Life Threatening);Pneumonitis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010638387	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638395	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010638425	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638428	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	DOVATO [LAMIVUDINE, DOLUTEGRAVIR] (C - Acute HIV infection - n/a - [n/a - n/a - Oral])|KEPPRA 750 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638438	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638439	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638440	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638443	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibromyalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638552	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638567	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010638574	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010638585	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Joint stiffness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010638589	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Micturition disorder (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory arrest (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638601	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Autoimmune haemolytic anaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638605	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (6d - Recovered/Resolved - Other Medically Important Condition);Anosmia (6d - Recovered/Resolved - Other Medically Important Condition);Arthralgia (6d - Recovered/Resolved - Other Medically Important Condition);Asthenia (6d - Recovered/Resolved - Other Medically Important Condition);Headache (6d - Recovered/Resolved - Other Medically Important Condition);Odynophagia (6d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (6d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010638610	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638613	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010638615	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010638618	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638632	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010638698	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010638703	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (88d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010638711	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638716	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638729	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Throat irritation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638736	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638742	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Synovitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638817	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site inflammation (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Injection site warmth (3d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010638824	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (45mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638840	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638846	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638857	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - );Skin odour abnormal (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638865	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638866	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638889	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010638904	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638905	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638910	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638911	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638919	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638941	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638947	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638961	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site induration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638975	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638977	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Recovered/Resolved - );Injection site haematoma (n/a - Recovered/Resolved - );Injection site inflammation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - );Injection site warmth (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010638985	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010638986	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010638986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639002	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639197	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639211	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639222	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639257	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Speech disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010639260	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (4h - Recovered/Resolved - );Chills (2h - Recovered/Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010639287	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	Yes	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639326	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639698	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010639700	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010639731	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010639755	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (28d - Recovered/Resolved - );Malaise (28d - Recovered/Resolved - );Nausea (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010639760	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Energy increased (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Insomnia (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010639848	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - );Vaccination site rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639854	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639860	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Skin exfoliation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639876	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639897	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010639899	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010639906	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010639931	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Skin reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639949	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639966	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (2d - Recovered/Resolved - );Burning sensation (8d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pruritus (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639994	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site discomfort (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Weight increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010639997	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010639997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640004	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640011	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - );Puncture site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640023	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640082	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640109	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640129	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (1wk - Recovered/Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Photophobia (1wk - Recovered/Resolved - );Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FEXOFENADINE HYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - 180mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640144	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Nasal congestion (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640157	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640167	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640173	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640192	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640212	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640213	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Scrotal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640219	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640225	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640276	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010640277	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[INSULIN INJECTION SOLUBLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640307	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640308	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640311	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640313	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640317	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640352	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640354	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640375	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640378	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640380	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640386	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640388	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640405	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640423	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640431	Spontaneous	2021-11-13 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010640437	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640440	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640441	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640443	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640447	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010640458	Spontaneous	2021-11-13 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010640458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010624899	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624936	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624951	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624970	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nasal congestion (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625018	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate irregular (n/a - Not Recovered/Not Resolved - );Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010625071	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - );Ventricular extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010625074	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625093	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625124	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625146	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625148	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625312	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010625350	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625413	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010625439	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010625495	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625541	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Disorientation (n/a - Not Recovered/Not Resolved - );Eye disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625607	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE, FLUTICASONE, SALMETEROL] (S - Asthma - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625651	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (6d - Recovered/Resolved - );Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625661	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (62d - Recovered/Resolved - );Myalgia (62d - Recovered/Resolved - );Paraesthesia (62d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010625675	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening);Head injury (n/a - Not Recovered/Not Resolved - Life Threatening);Syncope (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010625677	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Rash papular (n/a - Not Recovered/Not Resolved - Disabling);Skin burning sensation (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010625683	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (4d - Recovered/Resolved - );Vaccination site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625710	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625742	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010625743	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess of external ear (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal abscess (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oral herpes (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010625759	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010625765	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010625774	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Stress cardiomyopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010625775	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010625777	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure diastolic increased (n/a - Unknown - );Skin discolouration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625788	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flushing (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625790	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Drug withdrawn - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010625793	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Leukoencephalopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010625807	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Recovering/Resolving - Disabling);Vision blurred (n/a - Recovering/Resolving - Disabling);Visual impairment (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010625814	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Pericardial effusion (n/a - Not Recovered/Not Resolved - Life Threatening);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010625820	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010625825	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010625977	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Chest discomfort (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Palpitations (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010625979	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Pain in extremity (7d - Recovered/Resolved - );Palpitations (7d - Recovered/Resolved - );Paraesthesia (7d - Recovered/Resolved - );Tachycardia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010625979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010626009	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010626027	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Confusional state (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010626035	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Dry mouth (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Lip oedema (n/a - Recovering/Resolving - );Sense of oppression (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010626038	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010626085	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombocytopenia (7d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010626104	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transverse sinus thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 16mg - n/a])|[OMEGA-3-ACID ETHYL ESTERS 90 WITH A SPECIFIC COMPOSITION FOR EPA AND DHA NOT LOWER THAN 85%.] (C - n/a - n/a - [n/a - n/a - n/a])|[VALACICLOVIR] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010626112	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fungal infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010626114	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coronary artery thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Infarction (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010626117	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010626128	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626138	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved With Sequelae - );Migraine with aura (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010626149	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010626409	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010626411	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626432	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Colitis (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Rectal haemorrhage (n/a - Unknown - Other Medically Important Condition);Symptom recurrence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626447	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626457	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626464	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute lymphocytic leukaemia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Subarachnoid haemorrhage (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DOMPERIDONE] (C - Gastrooesophageal reflux disease - n/a - [1mo - n/a - Oral])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN] (C - Dyslipidaemia - n/a - [2346d - n/a - Oral])|[ZOLPIDEM TARTRATE] (C - Insomnia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010626469	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Skin injury (32d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010626488	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypersensitivity (n/a - Recovering/Resolving - Life Threatening);Myocarditis (n/a - Recovering/Resolving - Life Threatening);Pericarditis (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010626616	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626736	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Hyporeflexia (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010626737	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010626737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010627035	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627038	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Muscular weakness (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627067	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627073	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010627075	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010627076	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010627081	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627085	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );Chest discomfort (n/a - Recovered/Resolved - );Cyst (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Meniscus injury (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Phlebitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010627093	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ENBREL [ETANERCEPT] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFASALAZINE, SULFASALAZINE PH. EUR.] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010627094	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - );Interchange of vaccine products (n/a - Unknown - );Iritis (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627152	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627160	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Autoimmune thyroiditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627169	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Agnosia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010627191	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010627281	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hepatic enzyme increased (n/a - Not Recovered/Not Resolved - Life Threatening);Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening);Peripheral swelling (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010627405	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627466	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Salivary gland enlargement (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627545	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (19d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (19d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010627653	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010627654	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627799	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (5d - Recovered/Resolved - );Cerebral artery occlusion (5d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (5d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coordination abnormal (5d - Recovered/Resolved - );Diplopia (5d - Recovered/Resolved - );Tinnitus (5d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010627812	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (7d - Recovered/Resolved - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010627816	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627818	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627823	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627839	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627872	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010627895	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash maculo-papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010627903	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (114d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010627918	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (5d - Recovering/Resolving - );Trigeminal neuralgia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010627961	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gilbert's syndrome (n/a - Not Recovered/Not Resolved - );Hyperaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Intervertebral disc annular tear (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Intervertebral disc protrusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - );Radiculopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sick leave (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Disabling);Vertebral foraminal stenosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010627962	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010627962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628085	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Ejection fraction decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010628089	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628092	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010628099	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (n/a - Unknown - );Metamorphopsia (n/a - Unknown - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628113	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628166	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628196	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood cholesterol increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscle tightness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paradoxical embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628279	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aggression (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Confusional state (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Delirium (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Restlessness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Antiplatelet therapy - n/a - [n/a - 75mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[CYANOCOBALAMIN, HYDROXOCOBALAMIN] (C - Vitamin B12 deficiency - n/a - [n/a - 1mg - Oral])|[GABAPENTIN] (C - Pain - n/a - [n/a - 300mg - Oral])|[PARACETAMOL, PARACETAMOL, ASPARTAME] (C - Pain - n/a - [n/a - 1000mg - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 40mg - Oral])|[VALSARTAN] (C - Hypertension - n/a - [n/a - 160mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628287	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye inflammation (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Retinal vascular thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Unknown - );White blood cell disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628386	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010628394	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrioventricular block complete (n/a - Unknown - Life Threatening, Other Medically Important Condition);Bradycardia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Chest pain (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Heart rate decreased (n/a - Recovered/Resolved - Life Threatening);Mydriasis (n/a - Unknown - );Seizure (n/a - Unknown - Life Threatening, Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010628423	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010628431	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Weight decreased (n/a - Recovering/Resolving - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010628440	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death);Confusional state (6h - Recovered/Resolved - );Diplopia (0d - Recovered/Resolved - );Dizziness (n/a - Unknown - );Dysarthria (0d - Recovered/Resolved - );Fall (n/a - Unknown - );Lower respiratory tract congestion (0d - Recovered/Resolved - );Myocardial infarction (n/a - Fatal - Results in Death);Oxygen saturation decreased (0d - Recovered/Resolved - );Psychomotor skills impaired (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Sedation (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLCYSTEINE] (C - Drug dependence - n/a - [n/a - n/a - n/a])|[ALIMEMAZINE, ALIMEMAZINE TARTRATE] (C - Anxiolytic therapy - n/a - [n/a - n/a - n/a])|[CYAMEMAZINE, CYAMEMAZINE TARTRATE] (C - Anxiolytic therapy - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Alcoholism - n/a - [n/a - n/a - n/a])|[METHADONE, METHADONE HYDROCHLORIDE] (C - Drug dependence - n/a - [n/a - n/a - n/a])|[NICOTINE, NICOTINE BITARTRATE DIHYDRATE, NICOTINE POLACRILEX, NICOTINE TARTRATE] (C - Ex-tobacco user - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010628475	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010628485	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010628498	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (2d - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site discomfort (4d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (3d - Recovered/Resolved - );Tongue discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628503	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	DUOTRAV 40 MICROGRAMS/ML+ 5 MG/ML EYE DROPS SOLUTION [TIMOLOL, TRAVOPROST] (C - n/a - n/a - [n/a - 1[drp] - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 1[drp] - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 40mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 5mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 70mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 75mg - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[KETOROLAC TROMETAMOL] (C - n/a - n/a - [n/a - 1[drp] - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628526	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Recovering/Resolving - Disabling);Dizziness (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010628527	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010628541	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628554	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628555	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina unstable (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628579	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	IVth nerve paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628582	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628583	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Sinusitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628589	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 30ug - Intramuscular])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 200mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 80mg - Oral])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - 75mg - Oral])|[DIGOXIN] (C - n/a - n/a - [n/a - .125mg - Oral])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - 125mg - Oral])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - 10mg - Oral])|[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - 3g - Oral])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 50mg - Oral])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628590	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628593	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628596	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628603	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (323h - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (323h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CANDESARTAN, HYDROCHLOROTHIAZIDE] (C - Blood pressure abnormal - n/a - [n/a - n/a - Oral])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628616	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cellulitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fat tissue increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628619	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628622	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Face oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nasal congestion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Periorbital oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Throat tightness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628629	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628636	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Disabling);Back pain (n/a - Not Recovered/Not Resolved - Disabling);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010628661	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628667	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010628675	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628797	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - );Rash (163d - Recovered/Resolved - );Taste disorder (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010628810	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Not Recovered/Not Resolved - );Eyelid oedema (1d - Not Recovered/Not Resolved - );Swollen tongue (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628812	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628837	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - );Limb discomfort (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628839	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - );Limb discomfort (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628845	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (10d - Not Recovered/Not Resolved - );Atrial fibrillation (10d - Not Recovered/Not Resolved - );Diarrhoea (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628865	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010628870	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Monoparesis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010628876	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010628898	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628908	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628913	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010628914	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628943	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628948	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Peripheral swelling (2d - Not Recovered/Not Resolved - );Pruritus (2d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010628952	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010628952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629011	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629015	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629026	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629035	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling cold (2d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629036	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myositis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	TOLURA [TELMISARTAN] (C - Hypertension - n/a - )|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629070	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629131	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010629167	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010629169	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Recovering/Resolving - Disabling);Lymphadenopathy (n/a - Recovering/Resolving - Disabling);Musculoskeletal pain (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010629178	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|[SULFASALAZINE, SULFASALAZINE PH. EUR.] (C - Rheumatic disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010629240	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629288	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629298	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629300	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629302	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629310	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629323	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010629388	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629399	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629419	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629443	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629463	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neurological symptom (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010629470	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010629479	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (2225min - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (2257min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010629526	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Recovered/Resolved - );Cerebral disorder (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Hallucination, olfactory (n/a - Recovered/Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Taste disorder (n/a - Recovered/Resolved - );Thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site scar (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010629609	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629611	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629613	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629614	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010629620	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629621	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629628	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010629648	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010629669	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatic infarction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal infarct (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Retinal artery thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010629669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010630024	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010630034	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Varicophlebitis (n/a - Recovering/Resolving - );Vasodilatation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010630050	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630054	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630056	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630058	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630067	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Madarosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630075	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630083	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010630121	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630335	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010630366	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Cough (9d - Not Recovered/Not Resolved - );Dizziness (13d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (0d - Recovering/Resolving - );Paraesthesia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010630370	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Eye pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Ocular hyperaemia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630373	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Ageusia (14d - Recovered/Resolved - );Anosmia (14d - Recovered/Resolved - );Dyspnoea (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010630397	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coombs positive haemolytic anaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	BUPRENORPHINE [BUPRENORPHINE] (C - n/a - n/a - [n/a - n/a - Oral])|[ETODOLAC] (C - Humerus fracture - n/a - [n/a - 400mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010630402	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (0d - Recovered/Resolved - );Hypotension (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630414	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Mesenteric vascular occlusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mesenteric vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010630422	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630435	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye swelling (n/a - Recovering/Resolving - );Fatigue (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630436	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010630454	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (7d - Recovered/Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630456	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630457	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (48d - Not Recovered/Not Resolved - );Myalgia (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010630458	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye swelling (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Lymphadenopathy (7d - Not Recovered/Not Resolved - );Ocular hyperaemia (7d - Not Recovered/Not Resolved - );Skin swelling (7d - Not Recovered/Not Resolved - );Spinal pain (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630468	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Endocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Infectious pleural effusion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010630470	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain upper (42d - Not Recovered/Not Resolved - );Influenza (42d - Not Recovered/Not Resolved - );Musculoskeletal chest pain (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010630471	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010630472	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Eye pain (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630475	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630498	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630503	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Dysphagia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630505	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630511	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Panic reaction (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010630516	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010630518	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (14d - Recovering/Resolving - );Herpes zoster (14d - Recovering/Resolving - );Rash (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010630523	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Bone pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630546	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010630550	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (13d - Recovered/Resolved With Sequelae - );Influenza like illness (13d - Recovered/Resolved With Sequelae - );Pain (13d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010630552	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (6d - Recovered/Resolved - );Injection site swelling (6d - Recovered/Resolved - );Lymphadenitis (6d - Recovered/Resolved - );Vaccination site movement impairment (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630622	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630623	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630624	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630628	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630629	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630630	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630633	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630635	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010630757	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heart rate variability increased (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Disabling);Tachycardia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010630860	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630891	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630895	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vitamin B12 decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010630904	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Life Threatening);Myalgia (n/a - Recovering/Resolving - );Myocardial infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010630922	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010630998	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010630998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631002	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631003	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631009	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631042	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Feeling abnormal (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling);Poor quality sleep (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010631293	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Weight increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 6mg - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - Dose not changed - [n/a - 32mg - n/a])|[CYPROHEPTADINE] (C - n/a - Dose not changed - [n/a - 100mg - n/a])|[FUROSEMIDE] (C - n/a - Dose not changed - [n/a - 20mg - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - Dose not changed - [n/a - 75ug - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 1700mg - n/a])|[RILMENIDINE, RILMENIDINE DIHYDROGEN PHOSPHATE] (C - n/a - Dose not changed - [n/a - 1mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010631305	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631383	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010631487	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631488	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631542	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Meningism (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010631568	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010631578	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (20d - Recovered/Resolved - Other Medically Important Condition);Blood sodium abnormal (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lyme disease (n/a - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631581	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ejection fraction decreased (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	INFLECTRA [INFLIXIMAB] (C - n/a - n/a - [n/a - 5mg/kg - Intravenous (not otherwise specified)])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631587	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Odynophagia (n/a - Not Recovered/Not Resolved - Disabling);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Disabling);Spondylitis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010631608	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010631619	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Decreased appetite (n/a - Not Recovered/Not Resolved - Life Threatening);Discomfort (n/a - Fatal - Results in Death, Life Threatening);Dizziness (n/a - Fatal - Results in Death, Life Threatening);Fall (n/a - Not Recovered/Not Resolved - Life Threatening);Head injury (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Hypotension (n/a - Fatal - Results in Death, Life Threatening);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Syncope (n/a - Fatal - Results in Death);Taste disorder (n/a - Not Recovered/Not Resolved - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010631622	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631624	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary congestion (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631634	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oral herpes (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631635	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631641	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010631649	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631743	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631747	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631756	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010631801	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Life Threatening);Dizziness (n/a - Recovered/Resolved - Life Threatening);Presyncope (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010631832	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Life Threatening);Clumsiness (n/a - Recovered/Resolved - Life Threatening);Confusional state (n/a - Recovered/Resolved - Life Threatening);Headache (n/a - Recovered/Resolved - Life Threatening);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010631834	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Crnej, A.. Acute corneal endothelial graft rejection following COVID-19 vaccination. Journal francais d&apos;ophtalmologie. 2021;44(2021):e445-e447. doi:10.1016/j.jfo.2021.06.001	65-85 Years	Not Specified	No	Male	Transplant rejection (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631843	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Mieczkowska, K.. Exacerbation of psoriasis following COVID-19 vaccination in a patient previously treated with PD-1 inhibitor. Dermatologic Therapy. 2021;34(5):10.1111/dth.15055. doi:10.1111/dth.15055	65-85 Years	Not Specified	No	Male	Psoriasis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631844	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631850	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Oomi, M.. A case manifesting pathological features of vasculitis with the onset of fever and meralgia after coronavirus vaccination. The 672nd Kanto Regional Meeting of the Japanese Society of Internal medicine. 2021;672nd	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Leukocytosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631880	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Recovered/Resolved With Sequelae - Disabling);Flank pain (n/a - Recovered/Resolved With Sequelae - Disabling);Heart rate irregular (n/a - Recovered/Resolved With Sequelae - Disabling);Muscle strain (n/a - Recovered/Resolved With Sequelae - Disabling);Palpitations (n/a - Recovered/Resolved With Sequelae - Disabling);Peripheral vein thrombosis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Blood pressure measurement - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010631902	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631907	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (3d - Recovered/Resolved - Other Medically Important Condition);Chest pain (1d - Recovered/Resolved - );Feeling cold (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Myocarditis (3d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631910	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (47d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Asthenia (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);CSF lymphocyte count increased (n/a - Unknown - Other Medically Important Condition);CSF protein increased (n/a - Unknown - Other Medically Important Condition);Guillain-Barre syndrome (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hydronephrosis (48d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyporeflexia (47d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Muscular weakness (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (50d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Quadriplegia (47d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensory disturbance (47d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Urinary retention (49d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (48d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631915	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631919	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Epilepsy (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypertonia (n/a - Recovered/Resolved - Other Medically Important Condition);Oral discharge (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ELOBIXIBAT HYDRATE] (C - Constipation - n/a - [n/a - n/a - Oral])|[PHENOBARBITAL, PHENOBARBITAL SODIUM] (C - Epilepsy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631920	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eosinophil count increased (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Skin exfoliation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631933	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure diastolic decreased (n/a - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631937	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631948	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Oesophageal pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010631952	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631953	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Alanine aminotransferase decreased (n/a - Unknown - );Albumin globulin ratio increased (n/a - Unknown - );Bilirubin conjugated increased (n/a - Unknown - );Blood alkaline phosphatase increased (n/a - Unknown - );Blood bilirubin increased (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Blood potassium decreased (n/a - Unknown - );Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Blood sodium decreased (n/a - Unknown - );Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Mean platelet volume decreased (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Protein total decreased (n/a - Unknown - );Shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631959	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (6d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Unknown - );Decreased appetite (6d - Recovered/Resolved - Other Medically Important Condition);Erythema (8d - Recovered/Resolved - Other Medically Important Condition);Kawasaki's disease (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (8d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (8d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631960	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyslalia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631961	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Dysgeusia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (1d - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631962	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Dysphoria (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631963	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010631970	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Productive cough (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631971	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010631975	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eating disorder (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Mouth ulceration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Tongue ulceration (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010631976	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Embolic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hydrocephalus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Rhabdomyolysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010631990	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010631990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632020	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Portal vein occlusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Splenic infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632023	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632050	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - );Neuralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010632060	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depressive symptom (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mobility decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632078	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (8d - Not Recovered/Not Resolved - );Injection site pain (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632080	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632084	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovering/Resolving - );Local reaction (1d - Recovering/Resolving - );Paraesthesia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632087	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632088	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632092	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632093	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010632109	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632113	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632121	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632124	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632130	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632145	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632153	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632155	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632157	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632164	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632175	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632176	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632177	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632179	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632186	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632187	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632196	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632199	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632201	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632210	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632220	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dissociation (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Somnambulism (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632245	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (1wk - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632256	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632260	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632263	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632268	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632272	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010632280	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632283	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632302	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (1d - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632304	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632308	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632333	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632338	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632341	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632344	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632345	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632349	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632365	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632376	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010632380	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632391	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632479	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632531	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632663	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (7d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632682	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TELMISARTAN 40 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010632686	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010632816	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypokinesia (1d - Recovered/Resolved - );Injection site pain (15h - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE, AMLODIPINE] (C - n/a - n/a - )|[RILMENIDINE DIHYDROGEN PHOSPHATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632958	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010632965	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypoaesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Mouth swelling (1d - Recovered/Resolved - Other Medically Important Condition);Rash (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632967	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010632969	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (0d - Recovered/Resolved - Other Medically Important Condition);Defaecation urgency (n/a - Unknown - Other Medically Important Condition);Dehydration (0d - Recovered/Resolved - Other Medically Important Condition);Delirium (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632975	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010632983	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632990	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632996	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010632999	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010632999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010633006	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633019	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocardial infarction (257h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN, INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010633022	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - 300mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633028	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Depressed level of consciousness (10min - Recovered/Resolved - Other Medically Important Condition);Discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (10min - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Shock (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010633105	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010633108	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633113	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633271	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633388	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010633389	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633391	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling, Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Disorientation (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Fall (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010633429	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010633431	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|KRUIDENPREPARAAT [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633434	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Blister (n/a - Unknown - );Burning sensation (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Unknown - );Hypertension (n/a - Unknown - );Pain (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash macular (n/a - Unknown - );Scar (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	SUPER BETA PROSTATE [BORON, CHROMIUM, COPPER, GERMANIUM, IODINE, MANGANESE, MOLYBDENUM, SELENIUM, SILICON, SITOSTEROL, VANADIUM, VITAMIN D NOS, ZINC] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[ASCORBIC ACID, BETACAROTENE, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, THIAMINE NITRATE, POTASSIUM CHLORIDE, ZINC OXIDE, CHROMIC CHLORIDE, CUPRIC OXIDE, FERROUS FUMARATE, MAGNESIUM OXIDE, MANGANESE SULFATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, SODIUM MOLYBDATE, CALCIUM HYDROGEN PHOSPHATE, SODIUM SELENATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 4mg - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - 1200mg - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[RED YEAST RICE] (C - n/a - n/a - [n/a - 600mg - n/a])|[VITAMIN D, CALCIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633499	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Multiple sclerosis relapse (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633502	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633506	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye disorder (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633520	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [73d - 1{DF} - Intramuscular])|ODEFSEY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, RILPIVIRINE] (C - HIV infection - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633521	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010633524	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633544	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633569	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010633579	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633580	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pleural effusion (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633585	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Product preparation error (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633586	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010633587	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633599	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Hepatic cytolysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - );Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633601	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Appendicitis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peritonitis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633602	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute coronary syndrome (1mo - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633605	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (1h - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010633607	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010633613	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Hypertension (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[TOPIRAMATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010633614	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633616	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ENALAPRIL MALEATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633648	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Plasma cell myeloma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633669	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dermatitis bullous (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633671	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [32d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633676	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633682	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Pruritus genital (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633696	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633703	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633710	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010633714	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633726	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010633727	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010633760	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633783	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633786	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633790	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633793	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Loss of consciousness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633797	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633799	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633800	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[AMOXICILLIN, AMOXICILLIN SODIUM, AMOXICILLIN TRIHYDRATE] (S - n/a - Dose reduced - [n/a - n/a - Oral])|[CLAVULANIC ACID] (S - n/a - Dose reduced - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633802	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633810	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633813	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Antinuclear antibody positive (n/a - Not Recovered/Not Resolved - );Appendicitis (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633833	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633837	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633843	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633846	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633857	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tremor (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [23d - 1{DF} - Intramuscular])	KEPPRA 1000 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - Epilepsy - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633858	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperleukocytosis (n/a - Not Recovered/Not Resolved - );Vertigo positional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	JCOVDEN [COVID-19 VACCINE JANSSEN (AD26.COV2.S)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633869	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633870	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Diarrhoea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633871	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633873	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633879	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633884	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633894	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633898	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cholestatic liver injury (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633907	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Peripheral ischaemia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633918	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633925	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633932	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633936	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633940	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Hyperreflexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633945	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633946	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[CREATINE] (C - Supplementation therapy - n/a - [n/a - n/a - n/a])|[OMEGA-3 FATTY ACIDS] (C - Supplementation therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633953	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633959	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (14d - Recovered/Resolved - );Myalgia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633963	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633964	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hemiparaesthesia (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010633985	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010633998	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010633998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634001	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634027	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634030	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634031	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Formication (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634047	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Coordination abnormal (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	ADENURIC 80 MG FILM-COATED TABLETS [FEBUXOSTAT] (C - Product used for unknown indication - n/a - [n/a - 120mg - n/a])|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634053	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hemihyperaesthesia (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634064	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634068	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634072	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634074	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin plaque (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634075	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Headache (n/a - Unknown - );Urticaria (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634077	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634091	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634095	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyskinesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Speech disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634107	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634108	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634112	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634131	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Product used for unknown indication - n/a - [n/a - 4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634135	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634137	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634140	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634143	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (n/a - Recovered/Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634147	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634167	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (8d - Recovering/Resolving - );Idiopathic CD4 lymphocytopenia (n/a - Recovered/Resolved - );Increased viscosity of upper respiratory secretion (8d - Recovering/Resolving - );Lymphadenopathy (8d - Recovering/Resolving - );Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634169	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634180	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site inflammation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634183	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634186	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634188	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site oedema (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634189	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634190	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634201	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [34d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634202	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634210	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634215	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634216	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634222	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634228	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634229	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634231	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634240	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634244	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634245	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634268	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Face oedema (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634269	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634276	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634287	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis chronic (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634303	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burn oesophageal (14d - Recovered/Resolved - );Immunisation reaction (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634307	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anosmia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	[CARTEOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634312	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634313	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634329	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Temporomandibular pain and dysfunction syndrome (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634332	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Muscle tightness (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634333	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash rubelliform (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634347	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Vaccination site induration (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634356	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BROMAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634358	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634376	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatitis toxic (4mo - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	BIRESP SPIROMAX [BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Respiratory (inhalation)])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[DUTASTERIDE, TAMSULOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[MOMETASONE] (C - Product used for unknown indication - n/a - [n/a - n/a - Nasal])|[OLMESARTAN MEDOXOMIL] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010634379	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634391	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634394	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634395	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634399	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634402	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010634413	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010634418	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	ALECENSA [ALECTINIB] (C - n/a - Unknown - )|PREGABALIN [PREGABALIN] (C - n/a - n/a - )|[FENTANYL] (C - n/a - n/a - )|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010634419	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634422	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634472	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634500	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Lip swelling (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010634516	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010634525	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Giant cell arteritis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Presyncope (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PRASUGREL [PRASUGREL] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[BUSPIRONE] (C - n/a - n/a - [n/a - n/a - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - Oral])|[FLUOXETINE] (C - n/a - n/a - [n/a - n/a - Oral])|[ISOSORBIDE DINITRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[POTASSIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010634579	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (15h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634619	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634644	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010634652	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634667	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (24h - Recovered/Resolved - );Chills (24h - Recovered/Resolved - );Myalgia (24h - Recovered/Resolved - );Oedema (24h - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634836	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010634900	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hyperacusis (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634908	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010634914	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634925	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hepatic pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010634993	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010634993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010635028	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (2d - Recovered/Resolved - );Heart rate increased (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010635098	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Sudden hearing loss (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635129	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN] (S - n/a - Drug withdrawn - [n/a - 3g - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010635176	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635279	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Fatal - Results in Death, Other Medically Important Condition);Physical deconditioning (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010635292	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Diplopia (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - );Multiple sclerosis relapse (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myalgia (n/a - Unknown - );Ophthalmoplegia (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010635307	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cardiac flutter (2d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635361	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - );Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - )|[BISOPROLOL FUMARATE] (C - n/a - n/a - )|[EPLERENONE] (C - n/a - n/a - )|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - )|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010635369	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635503	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010635520	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Back pain (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010635564	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Central vision loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Impaired work ability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Iridocyclitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lymphocytosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Macular degeneration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyarteritis nodosa (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Retinal pigment epitheliopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Retinal pigmentation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vasculitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010635567	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - );Disturbance in attention (103h - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Mental impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635601	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635606	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	CELLCEPT 500 MG TABLETS [MYCOPHENOLATE MOFETIL] (S - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	CELLCEPT 500 MG TABLETS [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635617	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635619	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635627	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010635635	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010635647	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Myalgia (1d - Recovered/Resolved - );Myofascial pain syndrome (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010635740	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PARACETAMOL] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635777	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635838	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (3d - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Somnolence (3d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (3d - Recovered/Resolved - Other Medically Important Condition);Vertigo (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MELATONIN [MELATONIN] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635876	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (26min - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (19min - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Gaze palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (1min - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010635959	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site erythema (3d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010635976	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010635976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010636039	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - );Arthralgia (n/a - Unknown - );Aspartate aminotransferase increased (n/a - Unknown - );Bone pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - );Chills (n/a - Unknown - );Conjunctivitis (n/a - Unknown - );Drug hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - );Gait disturbance (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - );Insomnia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Unknown - );Limb discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - );Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rheumatoid arthritis (21d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010636048	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Heart rate increased (n/a - Recovering/Resolving - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010636061	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug eruption (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BETAMETHASONE] (C - Otitis media - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636141	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010636166	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010636204	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636216	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636255	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diabetes mellitus (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636326	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010636343	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyskinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eyelid function disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010636378	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636405	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010636535	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood cholesterol increased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Varicose vein (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010636700	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010636819	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (3mo - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636858	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010636866	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (n/a - Unknown - );Shock (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010636902	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010636979	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010636984	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010636984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010637051	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Results in Death);Chest pain (n/a - Unknown - Results in Death);Dyspnoea (n/a - Unknown - Results in Death);Fatigue (n/a - Unknown - Results in Death);Myocarditis (n/a - Unknown - Results in Death);Palpitations (n/a - Unknown - Results in Death);Pyrexia (n/a - Unknown - Results in Death);Syncope (n/a - Unknown - Results in Death);Tachycardia (n/a - Unknown - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010637055	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Lip swelling (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Swollen tongue (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Wheezing (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Withdrawal syndrome (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010637126	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovered/Resolved - );Vaccination site inflammation (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637164	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637168	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637184	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637186	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (13d - Recovered/Resolved - );Vaccination failure (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637188	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637189	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (19d - Recovered/Resolved - );Vaccination failure (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637205	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (7d - Recovered/Resolved - );Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637216	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637217	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637218	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637220	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637221	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637235	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010637243	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637249	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637259	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637267	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637275	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637278	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - );Dyskinesia (1d - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637289	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637297	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637304	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (19d - Recovered/Resolved - );Vaccination failure (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010637306	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Muscular weakness (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010637326	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010637369	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010637403	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010637407	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010637417	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Fatal - Results in Death, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010637427	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010637428	Spontaneous	2021-11-12 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010637467	Spontaneous	2021-11-12 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010637467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010613245	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Disturbance in attention (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Eye haemorrhage (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010613334	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Quadriparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010613362	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613383	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613410	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613418	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613419	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613426	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - );Type I hypersensitivity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613430	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Sense of oppression (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010613453	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613487	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613493	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613495	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613497	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613578	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613588	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010613599	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (8d - Recovered/Resolved - );Vaccination failure (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613602	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010613611	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening);Dyspnoea (n/a - Unknown - Life Threatening);Pyrexia (n/a - Unknown - Life Threatening);Rash (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010613641	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Presyncope (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613647	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BACILLUS CLAUSII, BACILLUS CLAUSII, SPORES OF POLY-ANTIBIOTIC RESISTANT, BACILLUS CLAUSII, STRAINS SIN, O/C, T, N/R, POLYANTIBIOTIC RESISTANT SPORES] (C - n/a - n/a - [n/a - n/a - n/a])|[KETOPROFEN LYSINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM, GLUCURONYL GLYCOSAMINOGLYCAN] (C - n/a - n/a - [n/a - n/a - n/a])|[NIMESULIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613684	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010613715	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[MESALAZINE] (C - n/a - n/a - [n/a - 3g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613727	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613730	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613732	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (10d - Recovered/Resolved - );Vision blurred (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613740	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613746	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010613767	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acanthamoeba keratitis (n/a - Unknown - Other Medically Important Condition);Retinal detachment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010613780	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613782	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[MESALAZINE] (C - n/a - n/a - [n/a - 3g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613790	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010613811	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010613813	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613815	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613816	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613820	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613826	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613828	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613830	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613834	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010613839	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613862	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613984	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010614060	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - );Chills (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Vision blurred (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010614065	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Gravitational oedema (n/a - Not Recovered/Not Resolved - );Hyperaemia (n/a - Not Recovered/Not Resolved - );Pleural effusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMLODIPINE] (C - n/a - n/a - [n/a - 5mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 25mg - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1000mg - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - .4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010614087	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614092	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dermatosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ocular hyperaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Psoriasis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Secretion discharge (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensation of foreign body (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|PRADAXA 75 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - 300mg - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - 200mg - n/a])|[SOTALOL, SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 160mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010614096	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised anxiety disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ETORICOXIB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010614140	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010614156	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010614162	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (46d - Recovered/Resolved - );Paraesthesia oral (46d - Recovered/Resolved - );Paralytic lagophthalmos (46d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010614169	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010614187	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CITALOPRAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010614354	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyskinesia (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperventilation (n/a - Recovering/Resolving - Other Medically Important Condition);Somatic symptom disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614365	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Feeling cold (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010614382	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010614396	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614397	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Plasse, R.. Acute kidney injury with gross hematuria and IgA nephropathy after COVID-19 vaccination. Kidney International. 2021;100:944-945. doi:10.1016/j.kint.2021.07.020	Not Specified	Not Specified	No	Male	Acute kidney injury (n/a - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Haematuria (n/a - Recovered/Resolved - );IgA nephropathy (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614408	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614416	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010614442	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [965d - 10mg - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [625d - 8mg - n/a])|[DIAZEPAM] (C - Sleep disorder - n/a - [2064d - 2mg - n/a])|[FOLIC ACID] (C - n/a - n/a - [2742d - 5mg - n/a])|[METHOTREXATE, METHOTREXATE DISODIUM, METHOTREXATE SODIUM] (C - n/a - n/a - [653d - 25mg - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [1009d - 20mg - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [939d - 150mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010614444	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614450	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614609	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614621	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614625	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Chills (2d - Recovered/Resolved - Other Medically Important Condition);Gait inability (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Injection related reaction (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Sweating fever (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614628	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614665	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	No	Male	Exposure via breast milk (n/a - Recovering/Resolving - Other Medically Important Condition);Petechiae (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614735	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614737	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614738	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614739	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypopnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614740	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614743	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614744	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614751	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperglycaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614755	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614759	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dysphagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614760	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - );Malaise (n/a - Unknown - );Pain (n/a - Unknown - );Swelling (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010614771	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614774	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614775	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614779	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614781	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Pallor (n/a - Unknown - );Presyncope (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614799	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010614875	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sudden onset of sleep (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010614879	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Alopecia (n/a - Unknown - Disabling);Menstruation delayed (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010614882	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010614882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010615093	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	FORXIGA [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - Oral])|LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[ATENOLOL] (C - n/a - n/a - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010615170	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )|[ASCORBIC ACID, ZINC] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )|[CREATINE MONOHYDRATE] (C - n/a - n/a - )|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[LYMECYCLINE] (C - Acne - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010615277	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010615281	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MELATONIN [MELATONIN] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615286	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flatulence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gluten sensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (S - Contraception - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615292	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010615298	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010615299	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010615303	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (16d - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (23d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010615314	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615315	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dry eye (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615321	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615327	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010615330	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615342	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear infection (n/a - Unknown - );Epilepsy (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - );Lack of spontaneous speech (n/a - Unknown - );Malaise (n/a - Unknown - );Vocal cord paralysis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010615343	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615569	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cyanosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010615620	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615622	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615623	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615762	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615764	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615765	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615769	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615771	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615818	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Decreased activity (n/a - Not Recovered/Not Resolved - );Diaphragmatic hernia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Gastrooesophageal reflux disease (n/a - Unknown - );Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pericardial fibrosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010615819	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[RISPERIDONE] (C - Product used for unknown indication - n/a - [n/a - .5mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615839	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Intervertebral disc protrusion (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615898	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Recovered/Resolved - );Cough (2d - Not Recovered/Not Resolved - );Nasal congestion (3d - Recovered/Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Productive cough (n/a - Recovering/Resolving - );Pulmonary pain (2d - Not Recovered/Not Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615913	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615914	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615915	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010615938	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010615954	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Genital rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Localised oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Macule (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Papule (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus genital (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010615958	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010615961	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Testicular pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010615970	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010615970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616013	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (38d - Not Recovered/Not Resolved - );Fatigue (38d - Not Recovered/Not Resolved - );Muscle tightness (38d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010616120	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature (3d - Recovered/Resolved - );Diarrhoea (3d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616134	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[NAPROXEN SODIUM] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616145	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616178	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Injection site hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[EPINEPHRINE] (N - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616180	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616211	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616213	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616223	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Limb discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010616242	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616244	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616247	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616249	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616253	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616264	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616266	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616267	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Presyncope (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616269	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebrovascular disorder (n/a - Recovered/Resolved - );Haemangioma (n/a - Recovered/Resolved - );Haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616270	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic shock (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling face (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616272	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Throat tightness (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616276	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (62min - Recovered/Resolved - Life Threatening);Blood pressure decreased (62min - Recovered/Resolved - Life Threatening);Cold sweat (62min - Recovered/Resolved - Life Threatening);Conjunctival hyperaemia (62min - Recovered/Resolved - Life Threatening);Depressed level of consciousness (62min - Recovered/Resolved - Life Threatening);Eye pain (62min - Recovered/Resolved - Life Threatening);Fall (n/a - Unknown - );Pulse volume decreased (62min - Recovered/Resolved - Life Threatening);Shock (62min - Recovered/Resolved - Life Threatening);Tachycardia (62min - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010616283	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Unknown - );Dyspnoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pain (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616286	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616292	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616306	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (2d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616311	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Swollen tongue (1d - Recovered/Resolved - Other Medically Important Condition);Withdrawal syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616326	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Neutrophil count increased (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616340	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616346	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616347	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Influenza like illness (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616362	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumomediastinum (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Subcutaneous emphysema (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - Systemic lupus erythematosus - n/a - [n/a - n/a - Oral])|MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Antiphospholipid syndrome - n/a - [n/a - n/a - Oral])|[ALFACALCIDOL] (C - Osteoporosis prophylaxis - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - Prophylaxis against gastrointestinal ulcer - n/a - [n/a - n/a - Oral])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[PREDNISOLONE] (C - Systemic lupus erythematosus - n/a - [n/a - 6.5mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[SODIUM FERROUS CITRATE] (C - Anaemia - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - Pneumocystis jirovecii pneumonia - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Antiphospholipid syndrome - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616363	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cortisol decreased (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (17d - Recovered/Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010616364	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616365	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616371	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616377	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616378	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616380	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold-stimulus headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616390	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616391	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010616397	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616398	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616406	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Erythema (n/a - Recovering/Resolving - );Joint swelling (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616432	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood disorder (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010616434	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616540	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - );Thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616566	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Body temperature (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Eye pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616600	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616619	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE] (C - Hypertension - n/a - [3y - 5mg - Oral])|[BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - Peripheral venous disease - n/a - [20y - n/a - Oral])|[BUDESONIDE] (C - Asthma - n/a - [10y - 200ug - Respiratory (inhalation)])|[FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [10y - 12ug - Respiratory (inhalation)])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [2y - 850mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, SOLIFENACIN SUCCINATE] (C - Urinary tract disorder - n/a - [n/a - n/a - Oral])|[WARFARIN, WARFARIN SODIUM] (C - Thrombosis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010616723	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616727	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (5d - Not Recovered/Not Resolved - );Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616739	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Non-Hodgkin's lymphoma (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010616743	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (41d - Recovered/Resolved - );Rash (41d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616752	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010616763	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616765	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovering/Resolving - );Diarrhoea (1d - Recovering/Resolving - );Feeling cold (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616768	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Depressed mood (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616788	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616802	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616812	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Nausea (n/a - Unknown - );Paraesthesia (1d - Recovering/Resolving - );Sleep disorder (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616819	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Death (n/a - Fatal - Results in Death);Decreased appetite (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010616827	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Cough (n/a - Unknown - );Fatigue (n/a - Unknown - );Influenza (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616829	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (7d - Not Recovered/Not Resolved - );Fatigue (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Limb discomfort (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - );Tinnitus (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616837	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (1d - Recovering/Resolving - );Chills (0d - Recovered/Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616840	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (3d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616842	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Palpitations (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616843	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616850	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute disseminated encephalomyelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Injection site pain (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616860	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Diarrhoea (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Nausea (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616871	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616889	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovering/Resolving - );Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616902	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616909	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616915	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616917	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Venous thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010616919	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (6d - Not Recovered/Not Resolved - );Peripheral swelling (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616921	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616935	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (42d - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (42d - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616939	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010616946	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (10h - Recovered/Resolved - );Vomiting (10h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616952	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (1d - Recovering/Resolving - );Chills (0d - Recovered/Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616954	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010616956	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616957	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010616963	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (87d - Not Recovered/Not Resolved - );Head discomfort (87d - Not Recovered/Not Resolved - );Hyperhidrosis (87d - Not Recovered/Not Resolved - );Joint stiffness (87d - Not Recovered/Not Resolved - );Musculoskeletal stiffness (87d - Not Recovered/Not Resolved - );Neuralgia (87d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[BILASTINE] (C - n/a - Not applicable - )|[ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Not applicable - )|[PARACETAMOL] (C - n/a - Not applicable - )|[RAMIPRIL] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010616970	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertonia (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (1min - Recovered/Resolved - Other Medically Important Condition);Urinary incontinence (1min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616979	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010616985	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010616988	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait inability (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Liver disorder (n/a - Unknown - );Monoplegia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myositis (n/a - Unknown - );Pain (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Rash (n/a - Unknown - );Renal impairment (n/a - Unknown - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010616988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617064	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617068	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Iliotibial band syndrome (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Sinusitis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010617088	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010617256	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617281	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010617465	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Malaise (1d - Recovered/Resolved - Disabling);Musculoskeletal stiffness (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AZELNIDIPINE] (C - Hypertension - n/a - [n/a - 8mg - Oral])|[AZILSARTAN] (C - Hypertension - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010617466	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (2d - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Heart rate increased (n/a - Unknown - );Immunisation (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617470	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Disabling);Breath odour (1d - Recovered/Resolved - Disabling);Chills (1d - Recovered/Resolved - Disabling);Headache (1d - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nightmare (1d - Recovered/Resolved - Disabling);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010617474	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617482	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617485	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617493	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash vesicular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	COSENTYX [SECUKINUMAB] (C - Ankylosing spondylitis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617528	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617532	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617609	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (2d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010617633	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617634	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epicondylitis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617636	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Osteomyelitis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Swelling face (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010617638	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocardial oedema (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617641	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010617646	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617653	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Fatal - Results in Death);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010617664	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617668	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - );Dry mouth (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Taste disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thirst (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 100mg - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Hypersensitivity - n/a - [n/a - 10mg - n/a])|[ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617792	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010617854	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Adverse reaction (n/a - Not Recovered/Not Resolved - );C-reactive protein abnormal (n/a - Unknown - );COVID-19 immunisation (n/a - Unknown - );Cardiac discomfort (n/a - Unknown - );Chest pain (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [ELASOMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COLCHICINE] (C - n/a - n/a - )|[GINGER] (C - n/a - n/a - )|[IBUPROFEN] (C - Pericarditis - n/a - [148d - n/a - Oral])|[PREDNISOLONE] (C - Pericarditis - n/a - [n/a - n/a - Oral])|[TURMERIC] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617880	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (5d - Recovered/Resolved - );Heart rate increased (n/a - Unknown - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010617887	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial inflammatory dermatosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617894	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010617895	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|XIGDUO [METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010617908	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010617908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618094	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Psoriatic arthropathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - Oral])|[DICLOFENAC SODIUM] (C - n/a - n/a - [4y - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [10y - n/a - Oral])|[FINASTERIDE] (C - n/a - n/a - [10y - n/a - Oral])|[TIZANIDINE, TIZANIDINE HYDROCHLORIDE] (C - n/a - n/a - [4y - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010618136	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618140	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618143	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618151	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010618152	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebral haemorrhage (101d - Recovered/Resolved - Caused/Prolonged Hospitalisation);General physical condition abnormal (110d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618174	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Knee operation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618176	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Bedridden (3d - Recovered/Resolved - );Joint range of motion decreased (20d - Recovered/Resolved - );Limb discomfort (20d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618178	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Swelling face (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010618180	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (0d - Recovered/Resolved - );Local reaction (0d - Recovered/Resolved - );Somnolence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618185	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618203	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eczema (51d - Not Recovered/Not Resolved - );Rash (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010618214	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010618215	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (0d - Recovered/Resolved - );Arrhythmia (0d - Recovered/Resolved - );Cardiac discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010618220	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema nodosum (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618241	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - );Insomnia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618243	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (41d - Not Recovered/Not Resolved - );Hyperhidrosis (41d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010618248	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - );Injection site haemorrhage (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010618250	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (32d - Not Recovered/Not Resolved - );Injection site pruritus (32d - Not Recovered/Not Resolved - );Lymphadenopathy (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010618258	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Influenza like illness (1d - Recovering/Resolving - );Pain in extremity (1d - Recovering/Resolving - );Vaccination site reaction (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618260	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618263	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618267	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3mo - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation reaction (n/a - Unknown - );Mobility decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BUDESONIDE] (C - Mite allergy - n/a - [n/a - n/a - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010618269	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (4d - Not Recovered/Not Resolved - );Vaccination failure (4d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - Not applicable - [n/a - 20mg - Oral])|[ATORVASTATIN] (C - n/a - Not applicable - [n/a - 20mg - Oral])|[METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618277	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618288	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Mastication disorder (3d - Not Recovered/Not Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618292	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010618295	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coordination abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618303	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peyronie's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618311	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618319	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute disseminated encephalomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618327	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618331	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (6d - Unknown - );Limb discomfort (5d - Unknown - );Myalgia (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618332	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (6d - Not Recovered/Not Resolved - );Headache (6d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site erythema (5d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618333	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (63d - Recovering/Resolving - );Decreased appetite (63d - Recovering/Resolving - );Myalgia (63d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010618357	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (3d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010618358	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618359	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Back pain (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618367	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618370	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Hypersensitivity (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Paraesthesia oral (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010618372	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (5d - Recovered/Resolved - );Lymph node pain (33d - Recovered/Resolved - );Lymphadenopathy (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010618373	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Epilepsy (4d - Recovered/Resolved - );Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618392	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010618396	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lip swelling (4d - Recovered/Resolved - );Swelling face (4d - Recovered/Resolved - );Toothache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	[CLONIDINE HYDROCHLORIDE] (C - n/a - n/a - )|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - )|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618402	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618403	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618407	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618408	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618430	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618435	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);General physical health deterioration (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010618512	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (0d - Recovered/Resolved - Life Threatening);Burning sensation (0d - Recovered/Resolved - Life Threatening);Dysphonia (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010618611	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618620	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CALCIUM CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010618630	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618639	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Decreased appetite (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Nausea (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618651	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010618685	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site swelling (n/a - Recovered/Resolved - );Arthralgia (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Unknown - );Muscle spasms (n/a - Recovered/Resolved - );Myalgia (n/a - Unknown - );Pain (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010618812	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618832	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618889	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Anomalous pulmonary venous connection (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Atrial septal defect (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Atrioventricular septal defect (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Double outlet right ventricle (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Foetal exposure during pregnancy (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Heterotaxia (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Hypoplastic left heart syndrome (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Inferior vena caval occlusion (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - Transplacental])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (S - Anxiety - Not applicable - [n/a - 50mg - Transplacental])	[FOLIC ACID] (C - n/a - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	Severe reaction
EU-EC-10010618910	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE MESILATE MONOHYDRATE] (C - n/a - n/a - )|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010618924	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618926	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618931	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010618940	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Axillary pain (3d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010618940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619013	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619014	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619015	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (10d - Recovered/Resolved - );Mouth ulceration (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ovarian cyst (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619019	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619025	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ataxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyporeflexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Myoclonus (n/a - Unknown - Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Oscillopsia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraneoplastic syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619027	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	FYCOMPA [PERAMPANEL] (S - n/a - Dose not changed - [n/a - 2mg - Oral - More in ICSR])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619029	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619030	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Menstrual disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619031	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Lower respiratory tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - );Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - n/a - n/a - [n/a - n/a - n/a])|LEVETIRACETAM [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[BACLOFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PHENYTOIN] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[PROCYCLIDINE] (C - Dystonia - n/a - [n/a - n/a - n/a])|[SENNA ALEXANDRIAN] (C - Constipation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619032	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619037	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - 300mg - Oral])|[DOCUSATE SODIUM] (C - Constipation - n/a - [n/a - 200mg - Oral])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 20mg - Oral])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619042	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619046	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (7d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619051	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Meralgia paraesthetica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619052	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619053	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Pulmonary embolism - n/a - [n/a - 5mg - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619114	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Disturbance in attention (2h - Recovered/Resolved - Other Medically Important Condition);Fatigue (2h - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619118	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Unresponsive to stimuli (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619122	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619126	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Axillary pain (n/a - Unknown - );Burning sensation (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Headache (n/a - Unknown - );Heart rate abnormal (n/a - Unknown - );Insomnia (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Mydriasis (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Vein disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619130	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - );Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619134	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Skin discolouration (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619153	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619155	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - Epilepsy - n/a - [40y - 600mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619261	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Life Threatening, Other Medically Important Condition);Skin warm (n/a - Unknown - Life Threatening, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010619273	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Rash (n/a - Recovering/Resolving - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010619274	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blindness (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[WARFARIN SODIUM] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619287	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - );Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619295	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Dysphoria (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619297	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (1d - Recovered/Resolved - Life Threatening);Paraesthesia oral (1d - Recovered/Resolved - Life Threatening);Rash pruritic (1d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - 4{DF} - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 8{DF} - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 2{DF} - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010619298	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Anaphylactic reaction (n/a - Recovering/Resolving - Life Threatening);Immunisation (n/a - Unknown - Life Threatening);Interchange of vaccine products (n/a - Unknown - Life Threatening);Off label use (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010619299	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619306	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Neoplasm malignant (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619307	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619314	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619324	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619325	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619326	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Conjunctivitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619380	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619383	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619384	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619387	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619395	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010619423	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619495	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619496	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619498	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[NALOXONE HYDROCHLORIDE DIHYDRATE, TILIDINE HYDROCHLORIDE HEMIHYDRATE, NALOXONE HYDROCHLORIDE, TILIDINE HYDROCHLORIDE, TILIDINE, NALOXONE HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619541	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );Arthralgia (n/a - Unknown - Life Threatening);Back pain (n/a - Unknown - Life Threatening);Myalgia (n/a - Unknown - Life Threatening);Skin irritation (n/a - Unknown - Life Threatening);Somnolence (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010619547	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Influenza (2d - Recovered/Resolved - );Oropharyngeal pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rhinitis (2d - Recovered/Resolved - Disabling);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - Arrhythmia - n/a - [n/a - 25mg - Oral - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010619549	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619550	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (30d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (2d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619556	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chest pain (23d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACTINOQUINOL] (C - Eye infection - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoporosis - n/a - [n/a - n/a - n/a])|[LENOGRASTIM] (C - Neutropenia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 75ug - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Pain - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYALURONATE] (C - Eye infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010619559	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (20h - Recovered/Resolved With Sequelae - Other Medically Important Condition);Paraesthesia (20h - Recovered/Resolved - Other Medically Important Condition);Tenderness (20h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010619595	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axonal neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619671	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (13d - Recovered/Resolved - );Fatigue (30d - Recovered/Resolved - );Feeling hot (2d - Recovering/Resolving - );Injection site pain (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010619672	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619675	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619676	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619687	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619692	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619693	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619729	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619731	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (48h - Recovered/Resolved - );Memory impairment (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619737	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619752	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (14d - Recovered/Resolved - );Rash (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619762	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blepharospasm (6d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010619764	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (4d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Lymph node pain (4d - Not Recovered/Not Resolved - );Lymphadenopathy (4d - Not Recovered/Not Resolved - );Myalgia (4d - Recovered/Resolved - );Nausea (4d - Recovering/Resolving - );Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619767	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Somnolence (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619785	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619786	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (16d - Not Recovered/Not Resolved - );Vaccination site nerve damage (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619791	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Hallucination, auditory (1d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619793	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (9d - Recovered/Resolved - );Hypotonia (13d - Recovering/Resolving - );Limb discomfort (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619795	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (3d - Recovering/Resolving - );Body temperature increased (3d - Recovering/Resolving - );Injection site swelling (3d - Recovering/Resolving - );Lymphadenopathy (3d - Recovering/Resolving - );Peripheral swelling (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619831	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Recovering/Resolving - );Nasal congestion (2d - Recovering/Resolving - );Oropharyngeal pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619873	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619875	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (11d - Not Recovered/Not Resolved - );Headache (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619877	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619904	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Extrasystoles (n/a - Recovered/Resolved - Other Medically Important Condition);Myopericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010619929	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619932	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619939	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Oral herpes (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619955	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619962	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010619984	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010619992	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspepsia (11d - Recovering/Resolving - );Fatigue (11d - Recovering/Resolving - );Headache (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010619992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620016	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Paraesthesia oral (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Vision blurred (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010620017	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Cardiac discomfort (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Extrasystoles (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620020	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620026	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cellulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Marasmus (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	MICARDIS [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - Oral])|PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - Oral])|[AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE PH. EUR.] (C - Illness - n/a - [n/a - n/a - Oral])|[CASSIA, SENNA GLYCOSIDES STANDARDIZED 60%, SENNOSIDES CALCIUM SALTS] (C - Illness - n/a - [n/a - n/a - Oral])|[LEVETIRACETAM] (C - Illness - n/a - [n/a - n/a - Oral])|[LIMAPROST] (C - Illness - n/a - [n/a - n/a - Oral])|[MINODRONIC ACID] (C - Illness - n/a - [n/a - n/a - Oral])|[PROPIVERINE HYDROCHLORIDE] (C - Illness - n/a - [n/a - n/a - Oral])|[TAK 438] (C - n/a - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Illness - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010620098	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620118	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Colitis ulcerative (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620131	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620152	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysuria (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620221	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [n/a - n/a - Subcutaneous])|[LAMOTRIGINE] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620288	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620291	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Daydreaming (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620324	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature decreased (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620325	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Plasse, R.. Acute kidney injury with gross hematuria and IgA nephropathy after COVID-19 vaccination. Kidney International. 2021;100:944-945. doi:10.1016/j.kint.2021.07.020	Not Specified	Not Specified	No	Male	Acute kidney injury (n/a - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Haematuria (3d - Recovered/Resolved - );IgA nephropathy (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620327	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620329	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620330	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Dizziness exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myelitis transverse (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620335	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bronchospasm (n/a - Fatal - Results in Death);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010620344	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620377	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620391	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620400	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620425	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620432	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Muscle strength abnormal (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620446	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620470	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Rhinalgia (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620475	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeding disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Incontinence (4d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620480	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenopia (n/a - Recovering/Resolving - );Eye swelling (n/a - Recovering/Resolving - );Eyelid irritation (n/a - Recovering/Resolving - );Eyelid pain (n/a - Recovering/Resolving - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - );Feeling hot (n/a - Unknown - );Heart rate increased (n/a - Recovering/Resolving - );Hemiplegia (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Initial insomnia (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Pain (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620481	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Atrial tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - );Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Stress at work (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010620546	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (14d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (14d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010620557	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Autoscopy (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620685	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Cardiac flutter (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Hypertension (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Suicidal ideation (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010620717	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Recovered/Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[DRY EXTRACT OF GINKGO BILOBA LEAVES (35-67:1), EXTRACTION SOLVENT: ACETONE 60% ( M / M), GINKGO BILOBA] (C - n/a - n/a - )|[FOLIC ACID, DRIED FERROUS SULFATE, FOLIC ACID, FERROUS ION, FOLIC ACID, FERROUS SULFATE HYDRATE] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - )|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - )|[ROSUVASTATIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620718	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620719	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620725	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ATORVASTATIN] (C - n/a - n/a - )|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010620736	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620797	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain of skin (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620798	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (30min - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (30min - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620802	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010620854	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620868	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - );Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010620904	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620921	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620922	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620932	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ophthalmic migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[MORINGA OLEIFERA WHOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010620949	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Excessive cerumen production (n/a - Unknown - Disabling, Other Medically Important Condition);Illness (n/a - Unknown - Disabling, Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010620950	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Arthralgia (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Fatigue (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (4d - Recovered/Resolved - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Disabling, Other Medically Important Condition);Hyperhidrosis (5d - Recovered/Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010620950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010621054	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621055	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621057	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621065	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621073	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621137	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621160	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (9d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (9d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621164	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621171	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Exposure via breast milk (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621172	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621173	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Schwotzer, N.. Letter regarding &quot;Minimal change disease relapse following SARS-CoV-2 mRNA vaccine&quot;. Kidney International. 2021;100(2):458-459. doi:10.1016/j.kint.2021.05.006	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Nephrotic syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010621183	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (7d - Recovered/Resolved With Sequelae - Disabling);Neurosarcoidosis (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010621286	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621289	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Dysaesthesia (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621297	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621298	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621322	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621330	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621334	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621339	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperaesthesia (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	BENEPALI [ETANERCEPT] (C - Psoriatic arthropathy - n/a - [8y - 1{DF} - Subcutaneous])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - 5mg - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - 18ug - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621357	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral haemorrhage (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621358	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621361	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Left ventricular failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621438	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621443	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621450	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621453	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621459	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621460	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621462	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621469	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621475	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyskinesia (n/a - Recovered/Resolved With Sequelae - Disabling);Ear pain (n/a - Recovered/Resolved With Sequelae - Disabling);Facial pain (n/a - Recovered/Resolved With Sequelae - Disabling);Gingival pain (n/a - Recovered/Resolved With Sequelae - Disabling);Gingival recession (n/a - Recovered/Resolved With Sequelae - Disabling);Herpes zoster (n/a - Recovered/Resolved With Sequelae - Disabling);Toothache (n/a - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010621477	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010621478	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunodeficiency (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621540	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Gastrointestinal disorder (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Skin disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621541	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [1261d - n/a - Oral])|METFORMIN HYDROCHLORIDE, VILDAGLIPTIN [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Diabetes mellitus - n/a - [1261d - n/a - Oral])|[BETHANECHOL CHLORIDE] (C - n/a - n/a - [337d - n/a - Oral])|[GLIMEPIRIDE] (C - n/a - n/a - [513d - n/a - Oral])|[LANSOPRAZOLE] (C - Gastric ulcer - n/a - [1261d - n/a - Oral])|[PIOGLITAZONE HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [1261d - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [1261d - n/a - Oral])|[SILODOSIN] (C - n/a - n/a - [337d - 2{DF} - n/a])|[TELMISARTAN, AMLODIPINE BESILATE] (C - n/a - n/a - [919d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010621624	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621625	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621639	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Injection site inflammation (18d - Recovered/Resolved - );Injection site pain (18d - Recovered/Resolved - );Injection site warmth (18d - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621680	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621706	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photophobia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product administered at inappropriate site (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621761	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621762	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621765	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621769	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010621824	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac tamponade (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010621862	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621863	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621865	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621891	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010621894	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621902	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621903	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010621914	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (84d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[MESALAZINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621918	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (7d - Recovered/Resolved - );Feeling of body temperature change (7d - Recovered/Resolved - );Flushing (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Illness (7d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621919	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Haematochezia (2d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010621929	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (28d - Recovered/Resolved - Life Threatening);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Dizziness (7d - Recovered/Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Lymphadenopathy (28d - Recovered/Resolved - Life Threatening);Myalgia (15d - Recovered/Resolved - Life Threatening);Pyrexia (15d - Recovered/Resolved - Life Threatening);Vaccination site pain (6d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010621941	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Sudden hearing loss (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010621968	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010621982	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune system disorder (n/a - Recovering/Resolving - Disabling);Type 1 diabetes mellitus (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010621987	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lacunar infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010621988	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010621988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010622001	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010622002	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Unknown - Disabling);Cough (n/a - Not Recovered/Not Resolved - Disabling);Eye pain (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hyperphagia (n/a - Unknown - Disabling);Illness (n/a - Unknown - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010622009	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010622015	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pneumothorax spontaneous (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010622026	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010622170	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Edwards, A.. Acute hyperglycaemic crisis after vaccination against COVID-19: A case series. Diabetic Medicine. 2021;38(11):10.1111/dme.14631. doi:10.1111/dme.14631	18-64 Years	Not Specified	No	Male	Hyperglycaemia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010622213	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622242	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010622243	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (S - Seasonal allergy - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622245	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (79d - Recovered/Resolved - );Headache (79d - Recovered/Resolved - );Lymphadenopathy (79d - Recovered/Resolved - );VIth nerve paralysis (79d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010622247	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	CHEMOTHERAPIE (CYTOSTATICUM, ANTINEOPLASTISCHE MEDICATIE) [NOT AVAILABLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622327	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010622338	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysphoria (n/a - Unknown - );Erythema (n/a - Recovering/Resolving - );Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010622357	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622361	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010622381	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622383	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Anencephaly (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[FOLIC ACID] (C - Supplementation therapy - n/a - [n/a - n/a - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010622417	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Incomplete course of vaccination (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010622420	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622432	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622469	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010622529	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Fatal - Results in Death);Headache (n/a - Fatal - Results in Death);Illness (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010622540	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus management - n/a - [n/a - n/a - Oral])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - Oral])|[INSULIN GLARGINE] (C - Diabetes mellitus management - n/a - [n/a - n/a - Subcutaneous])|[LINAGLIPTIN] (C - Diabetes mellitus management - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus management - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010622543	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Anal incontinence (11h - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (11h - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (11h - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (11h - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperthermia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (11h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010622545	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Disabling);Nausea (3d - Recovered/Resolved With Sequelae - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010622558	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - );Hypertensive crisis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010622589	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010622718	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622745	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arterial occlusive disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Immunisation (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010622798	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - );Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622855	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Illness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010622859	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622865	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXYCARBAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622880	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010622884	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010622953	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010622966	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010622966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010623028	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Disease recurrence (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010623029	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623050	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010623053	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623058	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010623123	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (173d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623138	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623140	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623141	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (74d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623144	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623149	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623150	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (74d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623158	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623159	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (44d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623170	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (22d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623230	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (87d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010623302	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Ischaemic cerebral infarction (13d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623357	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (91d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623432	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623459	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Unknown - );Headache (n/a - Unknown - );Movement disorder (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - );Pain in jaw (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Toxic shock syndrome (n/a - Unknown - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010623465	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Drug hypersensitivity (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (n/a - Not Recovered/Not Resolved - );Face oedema (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Muscle tightness (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myoclonus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ocular discomfort (n/a - Not Recovered/Not Resolved - );Ocular hyperaemia (n/a - Not Recovered/Not Resolved - );Presyncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623495	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623543	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomegaly (n/a - Unknown - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoxia (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	XULTOPHY [LIRAGLUTIDE, INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - n/a])|[CHLORTALIDONE, AZILSARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623552	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010623581	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010623584	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoglycaemia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	GLIBENCLAMIDE [GLIBENCLAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623625	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010623670	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (13d - Recovered/Resolved - );Asthenia (13d - Recovered/Resolved - );Pyrexia (13d - Recovered/Resolved - );Vaccination site pain (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010623685	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623708	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Testicular oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Testicular pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010623715	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[DYDROGESTERONE, ESTRADIOL, DYDROGESTERONE, ESTRADIOL HEMIHYDRATE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010623717	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010623790	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	APIDRA 100 U/ML SOLUTION FOR INJECTION IN CARTRIDGE [INSULIN GLULISINE] (C - Product used for unknown indication - Not applicable - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - 2.5mg - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010623798	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diabetes mellitus inadequate control (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TRAJENTA 5 MG FILM-COATED TABLETS [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010623835	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010623909	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Limb discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Polymyalgia rheumatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypometabolism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010623985	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[MELATONIN] (C - Insomnia - n/a - [2329d - n/a - Oral])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Disturbance in attention - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010623985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624027	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Feeling abnormal (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010624033	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diaphragmalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624045	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in jaw (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CITALOPRAM] (C - Anxiety - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624051	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010624066	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dizziness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624068	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624070	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624075	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624079	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Unknown - );Feeling hot (n/a - Unknown - );Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624081	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624088	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624102	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624104	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624106	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624111	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Musculoskeletal chest pain (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624115	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation irregular (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624153	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624157	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624170	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624211	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624248	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Contusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Haematoma (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624262	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Aphasia (n/a - Unknown - Results in Death, Caused/Prolonged Hospitalisation, Disabling);Ataxia (n/a - Unknown - Results in Death, Caused/Prolonged Hospitalisation, Disabling);Hemiparesis (n/a - Unknown - Results in Death, Caused/Prolonged Hospitalisation, Disabling);Ischaemic cerebral infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE)] (S - Influenza immunisation - Not applicable - [n/a - .7mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010624283	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010624288	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (2d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CARVEDILOL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010624374	Spontaneous	2021-11-11 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|INTUNIV [GUANFACINE] (S - Attention deficit hyperactivity disorder - Unknown - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010624419	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gout (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010624421	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Exsanguination (n/a - Recovered/Resolved - Other Medically Important Condition);Incorrect route of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Other])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010624440	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Injection site swelling (2d - Recovered/Resolved - );Nausea (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	AERIUS 5 MG FILM-COATED TABLETS [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010624504	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624507	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (30d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010624514	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypertension (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624518	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624521	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Splenic rupture (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624526	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624537	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (124d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624538	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmoplegia (116d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624540	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (39d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624544	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (104d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624552	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624560	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624564	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Lymphadenopathy (208d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624568	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624583	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (115d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624603	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crohn's disease (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624605	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (42d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (17d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624626	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624642	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (80d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624651	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624657	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010624702	Spontaneous	2021-11-11 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chronic kidney disease (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010624702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601110	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hallucination (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010601136	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Injection site pain (n/a - Unknown - );Migraine (n/a - Unknown - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vertigo (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601138	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601157	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601219	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601223	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601232	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (0d - Recovered/Resolved - );Asthenia (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601239	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601240	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601276	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601291	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601317	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Musculoskeletal chest pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601342	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Salivary hypersecretion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601343	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute respiratory failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601354	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010601361	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010601370	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain stem stroke (n/a - Not Recovered/Not Resolved - Disabling);Monoparesis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010601375	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (39d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Confusional state (39d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ischaemic stroke (39d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - n/a])|VIPIDIA [ALOGLIPTIN] (C - n/a - n/a - [n/a - 25mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - 50mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - 60mg - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 30mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1500mg - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601377	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601390	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysgraphia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extrapyramidal disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Impaired work ability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle rigidity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601395	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010601398	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010601410	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Unknown - );Flank pain (n/a - Unknown - );Herpes zoster (n/a - Unknown - );Nausea (n/a - Unknown - );Pruritus (n/a - Unknown - );Pustule (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010601412	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601413	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601416	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601419	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010601425	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601426	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Disabling);Atrial flutter (n/a - Recovered/Resolved With Sequelae - Disabling);Atrial tachycardia (n/a - Recovered/Resolved With Sequelae - Disabling);Hypotension (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - 200mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010601427	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pleurisy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010601428	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010601447	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601449	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601488	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flushing (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Superficial vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010601493	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601500	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .45mL - Intramuscular])	[DELORAZEPAM] (C - Borderline personality disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601518	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010601524	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601545	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601549	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Furuncle (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601568	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601572	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral motor neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601577	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Crohn's disease (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Weight decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010601581	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to arthropod sting (n/a - Recovered/Resolved - );Axillary pain (n/a - Recovered/Resolved - );Injection site oedema (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601630	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - );Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - .3mL - n/a])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010601659	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Band sensation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010601679	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Cough (n/a - Unknown - );Disorientation (n/a - Unknown - );Dysgeusia (n/a - Unknown - );Malaise (n/a - Unknown - );Rhinitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010601691	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601696	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601722	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bladder sphincter atony (n/a - Recovering/Resolving - Disabling);Hemiparesis (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Myelopathy (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010601723	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010601734	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010601734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010602103	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Contusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[PREDNISONE] (S - n/a - Dose not changed - [n/a - 8mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602104	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602112	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Anxiety disorder (n/a - Not Recovered/Not Resolved - );Capillary disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Spider vein (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Telangiectasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site bruising (n/a - Not Recovered/Not Resolved - );Vein disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 125ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602121	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neuromyelitis optica spectrum disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010602122	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematochezia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602134	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria thermal (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602136	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Sinus node dysfunction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602152	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602165	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pancreatitis acute (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602167	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602177	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602189	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (195min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602192	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[ALGELDRATE, TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN, ALUMINIUM, TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN, TICK-BORNE ENCEPHALITIS VIRUS, TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN] (S - Immunisation - Not applicable - [1d - .5mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010602193	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602195	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602202	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Polycythaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010602211	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Reflux gastritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602215	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypervolaemia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Mass (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010602216	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Myocardial necrosis marker increased (0d - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (0d - Recovered/Resolved - Other Medically Important Condition);Retrograde amnesia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CONSTELLA [LINACLOTIDE] (C - n/a - n/a - [n/a - 250mg - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Prophylaxis - n/a - [n/a - 40mg - Oral])|[HYDROMORPHONE HYDROCHLORIDE] (C - Pain - n/a - [n/a - 48mg - Oral])|[LISINOPRIL] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602222	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602235	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602240	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602242	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602245	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010602257	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (10min - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602278	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[PREDNISOLONE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010602283	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010602289	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Coma (n/a - Unknown - Other Medically Important Condition);Haemorrhagic stroke (2d - Fatal - Results in Death);Thalamus haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[BROMAZEPAM] (C - n/a - n/a - [n/a - 12[drp] - Oral])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010602439	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Night sweats (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ocular hyperaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010602448	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);White blood cell count increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010602832	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (S - n/a - Unknown - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (S - Chest pain - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (S - Myocarditis - n/a - [n/a - n/a - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010602832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603084	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (1mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603104	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest discomfort (n/a - Recovering/Resolving - );Dysphagia (n/a - Unknown - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - );Throat tightness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[TESTOSTERONE ENANTATE] (C - n/a - n/a - [n/a - 2mg - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010603135	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603165	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site bruising (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603169	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Pelvic pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603172	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603217	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010603220	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603226	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603272	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - );Injection site pruritus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603275	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	AVAMYS NASAL SPRAY SUSPENSION [FLUTICASONE FUROATE] (C - Chronic sinusitis - n/a - [n/a - n/a - n/a])|[ACETYLCYSTEINE] (C - n/a - n/a - )|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - Bronchiectasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603329	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (3d - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603344	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[BUDESONIDE, BUDESONIDE, MICRONISED] (C - Asthma - n/a - [n/a - n/a - n/a])|[FOLIC ACID, FOLIC ACID, ANHYDROUS] (C - Nausea, Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[METHOTREXATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603357	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspepsia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603509	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603608	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603610	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603622	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperaesthesia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603623	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Flushing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sneezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wheezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603625	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Infantile vomiting (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603631	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Relapsing fever (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603637	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603642	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603645	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603649	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature fluctuation (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603654	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Eye pruritus (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010603661	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603676	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603681	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Disorientation (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603684	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603705	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Back pain (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mobility decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary retention (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISDEXAMFETAMINE DIMESYLATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603721	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (47d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (47d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral swelling (47d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (47d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010603730	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603736	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603737	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603741	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Appetite disorder (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Dysstasia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603747	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603750	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphoma (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010603754	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603756	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Arthropathy (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603758	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Neutrophil count increased (n/a - Unknown - Other Medically Important Condition);Pyrexia (12d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603776	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (36h - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (36h - Recovered/Resolved - Other Medically Important Condition);Myocarditis (2d - Recovered/Resolved - Other Medically Important Condition);Palpitations (36h - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603785	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603793	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Ankylosing spondylitis (n/a - Unknown - Other Medically Important Condition);Extra dose administered (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603794	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Influenza (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603799	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Subarachnoid haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[LATANOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603801	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603804	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Blood pressure decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Body temperature increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - );Chronic obstructive pulmonary disease (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Hypophagia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleurisy (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rales (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CELECOXIB [CELECOXIB] (C - Femoral neck fracture - n/a - [n/a - 400mg - Oral])|CLOPIDOGREL HYDROGEN SULFATE [CLOPIDOGREL HYDROGEN SULFATE] (C - Colitis ischaemic - n/a - [n/a - 75mg - Oral])|[AMBROXOL HYDROCHLORIDE] (C - Sputum increased - n/a - [n/a - 45mg - Oral])|[BROMHEXINE HYDROCHLORIDE] (C - Productive cough - n/a - [11d - 4mL - Respiratory (inhalation) - More in ICSR])|[GINSENG, RIKKUNSHITO] (C - Postoperative care - n/a - [n/a - n/a - Oral])|[REBAMIPIDE] (C - Femoral neck fracture - n/a - [n/a - 200mg - Oral])|[SALBUTAMOL SULFATE] (C - Productive cough - n/a - [11d - 1mg - Respiratory (inhalation) - More in ICSR])|[SODIUM CHLORIDE SOLUTION 0.9%] (C - Productive cough - n/a - [11d - 8mL - Respiratory (inhalation) - More in ICSR])|[TULOBUTEROL] (C - Chronic obstructive pulmonary disease - n/a - [22d - 2mg - Transdermal])|[TULOBUTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - 1mg - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010603830	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Brain fog (n/a - Unknown - Other Medically Important Condition);Depression (n/a - Recovering/Resolving - );Road traffic accident (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603832	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Mental impairment (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603833	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603834	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603838	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603840	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - );Chest discomfort (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Painful respiration (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603842	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypotension (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603847	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603849	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010603855	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Physical deconditioning (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Polyarthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rheumatoid arthritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PREDNISOLONE, PREDNISOLONE ACETATE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010603862	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010603868	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin I increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603873	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010603895	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603917	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603918	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HUMIRA 40 MG [ADALIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010603976	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010603976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604052	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010604097	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604148	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoplegia (n/a - Not Recovered/Not Resolved - Disabling);Oedema peripheral (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[DIAZEPAM] (C - Drug abuser - n/a - [n/a - n/a - Oral])|[MIRTAZAPINE] (C - Drug abuser - n/a - [n/a - n/a - Oral])|[QUETIAPINE] (C - Drug abuser - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010604149	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Musculoskeletal discomfort (0d - Recovered/Resolved - Other Medically Important Condition);Nocturnal dyspnoea (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Spinal pain (n/a - Unknown - Other Medically Important Condition);Therapeutic product effect incomplete (n/a - Unknown - Other Medically Important Condition);Walking aid user (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [1d - n/a - n/a])|[FUROSEMIDE] (S - Product used for unknown indication - Unknown - [34d - 40mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010604176	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604179	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604180	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604220	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arterial rupture (n/a - Recovered/Resolved - Other Medically Important Condition);Haematuria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010604395	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dermatitis allergic (n/a - Recovering/Resolving - Other Medically Important Condition);Eye swelling (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Unknown - Other Medically Important Condition);Pharyngeal swelling (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604398	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010604402	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604409	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Eczema (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604416	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604419	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Unknown - );Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604423	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (6d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Mediastinal mass (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010604424	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604429	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Monoplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ACTOS [PIOGLITAZONE, PIOGLITAZONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLCYSTEINE] (C - n/a - n/a - [n/a - n/a - Oral])|[AMBROXOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[BETAHISTINE MESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SOLIFENACIN, SOLIFENACIN SUCCINATE] (C - n/a - n/a - [n/a - n/a - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010604437	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Joint swelling (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604438	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604444	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010604446	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - Other Medically Important Condition);Syncope (18h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010604449	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010604454	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (10d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sputum increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE BESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Antiallergic therapy - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604461	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604467	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );COVID-19 (15d - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (15d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010604476	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Depression (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604504	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604505	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Lethargy (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604565	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010604577	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604639	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - 150mg - Oral])|[GLICLAZIDE] (C - n/a - n/a - [n/a - 30mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604659	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604661	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010604664	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myositis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [60d - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604697	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Unknown - Life Threatening);Myocardial infarction (1d - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010604843	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Unknown - );Injection site reaction (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604846	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604849	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Sluggishness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604875	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Metastatic bronchial carcinoma (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010604876	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovering/Resolving - );Hemiparaesthesia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604887	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010604888	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Lacrimation increased (1d - Recovered/Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Myalgia (4d - Recovering/Resolving - );Pain (1d - Recovered/Resolved - );Photophobia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604893	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (0d - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604910	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Metastatic bronchial carcinoma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010604917	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010604931	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010604982	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Nerve injury (43d - Not Recovered/Not Resolved - );Paralysis (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010604982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010605010	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Brugada syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010605012	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (16d - Recovered/Resolved With Sequelae - );Arrhythmia (16d - Recovered/Resolved With Sequelae - );Dyspnoea (16d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010605014	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (47d - Not Recovered/Not Resolved - );Rash (47d - Not Recovered/Not Resolved - );Swelling (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010605017	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (21d - Not Recovered/Not Resolved - );Dizziness (21d - Not Recovered/Not Resolved - );Headache (21d - Not Recovered/Not Resolved - );Memory impairment (21d - Not Recovered/Not Resolved - );Visual impairment (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010605029	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (95d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010605038	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605048	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (0d - Unknown - );Myalgia (0d - Unknown - );Pain in extremity (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605060	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605063	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Gingival disorder (0d - Not Recovered/Not Resolved - );Gingival pain (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605064	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605070	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fall (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010605072	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605086	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (11d - Recovering/Resolving - );Dyspnoea (22d - Not Recovered/Not Resolved - );Headache (20d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (23d - Unknown - );Pyrexia (14d - Unknown - );Weight bearing difficulty (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010605089	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605090	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605096	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (1d - Recovered/Resolved - );Lymph node pain (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Peripheral vascular disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605102	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605115	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010605117	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605118	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605131	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spondylitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010605202	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Insomnia (3d - Recovered/Resolved - );Palpitations (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010605318	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Respiratory symptom (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605319	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea haemorrhagic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010605567	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic dissection (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Aortic dissection rupture (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Carotid artery stenosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebrovascular stenosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Drainage (n/a - Unknown - Caused/Prolonged Hospitalisation);Femoral artery embolism (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Groin pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Intrapericardial thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Orchitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral artery surgery (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Peripheral ischaemia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Precerebral artery occlusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Sepsis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Testicular abscess (n/a - Unknown - Caused/Prolonged Hospitalisation);Testicular operation (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010605639	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605651	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood glucose increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Drug hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Leukocytosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (I - n/a - Not applicable - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (I - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010605802	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605816	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010605863	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010605865	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605877	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (20min - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (20min - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Sense of oppression (20min - Recovered/Resolved - );Tremor (20min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010605878	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605879	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605881	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605883	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605895	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010605896	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010605896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606022	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (8d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010606193	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606196	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010606330	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Not Recovered/Not Resolved - );Dizziness (n/a - Unknown - );Headache (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606338	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Migraine with aura (0d - Recovering/Resolving - );Night sweats (0d - Recovering/Resolving - );Paraesthesia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606341	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Recovering/Resolving - );Injection site erythema (8d - Recovering/Resolving - );Tachycardia (8d - Recovering/Resolving - );Vaccination site swelling (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606364	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain lower (0d - Not Recovered/Not Resolved - );Chills (61d - Not Recovered/Not Resolved - );Dizziness (9d - Not Recovered/Not Resolved - );Fatigue (50d - Not Recovered/Not Resolved - );Loss of consciousness (9d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Peripheral vascular disorder (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606369	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606375	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606378	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606380	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (23d - Recovering/Resolving - );Headache (23d - Recovering/Resolving - );Influenza (23d - Recovering/Resolving - );Limb discomfort (23d - Recovering/Resolving - );Oropharyngeal pain (23d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010606390	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Balance disorder (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Muscle spasms (0d - Recovered/Resolved - );Muscle twitching (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606391	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (5d - Recovering/Resolving - );Chest discomfort (5d - Recovering/Resolving - );Dyspnoea (5d - Recovering/Resolving - );Heart rate increased (5d - Recovering/Resolving - );Sense of oppression (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606396	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010606399	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606405	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - );Hypoaesthesia (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606409	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Unknown - );Angina pectoris (n/a - Unknown - );Arrhythmia (n/a - Unknown - );Feeling hot (n/a - Unknown - );Influenza (n/a - Unknown - );Injection site pain (n/a - Unknown - );Nausea (n/a - Unknown - );Pulmonary pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606435	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Neck pain (0d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606436	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010606437	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010606441	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606447	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (0d - Recovered/Resolved - );Feeling cold (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606466	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606473	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010606485	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure diastolic increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010606488	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Malaise (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606490	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606499	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (36d - Recovering/Resolving - );Rash (36d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606521	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	EXFORGE [VALSARTAN, AMLODIPINE, VALSARTAN, AMLODIPINE BESILATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010606524	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606536	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606538	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606546	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - );Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010606547	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606552	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Asthenia (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606566	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606567	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606573	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606574	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606579	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606585	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606611	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Swelling (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606613	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Movement disorder (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010606628	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010606633	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Psoriasis (13d - Recovering/Resolving - );Rash (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606636	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606640	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (3d - Not Recovered/Not Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606642	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606649	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (5d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606651	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatitis (11d - Recovering/Resolving - );Pruritus (11d - Recovering/Resolving - );Rash (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606662	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (15d - Not Recovered/Not Resolved - );Influenza like illness (15d - Not Recovered/Not Resolved - );Myalgia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606796	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606799	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010606906	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606907	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606911	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606914	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606919	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606925	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606931	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606933	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606938	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010606943	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (20d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010606943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010607027	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (6d - Not Recovered/Not Resolved - );Abdominal distension (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010607030	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010607043	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal discomfort (4d - Recovered/Resolved - Other Medically Important Condition);Abdominal pain upper (17h - Recovered/Resolved - Other Medically Important Condition);Asthenia (5d - Recovered/Resolved - Other Medically Important Condition);Bedridden (n/a - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Flushing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (2d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (2d - Recovered/Resolved - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus congestion (1wk - Recovered/Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CETIRIZINE DIHYDROCHLORIDE] (C - Multiple allergies - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607049	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010607068	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Cardiac arrest (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010607174	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607248	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607256	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607261	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607263	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607273	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607278	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607280	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607283	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607288	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607292	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607293	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607294	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607300	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607306	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607309	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607311	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607358	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Brain oedema (0d - Fatal - Results in Death);Cerebral haemorrhage (0d - Fatal - Results in Death);Fall (0d - Fatal - Results in Death);Skull fracture (0d - Fatal - Results in Death);Subdural haematoma (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607411	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenopia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010607435	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607438	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (8d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vascular pseudoaneurysm (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607440	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607441	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin abnormal (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607453	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	FLUTICASONE FUROATE [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607454	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood pressure increased (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[EPLERENONE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[MOXONIDINE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607459	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607466	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607468	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607471	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607472	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Nodule (n/a - Unknown - Caused/Prolonged Hospitalisation);Sensory loss (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607477	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (2wk - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607577	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gingival bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	RIVAROXABAN [RIVAROXABAN] (C - Pulmonary resection - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607583	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Depressed level of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition);Ventricular tachycardia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BACILLUS MESENTERICUS, CLOSTRIDIUM BUTYRICUM, LACTOMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CILNIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERRIC CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[POLAPREZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607592	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607598	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607601	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (3d - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607603	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - );Sinus arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607607	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (286min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607611	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607614	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607616	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607620	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diverticulum intestinal (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Gastrointestinal haemorrhage (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010607621	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in jaw (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607623	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607624	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Aphasia (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Confusional state (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait disturbance (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Peripheral coldness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607625	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607626	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved - Other Medically Important Condition);Vertigo (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607630	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Fatal - Results in Death);Cough (n/a - Fatal - Results in Death);Diarrhoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607631	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Fall (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607635	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607637	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607644	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyskinesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling cold (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607651	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hepatic encephalopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607653	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MORPHINE POLY(STYRENE-CO-DIVINYLBENZENE) SULFONATE, MORPHINE SULFATE, MORPHINE SULFATE PH. EUR.] (C - Abdominal pain, Pain - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - Abdominal pain, Pain - n/a - [n/a - n/a - n/a])|[MORPHINE, MORPHINE HYDROCHLORIDE] (C - Abdominal pain, Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607654	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Arthropathy (n/a - Unknown - Other Medically Important Condition);Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607666	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607676	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607679	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Heavy menstrual bleeding (0d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607686	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607690	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010607705	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle fatigue (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010607709	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607722	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Pulse absent (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607724	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasal congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607729	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010607732	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Dysarthria (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Mobility decreased (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Transient ischaemic attack (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - Thrombosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010607737	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607739	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607742	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Angioedema (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010607749	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607751	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607754	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607757	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypokinesia (n/a - Unknown - Other Medically Important Condition);Inflammation (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607763	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607769	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607772	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arteriosclerosis coronary artery (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac arrest (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebral arteriosclerosis (n/a - Fatal - Results in Death, Other Medically Important Condition);Emphysema (n/a - Fatal - Results in Death);Fall (n/a - Unknown - );Pneumothorax (n/a - Fatal - Results in Death);Traumatic haemothorax (n/a - Fatal - Results in Death);Vaccination site pain (n/a - Unknown - );Vaccination site pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ANGELICA ACUTILOBA ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[ANGELICA ROOT, YOKUKANSANKACHIMPIHANGE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATRACTYLODES LANCEA ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[BUPLEURUM FALCATUM ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[CNIDIUM OFFICINALE ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[DONEPEZIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LIQUORICE ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[PINELLIA TERNATA ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[PORIAE COCOS SCLEROTIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TANGERINE PEEL] (C - n/a - n/a - [n/a - n/a - n/a])|[UNCARIA] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607777	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (72h - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiovascular disorder (n/a - Unknown - );Cognitive disorder (n/a - Recovered/Resolved - );Hypotension (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Shock (n/a - Unknown - Other Medically Important Condition);Ventricular fibrillation (72h - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010607793	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010607798	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Congenital anomaly (n/a - Fatal - Results in Death);Maternal exposure during pregnancy (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607799	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607801	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607803	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Genital pain (n/a - Not Recovered/Not Resolved - );Genital paraesthesia (n/a - Recovering/Resolving - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Unknown - Disabling);Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Panic attack (n/a - Unknown - );Paraesthesia (n/a - Recovering/Resolving - Disabling);Polyneuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);White blood cell count decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010607805	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - 200ug - n/a])|[LORATADINE] (C - Seasonal allergy - n/a - [n/a - 10mg - n/a])|[PARACETAMOL] (C - Migraine - n/a - [n/a - 1000mg - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - 400mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010607816	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Skin irritation (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010607838	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death);Body temperature increased (n/a - Unknown - );Cardiac failure acute (n/a - Fatal - Results in Death);Cardiopulmonary failure (n/a - Fatal - Results in Death);Pulmonary oedema (n/a - Fatal - Results in Death);Pulse absent (n/a - Fatal - Results in Death);Seizure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010607886	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607889	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607896	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607903	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607905	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607907	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010607974	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axonal neuropathy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eosinophilic granulomatosis with polyangiitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypokalaemia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Iron deficiency anaemia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010607974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010608063	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myasthenia gravis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608075	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Sleep disorder (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010608081	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cold sweat (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (2d - Recovered/Resolved - Other Medically Important Condition);Sinusitis (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - Arthritis - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010608085	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Eye pruritus (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Recovering/Resolving - );Tinnitus (2mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608109	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608116	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Unknown - );Swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608140	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Temporomandibular pain and dysfunction syndrome (n/a - Recovering/Resolving - );Toothache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608141	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608171	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Joint swelling (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608173	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608174	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Peripheral vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608175	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Epilepsy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608183	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608185	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608193	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (26d - Not Recovered/Not Resolved - );Fatigue (26d - Not Recovered/Not Resolved - );Fluid intake restriction (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010608194	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Subclavian vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608196	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac discomfort (0d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608197	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608198	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608201	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608213	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608226	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010608228	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pustule (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608229	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Photosensitivity reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608231	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (43d - Recovering/Resolving - );Limb discomfort (43d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010608237	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (25d - Not Recovered/Not Resolved - );Rash (25d - Not Recovered/Not Resolved - );Upper respiratory tract infection (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010608268	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Cardiopulmonary exercise test abnormal (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608290	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608318	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Influenza (n/a - Unknown - );Injection site erythema (n/a - Unknown - );Injection site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608321	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Heart rate increased (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608356	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnestic disorder (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608366	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Recovering/Resolving - );Herpes zoster (4d - Recovering/Resolving - );Rash (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608367	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved With Sequelae - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010608370	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (3d - Recovered/Resolved - );Arthralgia (5d - Recovered/Resolved - );Body temperature increased (3d - Recovered/Resolved - );Crying (4d - Recovered/Resolved - );Decreased appetite (7d - Unknown - );Delusion (7d - Unknown - Caused/Prolonged Hospitalisation);Fatigue (7d - Unknown - );Hallucination (7d - Unknown - Caused/Prolonged Hospitalisation);Headache (3d - Recovered/Resolved - );Insomnia (7d - Unknown - );Irritability (7d - Unknown - );Mood altered (7d - Unknown - );Muscle strength abnormal (7d - Unknown - Caused/Prolonged Hospitalisation);Myalgia (5d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Restlessness (7d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608393	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608407	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010608417	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Sluggishness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608424	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608426	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchial disorder (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Pharyngeal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608427	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608430	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608435	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608439	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608440	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608442	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608453	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608469	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608567	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Child	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608572	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010608574	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608583	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608614	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Nasal congestion (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608629	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Unknown - );Foreign body sensation in eyes (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tinnitus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608635	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Hospitalisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoacusis (n/a - Recovering/Resolving - );Impaired work ability (n/a - Unknown - );Intracranial hypotension (n/a - Unknown - );Neck pain (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, BIOTIN, CYANOCOBALAMIN, FOLIC ACID, MONOPHOSPHOTHIAMINE, NICOTINAMIDE, RIBOFLAVIN, MAGNESIUM CARBONATE HEAVY, CALCIUM CARBONATE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM SULFATE DIHYDRATE, ZINC CITRATE TRIHYDRATE, ASCORBIC ACID, BIOTIN, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, ZINC, CALCIUM, MAGNESIUM, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, ASCORBIC ACID, BIOTIN, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, MAGNESIUM CARBONATE HEAVY, MAGNESIUM OXIDE, LIGHT, CALCIUM CARBONATE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, ZINC CITRATE TRIHYDRATE, THIAMINE HYDROCHLORIDE, ASCORBIC ACID, BIOTIN, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, ZINC, CALCIUM, MAGNESIUM, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCONEXENT, ICOSAPENT, FISH OIL, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608641	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608650	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608652	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Inflammation (n/a - Unknown - );Plantar fasciitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608800	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aura (n/a - Unknown - Other Medically Important Condition);Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Unknown - Other Medically Important Condition);Musculoskeletal discomfort (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010608801	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (70d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Tubulointerstitial nephritis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608804	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blister (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Toxic skin eruption (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608807	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Unknown - );Haemorrhage subcutaneous (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010608922	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608944	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608949	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010608950	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608952	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010608954	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspepsia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Performance status decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010608963	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brain fog (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010608985	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010608988	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010608988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010609023	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010609084	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010609086	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Transient ischaemic attack (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010609104	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gait disturbance (3mo - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pain in extremity (3mo - Recovered/Resolved - Disabling, Other Medically Important Condition);Paraesthesia (3mo - Recovered/Resolved - Disabling, Other Medically Important Condition);Peripheral coldness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010609121	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure timing unspecified (n/a - Recovering/Resolving - Other Medically Important Condition);Premature delivery (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010609158	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, BUDESONIDE, MICRONISED] (C - Colitis microscopic - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010609205	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010609239	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010609505	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PROSTAATMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|SCHILDKLIERMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010609556	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609704	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010609814	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (23d - Not Recovered/Not Resolved - );Fatigue (23d - Not Recovered/Not Resolved - );Tachycardia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010609815	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (23d - Recovered/Resolved - );Limb discomfort (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010609819	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010609842	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609847	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010609856	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609862	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Not Recovered/Not Resolved - );Limb discomfort (9d - Not Recovered/Not Resolved - );Rash (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609873	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609875	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609888	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (8d - Recovered/Resolved - );Rash (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609894	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609912	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609921	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiomyopathy (0d - Unknown - );Tachycardia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010609931	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609957	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010609985	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010609988	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Haematoma (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010609988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610046	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610051	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovering/Resolving - );Dyskinesia (n/a - Unknown - );Dysstasia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate decreased (n/a - Recovering/Resolving - );Shock (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610080	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610082	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610085	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610087	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010610088	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610095	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiplegic migraine (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610102	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Exposure during pregnancy (n/a - Unknown - );Sepsis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010610104	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610105	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610106	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610109	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immune thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610115	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial flutter (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610140	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010610150	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Subarachnoid haemorrhage (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610156	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Hyperthermia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610162	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610165	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610167	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (1h - Recovered/Resolved - );Pallor (1h - Recovered/Resolved - );Presyncope (1h - Recovered/Resolved - );Seizure (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610172	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periarthritis (2mo - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610173	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610196	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Retinal artery occlusion (46d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610200	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610214	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610225	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Blindness transient (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - );Vitreous haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610230	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610233	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (30d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610238	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual acuity reduced (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010610243	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - 200mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[EBASTINE] (C - n/a - n/a - [n/a - 10mg - Ophthalmic])|[INDAPAMIDE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 3000mg - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610245	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610254	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PYGEUM AFRICANUM, PYGEUM AFRICANUM EXTRACT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610262	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010610267	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010610269	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [9d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610291	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COAPROVEL 300 MG/12.5 MG FILM-COATED TABLETS [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610296	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (36h - Recovered/Resolved - );Cardiac discomfort (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610304	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (45min - Recovered/Resolved - );Tachycardia (45min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIZOLASTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610305	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610308	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610309	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610312	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610322	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Musculoskeletal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610330	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610398	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610399	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610407	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610410	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610417	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610419	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute pulmonary oedema (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610430	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610431	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610432	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Recovered/Resolved - );Injection site pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610433	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610434	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610436	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610437	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610439	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610441	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610442	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610443	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610444	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Peripheral swelling (12d - Recovered/Resolved - );Rash (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610445	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610446	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610451	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610458	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610463	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Rhinalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[CICLOSPORIN] (C - Corneal transplant - n/a - )|[FLUOROMETHOLONE] (C - Corneal transplant - n/a - )|[VALACICLOVIR HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610470	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610476	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610477	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610480	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular extrasystoles (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610487	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610502	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610508	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610530	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610543	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610544	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anxiety (n/a - Unknown - );Insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610550	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Immunisation reaction (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610551	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610563	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Phlebitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610566	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610567	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	International normalised ratio increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610587	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610595	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610597	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610599	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adolescent	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610611	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610620	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610624	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610632	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610645	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610648	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610649	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610650	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (4d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610656	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Constipation (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610667	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610668	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610669	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610671	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610683	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610692	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610694	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610696	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610703	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610704	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610705	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610707	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - );Rash papular (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610709	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610711	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610712	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610718	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610720	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610721	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610722	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610723	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610724	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610727	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610728	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610729	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610731	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610738	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610744	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610751	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610757	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610763	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610769	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610770	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610790	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610807	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610812	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610816	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610820	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010610824	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610825	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610829	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010610834	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2wk - Recovered/Resolved - );Blood creatine phosphokinase increased (n/a - Recovering/Resolving - );Chest discomfort (1wk - Recovered/Resolved - );Lymphadenopathy (2wk - Recovered/Resolved - );Myalgia (2wk - Recovered/Resolved - );Transaminases increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610835	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (10h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610842	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	PREGABALIN MYLAN 50 MG HARD CAPSULES [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010610856	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610867	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling cold (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610870	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (10d - Recovered/Resolved - );Headache (10d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610885	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610893	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Hidradenitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610902	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610915	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Musculoskeletal chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010610951	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin warm (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Headache - n/a - [n/a - n/a - n/a])|[CYCLIZINE] (C - Nausea - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[MAGNESIUM CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Headache - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Postural orthostatic tachycardia syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010610996	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Cough (n/a - Unknown - );Immunisation (n/a - Unknown - );Pneumonia (n/a - Unknown - Other Medically Important Condition);Pyrexia (7d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010610996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010611012	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611024	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611026	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ECZEEMMEDICATIE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611030	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611036	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010611040	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611042	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Fatigue (13d - Recovered/Resolved - );Headache (20d - Recovered/Resolved - );Malaise (20d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611046	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611065	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611068	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Malaise (7d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - );Vascular stent thrombosis (0d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010611071	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611073	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611078	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site inflammation (3d - Recovered/Resolved - );Injection site warmth (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611197	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010611372	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010611453	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Child	Yes	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - );Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010611492	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis acute (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010611493	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Circulatory collapse (n/a - Recovered/Resolved - Life Threatening);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010611533	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Ischaemic stroke (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Venous thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010611586	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611614	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611627	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010611628	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Fatal - Results in Death, Congenital Anomaly);Foetal heart rate abnormal (n/a - Fatal - Results in Death, Congenital Anomaly);Foetal heart rate decreased (n/a - Fatal - Results in Death, Congenital Anomaly);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010611724	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaesthesia oral (n/a - Recovered/Resolved - );Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperacusis (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010611767	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (2d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovering/Resolving - );Malaise (2d - Not Recovered/Not Resolved - );Paraesthesia (2d - Not Recovered/Not Resolved - );Renal pain (1d - Not Recovered/Not Resolved - );Tachycardia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010611776	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Orthostatic intolerance (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010611822	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Flushing (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010611834	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abnormal sensation in eye (n/a - Unknown - Other Medically Important Condition);Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Hot flush (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Sensory disturbance (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010611846	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010611912	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Disturbance in attention (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Nervousness (2d - Not Recovered/Not Resolved - );Retching (2d - Not Recovered/Not Resolved - );Tremor (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010611928	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010611928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612055	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612124	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010612170	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensorimotor disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010612177	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010612207	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Leukopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612209	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extensive swelling of vaccinated limb (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Monoplegia (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleurisy (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATENOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[DIPOTASSIUM CLORAZEPATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[MOXONIDINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010612259	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Autoimmune haemolytic anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010612313	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010612431	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612461	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Atrial fibrillation (3150min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pruritus (n/a - Recovering/Resolving - );Skin exfoliation (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	DUPIXENT [DUPILUMAB] (C - Dermatitis atopic - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010612510	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010612548	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010612564	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612696	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612712	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Embolic cerebellar infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	[INSULIN, INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010612718	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612727	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (10d - Recovered/Resolved - Other Medically Important Condition);Fatigue (10d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])|[B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, WILD TYPE), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Drug withdrawn - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612730	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612731	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010612740	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vaccination site paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612742	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Temperature regulation disorder (3d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612752	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612762	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612771	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612774	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612810	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	BETMIGA 50 MG PROLONGED-RELEASE TABLETS [MIRABEGRON] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612813	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612841	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cluster headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Primary headache associated with sexual activity (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010612843	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612849	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612859	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [22d - 1{DF} - Unknown - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612860	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - );Paraesthesia (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612861	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612865	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010612868	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612870	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612872	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612874	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovered/Resolved - );Vaccination site lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612881	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612883	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site inflammation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612885	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site inflammation (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612889	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612892	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Temperature regulation disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612898	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010612927	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010612948	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[NOT AVAILABLE] (S - n/a - Dose increased - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010612948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010613028	Spontaneous	2021-11-10 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Conjunctival hyperaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010613054	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Furuncle (n/a - Unknown - );Hypersensitivity (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Pruritus (n/a - Unknown - );Sleep deficit (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - Oral])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[LOSARTAN POTASSIUM] (C - Blood pressure abnormal - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010613094	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010613106	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (42d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010613110	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010613115	Spontaneous	2021-11-10 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain stem ischaemia (n/a - Unknown - Other Medically Important Condition);Monoparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010613115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010585641	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Life Threatening);Application site pain (38d - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Brain fog (n/a - Unknown - );Conjunctivitis (19d - Recovered/Resolved - Life Threatening);Discomfort (n/a - Recovered/Resolved - );Eye irritation (19d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (38d - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Gait disturbance (n/a - Recovered/Resolved - );Headache (38d - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Lethargy (38d - Recovered/Resolved - );Memory impairment (38d - Recovered/Resolved - );Nausea (7d - Recovered/Resolved - );Neck pain (38d - Recovered/Resolved - );Neuralgia (n/a - Recovered/Resolved - );Nightmare (n/a - Recovered/Resolved - );Ocular hyperaemia (19d - Recovered/Resolved - Life Threatening);Oropharyngeal pain (19d - Recovered/Resolved - Life Threatening);Paraesthesia (n/a - Recovered/Resolved - );Swelling (19d - Recovered/Resolved - Life Threatening);Urticaria (19d - Recovered/Resolved - Life Threatening);Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010585679	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585681	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585724	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash erythematous (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585735	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585814	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Eructation (n/a - Not Recovered/Not Resolved - );Exposure via breast milk (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585854	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	No	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010585857	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood creatine phosphokinase increased (n/a - Unknown - );Muscular weakness (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Unknown - );Myasthenia gravis (n/a - Unknown - Other Medically Important Condition);Rhabdomyolysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[ROSUVASTATIN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010585869	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010585967	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010585974	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Injection site swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010585986	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010585996	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (10d - Recovered/Resolved - Other Medically Important Condition);Dizziness (5d - Recovered/Resolved - Other Medically Important Condition);Eye pain (2d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (4d - Recovered/Resolved - Other Medically Important Condition);Memory impairment (5d - Recovered/Resolved - Other Medically Important Condition);Pain (5d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (6d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586000	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586009	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Depression (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586010	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586013	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cognitive disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586017	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mobility decreased (7d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (7d - Recovered/Resolved - Other Medically Important Condition);Vaccination site discomfort (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586051	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Wheezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586073	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586288	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586302	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anxiety (n/a - Not Recovered/Not Resolved - );Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586304	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586315	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586317	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pruritus (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586321	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - 1{DF} - n/a])|[PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586329	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nightmare (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586360	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Body temperature increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586362	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586363	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586364	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	No	Not Specified	Foetal growth abnormality (n/a - Unknown - Other Medically Important Condition);Maternal exposure timing unspecified (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586367	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (17d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (17d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586372	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	SEMAGLUTIDE [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010586440	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586444	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586450	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586458	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Abscess (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bowel movement irregularity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fistula (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gastroenteritis viral (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Genital pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Groin pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensitive skin (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wound complication (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wound haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wound secretion (20d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010586463	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Recovered/Resolved With Sequelae - );Restless legs syndrome (n/a - Recovered/Resolved With Sequelae - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	PROBIOTICS [NOT AVAILABLE] (C - n/a - n/a - )|[ASCORBIC ACID] (C - n/a - n/a - )|[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - )|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[FOLIC ACID] (C - n/a - n/a - )|[PHOSPHATIDYL CHOLINE] (C - n/a - n/a - )|[TAURINE] (C - n/a - n/a - )|[TURMERIC] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )|[VITAMINS NOS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010586472	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - 350mg - n/a])|[HYDROXYZINE HYDROCHLORIDE] (C - Anxiety, Restlessness - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586475	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Palpitations (20min - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010586478	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (4d - Recovered/Resolved - );Musculoskeletal stiffness (4d - Recovered/Resolved - );Neuralgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586509	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Feeling hot (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CYANOKOBALAMIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586510	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Dizziness (n/a - Not Recovered/Not Resolved - );Dry mouth (n/a - Unknown - );Dry throat (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Impaired work ability (n/a - Unknown - );Throat irritation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[GARLIC POWDER] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586526	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586532	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Disabling);Neck pain (n/a - Recovering/Resolving - Disabling);Neuritis (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010586533	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010586565	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586566	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010586745	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010586748	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586749	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Muscle spasms (n/a - Unknown - Other Medically Important Condition);Muscle twitching (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586754	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Appendicitis (n/a - Unknown - Other Medically Important Condition);Cardiac infection (n/a - Unknown - Other Medically Important Condition);Pericarditis infective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586758	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Areflexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010586764	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Night sweats (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586775	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586781	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586784	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Life Threatening, Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Life Threatening);Dehydration (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Kidney infection (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010586789	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010586808	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586812	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysphagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Stress (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586854	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infertility (n/a - Unknown - Other Medically Important Condition);Sperm concentration decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586867	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010586882	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Night sweats (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586901	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010586906	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALVERINE CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[ISPAGHULA HUSK BP, MEBEVERINE HYDROCHLORIDE, ISPAGHULA HUSK] (C - n/a - n/a - [n/a - n/a - n/a])|[MEDROXYPROGESTERONE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010586908	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010586908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587018	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Life Threatening);Blood glucose increased (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010587105	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (0d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010587108	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587171	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Raynaud's phenomenon (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010587172	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010587175	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587178	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac infection (n/a - Unknown - Other Medically Important Condition);Chest pain (4h - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587188	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dermatomyositis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587192	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587199	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Iritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587204	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587210	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dysuria (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010587222	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587223	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587224	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587237	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587429	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening);Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010587435	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010587467	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|ZYPREXA [OLANZAPINE] (C - n/a - n/a - [n/a - n/a - Oral])|[FLUNITRAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010587492	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010587522	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Periarthritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010587532	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	General physical health deterioration (n/a - Not Recovered/Not Resolved - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010587550	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010587612	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587614	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587634	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Eye pruritus (5d - Recovered/Resolved - );Eyelid oedema (5d - Recovered/Resolved - );Ocular hyperaemia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010587714	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Extrasystoles (n/a - Not Recovered/Not Resolved - Disabling);Pericardial disease (n/a - Not Recovered/Not Resolved - Disabling);Stress (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010587716	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010587734	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sleep apnoea syndrome (n/a - Not Recovered/Not Resolved - Disabling);Snoring (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010587744	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - Disabling);Dizziness (n/a - Recovered/Resolved With Sequelae - Disabling);Fall (n/a - Recovered/Resolved With Sequelae - Disabling);Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010587750	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Parosmia (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010587767	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Joint stiffness (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010587795	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587797	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587798	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587803	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587805	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587809	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587814	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587820	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587821	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587835	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (50min - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010587872	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Administration site pain (n/a - Recovered/Resolved - );Arthralgia (12h - Recovered/Resolved - );Headache (12h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - );Pyrexia (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010587907	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587909	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587910	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angioedema (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - Immunosuppression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587912	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Peripheral coldness (n/a - Not Recovered/Not Resolved - Life Threatening);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Thrombosis in device (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010587917	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010587918	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Abdominal rigidity (n/a - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587919	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Balance disorder (n/a - Unknown - );Brain fog (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Proteinuria (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587925	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587937	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - );Cough (n/a - Unknown - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587939	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587941	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	REMICADE [INFLIXIMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CLARITHROMYCIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010587944	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587945	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (6d - Recovered/Resolved With Sequelae - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Unknown - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling);Skin haemorrhage (n/a - Not Recovered/Not Resolved - Disabling);Urticaria (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010587951	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587959	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587968	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587969	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|SILDENAFIL [SILDENAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[BENZYDAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 15mL - n/a])|[BETAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - 4{DF} - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [1d - 30mL - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[SODIUM HYDROGEN CARBONATE PHEUR, CALCIUM CARBONATE PH. EUR., SODIUM ALGINATE PH. EUR., SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - 10mL - n/a])|[SOFT SOAP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010587974	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587977	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dizziness postural (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587979	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587984	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Mancianti, N.. Minimal change disease following vaccination for SARS-CoV-2. Journal of Nephrology. 2021;34 (4):1039-1040. doi:10.1007/s40620-021-01091-1	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Glomerulonephritis minimal lesion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010587992	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Abdominal distension (n/a - Recovering/Resolving - Other Medically Important Condition);Aortic dissection (n/a - Fatal - Results in Death);Heat illness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BENZBROMARONE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010587995	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Nerve compression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010587996	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Initial insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pollakiuria (n/a - Recovering/Resolving - Other Medically Important Condition);Restless legs syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition);Urine output decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Nasopharyngitis - n/a - [7d - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010587997	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010587997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588001	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pollakiuria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMCX-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Influenza - n/a - [1d - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588003	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Cold sweat (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588014	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588021	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588023	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010588026	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588030	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588032	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pyrexia (n/a - Unknown - Life Threatening);Seizure (1d - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010588034	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010588051	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588052	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588069	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (172h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010588070	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (1wk - Recovered/Resolved - );Epididymitis (1wk - Recovered/Resolved - Other Medically Important Condition);Malaise (1wk - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (1wk - Recovered/Resolved - );Testicular pain (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DIMENHYDRINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HOMATROPINE METHYLBROMIDE, METAMIZOLE SODIUM, HYOSCINE, HYOSCYAMINE HYDROBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588071	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Recovered/Resolved - );Chest pain (2h - Recovered/Resolved - );Discomfort (2h - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588073	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588075	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal heart rate abnormal (n/a - Fatal - Results in Death);Foetal hypokinesia (n/a - Fatal - Results in Death);Maternal exposure during pregnancy (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010588106	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588116	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588191	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588200	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588202	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588203	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588209	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588210	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588212	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588213	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588217	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588220	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588221	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588261	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden death (1h - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010588302	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588412	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588413	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Recovered/Resolved - );Dizziness (7d - Recovered/Resolved - );Fatigue (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588419	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (6d - Recovering/Resolving - );Influenza like illness (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588422	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588425	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (21d - Not Recovered/Not Resolved - );Dizziness (21d - Not Recovered/Not Resolved - );Fatigue (21d - Not Recovered/Not Resolved - );Headache (21d - Not Recovered/Not Resolved - );Hypertension (21d - Not Recovered/Not Resolved - );Tinnitus (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010588427	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pallor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588430	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast engorgement (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - );Peripheral swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588432	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradycardia (n/a - Recovering/Resolving - );Fatigue (4d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588435	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588450	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588455	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cold sweat (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Peripheral circulatory failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588463	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling hot (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588477	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588479	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Unknown - );Malaise (1d - Recovered/Resolved - );Visual impairment (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588486	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Sudden hearing loss (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010588492	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588497	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - );Myalgia (2d - Unknown - );Pain in extremity (2d - Unknown - );Peripheral vascular disorder (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588526	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Not Recovered/Not Resolved - );Pollakiuria (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588532	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588535	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Tachycardia (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588539	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (5d - Not Recovered/Not Resolved - );Feeling hot (4d - Not Recovered/Not Resolved - );Injection site pain (5d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588549	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588556	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588560	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588570	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588571	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588576	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588585	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010588589	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Lack of spontaneous speech (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588591	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588598	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Chills (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588608	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Ophthalmic herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588625	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588626	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588631	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition);Troponin I increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588632	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588637	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pemphigoid (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588641	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Unknown - );Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL HYDROGEN SULFATE [CLOPIDOGREL HYDROGEN SULFATE] (C - Thrombosis - n/a - [n/a - n/a - Oral])|METHYL CPG [BETAINE, FOLIC ACID, MECOBALAMIN, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN] (C - Supplementation therapy - n/a - [n/a - n/a - n/a])|XARELTO [RIVAROXABAN] (C - Thrombosis - n/a - [n/a - 20mg - Oral])|[AMIODARONE HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - 800mg - Oral])|[ATORVASTATIN CALCIUM] (C - Blood cholesterol abnormal - n/a - [n/a - 10mg - Oral])|[BUSPIRONE HYDROCHLORIDE] (N - Anxiety - n/a - [n/a - 20mg - Oral])|[COLECALCIFEROL] (C - Supplementation therapy - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Blood pressure abnormal - n/a - [n/a - 120mg - Oral])|[FISH OIL] (C - Vitamin supplementation - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Chest pain - n/a - [n/a - 60mg - Oral])|[MENAQUINONE 6] (C - Supplementation therapy - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - 1000mg - Oral])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588666	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Sleep apnoea syndrome (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010588667	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Basal cell carcinoma (n/a - Unknown - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tumour haemorrhage (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Cardiac operation - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart rate abnormal - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588673	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (2d - Recovering/Resolving - );Chills (2d - Recovering/Resolving - );Diarrhoea (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Vaccination site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588683	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amaurosis fugax (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588693	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588696	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Wolff-Parkinson-White syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588697	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588723	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588728	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588751	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010588757	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - [n/a - 12.5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588761	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Intracranial aneurysm (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010588789	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588791	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Body temperature increased (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - 100mg - n/a])|[CARBAMAZEPINE] (C - n/a - n/a - [n/a - 400mg - n/a])|[DONEPEZIL, DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE MONOHYDRATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 500mg - n/a])|[QUETIAPINE] (C - n/a - n/a - [n/a - 150mg - n/a])|[TIZANIDINE, TIZANIDINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588805	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588817	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (51d - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (51d - Recovering/Resolving - Other Medically Important Condition);Rhabdomyolysis (51d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010588820	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[METHOTREXATE] (C - Dermatomyositis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588833	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);COVID-19 immunisation (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588854	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotonia (n/a - Unknown - Other Medically Important Condition);Pain (15d - Unknown - Other Medically Important Condition);Pain in extremity (15d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010588888	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010588922	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010588922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010589076	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589079	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589081	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589082	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589084	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589085	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vena cava thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PREGABALIN [PREGABALIN] (C - n/a - n/a - )|[CANDESARTAN] (C - n/a - n/a - )|[LITHIUM ACETATE, LITHIUM CARBONATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010589154	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010589166	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye irritation (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589369	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589372	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010589381	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589385	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589390	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589391	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589399	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589435	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010589533	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (15min - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010589582	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589604	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589692	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589719	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bladder pain (3d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (3d - Recovered/Resolved - );Genital pain (3d - Recovered/Resolved - Other Medically Important Condition);Hangover (n/a - Not Recovered/Not Resolved - );Renal pain (3d - Recovered/Resolved - Other Medically Important Condition);Urinary straining (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589722	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bladder discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589772	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[NITROFURANTOIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Arthralgia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589775	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589776	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Lymphadenitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010589792	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Metastasis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010589800	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Communication disorder (n/a - Unknown - );Erythema (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Tremor (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589813	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589820	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589823	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589825	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589835	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589837	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589840	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589841	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010589930	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589935	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589937	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Renal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589941	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589947	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589948	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589949	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010589950	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589952	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589953	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589954	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010589975	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589976	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589979	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589983	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arterial stenosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589985	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589989	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589990	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589991	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589993	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition);Illness (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pleural effusion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589994	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589995	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589997	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010589998	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010589998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590015	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590084	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590091	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Asthenia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590115	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Feeling hot (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Hyperhidrosis (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590118	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovered/Resolved - );Rash (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590121	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590122	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - );Arthralgia (n/a - Recovered/Resolved With Sequelae - );Macule (n/a - Recovered/Resolved With Sequelae - );Nodule (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010590133	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (29d - Recovering/Resolving - );Injection site pain (29d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010590136	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (6d - Not Recovered/Not Resolved - );Vaccination site pain (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590159	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590162	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590163	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (13d - Not Recovered/Not Resolved - );Dyspnoea (13d - Not Recovered/Not Resolved - );Hyperhidrosis (13d - Not Recovered/Not Resolved - );Hypertension (13d - Not Recovered/Not Resolved - );Tachycardia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590173	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Recovered/Resolved - );Photophobia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590179	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590194	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (24d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010590195	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010590196	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Odynophagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590208	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (12d - Recovering/Resolving - );Migraine with aura (14d - Unknown - );Myalgia (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590212	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590213	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (35d - Unknown - );Dyspnoea (35d - Unknown - );Influenza like illness (35d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590214	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590234	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Blood potassium decreased (n/a - Unknown - Other Medically Important Condition);C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Infection (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590238	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination site pain (10h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590239	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010590240	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590246	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint range of motion decreased (3wk - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (3wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590250	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590259	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (11d - Recovered/Resolved - Other Medically Important Condition);COVID-19 (11d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (11d - Recovered/Resolved - Other Medically Important Condition);Malaise (11d - Recovered/Resolved - Other Medically Important Condition);Sneezing (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590263	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010590264	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Unknown - Disabling, Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Rash (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010590269	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Oral herpes (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590275	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590276	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain lower (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Impaired work ability (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590283	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590304	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590306	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (39d - Recovering/Resolving - );Rash (39d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010590318	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Ear discomfort (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590319	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590322	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (64d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010590343	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (20d - Not Recovered/Not Resolved - );Fatigue (26d - Not Recovered/Not Resolved - );Headache (20d - Not Recovered/Not Resolved - );Musculoskeletal stiffness (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010590344	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arrhythmia (33d - Not Recovered/Not Resolved - );Pruritus (34d - Not Recovered/Not Resolved - );Rash (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010590345	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cystitis noninfective (28d - Not Recovered/Not Resolved - );Influenza (28d - Not Recovered/Not Resolved - );Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010590360	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (137d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010590361	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590366	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590367	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590369	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590370	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590376	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590378	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590382	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590388	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590390	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590446	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Injection site reaction (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010590470	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Administration site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590486	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590491	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590538	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neuropathy peripheral (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590546	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010590610	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010590611	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	SILDENAFIL 50MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010590655	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010590661	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010590742	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Disabling);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010590744	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590755	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590757	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590765	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590771	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010590772	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590775	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590782	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590785	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590788	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010590802	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - Life Threatening);Gingival bleeding (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Intracranial pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vomiting (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010590802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010591168	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neovascular age-related macular degeneration (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	AZOPT [BRINZOLAMIDE] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])|[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[TIMOLOL MALEATE, TAFLUPROST, TIMOLOL, TAFLUPROST] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591170	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (73d - Not Recovered/Not Resolved - );Vaccination site pain (73d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010591186	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591192	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591194	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591196	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591197	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - );Flank pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010591198	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010591202	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591205	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591207	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591209	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591216	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591217	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591295	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010591300	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Eye irritation (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Memory impairment (n/a - Recovered/Resolved - );Muscle rigidity (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Tongue biting (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591304	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591307	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Febrile neutropenia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Hyperacusis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Lymph node pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - );Night sweats (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Parosmia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Photophobia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Platelet count increased (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation);Red blood cell count increased (n/a - Unknown - );Taste disorder (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010591310	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );Dizziness (n/a - Recovered/Resolved - );Dysphemia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Mental impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Swelling face (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[UBIDECARENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591311	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Presyncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	FLUENZ TETRA [A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE STRAIN (A/HAWAII/66/2019, MEDI 326775), A/HONG KONG/2671/2019 (H3N2) - LIKE STRAIN (A/HONG KONG/2671/2019, MEDI 325078), B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, MEDI 306444), B/WASHINGTON/02/2019 - LIKE STRAIN (B/WASHINGTON/02/2019, MEDI 323797), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, MEDI 237514), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), B/MASSACHUSETTS/2/2012 (YAMAGATA LINEAGE)-LIKE STRAIN (B/MASSACHUSETTS/2/2012, MEDI 237751), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, MEDI 228029), B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030), A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/BOLIVIA/559/2013, MEDI 255962), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/NEW CALEDONIA/71/2014, MEDI 263122), B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE STRAIN (B/PHUKET/3073/2013, MEDI 254977), A/MICHIGAN/45/2015 (H1N1)PDM09 - LIKE STRAIN (A/SLOVENIA/2903/2015, MEDI 279432), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, MEDI 291690), B/COLORADO/06/2017-LIKE STRAIN (B/COLORADO/06/2017, MEDI 293454)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591314	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010591330	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood immunoglobulin A decreased (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010591351	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591357	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591364	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591369	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Miliaria (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591372	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Not Recovered/Not Resolved - Other Medically Important Condition);COVID-19 (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591374	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591378	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591381	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Autoimmune disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591383	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - Disabling);Dizziness (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Illness (n/a - Recovered/Resolved With Sequelae - Disabling);Immunisation (n/a - Unknown - Disabling);Migraine (n/a - Unknown - Disabling);Nasal congestion (n/a - Unknown - );Off label use (n/a - Unknown - Disabling);Oropharyngeal pain (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - );Pharyngeal swelling (n/a - Unknown - );Pyrexia (n/a - Unknown - Disabling);Sinusitis (n/a - Unknown - );Vomiting (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010591384	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591402	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Viral infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591405	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Influenza like illness (24h - Recovered/Resolved - );SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591407	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591409	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591410	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591413	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591418	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - );Urinary incontinence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591420	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591431	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591433	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Unknown - );Chills (n/a - Unknown - );Diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Eating disorder (n/a - Unknown - );Fatigue (n/a - Unknown - );Illness (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591435	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591437	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Angiopathy (n/a - Unknown - );Autoimmune disorder (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - );Brain oedema (n/a - Unknown - Other Medically Important Condition);Cytokine storm (n/a - Unknown - Other Medically Important Condition);Deafness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Diplopia (n/a - Unknown - );Dizziness (n/a - Unknown - );Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Feeling of despair (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Unknown - );Inflammation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - );Mental disorder (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Suicidal ideation (n/a - Unknown - Disabling, Other Medically Important Condition);Systemic lupus erythematosus (n/a - Unknown - Other Medically Important Condition);Thinking abnormal (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vertigo (n/a - Unknown - );Vision blurred (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[HYDROCHLOROTHIAZIDE, TRIAMTERENE] (C - Tinnitus - n/a - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Blood pressure abnormal - n/a - [n/a - 12mg - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010591447	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591448	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Joint range of motion decreased (n/a - Not Recovered/Not Resolved - );Nerve injury (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site joint movement impairment (n/a - Not Recovered/Not Resolved - );Vaccination site joint pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010591450	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591452	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591457	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591467	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hemiparesis (n/a - Unknown - Other Medically Important Condition);Neuropathy peripheral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591474	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Haemoptysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591476	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gout (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	CIALIS [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIZANIDINE, TIZANIDINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591515	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591541	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591556	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Autoimmune blistering disease (n/a - Recovering/Resolving - Other Medically Important Condition);Odynophagia (n/a - Recovering/Resolving - );Oral mucosal blistering (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovering/Resolving - );Pemphigus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BUDESONIDE [BUDESONIDE] (C - Asthma, Seasonal allergy - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - Thyroid disorder - n/a - [n/a - n/a - n/a])|[TORASEMIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591657	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591661	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591664	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (1min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591685	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010591702	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Insomnia (n/a - Unknown - );Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010591704	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591706	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010591712	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591718	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591723	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591814	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Follicle centre lymphoma, follicular grade I, II, III (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591918	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591924	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591926	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bacterial infection (n/a - Unknown - );Bradykinesia (n/a - Unknown - );Cough (n/a - Unknown - );Exercise tolerance decreased (n/a - Unknown - );Immune system disorder (n/a - Unknown - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pain (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591927	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010591930	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010591937	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (53d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Tongue discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 8mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010591952	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - );Sensorimotor disorder (n/a - Recovered/Resolved - );Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010591979	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthralgia (47d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (47d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (17d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Decreased appetite (47d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (47d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (47d - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	VIAGRA 100 MG FILM-COATED TABLETS [SILDENAFIL, SILDENAFIL CITRATE] (C - Erectile dysfunction - Not applicable - [n/a - n/a - Oral])|YELLOX EYE DROPS SOLUTION 0.9 MG/ML [BROMFENAC] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010591979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010592104	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Intestinal haemorrhage (n/a - Fatal - Results in Death);Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|[B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), INFLUENZA A VIRUS, A/CAMBODIA/E0826360/2020 (H3N2) - LIKE STRAIN (A/TASMANIA/503/2020, IVR-221), INACTIVATED] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010592105	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592109	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592111	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010592116	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592122	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [1d - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592127	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Headache (n/a - Unknown - );Movement disorder (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Myelitis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Pyrexia (n/a - Unknown - );Radiculopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592136	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592138	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Multiple sclerosis relapse (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010592139	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Venous thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[TERAZOSIN, TERAZOSIN HYDROCHLORIDE DIHYDRATE] (C - Benign prostatic hyperplasia - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010592140	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (10min - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010592146	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Autoimmune arthritis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010592208	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Headache (n/a - Recovered/Resolved - Disabling);Influenza like illness (n/a - Recovered/Resolved - Disabling);Injection site pain (n/a - Recovered/Resolved - Disabling);Injection site reaction (n/a - Recovered/Resolved - Disabling);Malaise (n/a - Recovered/Resolved - Disabling);Myalgia (n/a - Recovered/Resolved - Disabling);Nausea (n/a - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010592221	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592227	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592229	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592242	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592244	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592246	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Carcinoembryonic antigen increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Colon cancer (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Iron deficiency (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Subileus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[COLECALCIFEROL] (C - n/a - n/a - )|[MEFENAMIC ACID] (C - n/a - n/a - )|[METAMIZOLE SODIUM, METAMIZOLE SODIUM MONOHYDRATE] (C - n/a - n/a - )|[NADROPARIN, NADROPARIN CALCIUM] (C - n/a - n/a - )|[RANITIDINE, RANITIDINE HYDROCHLORIDE] (C - n/a - n/a - )|[SIMVASTATIN] (C - n/a - n/a - )|[ZOLPIDEM TARTRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010592247	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592258	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[IBUPROFEN, IBUPROFEN SODIUM DIHYDRATE] (C - Migraine - n/a - [1421d - n/a - n/a])|[PARACETAMOL] (C - Migraine - n/a - [n/a - n/a - n/a])|[SERTRALINE] (C - Anxiety - n/a - [n/a - n/a - Oral])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010592266	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592273	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypothermia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BUSPIRONE] (C - n/a - n/a - [n/a - 10mg - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - 2500ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010592284	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Injection site pain (n/a - Unknown - );Injection site reaction (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592286	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gingival oedema (5d - Recovered/Resolved - );Influenza like illness (4d - Recovered/Resolved - );Odynophagia (n/a - Recovered/Resolved - );Puncture site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592454	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592455	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Recovered/Resolved - Other Medically Important Condition);Brain fog (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Night sweats (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592457	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592459	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592461	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592471	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592474	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Pallor (36min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ABILIFY [ARIPIPRAZOLE] (C - Anxiety - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592482	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592520	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (24d - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Pain in extremity (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010592542	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Perineal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pollakiuria (n/a - Not Recovered/Not Resolved - );Prostatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592602	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Injection site pain (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592631	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592635	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592640	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulse abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592641	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vocal cord paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592650	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592651	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site movement impairment (n/a - Recovered/Resolved - );Application site pain (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592656	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010592676	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Herpes zoster (n/a - Recovered/Resolved - );Skin disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010592707	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010592712	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinusitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592714	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592719	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592720	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - );Defaecation urgency (n/a - Unknown - );Dizziness (n/a - Unknown - );Dizziness postural (n/a - Unknown - );Pallor (n/a - Unknown - );Presyncope (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592807	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592810	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592811	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592812	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592818	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Endocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Flank pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010592854	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster oticus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592997	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592998	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010592999	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010592999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593002	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593003	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593006	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Polyarthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593007	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593009	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593069	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (8wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593088	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593091	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593096	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysphagia (30min - Recovered/Resolved - );Vomiting (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593103	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Livedo reticularis (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593108	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593111	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593113	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (1d - Recovered/Resolved - );Eye irritation (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593117	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593118	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593119	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593124	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593125	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	No	Male	Asthenia (2d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593127	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593136	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593139	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593151	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593165	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Hyperaesthesia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593167	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593171	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593172	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intradermal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593173	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593179	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593188	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593192	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593199	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Hyperglycaemia (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - );Irritability (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593200	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - );Disease recurrence (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593202	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593203	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash erythematous (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593204	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593205	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593206	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593207	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593209	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593213	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593216	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593218	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593220	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593222	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (8d - Recovered/Resolved - );Nausea (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593225	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593228	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593232	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [26d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593234	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bursitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593236	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593239	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Purpura (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593242	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593249	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eczema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (S - Arrhythmia - n/a - [n/a - 2{DF} - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593251	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593254	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593258	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	BIKTARVY 50 MG/200 MG/25 MG FILM-COATED TABLETS [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593270	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593296	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (5d - Recovering/Resolving - );Headache (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593299	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593301	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593302	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593305	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593306	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (n/a - Unknown - );Vaccination site photosensitivity reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593308	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [35d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593310	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (17d - Recovered/Resolved - );Dyspnoea exertional (17d - Recovered/Resolved - );Vaccination site eczema (17d - Recovered/Resolved - );Vaccination site hyperaesthesia (17d - Recovered/Resolved - );Vaccination site oedema (17d - Recovered/Resolved - );Vaccination site paraesthesia (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010593322	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593374	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593386	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Oral pain (n/a - Unknown - Other Medically Important Condition);Parotid gland enlargement (n/a - Unknown - Other Medically Important Condition);Sialoadenitis (n/a - Recovered/Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593390	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593391	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593397	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593401	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593404	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593639	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593664	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortic thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiovascular disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010593688	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Recovered/Resolved - );COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (5d - Recovered/Resolved - );Oropharyngeal pain (5d - Recovered/Resolved - );Rhinorrhoea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593689	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dermatomyositis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010593694	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593704	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593770	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anal pruritus (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010593853	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593857	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593861	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593866	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593907	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593908	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593943	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593950	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010593951	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010593961	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010593963	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010593965	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593970	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593971	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010593977	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Varicocele (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010593979	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010593981	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010593999	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tachyarrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010593999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594001	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Injection site reaction (2d - Recovered/Resolved - Disabling);Migraine (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010594002	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594027	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - Product used for unknown indication - Unknown - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - Product used for unknown indication - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - Dyslipidaemia - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010594051	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Atrial fibrillation - Dose not changed - [n/a - 15mg - Oral])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - Atrial fibrillation - Dose not changed - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594073	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594081	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594085	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010594090	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [27d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594099	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Laryngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594105	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010594106	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594107	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594111	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594112	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594114	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594117	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594119	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594125	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (10wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594128	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594139	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelodysplastic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594140	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594147	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594156	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594165	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (3d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594175	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594180	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594184	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594247	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Oral herpes (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Sensory disturbance (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594251	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010594270	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594275	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - );Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594277	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594365	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594406	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - );Vaccination site paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594407	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Confusional state (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010594411	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594412	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Inflammation (7d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Somnolence (7d - Recovered/Resolved - );Vaccination site reaction (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594465	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594466	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594489	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Recovered/Resolved - Other Medically Important Condition);Swollen tongue (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[DOMPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594490	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dermatitis psoriasiform (n/a - Recovered/Resolved - Other Medically Important Condition);Eyelid oedema (n/a - Recovered/Resolved - Other Medically Important Condition);Eyelids pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594495	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urinary incontinence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594496	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Trigeminal palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594499	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lip oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Skin reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[IBUPROFEN, IBUPROFEN BP, IBUPROFEN LYSINE, IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594508	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (3d - Recovered/Resolved - Other Medically Important Condition);Extrasystoles (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	NEUPRO [ROTIGOTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOSINOPRIL SODIUM] (C - n/a - n/a - [n/a - 5mg - n/a])|[LEVODOPA, CARBIDOPA MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SELEGILINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - 10mg - n/a])|[TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594518	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypotension (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tonic clonic movements (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594519	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594546	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertensive crisis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594550	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594552	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594562	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Disorientation (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010594579	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594582	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594610	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperpyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594616	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594626	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594628	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypertensive crisis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010594629	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594632	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010594640	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594660	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute febrile neutrophilic dermatosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594663	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertensive crisis (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594678	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Other Medically Important Condition);Injected limb mobility decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rheumatoid arthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594683	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010594690	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allergy to animal (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594695	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cardiac fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594701	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594725	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	AVAMYS 27.5 MICROGRAMS/SPRAY, NASAL SPRAY SUSPENSION [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BILASTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594735	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Visual impairment (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594738	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tic (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594744	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010594751	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594753	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010594775	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Inner ear disorder (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010594784	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Haematoma (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010594787	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Graves' disease (n/a - Not Recovered/Not Resolved - Disabling);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010594794	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bedridden (n/a - Recovering/Resolving - Life Threatening);Cognitive disorder (n/a - Recovering/Resolving - Life Threatening);Confusional state (n/a - Recovering/Resolving - Life Threatening);Decreased appetite (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010594795	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594798	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594802	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE, METOPROLOL TARTRATE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594840	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010594853	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594877	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594880	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594881	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594939	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (3d - Recovered/Resolved - );Vaccination site oedema (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010594950	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hot flush (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010594962	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010594963	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Testicular pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010594997	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010594997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595001	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swollen tongue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[MAGALDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595002	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balanoposthitis (n/a - Not Recovered/Not Resolved - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - );Nodule (n/a - Not Recovered/Not Resolved - );Oesophageal spasm (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595013	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595024	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595052	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595054	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Recovering/Resolving - );Facial spasm (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595062	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595070	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595106	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hyporeflexia (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595122	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - );Oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595131	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired driving ability (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Presyncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595133	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595180	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595202	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Constipation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595230	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595250	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595254	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595261	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595265	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595267	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Splenic infarction (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Splenic thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Venous thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010595276	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595280	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Musculoskeletal stiffness (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595281	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oral herpes (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595293	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595309	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Disabling);Peripheral vein thrombosis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010595310	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ADVAGRAF 0.5 MG PROLONGED-RELEASE HARD CAPSULES [TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])|CELLCEPT 1 G/5 ML POWDER FOR ORAL SUSPENSION [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])|LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE, OMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOFENOPRIL CALCIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595315	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595329	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Loss of consciousness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595336	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595387	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Headache (n/a - Recovering/Resolving - Life Threatening);Hypertensive crisis (n/a - Recovering/Resolving - Life Threatening);Insomnia (n/a - Recovering/Resolving - Life Threatening);Tachycardia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010595392	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595402	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eyelid oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595407	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - );Ecchymosis (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Euphoric mood (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595457	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595459	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595461	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595481	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010595483	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphonia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595495	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595501	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595503	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sedation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595505	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (8d - Recovered/Resolved - );Feeling cold (8d - Recovered/Resolved - );Tachycardia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595507	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ataxia (n/a - Unknown - );Balance disorder (n/a - Unknown - );Confusional state (n/a - Unknown - );Creutzfeldt-Jakob disease (n/a - Unknown - );Diabetes mellitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010595510	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010595515	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595546	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595557	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595568	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Delusion (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010595581	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cyanosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Epilepsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	KEPPRA 1000 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - n/a - n/a - [n/a - 2{DF} - n/a])|XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CANRENONE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - 3{DF} - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1500mg - n/a])|[OXYGEN] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE] (C - n/a - n/a - [n/a - 300mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595587	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Melaena (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - .5mg - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595605	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diplopia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Miller Fisher syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595642	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595738	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cranial nerve palsies multiple (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595744	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Arrhythmia (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - Life Threatening);Cold sweat (n/a - Unknown - Other Medically Important Condition);Dizziness exertional (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[CILNIDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010595788	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010595917	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010595957	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Putamen haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010595995	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myelitis (n/a - Unknown - Other Medically Important Condition);Paraparesis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010595995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596018	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596021	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596023	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596073	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (n/a - Unknown - );Nephritis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010596080	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596259	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596263	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Paraesthesia oral (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010596265	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved With Sequelae - );Ejection fraction decreased (n/a - Unknown - Other Medically Important Condition);Pacemaker generated arrhythmia (n/a - Recovered/Resolved With Sequelae - );Ventricular extrasystoles (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[METOPROLOL SUCCINATE] (C - Arrhythmia - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010596284	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596298	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596302	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010596310	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin I increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596312	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Diplegia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596316	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010596328	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596353	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596437	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596512	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Coordination abnormal (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[PREDNISONE] (S - n/a - Unknown - [n/a - 8mg - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596519	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Hyperaesthesia (n/a - Unknown - );Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596541	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (154d - Recovered/Resolved - Disabling);Dizziness (n/a - Recovered/Resolved - );Erectile dysfunction (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Genital hypoaesthesia (n/a - Recovering/Resolving - );Libido decreased (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Duration
EU-EC-10010596544	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Left ventricular dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596551	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596576	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596580	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Block vertebra (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Functional gastrointestinal disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Musculoskeletal disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myelitis transverse (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596593	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596595	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Drug interaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Localised oedema (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin I increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[MINOCYCLINE] (I - Acne - Drug withdrawn - [10d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596628	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596636	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596639	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596643	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596653	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596656	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596659	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dyspnoea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596667	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596668	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596683	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596684	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596690	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596693	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596695	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596699	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596701	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Completed suicide (n/a - Fatal - Results in Death);Depression (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010596703	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596706	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596711	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596712	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596713	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596720	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596722	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596732	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - );Vaccination site reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596734	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596736	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Tachycardia (117d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596739	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596744	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596746	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Dyspnoea (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596748	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (17d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovering/Resolving - );Injection site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596751	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596760	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Nausea (4d - Not Recovered/Not Resolved - );Vomiting (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596767	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596768	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (46d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010596776	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596786	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596787	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596795	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596796	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (29d - Recovered/Resolved - );Limb discomfort (29d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010596797	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596807	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596810	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596819	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596823	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596825	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596826	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596832	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596833	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596851	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596852	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010596853	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596858	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596869	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral artery thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596880	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596896	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Not Recovered/Not Resolved - );Myalgia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596935	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596936	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010596941	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596946	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596947	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovering/Resolving - );Fatigue (6d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site erythema (4d - Recovered/Resolved - );Injection site swelling (5d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596952	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Swelling (2d - Not Recovered/Not Resolved - );Vaccination site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596955	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (72d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac discomfort (72d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Exercise electrocardiogram abnormal (72d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (128d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hospitalisation (72d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010596967	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (1d - Not Recovered/Not Resolved - );Condition aggravated (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Rhinitis allergic (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010596968	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Recovering/Resolving - );Deafness (3d - Recovering/Resolving - Other Medically Important Condition);Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - );Injection site swelling (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Vaccination site reaction (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010596969	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (7d - Recovering/Resolving - );Dizziness (3d - Recovered/Resolved - );Headache (7d - Recovering/Resolving - );Influenza (2d - Not Recovered/Not Resolved - );Injection site pain (7d - Recovering/Resolving - );Limb discomfort (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010596969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597016	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Vaccination site reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597021	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovering/Resolving - );Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597026	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral venous sinus thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597032	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597034	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (4d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597039	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597045	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597049	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597074	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drowning (n/a - Fatal - Results in Death);Transient ischaemic attack (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010597075	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac ventricular thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597083	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - Asthma - n/a - [n/a - n/a - n/a])|EMPAGLIFLOZIN [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|METFORMIN HYDROCHLORIDE, SITAGLIPTIN [METFORMIN HYDROCHLORIDE, SITAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[AZITHROMYCIN, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN HYDRATE] (C - Bronchiectasis - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597118	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Bronchospasm (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597125	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597136	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Henoch-Schonlein purpura (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597144	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (24d - Not Recovered/Not Resolved - );Fatigue (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597151	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597162	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Epilepsy (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonitis (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597170	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Vaccination site haematoma (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597173	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597178	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597183	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Tendon pain (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597203	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Infertility (n/a - Unknown - Other Medically Important Condition);Sperm concentration decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010597206	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (0d - Recovered/Resolved - );Oropharyngeal discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597240	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Not Recovered/Not Resolved - );Tremor (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597259	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - );Dyspnoea (0d - Recovering/Resolving - );Hyperhidrosis (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597261	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597266	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597271	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Impaired quality of life (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597277	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597279	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Congenital aortic stenosis (n/a - Unknown - Other Medically Important Condition);Foetal cardiac disorder (n/a - Unknown - Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Unknown - Other Medically Important Condition);Ventricular septal defect (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597282	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597283	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597295	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597309	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010597316	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597323	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash (4wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597330	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597332	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovered/Resolved - );Vaccination site movement impairment (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597333	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Varicella zoster virus infection (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597338	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (43d - Not Recovered/Not Resolved - );Dizziness (43d - Not Recovered/Not Resolved - );Fatigue (43d - Not Recovered/Not Resolved - );Lymphadenopathy (44d - Not Recovered/Not Resolved - );Malaise (44d - Not Recovered/Not Resolved - );Nausea (43d - Not Recovered/Not Resolved - );Pyrexia (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010597343	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597366	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (42d - Recovered/Resolved With Sequelae - );Visual impairment (42d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010597417	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597426	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597445	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (1d - Not Recovered/Not Resolved - );Tinnitus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597456	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010597492	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010597520	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Unknown - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Unknown - );Cognitive disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Impaired work ability (n/a - Unknown - );Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597526	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597545	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (134d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (134d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Somnolence (134d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597547	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Limb discomfort (n/a - Recovered/Resolved - );Performance status decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597548	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (30d - Recovered/Resolved - );Fatigue (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010597554	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597555	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic ischaemic neuropathy (4d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Visual field defect (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010597566	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (42d - Not Recovered/Not Resolved - );Mobility decreased (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010597585	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597593	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[METHOTREXATE, METHOTREXATE DISODIUM, METHOTREXATE SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597596	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dysuria (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Haematuria (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ocular hyperaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tubulointerstitial nephritis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	OPATANOL [OLOPATADINE, OLOPATADINE HYDROCHLORIDE] (C - Rhinitis allergic - n/a - [n/a - n/a - Ophthalmic])|[MECILLINAM, PIVMECILLINAM, PIVMECILLINAM HYDROCHLORIDE] (C - Urinary tract infection - n/a - [45d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597624	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597672	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epstein-Barr virus infection (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Hepatitis C (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - );Lymphocyte count decreased (n/a - Recovering/Resolving - );Lymphoedema (n/a - Recovering/Resolving - );Red blood cell count decreased (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010597690	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (11d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597708	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis bullous (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Eczema (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010597714	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597725	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (30d - Not Recovered/Not Resolved - );Headache (30d - Not Recovered/Not Resolved - );Lymphadenopathy (30d - Not Recovered/Not Resolved - );Tinnitus (30d - Not Recovered/Not Resolved - );Weight bearing difficulty (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010597727	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovering/Resolving - );Levator syndrome (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597728	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac discomfort (133d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (133d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597748	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597749	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Headache (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597759	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597773	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Temperature regulation disorder (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597790	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597793	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Influenza (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597804	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597806	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site induration (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597829	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Varicella zoster virus infection (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597840	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597849	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597857	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Injection site pain (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597865	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (121d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597873	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597881	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Discomfort (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597886	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597897	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010597912	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597921	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597933	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597937	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597939	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010597941	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597944	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597945	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597952	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010597957	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597963	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597964	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597978	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597986	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (2d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010597989	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (4d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (4d - Recovering/Resolving - );Nausea (4d - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010597996	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (16d - Not Recovered/Not Resolved - );Dyspnoea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010597996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598005	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immune thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010598009	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hepatitis (79d - Recovered/Resolved - Other Medically Important Condition);Hyperbilirubinaemia (79d - Recovered/Resolved - Other Medically Important Condition);Jaundice (79d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010598011	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Transient ischaemic attack (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010598020	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598026	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598029	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598042	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (15d - Not Recovered/Not Resolved - );Limb discomfort (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598044	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598048	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598054	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598059	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pain in extremity (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598071	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598086	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovered/Resolved - );Dyspnoea (35d - Not Recovered/Not Resolved - );Fatigue (36d - Not Recovered/Not Resolved - );Headache (4d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598097	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598099	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598110	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598118	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598123	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Vascular stent thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010598125	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598129	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598131	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010598134	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598144	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010598147	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598150	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598175	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598190	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010598192	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598194	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598196	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598197	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598199	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010598207	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010598222	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598234	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (40h - Recovered/Resolved - );Headache (40h - Recovered/Resolved - );Vaccination site pain (40h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598241	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598248	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598261	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Food allergy (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010598268	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Vascular device user - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Vascular device user - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Vascular device user - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - Vascular device user - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Vascular device user - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - Vascular device user - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010598282	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598289	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain lower (4d - Not Recovered/Not Resolved - );Colitis (4d - Not Recovered/Not Resolved - );Diarrhoea (4d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Vaccination site reaction (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598294	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010598299	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598301	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myositis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BONVIVA [IBANDRONATE SODIUM HYDRATE, IBANDRONIC ACID] (C - Osteoporosis - n/a - [n/a - n/a - n/a])|[ALFACALCIDOL] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - 5mg - n/a])|[L-ARGININE HYDROCHLORIDE] (C - Inclusion body myositis - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Inclusion body myositis - n/a - [n/a - 5mg - n/a])|[TEPRENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010598310	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (4d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010598330	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598336	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598345	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598353	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598359	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598360	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598362	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598364	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598367	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598369	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598378	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598379	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Not Recovered/Not Resolved - );Fatigue (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598380	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598381	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010598385	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598389	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598390	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598392	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010598393	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (31d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010598396	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010598397	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598398	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598399	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598400	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - );Injection site swelling (3d - Recovering/Resolving - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598403	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598404	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598407	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598410	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598412	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598413	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598416	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (3d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - );Malaise (5d - Not Recovered/Not Resolved - );Myalgia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598417	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598418	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598420	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598424	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598425	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598426	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598427	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598432	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598435	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598438	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598443	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598460	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598462	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598468	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (2d - Not Recovered/Not Resolved - );Influenza (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598476	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598481	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598509	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598510	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598514	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598516	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598522	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598528	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Paraesthesia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598539	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598543	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598563	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovering/Resolving - );Malaise (4d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598564	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598578	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598584	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598589	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (0d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598602	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598605	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598623	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598625	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598636	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010598647	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010598649	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598668	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598675	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010598683	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598691	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598703	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598712	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598716	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site pruritus (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010598722	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598751	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Hyperhidrosis (0d - Recovered/Resolved - );Hypotension (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598762	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Catheterisation cardiac (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010598771	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598779	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (39d - Not Recovered/Not Resolved - );Feeling hot (39d - Not Recovered/Not Resolved - );Headache (39d - Not Recovered/Not Resolved - );Malaise (39d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010598794	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598817	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598822	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598829	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598831	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598832	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598834	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598841	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (4d - Not Recovered/Not Resolved - );Dizziness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598850	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Dizziness (9d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Headache (9d - Recovered/Resolved - );Limb discomfort (9d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598851	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598852	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598854	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Lymphadenopathy (14d - Not Recovered/Not Resolved - );Vaccination site reaction (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598857	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598867	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598871	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598877	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598879	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (12d - Recovered/Resolved - );Limb discomfort (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598882	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598897	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598905	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598913	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (5d - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598936	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598939	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598951	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Alopecia (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010598959	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010598970	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (17d - Recovering/Resolving - );Sciatica (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010598980	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010598983	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (1d - Recovering/Resolving - );Rash (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010598983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599001	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599003	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast pain (4d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599019	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immune-mediated lung disease (4wk - Not Recovered/Not Resolved - );Lung infiltration (4wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599037	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fall (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599044	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010599048	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599078	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599086	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599097	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Effusion (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599102	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Flushing (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599110	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599114	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599119	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oligoarthritis (179d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Synovial disorder (179d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599127	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599136	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (1d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599150	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599152	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599170	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599172	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Motor dysfunction (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599178	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599194	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599201	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599203	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Injection site pain (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010599208	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599212	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599216	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599233	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Limb discomfort (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599235	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599246	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599247	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599252	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovering/Resolving - );Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Injection site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599254	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599258	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599260	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599262	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599280	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599291	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599293	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599294	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - );Limb discomfort (3d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Pyrexia (30d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010599306	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599311	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599322	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (32d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599328	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Dizziness (n/a - Recovered/Resolved With Sequelae - );Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010599343	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Muscle spasms (78d - Not Recovered/Not Resolved - );Myalgia (86d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599344	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599353	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599359	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599364	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599369	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599373	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (3d - Not Recovered/Not Resolved - );Dyspnoea (3d - Not Recovered/Not Resolved - );Heart rate increased (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599377	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cardiac pacemaker insertion (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dementia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599385	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (58d - Unknown - );Limb discomfort (58d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010599392	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral arterial occlusive disease (168d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599393	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (10d - Recovered/Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood cholesterol increased (n/a - Unknown - );Brain fog (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Unknown - );Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pruritus (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Nausea (n/a - Unknown - );Neurological symptom (n/a - Unknown - );Ocular hyperaemia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Swelling (n/a - Unknown - );Vertigo (n/a - Unknown - );Visual impairment (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599400	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Clinically isolated syndrome (145d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (145d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pleocytosis (145d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Visual field defect (145d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599409	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Weight bearing difficulty (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599412	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (1d - Not Recovered/Not Resolved - );Diarrhoea (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599417	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599419	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site swelling (5d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599420	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599430	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (21d - Unknown - );Rash pruritic (21d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010599434	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599444	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599454	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (55d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010599456	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Central serous chorioretinopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010599470	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599472	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599479	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hospitalisation (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleurisy (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Still's disease (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599486	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Vertigo (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599491	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599500	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Derailment (53d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599540	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (72d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hemihypoaesthesia (72d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Multiple sclerosis (72d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599543	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sarcoidosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599572	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599580	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIGLITOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599596	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599601	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (10d - Recovering/Resolving - );Fatigue (10d - Recovering/Resolving - );Pyrexia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599623	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (40d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599627	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (4d - Unknown - );Lymphadenopathy (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599658	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Not Recovered/Not Resolved - );Dyspnoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Feeling cold (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599666	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Demyelination (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Multiple sclerosis (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599682	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Swelling of eyelid (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599692	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Unknown - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599695	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - );Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling hot (n/a - Unknown - );Headache (n/a - Unknown - );Influenza (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599698	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599702	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599703	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Child	No	Male	Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599715	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599724	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate decreased (n/a - Not Recovered/Not Resolved - );Oropharyngeal discomfort (n/a - Not Recovered/Not Resolved - );Weight bearing difficulty (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599726	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599731	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599732	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599734	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crohn's disease (23d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599736	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599740	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (2d - Unknown - );Myalgia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599751	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599769	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599774	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (2d - Recovering/Resolving - );Rash (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599776	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599778	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599781	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599782	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599813	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599815	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599820	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - );Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599824	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599831	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599841	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599843	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010599850	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (10d - Recovering/Resolving - );Fatigue (10d - Recovering/Resolving - );Pyrexia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599854	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599856	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Diplopia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Eye infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Giant cell arteritis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vasculitis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010599859	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599862	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599863	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug eruption (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599865	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599866	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599875	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599881	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599882	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599887	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599888	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599893	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599896	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599898	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (27d - Not Recovered/Not Resolved - );Fatigue (28d - Not Recovered/Not Resolved - );Headache (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599900	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599903	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599907	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599909	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (0d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599917	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599922	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599926	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599927	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599929	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599932	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599935	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599942	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (3wk - Recovered/Resolved - Disabling);Bell's palsy (n/a - Unknown - Other Medically Important Condition);Dysstasia (3wk - Recovered/Resolved - );Gait disturbance (3wk - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Vaccination site erythema (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCONEXENT] (C - n/a - n/a - [n/a - n/a - n/a])|[GINGER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TURMERIC EXTRACT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010599947	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (74d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010599948	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599951	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Cough (72d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010599953	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599959	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599966	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599975	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599978	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010599981	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010599986	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010599986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600000	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600001	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600004	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600013	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600021	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (1d - Recovered/Resolved - );Dyspnoea (0d - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Paraesthesia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600044	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600048	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (57d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600052	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600058	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010600061	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600062	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Myalgia (1d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600067	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600070	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600076	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600081	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600085	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600089	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tachycardia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600095	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (62d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010600115	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600124	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600136	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010600139	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600141	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600142	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (14d - Not Recovered/Not Resolved - );Fatigue (14d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600164	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600179	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600187	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600191	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600200	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600255	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600308	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600310	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010600355	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600365	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600378	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600383	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600386	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600449	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Heart rate (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010600452	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600458	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600482	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600502	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600514	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600552	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600576	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600589	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600591	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600599	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600601	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600602	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600604	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600611	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Cough (4d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Injection site pain (4d - Not Recovered/Not Resolved - );Limb discomfort (3d - Recovering/Resolving - );Malaise (2d - Not Recovered/Not Resolved - );Myalgia (4d - Recovering/Resolving - );Tachycardia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600612	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600615	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600617	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (20d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600618	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600620	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600621	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600629	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600631	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600636	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovering/Resolving - );Injection site swelling (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600645	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600650	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600655	Spontaneous	2021-11-09 00:00:00	Healthcare Professional	European Economic Area	Conticini, E.. Relapse of microscopic polyangiitis after vaccination against COVID-19: A case report.. Journal of Medical Virology.. 2021;93(12):6439-6441. doi:10.1002/jmv.27192	65-85 Years	Not Specified	No	Male	Microscopic polyangiitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010600665	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600667	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600668	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600670	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (43d - Not Recovered/Not Resolved - );Dizziness (43d - Not Recovered/Not Resolved - );Fatigue (43d - Not Recovered/Not Resolved - );Lymphadenopathy (44d - Not Recovered/Not Resolved - );Malaise (44d - Not Recovered/Not Resolved - );Nausea (43d - Not Recovered/Not Resolved - );Pyrexia (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010600671	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600672	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Tachycardia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600683	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600684	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010600698	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pyrexia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600700	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600708	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010600709	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600710	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600712	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Not Recovered/Not Resolved - );Nuchal rigidity (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600717	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600718	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Unevaluable event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600721	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Unknown - );Headache (2d - Recovered/Resolved - );Injection site swelling (3d - Unknown - );Nausea (1d - Unknown - );Pain in extremity (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600722	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600725	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Herpes zoster (4d - Not Recovered/Not Resolved - );Lymphadenopathy (4d - Not Recovered/Not Resolved - );Pain of skin (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600726	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600731	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Renal failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010600739	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010600746	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure immeasurable (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Deafness (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericardial haemorrhage (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010600749	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600790	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (18d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600797	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600800	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600810	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600814	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010600821	Spontaneous	2021-11-09 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010600821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574907	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574912	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Impaired work ability (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574913	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575111	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DEXAMETHASONE [DEXAMETHASONE, DEXAMETHASONE SODIUM PHOSPHATE] (C - COVID-19 treatment - n/a - [n/a - n/a - n/a])|REMDESIVIR [REMDESIVIR] (C - COVID-19 treatment - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - COVID-19 treatment - n/a - [n/a - n/a - n/a])|[DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE MONOHYDRATE] (C - COVID-19 treatment - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010575121	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Radius fracture (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Ulna fracture (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575128	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575129	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - Life Threatening);Swelling (n/a - Unknown - Life Threatening);Thrombosis (n/a - Unknown - Life Threatening)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010575142	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575161	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Brain hypoxia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly);Maternal exposure during pregnancy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 5mg - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575166	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575170	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Neoplasm malignant (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575173	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema multiforme (n/a - Recovering/Resolving - Other Medically Important Condition);Pharyngitis streptococcal (n/a - Recovering/Resolving - );Rash (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575180	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Hot flush (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - 2.5mg - Oral])|[OMEPRAZOLE, PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - 25mg - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575182	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575189	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (76h - Recovered/Resolved - Other Medically Important Condition);Cough (147h - Recovered/Resolved - );Drug ineffective (76h - Recovered/Resolved - Other Medically Important Condition);Headache (51h - Recovered/Resolved - );Nasopharyngitis (76h - Recovered/Resolved - );Pyrexia (50h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575194	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (1h - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (1d - Recovered/Resolved - Other Medically Important Condition);Procedural vomiting (1h - Recovered/Resolved - Other Medically Important Condition);Throat tightness (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALFACALCIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575196	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (0d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575267	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thirst (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575410	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (15min - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010575486	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010575487	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575508	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575527	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bedridden (n/a - Not Recovered/Not Resolved - Disabling);Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling);Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Cold sweat (n/a - Not Recovered/Not Resolved - Disabling);Head titubation (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Hot flush (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling);Muscle twitching (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Renal pain (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010575531	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Myocardial injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575536	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575590	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Anxiety (n/a - Recovering/Resolving - );Discomfort (n/a - Recovering/Resolving - );Hypertension (749min - Recovered/Resolved - );Hypoaesthesia (n/a - Recovering/Resolving - );Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BILASTINE] (C - Asthma, Seasonal allergy - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE FUROATE] (C - Seasonal allergy - n/a - [n/a - n/a - Nasal])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575689	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010575702	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous sinus thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575711	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vomiting (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010575823	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010575829	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575836	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ZOPICLONE] (C - Sleep disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010575841	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010575849	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Extra dose administered (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575862	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nystagmus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[FUROSEMIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575863	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Hand deformity (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (1d - Recovered/Resolved - Other Medically Important Condition);Muscle rigidity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition);Pharyngeal paraesthesia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010575864	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bronchospasm (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dilatation ventricular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electroencephalogram abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Encephalopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling drunk (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neurological symptom (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575869	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010575870	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575871	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint stiffness (n/a - Unknown - Other Medically Important Condition);Night sweats (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575888	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	SEMAGLUTIDE [SEMAGLUTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010575889	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Tenderness (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])|[SERTRALINE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010575897	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010575897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576411	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Myocarditis (20d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LORATADINE] (C - Hypersensitivity - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010576462	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010576542	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010576572	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576574	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576637	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010576671	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (10s - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576674	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haemorrhage intracranial (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 8mg - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - 40mg - Oral])|[GLIQUIDONE] (C - n/a - n/a - [n/a - 30mg - Oral])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 8mg - Oral])|[VITAMIN D] (C - n/a - n/a - )|[WARFARIN, WARFARIN SODIUM BP] (C - Atrial fibrillation - n/a - [n/a - 3mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010576829	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Memory impairment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Mood swings (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscular weakness (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010576836	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576837	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (4d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (48h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576842	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Photophobia (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition);Visual field defect (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576846	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010576856	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576858	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576860	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Food intolerance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Irritable bowel syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576862	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576864	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mobility decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Vaccination site inflammation (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576866	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576877	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576884	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Cerebral infarction (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Lacunar infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576887	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576890	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (1d - Recovered/Resolved - Other Medically Important Condition);Discomfort (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Unresponsive to stimuli (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576894	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Contusion (n/a - Unknown - Other Medically Important Condition);Dermatitis atopic (n/a - Unknown - Other Medically Important Condition);Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - Unknown])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - Eczema - Unknown - [n/a - n/a - Unknown])|[FLUOCINONIDE] (C - Eczema - Unknown - [n/a - n/a - Unknown])|[MUPIROCIN] (C - Eczema - Unknown - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576896	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling, Other Medically Important Condition);Coordination abnormal (n/a - Unknown - Disabling, Other Medically Important Condition);Joint swelling (n/a - Unknown - Disabling, Other Medically Important Condition);Myalgia (n/a - Unknown - Disabling, Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Restless legs syndrome (n/a - Unknown - Disabling, Other Medically Important Condition);Sensory disturbance (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PRALUENT [ALIROCUMAB] (C - Hypercholesterolaemia - n/a - [138d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010576900	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010576901	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576934	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576937	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576940	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dermatitis atopic (n/a - Recovering/Resolving - Other Medically Important Condition);Eczema (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576944	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Heart rate irregular (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	GANFORT [TIMOLOL MALEATE, BIMATOPROST] (C - Glaucoma - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID, CALCIUM GLUBIONATE, CALCIUM CARBONATE, CALCIUM, CALCIUM GLUBIONATE, CALCIUM CARBONATE, COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TRYPTOPHAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576946	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear disorder (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Ear pain (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Eye irritation (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Eye swelling (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Facial paralysis (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Herpes zoster oticus (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Intracranial pressure increased (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Swelling face (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010576960	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576967	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebral atrophy (n/a - Unknown - Other Medically Important Condition);Cognitive disorder (44d - Recovered/Resolved With Sequelae - Disabling);Disorientation (n/a - Unknown - );Encephalitis (n/a - Recovering/Resolving - Other Medically Important Condition);Encephalitis autoimmune (46d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Unknown - );Hyponatraemia (n/a - Recovering/Resolving - );Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - );Meningitis bacterial (n/a - Unknown - Other Medically Important Condition);Pleural effusion (n/a - Unknown - );Renal impairment (n/a - Unknown - Other Medically Important Condition);Type 1 diabetes mellitus (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[AMLODIPINE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010576968	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576979	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Band neutrophil percentage increased (n/a - Unknown - Other Medically Important Condition);Infectious mononucleosis (n/a - Unknown - );Lymphocyte morphology abnormal (n/a - Unknown - );Malaise (n/a - Unknown - );Monocyte percentage increased (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - );Pyrexia (7d - Recovered/Resolved - );White blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576981	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576982	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576983	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chromaturia (16h - Recovered/Resolved - Other Medically Important Condition);Dysuria (2d - Recovered/Resolved - Other Medically Important Condition);Haematuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Arrhythmia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576988	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010576992	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010576993	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Presyncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010576993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010577000	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577010	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577342	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site abscess (n/a - Recovering/Resolving - Disabling);Vaccination site joint effusion (n/a - Recovering/Resolving - Disabling);Vaccination site movement impairment (n/a - Recovering/Resolving - Disabling);Vaccination site oedema (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling);Wrong technique in product usage process (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010577359	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - );Eye injury (n/a - Not Recovered/Not Resolved - );Eye swelling (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Limb injury (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010577370	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Ear inflammation (28d - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010577385	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysmetria (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Illusion (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577395	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Injection site pruritus (n/a - Unknown - );Rash (n/a - Unknown - );Vaccination site pustule (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577415	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010577429	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Dizziness (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Influenza like illness (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577430	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577432	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577436	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arthralgia (18d - Recovering/Resolving - );Blood pressure increased (18d - Recovering/Resolving - );Dizziness (18d - Recovering/Resolving - );Fatigue (18d - Recovering/Resolving - );Limb discomfort (18d - Recovering/Resolving - );Nausea (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577437	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Burning sensation (49d - Recovered/Resolved - );Chest pain (49d - Recovered/Resolved - );Myalgia (49d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010577524	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577540	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577541	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577542	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577544	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577579	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010577688	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral swelling (2mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577711	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Vaccination site reaction (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577718	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neck pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577752	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010577818	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Insomnia (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Postural orthostatic tachycardia syndrome (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensitive skin (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skin discolouration (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (3mo - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010577843	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577849	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577853	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577888	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010577960	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Malaise (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovering/Resolving - Disabling);Nausea (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010577980	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (22d - Unknown - );Injection site pain (28d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010577980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010578051	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2wk - Recovered/Resolved - Life Threatening, Disabling);Oedema peripheral (n/a - Recovered/Resolved - Life Threatening, Disabling);Pain in extremity (3mo - Recovered/Resolved - Life Threatening, Disabling);Pyrexia (2wk - Recovered/Resolved - Life Threatening, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010578189	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578194	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578196	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578392	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Fatal - Results in Death);Dyspnoea exertional (n/a - Fatal - Results in Death);Fibrin D dimer increased (n/a - Fatal - Results in Death);Hypotonia (n/a - Fatal - Results in Death);Hypotonic-hyporesponsive episode (n/a - Fatal - Results in Death);Pallor (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010578399	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578404	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovered/Resolved - );Arterial thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Metamorphopsia (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - );Visual field defect (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010578408	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Eye pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578411	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Malaise (2d - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578429	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (3wk - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578481	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conversion disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	STELARA 90 MG SOLUTION FOR INJECTION [USTEKINUMAB] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010578492	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578504	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening);Fatigue (n/a - Recovering/Resolving - );Headache (7d - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - );Night sweats (2mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010578511	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (121d - Recovering/Resolving - );Balance disorder (121d - Recovering/Resolving - );Bradycardia (121d - Recovering/Resolving - );Chest pain (121d - Recovering/Resolving - );Dizziness (121d - Recovering/Resolving - );Dyspepsia (121d - Recovering/Resolving - );Dyspnoea (121d - Recovering/Resolving - );Fatigue (121d - Recovering/Resolving - );Headache (121d - Recovering/Resolving - );Memory impairment (121d - Recovering/Resolving - );Muscle spasms (121d - Recovering/Resolving - );Neck pain (121d - Recovering/Resolving - );Oral candidiasis (121d - Recovering/Resolving - );Pain in extremity (121d - Recovering/Resolving - );Panic attack (121d - Recovering/Resolving - );Paraesthesia (121d - Recovering/Resolving - );Photophobia (121d - Recovering/Resolving - );Tinnitus (121d - Recovering/Resolving - );Vestibular disorder (89d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (121d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578605	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578613	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578617	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dilated cardiomyopathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Ejection fraction decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578618	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Circulatory collapse (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fall (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	INSULIN ASPART [INSULIN ASPART] (C - n/a - n/a - )|LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - n/a - )|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[DIGITOXIN] (C - n/a - n/a - )|[DONEPEZIL] (C - n/a - n/a - )|[SPIRONOLACTONE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578621	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578624	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Heart rate irregular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010578708	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vasodilatation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578770	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Recovered/Resolved With Sequelae - );Pericardial effusion (7d - Not Recovered/Not Resolved - );Tachycardia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010578783	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (2d - Recovering/Resolving - );Furuncle (2d - Recovering/Resolving - );Gingival bleeding (2d - Recovering/Resolving - );Head discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578785	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (45d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Limb discomfort (35d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Peripheral swelling (35d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578797	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (43d - Not Recovered/Not Resolved - );Malaise (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010578804	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010578808	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute kidney injury (7d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Appendicitis (7d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010578812	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Rash (5d - Not Recovered/Not Resolved - );Urticaria (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578816	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Feeling hot (7d - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Pruritus (3d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578817	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Hypoaesthesia (0d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578820	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Euphoric mood (0d - Recovered/Resolved - );Fatigue (35d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Somnolence (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - );Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010578832	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010578841	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010578842	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Recovering/Resolving - );Eczema (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Periorbital discomfort (n/a - Recovering/Resolving - );Petechiae (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Skin discharge (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010578847	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010578851	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Unknown - );Malaise (n/a - Recovering/Resolving - );Neuralgia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Sensory disturbance (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578854	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (19d - Not Recovered/Not Resolved - );Erythema (19d - Not Recovered/Not Resolved - );Pruritus (19d - Not Recovered/Not Resolved - );Rash (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578857	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Vomiting (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010578870	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010578876	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578881	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sudden hearing loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010578902	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Hypoaesthesia (0d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010578956	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578959	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578963	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010578967	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010578970	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010578970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579046	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory loss (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010579136	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010579180	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010579192	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010579215	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579220	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Oropharyngeal pain (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Subcutaneous abscess (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579238	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Sciatica (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010579290	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Unknown - Disabling);Headache (1d - Recovered/Resolved With Sequelae - Disabling);Immunisation (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010579291	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dysarthria (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010579293	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579294	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010579297	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Rest regimen (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579298	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TRIUMEQ [ABACAVIR, LAMIVUDINE, DOLUTEGRAVIR] (C - HIV test positive - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579302	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579304	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ocular discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579306	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (2d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting projectile (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579307	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579312	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579331	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paralysis (4d - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010579356	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579359	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579360	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cataract (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579452	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Wheezing (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579467	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010579582	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579583	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579586	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579590	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010579591	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Dyspnoea exertional (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010579625	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579720	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood pressure decreased (n/a - Unknown - );Incorrect dose administered (n/a - Unknown - );Overdose (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579726	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site reaction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579728	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Malaise (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579732	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579735	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579738	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579739	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Ill-defined disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579747	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (1d - Recovered/Resolved - Other Medically Important Condition);Heart rate irregular (1d - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579756	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010579758	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Osteoarthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Osteoporosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579775	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010579793	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (4d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010579909	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Disabling);Anosmia (n/a - Not Recovered/Not Resolved - Disabling);Hallucination, olfactory (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010579913	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LEVODOPA [LEVODOPA] (C - Parkinsonism - n/a - [n/a - n/a - Oral])|XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CARBIDOPA] (C - Parkinsonism - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[VOGLIBOSE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579917	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579924	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Disabling, Other Medically Important Condition);Gastrointestinal disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Lung disorder (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Disabling, Other Medically Important Condition);Systemic scleroderma (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010579926	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (0d - Recovered/Resolved - Other Medically Important Condition);Headache (2235min - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Oropharyngeal pain (0d - Recovered/Resolved - );Pain (2235min - Recovered/Resolved - );Swelling face (0d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2235min - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579927	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Influenza - n/a - [1d - n/a - n/a])|[MINOXIDIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579928	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579932	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010579934	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579936	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Labyrinthitis (n/a - Recovering/Resolving - Disabling);Sinusitis (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Sinusitis - n/a - [7d - n/a - n/a])|[BETAHISTINE, BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE MESILATE] (C - Dizziness - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Palpitations - n/a - [460d - n/a - n/a])|[ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - Ear infection - n/a - [5d - n/a - n/a])|[MOMETASONE] (C - Labyrinthitis - n/a - [n/a - n/a - n/a])|[PROCHLORPERAZINE, PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE BP, PROCHLORPERAZINE MESILATE] (C - Dizziness - n/a - [n/a - n/a - n/a])|[PROGESTERONE, PROGESTERONE, MICRONISED] (C - Hormone replacement therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579938	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LISINOPRIL ANHYDROUS] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010579940	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Inflammation (n/a - Unknown - );Limb injury (n/a - Unknown - );Malaise (n/a - Unknown - );Oedema peripheral (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Tinea infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579949	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pancreatic cyst (n/a - Unknown - Other Medically Important Condition);Pancreatitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010579951	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Glomerulonephritis (n/a - Unknown - Other Medically Important Condition);Renal vasculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[DAPAGLIFLOZIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[MELOXICAM] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010579997	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Musculoskeletal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010579997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580008	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (3d - Recovering/Resolving - );Pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580085	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Off label use (n/a - Unknown - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM ANHYDROUS] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010580087	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580096	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Rhabdomyolysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010580117	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580350	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010580382	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010580396	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580402	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Palpitations - n/a - [18d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580411	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovering/Resolving - );Gait disturbance (n/a - Unknown - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580415	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash vesicular (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580425	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Endocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010580428	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Micturition disorder (n/a - Recovering/Resolving - );Pollakiuria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580430	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (7d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (7d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010580451	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	XEPLION [PALIPERIDONE PALMITATE] (C - n/a - n/a - [n/a - n/a - Intramuscular])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GAMMA-AMINOBUTYRIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, P-AMINOBENZOIC ACID, THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, P-AMINOBENZOIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580461	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysphagia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eye disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Influenza (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mastication disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Swollen tongue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tonsillitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010580462	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580471	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010580472	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (7d - Recovered/Resolved - Other Medically Important Condition);Mental fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580476	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010580483	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010580490	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580491	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010580492	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580493	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010580503	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010580509	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vascular graft thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010580521	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);COVID-19 immunisation (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580522	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 immunisation (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580523	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010580593	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition);Vertigo (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580620	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580622	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580626	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580627	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580628	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580667	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac arrest (1d - Fatal - Results in Death, Other Medically Important Condition);Circulatory collapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Fatal - Results in Death);Interchange of vaccine products (n/a - Fatal - Results in Death);Off label use (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	SILDENAFIL [SILDENAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFUZOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DABIGATRAN] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010580705	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010580898	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	FENTANYL [FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010580901	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[OXYGEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010580936	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010580987	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580990	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580995	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010580998	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010580998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581004	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581049	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Cervical radiculopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Spinal cord compression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581060	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (850min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed level of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heat illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Lactic acidosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Physical deconditioning (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581063	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (1d - Recovered/Resolved - Other Medically Important Condition);Anaphylactic reaction (584min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Blood glucose increased (n/a - Unknown - );Cough (39min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cyanosis (39min - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (575min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (1h - Recovered/Resolved - Other Medically Important Condition);Tachypnoea (39min - Recovered/Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581192	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581197	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010581283	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inflammation (n/a - Unknown - );Laryngeal oedema (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - );Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition);Vocal cord paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581420	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Maternal exposure timing unspecified (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Premature baby (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581423	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Lung opacity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581426	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581517	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581518	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010581522	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010581531	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581538	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Asthenia (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010581545	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581548	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581551	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581555	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581561	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581563	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581635	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010581636	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Herpes zoster (n/a - Not Recovered/Not Resolved - Disabling);Nerve injury (n/a - Not Recovered/Not Resolved - Disabling);Platelet count decreased (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010581639	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Connor, B.. Monoclonal Antibody Therapy in a Vaccine Breakthrough SARS-CoV-2 Hospitalized Delta (B.1.617.2) Variant Case. International Journal of Infectious Diseases. 2021;110:232-234. doi:10.1016/j.ijid.2021.07.029	18-64 Years	Not Specified	No	Male	COVID-19 (3d - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581734	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010581742	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010581820	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581822	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581823	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010581826	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581829	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010581846	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);General physical health deterioration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010581857	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ruptured cerebral aneurysm (4d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010581867	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovered/Resolved - );Dysarthria (n/a - Recovering/Resolving - Disabling);Gait disturbance (n/a - Recovering/Resolving - Disabling);Hypertension (n/a - Recovered/Resolved - );Ischaemic stroke (n/a - Recovering/Resolving - Life Threatening);Memory impairment (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010581881	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581886	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581889	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute sinusitis (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581899	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sickle cell anaemia with crisis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	PREGABALIN [PREGABALIN] (C - Pain - n/a - [n/a - n/a - n/a])|SIKLOS 1000 MG FILM-COATED TABLETS [HYDROXYCARBAMIDE] (C - Sickle cell anaemia with crisis - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Pain - n/a - )|[FENTANYL] (C - Pain - n/a - )|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581913	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (12h - Recovered/Resolved - Other Medically Important Condition);Dysphagia (4h - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (4h - Recovered/Resolved - Life Threatening);Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation reaction (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010581928	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [61d - 3{DF} - Intramuscular])|[PREDNISONE] (S - Transplant rejection - n/a - [n/a - 40mg - Oral])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Reflux gastritis - n/a - [n/a - 40mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[ATOVAQUONE] (C - Parasitic infection prophylaxis - n/a - [n/a - 750mg - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), CALCIUM, CHOLECALCIFEROL CONCENTRATE, COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoporosis - n/a - [n/a - 1000mg - n/a])|[CICLOSPORIN] (C - Transplant rejection - n/a - [166d - 10mg - Oral])|[PHENOXYMETHYLPENICILLIN] (C - Opportunistic infection prophylaxis - n/a - [n/a - 1M[iU] - Oral])|[PICLOXYDINE DIHYDROCHLORIDE] (C - Eye infection bacterial - n/a - [n/a - 1[drp] - Ophthalmic])|[RISEDRONATE MONOSODIUM, RISEDRONATE SODIUM] (C - Osteoporosis - n/a - [n/a - 35mg - Oral])|[VALACICLOVIR] (C - Opportunistic infection prophylaxis - n/a - [n/a - 500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581936	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581937	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Atrial flutter (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Atrioventricular block complete (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581964	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010581965	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010581967	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010581973	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Mixed liver injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581976	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010581983	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010581997	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cardiac failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010581997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010582018	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Skin reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])|[FLUOROURACIL] (S - Actinic keratosis - n/a - [9d - n/a - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010582020	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [41d - 1{DF} - Intramuscular])|[RUXOLITINIB PHOSPHATE] (S - Myelofibrosis - n/a - [2y - 20mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010582025	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010582028	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - 1{DF} - Intramuscular])|METHOTREXATE [METHOTREXATE] (S - Rheumatoid arthritis - Dose not changed - [n/a - 25mg - Subcutaneous])|ORENCIA 125 MG SOLUTION FOR INJECTION [ABATACEPT] (S - Rheumatoid arthritis - Dose not changed - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010582043	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (5h - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010582052	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATENOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582064	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582067	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Blood thyroid stimulating hormone increased (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Thyroid mass (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582079	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582093	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582094	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (14d - Recovered/Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspnoea (14d - Recovered/Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Malaise (1d - Recovered/Resolved - );Pain in extremity (23d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vertigo (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582100	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582103	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582110	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Monoplegia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582114	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582125	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site hypoaesthesia (3d - Recovered/Resolved With Sequelae - );Oedema (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010582134	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582136	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Transaminases increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582143	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582154	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582156	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582157	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010582159	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (1d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582169	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (2d - Recovered/Resolved - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Faeces discoloured (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582174	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582176	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582180	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010582184	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010582189	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582190	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582191	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (29d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010582193	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582205	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582228	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582229	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582232	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582240	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582250	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582251	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582252	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582255	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582256	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582263	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582264	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperglycaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582267	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582270	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (10d - Recovering/Resolving - );Vertigo (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582274	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582276	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582280	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582285	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Arthritis (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582290	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582296	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582302	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582312	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582328	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anal haemorrhage (n/a - Recovered/Resolved - );Constipation (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582359	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582381	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582382	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582383	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582384	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582386	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rhinitis (2d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	IMBRUVICA 140 MG HARD CAPSULES [IBRUTINIB] (C - Chronic lymphocytic leukaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582387	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582407	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582417	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582426	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gastrointestinal disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582428	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582432	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582442	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582443	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582461	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582473	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582474	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	CYMBALTA 30 MG HARD GASTRO-RESISTANT CAPSULES [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582475	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582483	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582490	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (4wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582495	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582505	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582506	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582508	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582515	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphonia (6d - Recovered/Resolved - );Influenza like illness (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582517	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582519	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582520	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (15d - Recovered/Resolved - );Influenza like illness (15d - Recovered/Resolved - );Rhinitis (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582548	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582578	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582579	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ejaculation failure (20d - Not Recovered/Not Resolved - );Sciatica (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582582	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582584	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582587	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Nightmare (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582660	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010582671	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010582684	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010582718	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582726	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neurodermatitis (12d - Recovering/Resolving - );Rash (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582737	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582738	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Muscle spasms (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582743	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582748	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Unknown - );Headache (1d - Unknown - );Malaise (1d - Unknown - );Migraine (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582749	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (17d - Unknown - );Myalgia (17d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010582775	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582776	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582788	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010582791	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (1d - Unknown - );Dizziness (1d - Unknown - );Myalgia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582796	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Recovering/Resolving - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010582841	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010582841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010583083	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PROBIOTICA [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010583086	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583094	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Musculoskeletal stiffness (n/a - Recovering/Resolving - );Penis disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583105	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010583161	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Tachypnoea (n/a - Recovering/Resolving - );Vision blurred (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583179	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Atelectasis (n/a - Unknown - Other Medically Important Condition);Pleural effusion (n/a - Unknown - Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583200	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - );Mental impairment (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583295	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583298	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Neck pain (89d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|IRBESARTAN HYDROCHLORIDE [IRBESARTAN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Neck pain - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583300	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Overdose (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010583342	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010583347	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583457	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ISOTRETINOIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583473	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly);Dysstasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly);Thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Congenital Anomaly)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010583475	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Transient ischaemic attack (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 1{DF} - n/a])|[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583485	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583505	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583513	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1mo - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583537	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Recovering/Resolving - Disabling);Polymyositis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Myocardial infarction - n/a - [1035d - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010583540	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal loss of weight (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anxiety (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nasal congestion (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - 400mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010583541	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Unknown - Other Medically Important Condition);Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition);Hepatic function abnormal (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583562	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoacusis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skin burning sensation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MIRAPEXIN [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - n/a - [n/a - n/a - Oral])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010583638	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Myocardial strain imaging (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010583640	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cold sweat (n/a - Recovered/Resolved - );Diarrhoea (0d - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583641	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - );Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Illness (n/a - Unknown - );Malaise (n/a - Unknown - );Muscle spasms (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[GABAPENTIN] (S - Neuralgia, Partial seizures - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583653	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NIFEDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010583659	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010583753	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010583776	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchopulmonary disease (n/a - Unknown - );Cardiac arrest (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583852	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010583866	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583872	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010583880	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010583883	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010583902	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain (24h - Recovered/Resolved - );Back pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583906	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010583908	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Enterocolitis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neutropenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Septic shock (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transfusion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - Unknown])|TRASTUZUMAB [TRASTUZUMAB] (S - n/a - Unknown - [n/a - 265mg - Intravenous (not otherwise specified)])|[CALCIUM FOLINATE, CALCIUM FOLINATE PENTAHYDRATE, FOLINIC ACID] (S - n/a - Unknown - [n/a - 720mg - Intravenous (not otherwise specified)])|[FLUOROURACIL] (S - n/a - Unknown - [n/a - 4320mg - Intravenous (not otherwise specified)])|[FLUOROURACIL] (S - n/a - Unknown - [n/a - 720mg - Intravenous (not otherwise specified)])|[OXALIPLATIN] (S - n/a - Unknown - [n/a - 150mg - Intravenous (not otherwise specified)])	CHAMPIX [VARENICLINE, VARENICLINE TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACRIVASTINE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - Unknown])|[DEXAMETHASONE, DEXAMETHASONE PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOCLOPRAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NYSTATIN, DIPHENHYDRAMINE, HYDROCORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[ONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010583914	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010583920	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010583946	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Infrequent bowel movements (n/a - Unknown - );Urinary retention (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010583946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010584019	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584036	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584073	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584085	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584209	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584217	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Bedridden (27d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Erythema (33d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Heart rate irregular (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Palpitations (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (31d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Rash (33d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010584220	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010584283	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584315	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal vascular thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010584335	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010584339	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010584341	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010584352	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Night sweats (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010584381	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584584	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood pressure diastolic decreased (n/a - Unknown - );COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Illness (n/a - Unknown - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - Sleep disorder - n/a - [n/a - 20mg - Oral])|[LEVOTHYROXINE, LIOTHYRONINE] (C - Thyroid disorder - n/a - [n/a - 90mg - Oral])|[PLECANATIDE] (C - Constipation - n/a - [n/a - 3mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584586	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pacemaker generated arrhythmia (8wk - Recovered/Resolved With Sequelae - Other Medically Important Condition);Tachycardia (16wk - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ventricular extrasystoles (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[METOPROLOL SUCCINATE] (C - Arrhythmia - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010584667	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Disabling);Deafness unilateral (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Hypertension (n/a - Unknown - );Hypoacusis (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Lung disorder (n/a - Unknown - );Movement disorder (n/a - Unknown - );Muscular weakness (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - );Skin discolouration (n/a - Unknown - );Throat tightness (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition);Vaccination site mass (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010584672	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010584779	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584785	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pyrexia (5d - Recovered/Resolved - );Vomiting (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584789	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584810	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Atrial flutter (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010584913	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	No	Not Specified	Autonomic neuropathy (n/a - Unknown - Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584940	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584950	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584956	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584963	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584966	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle contracture (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584967	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584974	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584977	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584982	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584984	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site movement impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])|[B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, WILD TYPE), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (S - Influenza immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010584990	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010584998	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010584998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585006	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010585018	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585023	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585038	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cutaneous sarcoidosis (48d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly);Rash (48d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	REVINTY ELLIPTA 184 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])|ROLUFTA ELLIPTA 55 MICROGRAMS INHALATION POWDER, PRE-DISPENSED [UMECLIDINIUM BROMIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BILASTINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[BUDESONIDE] (C - Sinusitis - n/a - [n/a - n/a - n/a])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE] (C - Eye allergy - n/a - [n/a - n/a - n/a])|[CITALOPRAM, CITALOPRAM HYDROBROMIDE] (C - Depression - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Depression - n/a - [n/a - n/a - n/a])|[KETOTIFEN HYDROGEN FUMARATE] (C - Eye allergy - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010585044	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585053	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585063	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585065	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585073	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Nausea (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585075	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Unknown - );Constipation (n/a - Unknown - );Mesenteric lymphadenitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585087	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585090	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585093	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585105	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585108	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585111	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585112	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatitis acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010585119	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Odynophagia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585120	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585126	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010585224	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (1d - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])|INSULIN LISPRO [INSULIN LISPRO] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010585228	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (24d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (24d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010585338	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypophagia (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010585377	Spontaneous	2021-11-08 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Generalised tonic-clonic seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary incontinence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010585393	Spontaneous	2021-11-08 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Respiratory disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010585393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010574074	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site haematoma (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574083	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Swelling of eyelid (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574215	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574217	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574220	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574221	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574225	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574228	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574229	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574231	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574247	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574251	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574260	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574261	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574262	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574361	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Disturbance in attention (n/a - Unknown - );Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574364	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[URSODEOXYCHOLIC ACID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574372	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Nightmare (4h - Recovered/Resolved - );Sleep disorder (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574386	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovered/Resolved - );Injection site erythema (n/a - Recovered/Resolved - );Injection site haematoma (n/a - Recovered/Resolved - );Injection site inflammation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - );Injection site warmth (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574394	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574395	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574398	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574400	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574401	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574407	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574426	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574428	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574430	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574441	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010574448	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574453	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574462	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574464	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574471	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Unknown - );Headache (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574491	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctival haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010574530	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - )|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010574552	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574604	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574606	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Facial paralysis (28d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010574609	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Dry mouth (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574615	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Axillary pain (n/a - Recovered/Resolved - Other Medically Important Condition);Breast pain (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ISPAGHULA HUSK BP, MEBEVERINE HYDROCHLORIDE, ISPAGHULA HUSK] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE SULPHATE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574618	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dysphoria (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574620	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Thunderclap headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010574633	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010574647	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoglycaemia (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Diabetes mellitus - n/a - [1d - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574650	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Varicose vein (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574655	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Lyme disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574665	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574666	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574668	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574670	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574671	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574672	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574686	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574731	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site warmth (2d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574753	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574755	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - [11y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574769	Spontaneous	2021-11-07 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574798	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Nausea (2d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574836	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain of skin (n/a - Not Recovered/Not Resolved - );Skin burning sensation (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574850	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (90min - Recovered/Resolved - );Nausea (90min - Recovered/Resolved - );Pyrexia (90min - Recovered/Resolved - );Vomiting (90min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Seizure - n/a - [7y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010574854	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5min - Recovered/Resolved - );Body temperature decreased (5min - Recovered/Resolved - );Muscle spasms (5min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010574858	Spontaneous	2021-11-07 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ocular hyperaemia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571346	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571354	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - );Eyelid oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571466	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571498	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571499	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571505	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571552	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571556	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010571561	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571579	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571589	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Joint swelling (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571594	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	AZATHIOPRINE [AZATHIOPRINE] (C - Prophylaxis against transplant rejection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571597	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571599	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571602	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010571612	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571615	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571621	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571640	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Bronchospasm (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010571676	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571688	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571690	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571692	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571693	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571695	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571711	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571723	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010571731	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571745	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571770	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571791	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571823	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Disorientation (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571837	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010571845	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571848	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Photosensitivity reaction (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571865	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Not Recovered/Not Resolved - Life Threatening);Electrocardiogram QT prolonged (n/a - Not Recovered/Not Resolved - Life Threatening);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Life Threatening);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening);Tachyarrhythmia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010571873	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571908	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010571988	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571997	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dermatitis (n/a - Not Recovered/Not Resolved - );Dry eye (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Panic disorder (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572002	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010572004	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572032	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (2d - Fatal - Results in Death);Coma (2d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010572034	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Recovering/Resolving - );Localised infection (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572068	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	CSF glucose abnormal (n/a - Fatal - Results in Death);Cerebrovascular accident (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010572070	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010572075	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010572096	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572102	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572143	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - .3mL - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[DESMOPRESSIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572145	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572165	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dehydration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sleep attacks (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sudden onset of sleep (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010572169	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Foot deformity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tenosynovitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572170	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Beta 2 microglobulin increased (n/a - Not Recovered/Not Resolved - );Blood albumin decreased (n/a - Not Recovered/Not Resolved - );Blood immunoglobulin A increased (n/a - Not Recovered/Not Resolved - );Proteinuria (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572179	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Gravitational oedema (n/a - Recovering/Resolving - Life Threatening);Tachyarrhythmia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|[CARBOPLATIN] (S - Lung adenocarcinoma - n/a - [n/a - 600mg - Intravenous (not otherwise specified)])|[GEMCITABINE] (S - Lung adenocarcinoma - n/a - [n/a - 2000mg - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010572181	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspepsia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Middle insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010572183	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010572186	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye oedema (n/a - Not Recovered/Not Resolved - Disabling);Macular oedema (n/a - Not Recovered/Not Resolved - Disabling);Venous occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010572191	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Analgesic therapy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572200	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010572215	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010572230	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (0d - Fatal - Results in Death);Headache (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010572255	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lip swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572323	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Taste disorder (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572330	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572354	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572368	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572369	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572375	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis contact (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572389	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572421	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572424	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010572465	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572469	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572484	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphthous ulcer (5d - Recovered/Resolved - );Epistaxis (5d - Recovered/Resolved - );Lip haemorrhage (5d - Recovered/Resolved - );Lip swelling (5d - Recovered/Resolved - );Penile haemorrhage (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010572492	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed mood (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572506	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (3d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (3d - Recovered/Resolved - );Swelling (3d - Recovered/Resolved - );Swelling face (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ROYAL JELLY] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[UBIDECARENONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010572524	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010572525	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010572726	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Cough (n/a - Recovering/Resolving - );Dark circles under eyes (n/a - Recovering/Resolving - );Eye irritation (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - );Throat irritation (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572757	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572758	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572759	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572761	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572764	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572765	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572811	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Cough (7d - Recovered/Resolved - );Dry mouth (n/a - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Puncture site pain (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2min - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572829	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (30min - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [3s - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572834	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Insomnia (n/a - Unknown - );Lymphadenopathy (3d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572836	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572843	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010572896	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Retching (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572941	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572953	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	AUBAGIO [TERIFLUNOMIDE] (S - Multiple sclerosis - Unknown - [n/a - 1{DF} - Oral])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010572990	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010572990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573040	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Memory impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573057	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Puncture site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573075	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Recovered/Resolved - );Presyncope (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573204	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573208	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573353	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573356	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573449	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573451	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573452	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573456	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573460	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573464	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573525	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573566	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573581	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573584	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573588	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573589	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573590	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573592	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573606	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573667	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010573682	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ANORO ELLIPTA 55 MICROGRAMS/22 MICROGRAMS [UMECLIDINIUM BROMIDE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|DUOTRAV EYE DROPS, SOLUTION [TIMOLOL, TRAVOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|LEVEMIR [INSULIN DETEMIR] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])|NOVORAPID [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[ALFACALCIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE, CIPROFLOXACIN LACTATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS FUMARATE, FERROUS FUMARATE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METRONIDAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573686	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573689	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573692	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573694	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573695	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573711	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2h - Recovered/Resolved - );Photophobia (2h - Recovered/Resolved - );Pyrexia (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573715	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010573716	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Skin warm (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573763	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573764	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573767	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (45min - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573785	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573788	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573791	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (5h - Recovered/Resolved - );Diarrhoea (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573798	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (0d - Recovered/Resolved - );Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573801	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573822	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573828	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573829	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573834	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573835	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573838	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573849	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573850	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573871	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573878	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573885	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573897	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573900	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573901	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573943	Spontaneous	2021-11-06 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010573981	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573989	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573992	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010573995	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010573995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574002	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574003	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574006	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010574007	Spontaneous	2021-11-06 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010574007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560732	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Ecchymosis (n/a - Recovering/Resolving - );Haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mL - Intramuscular])	TICAGRELOR [TICAGRELOR] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560751	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560752	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560762	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flank pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560787	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560794	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560798	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hiccups (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Type I hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560893	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560903	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560920	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010560922	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Agitation (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560952	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560953	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560963	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Petechiae (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010560987	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560990	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Disabling);Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010560992	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Muscle twitching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561007	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Epiglottic oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561010	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561018	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Platelet aggregation abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561023	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561050	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Psychiatric decompensation (n/a - Not Recovered/Not Resolved - );Retinopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - n/a - n/a])|[LITHIUM SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561077	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561097	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561100	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561180	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561183	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid oedema (n/a - Recovering/Resolving - );Lip oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 1{DF} - n/a])|[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN, A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN, B/FLORIDA/4/2006-LIKE STRAIN, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), A/MOSCOW/10/99 (H3N2) - LIKE STRAIN (A/PANAMA/2007/99 REASS. RESVIR-17), B/SICHUAN/379/99-LIKE STRAIN (B/JOHANNESBURG/5/99), A/SOUTH AUSTRALIA/55/2014 STRAIN, A/SWITZERLAND/9715293/2013 (H3N2) - LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)-LIKE STRAIN USED (NYMC X-223A) DERIVED FROM A/TEXAS/50/2012, B/MASSACHUSETTS/02/2012, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/VICTORIA/361/2011 (H3N2)–DERIVED STRAIN USED (IVR-165), B/WISCONSIN/1/2010-LIKE STRAIN USED (NYMC BX-39) DERIVED FROM B/HUBEI-WUJIAGANG/158/2009, A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, A/WISCONSIN/67/2005 (H3N2), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN, B/MALAYSIA/2506/2004 - LIKE STRAIN, B/BEIJING/184/93-LIKE STRAIN (B/YAMANASHI/166/98), A/SYDNEY/5/97 (H3N2)-LIKE STRAIN (A/SYDNEY/5/97 REASS. RESVIR 13), A/BEIJING/262/95 (H1N1) - LIKE STRAIN (A/BEIJING/262/95 REASS. X-127), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/MICHIGAN/45/2015, NYMC X-275), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009 (H1N1), A/PERTH/16/2009 (H3N2) - LIKE STRAIN, B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NIB-65), B/BRISBANE/60/2008-LIKE VIRUS, A/CALIFORNIA/7/2009(H1N1)-LIKE STRAIN (NYMC X-179A), A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), B/MASSACHUSETTS/02/2012, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, B/PHUKET/3073/2013-LIKE STRAIN, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SOUTH AUSTRALIA/55/2014, IVR-175), A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN USED NYMC X-179A, INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)] (S - Prophylaxis - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561201	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retching (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561218	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010561221	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Aspartate aminotransferase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Eosinophilia (n/a - Recovering/Resolving - Other Medically Important Condition);Faeces soft (n/a - Recovering/Resolving - Other Medically Important Condition);Gamma-glutamyltransferase increased (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561253	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561257	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oedema peripheral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561258	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis allergic (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561282	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561296	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561400	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561407	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561408	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle rigidity (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010561416	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site movement impairment (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010561430	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010561440	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561444	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561448	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561449	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561687	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctivitis (2d - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561688	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561689	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561707	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest crushing (1d - Recovered/Resolved - Other Medically Important Condition);Limb discomfort (24h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561710	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561713	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Cardiac failure - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561731	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Extra dose administered (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561738	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Brain fog (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Interchange of vaccine products (n/a - Unknown - Congenital Anomaly);Off label use (n/a - Unknown - Congenital Anomaly);Syncope (n/a - Recovering/Resolving - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	Severe reaction
EU-EC-10010561803	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin lesion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561823	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (7d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Rash erythematous (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561828	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Meningitis viral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Photophobia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN, NAPROXEN SODIUM] (C - Meningitis - n/a - [n/a - n/a - n/a])|[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - Herpes zoster - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TERBUTALINE SULFATE, TERBUTALINE SULFATE PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010561833	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Recovered/Resolved - );Panic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561837	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561838	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010561845	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypothyroidism (n/a - Recovered/Resolved With Sequelae - Disabling);Immunisation (n/a - Unknown - Disabling);Off label use (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010561851	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010561853	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561859	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010561869	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010561869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562028	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562036	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Insomnia (n/a - Unknown - Disabling, Other Medically Important Condition);Labyrinthitis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010562040	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562044	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010562049	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Heart sounds abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Musculoskeletal stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Psychomotor hyperactivity (n/a - Recovering/Resolving - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562061	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Tension headache (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562091	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral coldness (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])|INSULIN ASPART [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562150	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Death (n/a - Fatal - Results in Death, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010562152	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Serum ferritin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Still's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010562167	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injury (n/a - Unknown - );Loss of consciousness (n/a - Fatal - Results in Death);Respiratory arrest (n/a - Fatal - Results in Death);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ANGELICA ROOT, JUJUBE FRUIT, GINGER, GINSENG, ASTRAGALUS, ATRACTYLODES LANCEA ROOT, BUPLEURUM CHINENSE ROOT, GLYCYRRHIZA, CIMICIFUGA RHIZOME DRY EXTRACT, TANGERINE] (C - n/a - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Cardiac hypertrophy, Oedema - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010562245	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetic ketoacidosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypoacusis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Type 1 diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010562305	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood blister (n/a - Recovered/Resolved - Other Medically Important Condition);External ear pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562335	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Listless (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562343	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562345	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ear infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epistaxis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562349	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Localised infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010562359	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Not Specified	Exposure during pregnancy (n/a - Unknown - Life Threatening, Other Medically Important Condition);Premature baby (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010562361	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010562362	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Blood pressure increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562367	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Bronchitis (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562368	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Other Medically Important Condition);Limb injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562369	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562372	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blister (n/a - Unknown - Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562383	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lipoma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562384	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562385	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arteriosclerosis (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Artery dissection (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebral artery stenosis (17d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebral infarction (17d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyslalia (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Sensory disturbance (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombosis (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombotic cerebral infarction (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vasculitis (424h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010562397	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010562400	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hernia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562426	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (15d - Recovered/Resolved - );Vaccination failure (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562431	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crohn's disease (4mo - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562443	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562444	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Disabling);Mononeuropathy (n/a - Not Recovered/Not Resolved - Disabling);Winged scapula (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010562445	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562447	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562623	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (n/a - Recovered/Resolved With Sequelae - Life Threatening);Hypertension (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010562662	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010562807	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrioventricular block complete (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Bradycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	REMDESIVIR [REMDESIVIR] (C - COVID-19 pneumonia - Not applicable - [n/a - n/a - n/a])|[AMOXICILLIN SODIUM, POTASSIUM CLAVULANATE, AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID, AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID] (C - COVID-19 pneumonia - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010562865	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gout (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[TACROLIMUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010562872	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010562873	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010562935	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010562941	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vaccination site oedema (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010562941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010563016	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Gastrointestinal disorder (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Unknown - );Photosensitivity reaction (n/a - Unknown - );Weight decreased (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563096	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563117	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Disabling);Cough (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010563137	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Pruritus (n/a - Not Recovered/Not Resolved - Disabling);Rash papular (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010563152	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Body temperature increased (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563188	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Localised oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Mobility decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [82d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563212	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Unknown - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563245	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Urinary tract obstruction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010563247	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563251	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010563274	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563310	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematemesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Melaena (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563315	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563321	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010563333	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010563360	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Vaccination site joint movement impairment (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	[FOSINOPRIL SODIUM] (C - n/a - n/a - [15y - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [15y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563366	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (28h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563373	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eosinophilia (50d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);White blood cell count increased (50d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TEGAFUR, URACIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010563379	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Unknown - Other Medically Important Condition);Faeces discoloured (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563397	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563399	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563408	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Paraesthesia oral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010563419	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563425	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gynaecomastia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563427	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563428	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arteriosclerosis (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Varicose vein (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563429	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chorioretinitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemianopia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Retinal detachment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vitreous detachment (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, IBUPROFEN, OXYMETAZOLINE HYDROCHLORIDE, PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Oral])|[FINASTERIDE] (C - Alopecia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010563430	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neoplasm malignant (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	NITRIC OXIDE [NITRIC OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563434	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[METHOTREXATE, METHOTREXATE DISODIUM, METHOTREXATE SODIUM] (C - Psoriasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563441	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563442	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563443	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563447	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563460	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563465	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563525	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010563628	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563629	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010563753	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563813	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Influenza (51d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010563814	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010563817	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563818	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010563881	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010563887	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Other Medically Important Condition);Myoclonus (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010563994	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010563994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564119	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Localised oedema (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010564160	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Injection site warmth (2d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010564177	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Penile vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010564181	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Disabling);Muscular weakness (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010564305	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564306	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circadian rhythm sleep disorder (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DEXAMFETAMINE SULFATE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 50ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564315	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010564316	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Not Recovered/Not Resolved - );Muscle discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	PRE-WORKOUT PROTEIN SHAKE [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564321	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depression (n/a - Recovering/Resolving - );Eye irritation (n/a - Unknown - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564339	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564364	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564371	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (n/a - Unknown - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564390	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564404	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010564412	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - );Pain (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[SUMATRIPTAN] (C - Migraine, Prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564512	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pityriasis rosea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564513	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood urine present (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564691	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Episcleritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564744	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Prostatic specific antigen increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564770	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Respiratory disorder (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010564822	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (2d - Recovered/Resolved - );Peripheral swelling (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Skin disorder (2d - Recovered/Resolved - );Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010564824	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010564824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565177	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565184	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bone pain (78d - Not Recovered/Not Resolved - );Dizziness (78d - Not Recovered/Not Resolved - );Malaise (78d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010565188	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ear discomfort (n/a - Recovering/Resolving - );Ear swelling (n/a - Recovering/Resolving - );Pustule (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565190	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010565198	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pleurisy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565203	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [3wk - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565241	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis reactive (9d - Recovered/Resolved - );Limb discomfort (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565248	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polydipsia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565251	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Lacrimation increased (n/a - Unknown - );Ocular discomfort (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565254	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565255	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565260	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (4d - Unknown - );Myalgia (6d - Unknown - );Pain in extremity (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565272	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565392	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565400	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CABERGOLINE] (C - Blood prolactin increased - n/a - [n/a - .5mg - n/a])|[LEVOTHYROXINE SODIUM] (C - Autoimmune thyroiditis - n/a - [n/a - 100mg - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565401	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Unknown - );Drug eruption (n/a - Unknown - );Eosinophil count increased (n/a - Recovering/Resolving - );Erythema multiforme (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Unknown - );Viral infection (n/a - Unknown - );White blood cell count decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565406	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565408	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Subcutaneous abscess (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565409	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565413	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565415	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565419	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amyotrophic lateral sclerosis (n/a - Unknown - Other Medically Important Condition);Bell's palsy (n/a - Unknown - Other Medically Important Condition);Burning sensation (n/a - Unknown - );Concussion (n/a - Unknown - );Dry skin (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Head injury (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Menstrual disorder (n/a - Unknown - );Multiple sclerosis (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Recovered/Resolved - );Neuropathy peripheral (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Skin discolouration (n/a - Not Recovered/Not Resolved - );Sleep disorder due to general medical condition, insomnia type (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565431	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Constipation (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspepsia (n/a - Unknown - Other Medically Important Condition);Eating disorder (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565432	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (23d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (23d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010565433	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac infection (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Product use issue (n/a - Unknown - );Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565437	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565438	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565441	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565442	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565444	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565445	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	DUPIXENT [DUPILUMAB] (S - Dermatitis atopic - Dose not changed - [n/a - 300mg - Subcutaneous])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565450	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 75mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565451	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Cough variant asthma (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565452	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Spinal cord disorder (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565475	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - Disabling);Swollen tongue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010565477	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Fatal - Results in Death, Life Threatening);Ventricular fibrillation (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010565478	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (1d - Recovered/Resolved - );Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Heart rate - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - Abdominal distension - n/a - [n/a - n/a - n/a])|[QUININE SULFATE] (C - Muscle spasms - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Dyspnoea - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565480	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565482	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial ischaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565483	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (10d - Recovered/Resolved - Other Medically Important Condition);Disease recurrence (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565484	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	MIRAPEXIN 0.18 MG TABLETS [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - Not applicable - [n/a - .18mg - Oral])|XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - Not applicable - [n/a - 20mg - Oral])|[GLATIRAMER ACETATE] (C - n/a - Not applicable - [n/a - 40mg - Subcutaneous])|[PARACETAMOL, CODEINE] (C - n/a - Not applicable - )|[QUETIAPINE] (C - n/a - Not applicable - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565506	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head discomfort (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Occipital neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Sensory disturbance (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010565513	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565516	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565519	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death);Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010565527	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Cytokine storm (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Erythema multiforme (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatic function abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Serum ferritin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Splenomegaly (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Still's disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALFACALCIDOL] (C - Osteoporosis - n/a - [n/a - .25ug - Oral])|[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - 10mg - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - 20mg - Oral])|[SENNOSIDE A+B] (C - Constipation - n/a - [n/a - 12mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565536	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pallor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565540	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565663	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (30min - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Nausea (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565674	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010565774	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Fall (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565796	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	OCREVUS [OCRELIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010565825	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Platelet count decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010565878	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010565907	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (16d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [3wk - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010565907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566008	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure congestive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema peripheral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary congestion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010566046	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Pruritus (2d - Recovered/Resolved - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010566092	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566113	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566128	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hypersomnia (n/a - Unknown - );Mental fatigue (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Neck pain (n/a - Unknown - );Night sweats (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pain in jaw (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010566139	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Eye disorder (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CELECOXIB [CELECOXIB] (C - Anxiety - n/a - [n/a - 20mg - Oral])|[CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566145	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Unknown - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Sensory loss (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566149	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pruritus (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Nasal discomfort (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Unknown - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566182	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Costochondritis (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566191	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - Not applicable - [n/a - 850mg - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 50mg - Oral])|[OXCARBAZEPINE] (C - n/a - Not applicable - [n/a - 300mg - Oral])|[RAMIPRIL] (C - n/a - Not applicable - [n/a - 2.5mg - Oral])|[SPIRONOLACTONE] (C - n/a - Not applicable - [n/a - 25mg - Oral])|[TORASEMIDE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010566232	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - Other Medically Important Condition);Brain fog (1d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (1d - Recovered/Resolved - Other Medically Important Condition);Pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566264	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566266	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566271	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566272	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566277	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566282	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566283	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566284	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566323	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Oedema peripheral (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566334	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Intestinal haemorrhage (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010566400	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Eye haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566534	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - );Hypoaesthesia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[PARACETAMOL, CAFFEINE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566564	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010566573	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - );Feeding disorder (n/a - Unknown - );Fluid intake reduced (n/a - Unknown - );Hypokinesia (n/a - Unknown - );Mouth breathing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[WARFARIN POTASSIUM] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010566590	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010566591	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CIPROFIBRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010566634	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Fatal - Results in Death);Abdominal pain upper (n/a - Fatal - Results in Death);Asthenia (n/a - Fatal - Results in Death);Cardiopulmonary failure (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death);Diarrhoea (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Increased upper airway secretion (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death);Oxygen saturation decreased (n/a - Fatal - Results in Death);Pain in extremity (n/a - Fatal - Results in Death);Pulmonary oedema (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Rales (n/a - Fatal - Results in Death);Rash macular (n/a - Fatal - Results in Death);Respiratory arrest (n/a - Fatal - Results in Death);Respiratory tract haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010566637	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010566638	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566640	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566645	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566646	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566648	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566653	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Rhinitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566666	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010566673	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovering/Resolving - );Chills (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	EXFORGE HCT 10 MG/160 MG/25 MG [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE, VALSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|JANUMET 50 MG/1000 MG [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|JARDIANCE 25 MG [EMPAGLIFLOZIN] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|NOT AVAILABLE (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[ATORVASTATIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - .5{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566761	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition);Seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010566774	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dry throat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immune system disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Throat irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Viral infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010566781	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010566802	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010566874	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566901	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566906	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Joint effusion (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566929	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566933	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566935	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hyperhidrosis (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566936	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Vomiting (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566940	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Unknown - );Gastrointestinal pain (2d - Unknown - );Malaise (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566941	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566947	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (23d - Recovering/Resolving - );Influenza like illness (31d - Recovered/Resolved - );Limb discomfort (54d - Recovering/Resolving - );Myalgia (24d - Recovering/Resolving - );Pyrexia (31d - Recovered/Resolved - );Tachycardia (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566960	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain (3d - Recovered/Resolved - );Back pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566964	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Injection site swelling (2d - Not Recovered/Not Resolved - );Paraesthesia (2d - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566970	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566972	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010566979	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010566990	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	BEXSERO [ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE, OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE] (S - n/a - n/a - [1d - n/a - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010566991	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010566991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567009	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567012	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567020	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (3d - Not Recovered/Not Resolved - );Chest discomfort (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Injection site erythema (3d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Not Recovered/Not Resolved - );Neck pain (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010567040	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Oxygen saturation decreased (15320min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia aspiration (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (15320min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (14900min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[VOGLIBOSE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567067	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567070	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567071	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567073	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567074	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567108	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567263	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Transient ischaemic attack (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010567346	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Disabling);Fatigue (2d - Recovered/Resolved - Disabling);Headache (2d - Recovered/Resolved - Disabling);Myalgia (2d - Recovered/Resolved - Disabling);Pyrexia (2d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010567386	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mucosal haemorrhage (44d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Petechiae (44d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (18d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010567490	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cerebral infarction - n/a - [n/a - n/a - Oral])|PIOGLITAZONE [PIOGLITAZONE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[ALOGLIPTIN BENZOATE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[AZELNIDIPINE, OLMESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[GLIMEPIRIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[ROXATIDINE ACETATE HYDROCHLORIDE] (C - Gastritis - n/a - [n/a - n/a - Oral])|[SARPOGRELATE HYDROCHLORIDE] (C - Cerebral infarction - n/a - [n/a - n/a - Oral])|[SUVOREXANT] (C - Insomnia - n/a - [n/a - n/a - Oral])|[ZOLPIDEM TARTRATE] (C - Insomnia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010567521	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Disabling);Asthenia (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Pyrexia (n/a - Unknown - Disabling);Vaccination site hyperaesthesia (n/a - Unknown - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010567556	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567558	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Chills (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Ischaemic stroke (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Recovered/Resolved With Sequelae - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567566	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567569	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Pleural effusion (n/a - Unknown - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567639	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010567641	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Crohn's disease (n/a - Recovering/Resolving - Other Medically Important Condition);Drug interaction (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Joint stiffness (n/a - Unknown - );Lymphatic insufficiency (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - );Nausea (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Unknown - );Skin disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (I - Immunisation - n/a - [n/a - n/a - Intramuscular])|STELARA [USTEKINUMAB] (I - Crohn's disease - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	[CALANUS FINMARCHICUS] (C - n/a - n/a - )|[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - )|[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567645	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567675	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Life Threatening);Chest discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Diarrhoea (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Vomiting (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010567694	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	SILODYX 8 MG HARD CAPSULES [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567698	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	VIth nerve paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567699	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567704	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glomerulonephritis minimal lesion (77d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nephrotic syndrome (77d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567707	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567726	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567757	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Facial paralysis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010567772	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haemorrhagic stroke (2d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567776	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010567777	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (n/a - Unknown - Other Medically Important Condition);Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567779	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (1wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567783	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (n/a - Unknown - Other Medically Important Condition);Immunisation reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567784	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation reaction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567785	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567786	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567808	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (22d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567815	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567821	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Goitre (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Affective disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567823	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agranulocytosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tooth infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567825	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oral fungal infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567826	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567832	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden death (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010567836	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LIXIANA 60 MG [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010567848	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567872	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010567873	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010567879	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatoid arthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567883	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567890	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ischaemic stroke (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567895	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567898	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010567899	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chondrocalcinosis (n/a - Recovering/Resolving - Other Medically Important Condition);Synovitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010567914	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010567937	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010567979	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010567979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010568002	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (14d - Recovered/Resolved - Other Medically Important Condition);Fatigue (14d - Recovered/Resolved - Other Medically Important Condition);Headache (14d - Recovered/Resolved - Other Medically Important Condition);Photophobia (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010568058	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010568080	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568097	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Recovering/Resolving - );Gastrointestinal disorder (n/a - Recovering/Resolving - );Hypotension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568113	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568116	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568135	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure decreased (1d - Recovered/Resolved - );Cold sweat (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568136	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568140	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Vestibular disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568141	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568142	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568149	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568152	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568153	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568163	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568169	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Gastrointestinal disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568194	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568213	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin I increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010568216	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Grip strength decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010568224	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568225	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568226	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568227	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agitation (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dry mouth (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Insomnia (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Restlessness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010568230	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568235	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568237	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain fog (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568261	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Recovering/Resolving - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568268	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568271	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568274	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568276	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568277	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568278	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568281	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (2wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568283	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	SIFROL 0.26 MG PROLONGED-RELEASE TABLETS [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Parkinson's disease - Unknown - [n/a - .26mg - Oral])|SIFROL 1.05 MG PROLONGED-RELEASE TABLETS [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Parkinson's disease - Unknown - [n/a - 1.05mg - Oral])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - Unknown - [n/a - 125mg - Oral])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA] (C - Parkinson's disease - Unknown - [n/a - 62.5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568285	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568291	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Tension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568296	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568298	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568299	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sinusitis (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568313	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568314	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568329	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (4wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568332	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568334	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568353	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568363	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphasia (1d - Recovered/Resolved - );Balance disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - n/a - Dose not changed - [n/a - 150mg - Oral])|XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Atrial fibrillation - Dose not changed - [n/a - 20mg - Oral])|[ALLOPURINOL] (C - Hyperuricaemia - Dose not changed - [n/a - 100mg - Oral])|[FLECAINIDE ACETATE] (C - Atrial fibrillation - Dose not changed - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568365	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568380	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[DILTIAZEM HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - 300mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568381	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3wk - Recovering/Resolving - );Dyspnoea exertional (3wk - Recovering/Resolving - );Hypotension (3wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568385	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568386	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568387	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (6wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568392	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Gastrointestinal disorder (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568404	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	PLAVIX 75 MG FILM-COATED TABLETS [CLOPIDOGREL] (C - n/a - n/a - )|[PRAVASTATIN SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568411	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - n/a - n/a - )|[ESCITALOPRAM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568420	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568428	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Recovered/Resolved - );Vertigo (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568433	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568441	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rectal haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568443	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site oedema (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568450	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spontaneous haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568452	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Recovering/Resolving - );Hypersomnia (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568462	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Headache (n/a - Unknown - );Oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568464	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Body temperature increased (0d - Recovered/Resolved - );Epilepsy (n/a - Unknown - Other Medically Important Condition);Generalised tonic-clonic seizure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010568465	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010568480	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Inhibitory drug interaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[ALPROSTADIL] (I - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568486	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568521	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010568558	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568570	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coagulopathy (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Epistaxis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010568575	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (49d - Not Recovered/Not Resolved - );Influenza like illness (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010568601	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood sodium decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oral discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE] (C - n/a - n/a - [n/a - 200ug - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010568607	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010568736	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - )|[DESOGESTREL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568746	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anticoagulation drug level below therapeutic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a - More in ICSR])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010568858	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010568858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010569006	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010569011	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010569017	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cerebral disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[METHYLPHENIDATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010569057	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569087	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569140	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569296	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010569315	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovered/Resolved - Other Medically Important Condition);Electric shock sensation (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010569339	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010569425	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010569523	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569538	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	JARDIANCE 25 MG [EMPAGLIFLOZIN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|LYRICA 75 MG [PREGABALIN] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|MICARDIS 80 MG [TELMISARTAN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|XARELTO 15 MG [RIVAROXABAN] (C - n/a - Unknown - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[BROMAZEPAM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[BUMETANIDE] (C - n/a - Unknown - [n/a - .5mg - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569603	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrioventricular block second degree (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010569711	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Injection site inflammation (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569778	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscle discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569783	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569787	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010569795	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569812	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010569815	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569817	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myositis (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010569881	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010569884	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Burning sensation (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Spinal cord disorder (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010569884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010570033	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asphyxia (n/a - Fatal - Results in Death);Cardio-respiratory arrest (n/a - Unknown - Other Medically Important Condition);Coma (n/a - Unknown - Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AZOSEMIDE] (C - Hypertension - n/a - [n/a - 2{DF} - Oral])|[LAFUTIDINE] (C - Gastric ulcer - n/a - [n/a - .5{DF} - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[SODIUM HYDROGEN CARBONATE] (C - Gastric ulcer - n/a - [n/a - 2{DF} - Oral])|[TELMISARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010570221	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010570235	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Disease recurrence (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010570355	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Disabling);Dysphagia (n/a - Not Recovered/Not Resolved - Disabling);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010570359	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010570373	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Disabling);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010570380	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570386	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570393	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (0d - Recovered/Resolved - );Cough (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010570425	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570439	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010570452	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010570457	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis transverse (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010570466	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570496	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Joint effusion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010570532	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570541	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	General physical health deterioration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570562	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 20mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Anxiety - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010570580	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010570613	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mixed liver injury (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010570788	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Infection (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010570797	Spontaneous	2021-11-05 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Aspartate aminotransferase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood immunoglobulin E increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood lactate dehydrogenase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscle enzyme increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Renal impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rhabdomyolysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BUPRENORPHINE] (C - Analgesic therapy, Osteoarthritis - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010570841	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010570841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571125	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[NOT AVAILABLE] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571182	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Administration site joint pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571194	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010571199	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010571201	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Liver function test abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010571214	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Acute generalised exanthematous pustulosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fluid retention (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010571215	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571216	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (30d - Not Recovered/Not Resolved - );Myalgia (30d - Not Recovered/Not Resolved - );Sleep disorder (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010571222	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571228	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010571229	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010571231	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fibrosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010571235	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010571288	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010571293	Spontaneous	2021-11-05 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Erectile dysfunction (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010571293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010549041	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site erythema (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010549170	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010549172	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010549377	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - Disabling);Decreased appetite (3d - Recovered/Resolved - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Interchange of vaccine products (n/a - Unknown - );Monoplegia (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - );Pain (4d - Recovered/Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010549478	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549484	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549534	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Pericarditis (n/a - Unknown - Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010549578	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Taste disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549635	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (14min - Recovered/Resolved - Other Medically Important Condition);Dizziness (14min - Recovered/Resolved - );Hyperhidrosis (14min - Recovered/Resolved - );Hypotension (14min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549639	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549653	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549655	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549656	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549664	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549667	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549687	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549708	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010549898	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (138min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549931	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010549950	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550003	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Blood pressure increased (n/a - Recovering/Resolving - );Haemoptysis (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550020	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Koebner phenomenon (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - 2{DF} - Topical])|[CARBOMER 974P] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CYANOCOBALAMIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FLUOROURACIL] (C - n/a - n/a - [29d - 1{DF} - n/a])|[FUSIDIC ACID] (C - Skin infection - n/a - [8d - 3{DF} - Topical])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUININE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550021	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550037	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550040	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010550046	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550065	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (118min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550076	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved - );Heart rate decreased (0d - Recovered/Resolved - );Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Injury (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550078	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Androgenetic alopecia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Unknown - Disabling);Eczema (n/a - Not Recovered/Not Resolved - Disabling);Eye pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Myocarditis (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACICLOVIR, ACICLOVIR SODIUM] (C - Genital herpes - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010550145	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Atrial flutter - n/a - [1647d - n/a - n/a])|[RAMIPRIL] (C - Atrial flutter - n/a - [1647d - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Atrial flutter - n/a - [1651d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550166	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death);Drowning (n/a - Fatal - Results in Death);Histamine level increased (n/a - Fatal - Results in Death);Pain in extremity (n/a - Unknown - );Physical deconditioning (n/a - Unknown - );Tryptase increased (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CILNIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - n/a])|[TRELAGLIPTIN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010550291	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550300	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Arrhythmia (n/a - Unknown - Other Medically Important Condition);Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550336	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (5d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550350	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (27min - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (27min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550365	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010550370	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550419	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550459	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Suspected COVID-19 (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010550461	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (25min - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (25min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550494	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Respiratory arrest (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550518	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Anosmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010550534	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immune system disorder (48h - Unknown - Other Medically Important Condition);Nasopharyngitis (48h - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (48h - Recovered/Resolved - Other Medically Important Condition);Sinus pain (48h - Recovered/Resolved - Other Medically Important Condition);Upper respiratory tract infection (48h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550562	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALPHA-TOCOPHEROL] (C - n/a - n/a - [n/a - .5{DF} - Oral])|[AMLODIPINE] (C - n/a - n/a - [n/a - 10mg - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - .5{DF} - Oral])|[CALANUS FINMARCHICUS] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[L-SERINE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ZEAXANTHIN] (C - n/a - n/a - [n/a - .5{DF} - Oral])|[ZINC] (C - n/a - n/a - [n/a - .5{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010550576	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010550604	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cellulitis (n/a - Recovering/Resolving - Life Threatening);Peritonsillar abscess (n/a - Recovering/Resolving - Life Threatening);Streptococcal sepsis (n/a - Recovering/Resolving - Life Threatening);Tonsillectomy (n/a - Recovering/Resolving - Life Threatening);Tonsillitis (n/a - Recovering/Resolving - Life Threatening);Tooth abscess (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010550653	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010550696	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010550707	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010550731	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Disabling);Diplegia (n/a - Not Recovered/Not Resolved - Disabling);Dysphagia (2d - Recovered/Resolved - Disabling);Hypersensitivity (n/a - Recovering/Resolving - Disabling);Myoclonus (2d - Recovered/Resolved - Disabling);Vertigo (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010550735	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550764	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Prostate cancer (n/a - Recovered/Resolved - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	[CODEINE] (C - Pain - n/a - )|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550844	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550847	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550851	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550853	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550856	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550858	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (2d - Recovered/Resolved - Other Medically Important Condition);Tremor (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550871	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010550919	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Wheezing (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550920	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ocular hyperaemia (n/a - Not Recovered/Not Resolved - );Periorbital swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550921	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550927	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550945	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site mass (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CODEINE PHOSPHATE HEMIHYDRATE PHEUR, CAFFEINE PH. EUR., PARACETAMOL PH. EUR., PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - Pain - n/a - [n/a - n/a - n/a])|[DESOGESTREL] (C - Contraception - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550960	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010550972	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010550977	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PARACETAMOL] (C - Headache - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010550977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551199	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551202	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	CSF protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electroencephalogram abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Status epilepticus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010551318	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - Ophthalmic])|[TIMOLOL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010551338	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551345	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551355	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Toothache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010551395	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Monoparesis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010551403	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010551404	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Recovering/Resolving - );Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010551410	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010551413	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010551417	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010551421	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010551440	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551461	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010551462	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Dry eye (n/a - Unknown - );Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - );Lacrimation increased (n/a - Unknown - );Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010551471	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (137min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551472	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (75min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551480	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010551490	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pleural effusion (n/a - Unknown - );Pulmonary microemboli (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[NEBIVOLOL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010551494	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551501	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010551502	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010551503	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Physical deconditioning (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551504	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551510	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chronic gastritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010551580	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551615	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Recovered/Resolved - );Joint range of motion decreased (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[MEXAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010551654	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (19d - Recovered/Resolved - );Confusional state (n/a - Recovering/Resolving - );Diarrhoea (2d - Recovered/Resolved - );Fatigue (19d - Recovered/Resolved - );Headache (17d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (19d - Recovered/Resolved - );Oropharyngeal pain (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Taste disorder (1d - Recovered/Resolved - );Tic (n/a - Recovering/Resolving - )	COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PROTOPIC [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - Unknown - )|[CANDESARTAN CILEXETIL] (C - n/a - Unknown - )|[ECONAZOLE NITRATE, TRIAMCINOLONE ACETONIDE] (C - n/a - Unknown - )|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - Unknown - )|[FLUTICASONE PROPIONATE] (C - n/a - Unknown - )|[HYDROCORTISONE BUTYRATE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010551750	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551762	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551766	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551768	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551879	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Hypertension (n/a - Recovering/Resolving - Life Threatening);Lethargy (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010551884	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010551905	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010551905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010552066	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552108	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (10min - Recovered/Resolved - );Hypertension (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552130	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010552173	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Infection (11d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552346	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552376	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asphyxia (n/a - Not Recovered/Not Resolved - Life Threatening);Heart rate increased (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[METOPROLOL, METOPROLOL TARTRATE] (C - Bundle branch block right - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010552384	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dysphagia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[LEVOCETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010552428	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (12d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FENOFIBRATE] (C - n/a - n/a - [n/a - 200mg - Oral])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552449	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - Disabling);Vertigo (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010552454	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - );Dysgeusia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (14d - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Pyrexia (3d - Recovered/Resolved - );Vaccination site erythema (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010552478	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552479	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552481	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552482	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552516	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death);Respiratory failure (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010552519	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Caregiver (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010552522	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010552524	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coombs positive haemolytic anaemia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010552528	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diabetes mellitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552529	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ataxia telangiectasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010552531	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Quadriparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010552632	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphthous ulcer (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552649	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552686	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552687	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cluster headache (123d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010552688	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552690	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552813	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552841	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vestibular ataxia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010552860	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552863	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552864	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552865	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552868	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552873	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552875	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552878	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010552911	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory arrest (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - )|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010552925	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, COLECALCIFEROL, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552929	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Tenderness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552952	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552956	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552958	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - 2mg - Oral])|[LAMOTRIGINE] (C - Bipolar disorder - n/a - [n/a - 300mg - n/a])|[MONTELUKAST] (C - Hypersensitivity - n/a - [n/a - 10mg - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010552991	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010552991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553002	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depressed mood (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eyelid ptosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeding disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Irritability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Mood altered (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553003	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	Yes	Male	Glomerulonephritis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Granulomatosis with polyangiitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010553198	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553203	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553205	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010553209	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553211	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Not Recovered/Not Resolved - );Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Spinal fracture (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553212	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Axillary pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nerve injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Photosensitivity reaction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sleep disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MESALAZINE] (C - n/a - n/a - [n/a - 1g - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553214	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes pharyngitis (14d - Recovered/Resolved - Other Medically Important Condition);Oral herpes (14d - Recovered/Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DEXLANSOPRAZOLE, LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553216	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Nervous system disorder (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553218	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Hepatitis (n/a - Unknown - Other Medically Important Condition);Hepatomegaly (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553229	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Unknown - );Immunology test abnormal (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Respiratory failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553232	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Shoulder injury related to vaccine administration (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010553234	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010553242	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chorioretinopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Metamorphopsia (n/a - Not Recovered/Not Resolved - );Xanthopsia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553243	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553260	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Osteoporosis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553265	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Nausea (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010553277	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010553278	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553290	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553294	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553304	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Breast pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553308	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553313	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient ischaemic attack (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553366	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553382	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553386	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arthritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Arthropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Monoplegia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553387	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553388	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553403	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Hot flush (n/a - Recovering/Resolving - );Illness (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553405	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553409	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553410	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553414	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (12h - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Dizziness (12h - Recovered/Resolved - Other Medically Important Condition);Fatigue (12h - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (36h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553426	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553428	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure systolic decreased (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Shock (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553432	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553433	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553442	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553447	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553465	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553477	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (10d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553497	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Syncope (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553498	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fall (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Shock (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553511	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553512	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Hypothyroidism (10d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Neck pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Thyroiditis subacute (96d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010553523	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553524	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (20min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553525	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553535	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553537	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - );Multiple fractures (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553540	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553543	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Feeling cold (n/a - Unknown - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010553545	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553551	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Not Specified	Breast milk substitute intolerance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Lactose intolerance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553562	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HYDROXYCARBAMIDE [HYDROXYCARBAMIDE] (C - Polycythaemia - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Polycythaemia - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553572	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553574	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553576	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Unknown - Disabling);Inflammation (n/a - Not Recovered/Not Resolved - Disabling);Mobility decreased (n/a - Unknown - Disabling);Sciatica (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010553578	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553590	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Blood pH - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553610	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - );Pallor (n/a - Unknown - );Pyrexia (n/a - Unknown - );Subdural haematoma (166d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Other Medically Important Condition);Urinary tract infection (n/a - Unknown - Caused/Prolonged Hospitalisation)	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (S - Prophylaxis - Dose not changed - [n/a - 75mg - Oral])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|[ACETYLSALICYLIC ACID] (S - Cerebrovascular accident - Dose not changed - [n/a - 100mg - Oral])	[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a - More in ICSR])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - 80mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553771	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Skin irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553799	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[BISOPROLOL FUMARATE] (C - n/a - n/a - )|[BUPRENORPHINE] (C - n/a - n/a - )|[CILOSTAZOL] (C - n/a - n/a - )|[ENOXAPARIN SODIUM] (C - n/a - n/a - )|[FLUCONAZOLE] (C - n/a - n/a - )|[FOLIC ACID, DRIED FERROUS SULFATE, FOLIC ACID, FERROUS SULFATE] (C - n/a - n/a - )|[HYDROCORTISONE, HYDROCORTISONE BUTYRATE] (C - n/a - n/a - )|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[RAMIPRIL] (C - n/a - n/a - )|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - )|[TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - )|[TRIMETAZIDINE DIHYDROCHLORIDE] (C - n/a - n/a - )|[ZOLPIDEM TARTRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010553897	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553905	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Muscle tightness (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553910	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553911	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553913	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Chest discomfort (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Muscle tightness (n/a - Recovered/Resolved - );Respiration abnormal (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010553919	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010553920	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Burning sensation (n/a - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Eructation (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovered/Resolved - );Postural orthostatic tachycardia syndrome (n/a - Not Recovered/Not Resolved - Disabling);Sleep disorder (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010553922	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553927	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010553982	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010553983	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Chromaturia (1d - Not Recovered/Not Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling of relaxation (2d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Thirst (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553984	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);General physical health deterioration (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010553987	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Circulatory collapse (n/a - Fatal - Results in Death);Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010553990	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010553992	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual field defect (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010553992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554002	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (5d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554005	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Limb discomfort (6d - Recovering/Resolving - );Malaise (6d - Recovered/Resolved - );Myalgia (6d - Recovering/Resolving - );Oropharyngeal pain (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554010	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (6d - Not Recovered/Not Resolved - );Paraesthesia (6d - Not Recovered/Not Resolved - );Respiratory disorder (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010554011	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554012	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Neuritis (n/a - Not Recovered/Not Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010554016	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554025	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (4wk - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - Coronary artery disease - n/a - [n/a - 100mg - Oral])|[BUDESONIDE] (C - n/a - n/a - [n/a - 400ug - Respiratory (inhalation)])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 100ug - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Coronary artery disease - n/a - [n/a - 22.5mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010554037	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pruritus (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensation of foreign body (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Somnolence (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554039	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554041	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Gastrointestinal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Infection (n/a - Recovered/Resolved - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554055	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning feet syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Small fibre neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - 400mg - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554057	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554105	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fine motor skill dysfunction (n/a - Unknown - Disabling);Lack of vaccination site rotation (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Poor quality sleep (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010554106	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554117	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554119	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554121	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myositis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|IPILIMUMAB [IPILIMUMAB] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])|NIVOLUMAB [NIVOLUMAB] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])|PEMBROLIZUMAB [PEMBROLIZUMAB] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554122	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554126	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Blood albumin decreased (n/a - Unknown - );Blood creatinine increased (n/a - Unknown - );Blood triglycerides increased (n/a - Unknown - );Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Glomerular filtration rate decreased (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Lymphocyte count decreased (n/a - Unknown - );Tachypnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554128	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554129	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Dysphoria (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010554133	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Trismus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554137	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (1870min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Bronchospasm (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (1865min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Laryngeal discomfort (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (1865min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Respiratory distress (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sneezing (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachypnoea (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Wheezing (1890min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554183	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Injection site pruritus (0d - Recovered/Resolved - );Injection site warmth (n/a - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	FASENRA 30 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [BENRALIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIAMCINOLONE ACETONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554240	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Head discomfort (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554304	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554305	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate irregular (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554308	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554312	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554313	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554314	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554398	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554407	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - );Photophobia (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554408	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Cold sweat (1d - Recovering/Resolving - );Dizziness (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Pallor (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010554415	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554464	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554488	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Meningitis aseptic (24d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neurogenic bladder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Viral infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554490	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diverticulitis (0d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554502	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Axillary pain (n/a - Unknown - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Feeling abnormal (n/a - Unknown - Disabling);Groin pain (n/a - Recovering/Resolving - Disabling);Immunisation (n/a - Unknown - Disabling);Interchange of vaccine products (n/a - Unknown - Disabling);Joint swelling (n/a - Recovering/Resolving - Disabling);Limb discomfort (n/a - Unknown - Disabling);Muscle fatigue (n/a - Unknown - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010554506	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554510	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Mydriasis (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLLAGEN] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCONEXENT, ICOSAPENT, FISH OIL, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - [n/a - n/a - n/a])|[FERROUS SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554514	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (319min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010554522	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Somnolence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[AMYLASE, LIPASE, PROTEASE, PANCREALIPASE, PANCREAS POWDER, PANCREAS POWDER FROM PORCINE, PANCREATIN, PANCREATIN BP] (C - n/a - n/a - [n/a - n/a - n/a])|[CO-TRIMOXAZOLE, SULFAMETHOXAZOLE, TRIMETHOPRIM, TRIMETHOPRIM BP, SULFAMETHOXAZOLE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 120mg - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[HYPROMELLOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[MYCOPHENOLIC ACID] (C - n/a - n/a - [n/a - 500mg - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554528	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Other Medically Important Condition);Purpura (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554549	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554594	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (n/a - Recovered/Resolved - );Muscular weakness (n/a - Recovered/Resolved - );Urinary incontinence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010554608	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554610	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554611	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Arthralgia (2d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (3wk - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554614	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554636	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eczema (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN POTASSIUM] (C - n/a - n/a - [n/a - 1g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010554638	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ELDECALCITOL] (C - Osteoporosis - n/a - [n/a - n/a - Oral])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010554639	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[PHENPROCOUMON] (C - n/a - n/a - [n/a - n/a - n/a])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554678	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash papular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554825	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Other Medically Important Condition);Axillary pain (3d - Recovered/Resolved - Other Medically Important Condition);Hyperpyrexia (3d - Recovered/Resolved - Other Medically Important Condition);Pain (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010554850	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hypertension (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010554857	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cramp-fasciculation syndrome (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554895	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554903	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554905	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554977	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554996	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal faeces (n/a - Unknown - );Parosmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010554998	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TICLOPIDINE] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010554998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010555019	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010555036	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010555108	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Unknown - );Pain (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010555478	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010555486	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010555877	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010555913	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010555969	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010555994	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010555994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010556003	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (5d - Recovered/Resolved - );Flat affect (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556018	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (n/a - Recovering/Resolving - );Conjunctivitis viral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ESOMEPRAZOLE SODIUM] (C - Gastritis - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556026	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Muscle swelling (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Tachyarrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010556029	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556030	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Dose not changed - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556031	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aortitis (n/a - Not Recovered/Not Resolved - Life Threatening);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening);Vasculitis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010556061	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010556070	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556074	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556091	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoacusis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556093	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (1d - Recovered/Resolved - Life Threatening);Heart rate irregular (1d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010556095	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556124	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral ischaemia (n/a - Not Recovered/Not Resolved - Life Threatening);Depression (n/a - Not Recovered/Not Resolved - Life Threatening);Peripheral venous disease (n/a - Not Recovered/Not Resolved - Life Threatening);Pseudobulbar palsy (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010556157	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Recovering/Resolving - );Glycosylated haemoglobin increased (n/a - Recovering/Resolving - );Hyperglycaemia (n/a - Recovering/Resolving - );Muscle spasms (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Varicose vein (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010556168	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556170	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Conjunctivitis (n/a - Recovering/Resolving - );Eye pain (n/a - Recovering/Resolving - );Lacrimation increased (n/a - Recovering/Resolving - );Ocular hyperaemia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556187	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovered/Resolved - );Oxygen saturation decreased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556205	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556238	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Injection site oedema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556250	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2mo - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling);Arthritis (2mo - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556254	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556271	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - );Contusion (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - n/a - Intramuscular])	[BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL MONOHYDRATE, BETAMETHASONE, CALCIPOTRIOL] (C - Psoriasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556293	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556295	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Recovering/Resolving - );Injection site hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556300	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556302	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556306	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site swelling (7d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Pain in extremity (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556312	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hypoaesthesia (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556315	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556316	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (4d - Recovered/Resolved - );Muscle contracture (4d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556337	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (86d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556353	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556361	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010556364	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Diarrhoea (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL ANHYDROUS, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556397	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Recovered/Resolved - );Hemianaesthesia (n/a - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556404	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010556406	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Life Threatening);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Life Threatening);Fatigue (n/a - Recovered/Resolved With Sequelae - Life Threatening);Headache (n/a - Recovered/Resolved With Sequelae - Life Threatening);Malaise (n/a - Recovered/Resolved With Sequelae - Life Threatening);Muscle spasms (n/a - Recovered/Resolved With Sequelae - Life Threatening);Myalgia (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010556416	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal tear (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556435	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (0d - Recovered/Resolved - Other Medically Important Condition);Malaise (0d - Recovered/Resolved - Other Medically Important Condition);Throat tightness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010556450	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556456	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (33d - Recovered/Resolved - );Fatigue (33d - Recovered/Resolved - );Oropharyngeal pain (33d - Recovered/Resolved - );Pyrexia (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010556458	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	ENTRESTO [SACUBITRIL VALSARTAN SODIUM HYDRATE, VALSARTAN, SACUBITRIL] (C - Cardiac failure - n/a - [n/a - 98mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - 1700mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556459	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[BARNIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[FLECAINIDE ACETATE] (C - Supraventricular tachycardia - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556513	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - .3mL - Intramuscular])	DASSELTA [DESLORATADINE] (C - Seasonal allergy - Dose not changed - [n/a - 5mg - Oral])|[IBUPROFEN D,L-LYSINATE, IBUPROFEN LYSINE] (C - Headache - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556542	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Injection site pruritus (n/a - Not Recovered/Not Resolved - );Mouth swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556545	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovered/Resolved - );Joint swelling (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovered/Resolved - );Productive cough (n/a - Recovering/Resolving - );Pulmonary mass (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010556555	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010556556	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Lip swelling (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556571	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (0d - Recovered/Resolved - );Epilepsy (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556600	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223A), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/GUANGDONG-MAONAN/SWL1536/2019 (H1N1)PDM09 - LIKE VIRUS (A/GUANGDONG-MAONAN/SWL1536/2019, CNIC-1909), A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019 - LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE STRAIN (A/SINGAPORE/INFIMH-16-0019/2016, NIB-104), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE), B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327)] (C - Antiviral prophylaxis - Not applicable - [0d - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556623	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye swelling (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Mouth swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556656	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556657	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556688	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Febrile convulsion (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tonsillitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556711	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	ABASAGLAR [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556747	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556750	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Disturbance in attention (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Insomnia (n/a - Unknown - Caused/Prolonged Hospitalisation);Nystagmus (n/a - Unknown - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556752	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Areflexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Constipation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Demyelination (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyporeflexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lumbar spinal stenosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urinary retention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556755	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Idiopathic intracranial hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Unknown - );Noninfective encephalitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (1d - Recovered/Resolved - );Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556758	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010556812	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556827	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556831	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Skin hypertrophy (n/a - Unknown - Other Medically Important Condition);Skin tightness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010556862	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556876	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - );Ocular discomfort (4d - Recovered/Resolved - );Visual impairment (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556891	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010556955	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Urinary tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010556958	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Blood lactic acid increased (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DAPAGLIFLOZIN [DAPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [51d - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010556992	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010556992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010557009	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Anxiety (n/a - Unknown - Life Threatening, Other Medically Important Condition);Arthralgia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Headache (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Life Threatening, Other Medically Important Condition);Malaise (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myalgia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Nausea (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vertigo (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 25mg - Oral])|[BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010557018	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Terminal ileitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557026	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nystagmus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557030	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (46d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557031	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557035	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (n/a - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557038	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557045	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Swelling (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557052	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Injection site reaction (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557053	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Coronary artery disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010557061	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557063	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (6d - Recovered/Resolved - );Malaise (6d - Recovered/Resolved - );Paraesthesia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557067	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (1d - Recovering/Resolving - );Chills (1d - Recovering/Resolving - );Influenza like illness (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557073	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - );Cold sweat (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557079	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Head discomfort (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557089	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Paresis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557091	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557092	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (40d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Heart rate increased (25d - Recovered/Resolved - );Hypersensitivity (23d - Recovered/Resolved - );Influenza (23d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pain in extremity (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557098	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Right ventricular failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557101	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557102	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557142	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bloody discharge (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysphagia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Speech disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557163	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557199	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Sinusitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557217	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphonia (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Recovering/Resolving - );Pruritus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557228	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Depressed level of consciousness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557240	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557248	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral artery thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Subclavian vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557256	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557265	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vasculitis necrotising (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557273	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010557278	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	LEVEMIR [INSULIN DETEMIR] (C - n/a - n/a - )|LYRICA [PREGABALIN] (C - n/a - n/a - )|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - )|[BICALUTAMIDE] (C - n/a - n/a - )|[DIGOXIN] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - n/a - n/a - )|[OXAZEPAM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557279	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - );Trigeminal neuralgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [24d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557281	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Anxiety (n/a - Unknown - Life Threatening, Other Medically Important Condition);Arthralgia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Headache (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Life Threatening, Other Medically Important Condition);Malaise (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myalgia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Nausea (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vertigo (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - 25mg - Oral])|[BIOFLAVONOIDS, DIOSMIN, HESPERIDIN, MICRONISED PURIFIED FLAVONOIC FRACTION] (C - n/a - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010557285	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Choroiditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557291	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557299	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agranulocytosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])|FERRIPROX [DEFERIPRONE] (S - Iron overload - Drug withdrawn - [10d - 2000mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557301	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Periarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557305	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010557323	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	APROVEL 150 MG TABLETS [IRBESARTAN] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[AMIODARONE HYDROCHLORIDE] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[GLIMEPIRIDE] (C - Type 2 diabetes mellitus - Not applicable - [n/a - n/a - n/a])|[PYGEUM AFRICANUM, PYGEUM AFRICANUM EXTRACT] (C - Benign prostatic hyperplasia - Not applicable - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Dyslipidaemia - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557324	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[ASCIMINIB] (S - Chronic myeloid leukaemia - Dose not changed - [n/a - 2{DF} - Oral])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - Adrenal insufficiency - Not applicable - [n/a - n/a - n/a])|LYRICA [PREGABALIN] (C - Product used for unknown indication - Not applicable - [n/a - n/a - n/a])|TRULICITY [DULAGLUTIDE] (C - Diabetes mellitus - Not applicable - [n/a - n/a - n/a])|[ALLOPURINOL] (C - Hyperuricaemia - Not applicable - [n/a - n/a - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])|[EZETIMIBE] (C - Dyslipidaemia - Not applicable - [n/a - n/a - n/a])|[FOLIC ACID] (C - Prophylaxis - Not applicable - [n/a - n/a - n/a])|[FORMOTEROL FUMARATE, BUDESONIDE] (C - Chronic obstructive pulmonary disease - Not applicable - [n/a - n/a - n/a])|[FUROSEMIDE] (C - Chronic kidney disease - Not applicable - [n/a - n/a - n/a])|[MOLSIDOMINE] (C - Myocardial ischaemia - Not applicable - [n/a - n/a - n/a])|[MONTELUKAST] (C - Chronic obstructive pulmonary disease - Not applicable - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Mixed anxiety and depressive disorder - Not applicable - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - Mineral supplementation - Not applicable - [n/a - n/a - n/a])|[PRAZEPAM] (C - Mixed anxiety and depressive disorder - Not applicable - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - Not applicable - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - Dyslipidaemia - Not applicable - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Chronic obstructive pulmonary disease - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557325	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557329	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Lung disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ASCORBIC ACID, SODIUM ASCORBATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS, MACROGOL 3350] (C - Constipation - Unknown - [n/a - 1{DF} - Oral])|[CLOPIDOGREL] (C - Transient ischaemic attack - Unknown - [n/a - 75mg - Oral])|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - Benign prostatic hyperplasia - Unknown - [n/a - 2{DF} - Oral])|[MIRTAZAPINE] (C - Depression - Unknown - [n/a - 30mg - Oral])|[PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux prophylaxis - Unknown - [n/a - 20mg - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - Unknown - [n/a - 1{DF} - Oral])|[VALPROATE SEMISODIUM] (C - Depression - Unknown - [n/a - 750mg - Oral])|[ZOPICLONE] (C - Insomnia - Unknown - [n/a - 3.75mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557342	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tendonitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557344	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557345	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	General physical health deterioration (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557364	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557368	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory distress (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557371	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Portal vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557372	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Bone marrow failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010557375	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557381	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010557417	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (5wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557421	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557426	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557428	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557430	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hyperlipasaemia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557431	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557438	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (13d - Recovered/Resolved - );Diarrhoea haemorrhagic (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557444	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557452	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Petechiae (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557460	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Taste disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557468	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557476	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557496	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557499	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557507	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557508	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557535	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557537	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557562	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (4d - Recovered/Resolved - );Vaccination site erythema (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557571	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557573	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557574	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557575	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557576	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557578	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557609	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1wk - Recovered/Resolved - );Muscle spasms (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557614	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557618	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557620	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557623	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557626	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557628	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557636	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Gastrointestinal disorder (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intradermal])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557638	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2wk - Recovered/Resolved - );Asthenia (2wk - Recovered/Resolved - );Diarrhoea (2wk - Recovered/Resolved - );Headache (2wk - Recovered/Resolved - );Paraesthesia (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557640	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Hyperacusis (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557666	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557684	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557690	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (10d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557691	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (1d - Recovered/Resolved - );Influenza like illness (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557695	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557704	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557710	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Flushing (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1ug/kg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557713	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557715	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematochezia (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Tongue oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557717	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557747	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557758	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557760	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557763	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[MONTELUKAST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010557774	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557807	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010557820	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557912	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Cellulite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fluid retention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Limb discomfort (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Weight increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557945	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - );Vaccination site erythema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[MAGNESIUM OXIDE] (C - Constipation - n/a - [15d - n/a - n/a])|[RIBOFLAVIN SODIUM PHOSPHATE, ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CHOLINE CHLORIDE, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, LEVOCARNITINE, MENATETRENONE, NICOTINAMIDE, TRICAPRILIN, CORN OIL, FISH OIL, INULIN, PYRIDOXINE HYDROCHLORIDE, TOCOPHERYL ACETATE, FURSULTIAMINE HYDROCHLORIDE, CASEIN, SODIUM SALT, MILK PROTEIN CONCENTRATE] (C - Hypophagia - n/a - [3d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557949	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Peripheral swelling (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010557950	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Gilbert's syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010557951	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Cerebrovascular disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dizziness exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Loss of control of legs (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Motor dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Sensory disturbance (n/a - Unknown - );Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010557951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010558026	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Disabling);Fatigue (n/a - Recovering/Resolving - Disabling);Illness (1d - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010558028	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Blood pressure systolic increased (n/a - Recovering/Resolving - Other Medically Important Condition);Blood triglycerides increased (n/a - Unknown - );Blood uric acid increased (n/a - Unknown - );Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - );Electric shock sensation (n/a - Recovering/Resolving - Other Medically Important Condition);General physical health deterioration (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Metabolic disorder (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Near death experience (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Unknown - );Vascular pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558066	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558072	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (6d - Recovered/Resolved - );Haemorrhagic diathesis (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010558088	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558109	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010558117	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558122	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558143	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558146	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site induration (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558166	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558174	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Lacrimal gland enlargement (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558176	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (6h - Recovered/Resolved - );Lethargy (6h - Recovered/Resolved - );Somnolence (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558179	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Oral pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558189	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010558190	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010558231	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Fungal infection (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Multiple organ dysfunction syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010558251	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - Other Medically Important Condition);Sneezing (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FINASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LACIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558285	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558365	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Ear discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558376	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	DESCOVY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|RALTEGRAVIR [RALTEGRAVIR] (C - n/a - n/a - [n/a - n/a - n/a])|WAKIX [PITOLISANT] (C - n/a - n/a - [n/a - n/a - n/a])|[ACICLOVIR, ACICLOVIR SODIUM] (C - Nasal herpes - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain - n/a - [n/a - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Osteoporosis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|[TRAMADOL HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010558402	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Eosinophil count increased (n/a - Recovering/Resolving - Other Medically Important Condition);Laryngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lip swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558412	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558416	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558418	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558428	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558440	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (4d - Not Recovered/Not Resolved - );Influenza like illness (4d - Not Recovered/Not Resolved - );Vomiting (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558443	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast discomfort (4d - Not Recovered/Not Resolved - );Influenza like illness (4d - Not Recovered/Not Resolved - );Nausea (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558447	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558448	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558451	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Incomplete course of vaccination (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558454	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558467	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Toothache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558469	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558475	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Dizziness (30d - Not Recovered/Not Resolved - );Tinnitus (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010558489	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling);Obsessive-compulsive disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010558551	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rheumatoid arthritis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010558572	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010558573	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lip pruritus (n/a - Recovered/Resolved - );Lip swelling (n/a - Recovered/Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558575	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (122d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010558576	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558578	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Swelling of eyelid (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558589	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (5d - Recovered/Resolved - );Body temperature increased (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (5d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010558623	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (57d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010558662	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Haematochezia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558666	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558669	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (75d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010558693	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558695	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558704	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558720	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010558732	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558745	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait inability (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558763	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558822	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Crohn's disease (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558823	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010558833	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558847	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010558853	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Cardiomyopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010558857	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (30d - Recovered/Resolved - );Costochondritis (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010558866	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Swollen tongue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558915	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - );Asthenia (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Malaise (n/a - Unknown - );Movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010558947	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010558962	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Dehydration (n/a - Unknown - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia viral (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010558962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010559049	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559058	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010559099	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gastrointestinal haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010559102	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Peripheral vascular disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559114	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559116	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559121	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559127	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010559133	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559134	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Haematoma (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010559138	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559139	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559150	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Paraesthesia (10d - Not Recovered/Not Resolved - );Vaccination site pain (10d - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559154	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559156	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Appendicectomy (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010559171	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559180	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559183	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559191	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559192	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559201	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559204	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559207	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemophagocytic lymphohistiocytosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010559212	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559224	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559228	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559229	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559233	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559235	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559244	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559250	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559262	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559264	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559265	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559269	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559272	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acquired immunodeficiency syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seborrhoeic dermatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559273	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559281	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010559314	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010559404	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559408	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559410	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559417	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559466	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010559484	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition);Viral infection (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010559510	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [16y - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [136d - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [458d - n/a - n/a])|[SITAGLIPTIN PHOSPHATE] (C - n/a - n/a - [381d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559557	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559564	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559565	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559572	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Transient global amnesia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - Insomnia - Dose not changed - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559574	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559712	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559730	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - );Vaccination site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559745	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LYRICA 25 MG HARD CAPSULES [PREGABALIN] (C - Neoplasm malignant - Dose not changed - [n/a - n/a - Oral])|[BILASTINE] (C - Rhinitis - Dose not changed - [n/a - n/a - Oral])|[CLOBETASOL PROPIONATE] (C - Dermatitis - Dose not changed - [n/a - n/a - Topical])|[METHYLPREDNISOLONE ACEPONATE] (C - Dermatitis - Dose not changed - [n/a - n/a - Topical])|[METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MONOHYDRATE] (C - Nausea - Dose not changed - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - Dyspepsia - Dose not changed - [n/a - n/a - Oral])|[PARACETAMOL] (C - Enthesopathy - Dose not changed - [n/a - n/a - Oral])|[TACROLIMUS] (C - Dermatitis - Dose not changed - [n/a - n/a - Topical])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010559761	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559792	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559795	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559799	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559813	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559862	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010559867	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010559873	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559904	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010559914	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559927	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559928	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559930	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559937	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559941	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559942	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559947	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559955	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Nasal ulcer (5d - Recovered/Resolved - );Vaccination site inflammation (5d - Recovered/Resolved - );Vaccination site pain (5d - Recovered/Resolved - );Vaccination site paraesthesia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559962	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (n/a - Recovered/Resolved - );Catarrh (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559978	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559990	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010559997	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010559997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560025	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560056	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Oversensing (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010560103	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation reaction (1h - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010560126	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560144	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560183	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neuralgia (n/a - Recovering/Resolving - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560185	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstrual disorder (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560238	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dry mouth (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[SOMATROPIN] (C - Growth hormone deficiency - n/a - [796d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560252	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal vascular thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010560253	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amaurosis fugax (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	AVASTIN 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION [BEVACIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560259	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysarthria (n/a - Recovering/Resolving - );Fall (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hemiparesis (n/a - Recovering/Resolving - );Transient ischaemic attack (n/a - Unknown - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560290	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560310	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560336	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Arthralgia (3d - Recovered/Resolved - );Choking (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Glossodynia (n/a - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010560444	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560449	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysphonia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560450	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560452	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (0d - Recovered/Resolved - );Eyelid irritation (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560455	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560462	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010560463	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560464	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560475	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560477	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560483	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560492	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic ischaemic neuropathy (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010560502	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560503	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Enteritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560508	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560529	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560532	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560537	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (n/a - Unknown - );Neuritis (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560539	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Breast pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560541	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560542	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560543	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560545	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Aphasia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010560550	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560552	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560556	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560560	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560565	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Life Threatening);Muscle twitching (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening);Paraesthesia (n/a - Not Recovered/Not Resolved - );Restlessness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010560575	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560579	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Bacterial infection (14d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (39d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010560588	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560589	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyskinesia (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560590	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560592	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Lymphoedema (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010560597	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560600	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|[COVID-19 VACCINE] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010560601	Spontaneous	2021-11-04 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010560621	Spontaneous	2021-11-04 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010560621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010533320	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (45d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (45d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (45d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533323	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (81d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533324	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533519	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blister (89d - Recovered/Resolved - );Mouth ulceration (n/a - Recovered/Resolved - );Pemphigoid (n/a - Recovered/Resolved - );Pruritus (89d - Recovered/Resolved - );Rash (89d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010535898	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535899	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sudden hearing loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535904	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535907	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535911	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (27d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536017	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Memory impairment (33d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536023	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536121	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Motion sickness (n/a - Recovering/Resolving - );Narcolepsy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536124	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536136	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010536201	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536209	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536217	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536219	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536222	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536224	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536225	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536226	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (4d - Recovered/Resolved - );Injection site rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536227	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536230	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536232	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peripheral swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536233	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536261	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536262	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536264	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Skin warm (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536267	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536268	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536269	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536270	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536291	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536293	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Dysphonia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tracheitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536294	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010536297	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536303	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536352	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010536353	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536378	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (14d - Recovered/Resolved - );COVID-19 (14d - Recovered/Resolved - );Cough (14d - Recovered/Resolved - );Hyposmia (14d - Recovered/Resolved - );Pyrexia (14d - Recovered/Resolved - );Rhinorrhoea (14d - Recovered/Resolved - );SARS-CoV-2 test positive (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536400	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010536409	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (56d - Recovered/Resolved - );Dizziness (56d - Recovered/Resolved - );Dyspnoea (56d - Recovered/Resolved - );Fatigue (56d - Recovered/Resolved - );Headache (56d - Recovered/Resolved - );Hot flush (56d - Recovered/Resolved - );Hyperhidrosis (56d - Recovered/Resolved - );Pyrexia (56d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010536418	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening);Cold sweat (n/a - Not Recovered/Not Resolved - Life Threatening);Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Dyspepsia (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Hypotension (n/a - Not Recovered/Not Resolved - Life Threatening);Paraesthesia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[IBUPROFEN, IBUPROFEN BP, IBUPROFEN LYSINE, IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE] (C - Migraine - n/a - [n/a - 600mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010536437	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diplopia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536449	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536457	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536469	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|[BOLDENONE UNDECYLENATE] (S - Substance use - n/a - [n/a - n/a - n/a])|[NANDROLONE DECANOATE] (S - Substance use - n/a - [n/a - n/a - n/a])|[TESTOSTERONE ACETATE] (S - Substance use - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536472	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cognitive disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sinusitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536473	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal disorder (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocardial oedema (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536477	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536487	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010536493	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bundle branch block right (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536506	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010536608	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010536611	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Periorbital swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536613	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb injury (105d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010536617	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Haemorrhoids (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010536697	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536710	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (50min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536714	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Fatal - Results in Death, Congenital Anomaly, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[ANHYDROUS ESTRADIOL, ESTRADIOL, ESTRADIOL HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROGESTERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010536723	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010536754	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536773	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death);Headache (n/a - Fatal - Results in Death);Myalgia (n/a - Fatal - Results in Death);Pulmonary fibrosis (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Respiratory failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010536834	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010536847	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death);Neutrophil count increased (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010536856	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536860	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536862	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Lethargy (n/a - Unknown - );Malaise (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536866	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536871	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536872	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Febrile neutropenia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neutrophil count decreased (3d - Recovered/Resolved - Life Threatening);Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	GRANISETRON [GRANISETRON] (C - n/a - n/a - [n/a - n/a - n/a])|TISAGENLECLEUCEL [TISAGENLECLEUCEL] (C - n/a - n/a - [n/a - n/a - n/a])|TOCILIZUMAB [TOCILIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE, CIPROFLOXACIN LACTATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLEMASTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010536879	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536880	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536883	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Recovered/Resolved - );Oropharyngeal discomfort (0d - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536891	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - );SARS-CoV-2 antibody test negative (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536892	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536910	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536914	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Lymph node pain (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Lymphoedema (n/a - Unknown - );Near death experience (n/a - Unknown - Other Medically Important Condition)	ALIMTA [PEMETREXED] (S - n/a - Unknown - [n/a - n/a - n/a])|NEULASTA [PEGFILGRASTIM] (S - n/a - Unknown - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536918	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536920	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536921	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Rhabdomyolysis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010536922	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536925	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Liver function test abnormal (n/a - Recovering/Resolving - );Petechiae (n/a - Recovering/Resolving - );Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536926	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010536927	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536932	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536933	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Depressed mood (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Suicidal ideation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536934	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536940	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536947	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010536949	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Nausea (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010536954	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Recovering/Resolving - Other Medically Important Condition);Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010536954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537048	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010537139	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010537183	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537194	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537202	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537244	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537283	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537353	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010537360	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537366	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Confusional state (n/a - Recovered/Resolved - );Delirium (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537373	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain in extremity (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010537378	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537418	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537425	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Unknown - );Gastric ulcer (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537433	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Neuritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010537490	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Cleft lip and palate (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition);Congenital eye disorder (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Dysmorphism (n/a - Not Recovered/Not Resolved - Congenital Anomaly);Foetal damage (n/a - Fatal - Results in Death);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[DIPHTHERIA TOXOID, TETANUS TOXOID, HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ] (C - n/a - n/a - [n/a - n/a - Transplacental])|[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 5mg - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010537549	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (16h - Recovered/Resolved - Other Medically Important Condition);Goitre (16h - Recovered/Resolved - );Pain in extremity (80h - Recovered/Resolved - );Swelling face (16h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537568	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537647	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Insomnia (n/a - Unknown - );Night sweats (n/a - Unknown - );Pain (n/a - Recovered/Resolved With Sequelae - );Peripheral coldness (n/a - Unknown - );Pruritus (n/a - Not Recovered/Not Resolved - );Raynaud's phenomenon (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - )|[COD-LIVER OIL] (C - n/a - n/a - )|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010537763	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537790	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin I increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010537794	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010537980	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ZOLEDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010537989	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (3d - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010537993	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysarthria (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paralysis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Muscular weakness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010537993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010538004	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010538019	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538028	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Initial insomnia (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538031	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010538032	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538042	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010538045	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Areflexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Diplopia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Illness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Interchange of vaccine products (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Neuropathy peripheral (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Ophthalmoplegia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010538051	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (10d - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538053	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010538059	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Circulatory collapse (n/a - Fatal - Results in Death);Dyspnoea (n/a - Fatal - Results in Death);Malaise (n/a - Unknown - );Pulmonary embolism (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010538082	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Demyelination (3d - Recovering/Resolving - Other Medically Important Condition);Hypotonia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538088	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538107	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Product administered at inappropriate site (n/a - Unknown - );Sciatica (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538111	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - Disabling);Head discomfort (n/a - Not Recovered/Not Resolved - Disabling);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010538222	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Depression (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Lymphadenopathy (n/a - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Resuscitation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010538275	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538426	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Lung disorder (n/a - Unknown - Other Medically Important Condition);Sleep apnoea syndrome (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538431	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538438	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal distension (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Abdominal pain upper (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Carpal tunnel syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Depressed mood (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gastritis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Gastrointestinal pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Hepatic steatosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hiatus hernia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Mucous stools (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Skin odour abnormal (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010538440	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Hyperaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Sensory loss (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	HUMIRA [ADALIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010538445	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Heart rate increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010538472	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538474	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010538505	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - );Chest pain (6d - Recovered/Resolved - );Condition aggravated (n/a - Unknown - );Discomfort (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Palpitations (6d - Recovered/Resolved - );Paraesthesia (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Rhinitis - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538577	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyslexia (n/a - Unknown - Other Medically Important Condition);Intellectual disability (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Mental disorder (n/a - Unknown - Other Medically Important Condition);Myocardial infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neoplasm malignant (n/a - Unknown - Other Medically Important Condition);Retinal degeneration (n/a - Unknown - Other Medically Important Condition);Retinal detachment (n/a - Unknown - Other Medically Important Condition);Retinal tear (n/a - Unknown - Other Medically Important Condition)	SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010538596	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site haematoma (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])|[ACETYLSALICYLIC ACID] (S - n/a - n/a - [n/a - n/a - Oral])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538636	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010538662	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Dysphonia (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010538791	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010538864	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Lichen planus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	APROVEL [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010538883	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - );Musculoskeletal discomfort (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538905	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - );Blood pressure decreased (0d - Recovered/Resolved - );Bradycardia (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Loss of consciousness (10s - Recovered/Resolved - Other Medically Important Condition);Muscle twitching (10s - Recovered/Resolved - );Vertigo (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538906	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010538925	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010538926	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	AZILECT [RASAGILINE, RASAGILINE MESILATE] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - )|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - )|[TRANDOLAPRIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010538964	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Oropharyngeal discomfort (n/a - Recovering/Resolving - );Tonsillar hypertrophy (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010538984	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Fatal - Results in Death);Palpitations (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010538989	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Disabling);Arrhythmia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Disabling);Heart rate increased (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BUDESONIDE [BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010538989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010539000	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal death (n/a - Unknown - Life Threatening, Other Medically Important Condition);Foetal hypokinesia (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010539001	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Life Threatening);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Life Threatening);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening);Pain (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Syncope (n/a - Not Recovered/Not Resolved - Life Threatening);Tenderness (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010539014	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010539021	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chapped lips (n/a - Unknown - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Ear pain (3d - Recovered/Resolved - Other Medically Important Condition);Haemoptysis (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Histamine level increased (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Skin fissures (n/a - Unknown - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010539034	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Groin pain (5d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (5d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010539060	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	COVID-19 pneumonia (n/a - Fatal - Results in Death);Drug ineffective (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010539070	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010539072	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE, FENOTEROL HYDROBROMIDE, IPRATROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - Pain - n/a - [n/a - n/a - Oral])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010539081	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - 10mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[PHENPROCOUMON] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010539090	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspepsia (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010539096	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010539099	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010539296	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ocular hyperaemia (n/a - Recovering/Resolving - );Rash macular (n/a - Recovering/Resolving - );SARS-CoV-2 test negative (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010539330	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Unknown - );Blood disorder (n/a - Unknown - );Bone disorder (n/a - Unknown - );Connective tissue disorder (n/a - Unknown - );Headache (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Myalgia (n/a - Unknown - );Nervous system disorder (n/a - Unknown - );Pyrexia (n/a - Unknown - );Skin disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010539373	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010539378	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (2wk - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster oticus (2wk - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010539389	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Capsular warning syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Lacunar stroke (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transient ischaemic attack (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Thrombosis - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010539397	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010539406	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010539433	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Fatigue (n/a - Fatal - Results in Death);Nasopharyngitis (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010539453	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010539461	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear infection (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hordeolum (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010539536	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010539568	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulpitis dental (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Spinal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010539586	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Respiratory symptom (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010539629	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sleep disorder (n/a - Recovering/Resolving - Disabling);Urticaria (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010539678	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Administration site erythema (n/a - Unknown - );Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010539726	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Infant	Yes	Not Specified	Exposure via breast milk (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010539824	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Nerve injury (10d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010539824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540007	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540020	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [87d - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010540034	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010540087	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540090	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Facial paralysis (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010540095	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540126	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - );Abdominal pain upper (n/a - Recovering/Resolving - );Decreased appetite (2d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540127	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[WITHANIA SOMNIFERA ROOT] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010540157	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540188	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin wound (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540240	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE] (C - n/a - n/a - [n/a - 10mg - Oral])|[LOSARTAN] (C - n/a - n/a - [n/a - 100mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540317	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540364	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site haematoma (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540401	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Malaise (3d - Recovered/Resolved - );Muscle contractions involuntary (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (3d - Recovered/Resolved - );Varicose vein (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010540459	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010540460	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540496	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010540670	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	APIXABAN [APIXABAN] (C - n/a - Not applicable - [n/a - 5mg - Oral])|[FUROSEMIDE] (C - n/a - Not applicable - [n/a - 60mg - Oral])|[METOPROLOL TARTRATE] (C - n/a - Not applicable - [n/a - 50mg - Oral])|[SPIRONOLACTONE] (C - n/a - Not applicable - [n/a - 50mg - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - Not applicable - [n/a - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010540696	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010540721	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540722	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540726	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540729	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540730	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540736	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010540901	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Vaccination site pain (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010540928	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010540931	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anti-GAD antibody positive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Anti-islet cell antibody positive (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Latent autoimmune diabetes in adults (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 50ug - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010540937	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010540937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541004	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010541011	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 1{DF} - Oral])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 1{DF} - Oral])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 1{DF} - Oral])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - 1{DF} - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - 2{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010541018	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cerebral venous sinus thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010541019	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Dyspnoea exertional (n/a - Unknown - Other Medically Important Condition);General physical health deterioration (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Monoplegia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombotic thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010541030	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010541057	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Life Threatening);Syncope (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010541073	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541076	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541079	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010541085	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (3d - Recovering/Resolving - );Diarrhoea (3d - Recovering/Resolving - );Fatigue (2d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541089	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541095	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541102	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (1d - Not Recovered/Not Resolved - );Lacrimation increased (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010541124	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Muscle spasms (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010541125	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thalamic infarction (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010541154	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Life Threatening);Cerebral thrombosis (n/a - Recovering/Resolving - Life Threatening);Pleural effusion (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010541208	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541209	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541213	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition);Visual impairment (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010541215	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541265	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541562	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010541632	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010541686	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541696	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541698	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541703	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541763	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - );Vaccination failure (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010541980	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010541980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542009	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Dysphoria (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542019	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542021	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542022	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMOXICILLIN TRIHYDRATE, POTASSIUM CLAVULANATE] (C - Bacterial infection - n/a - [9d - 4{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542025	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542026	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Dysphagia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Foaming at mouth (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Respiratory arrest (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542030	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542037	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Unknown - );Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542039	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Sinus rhythm (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542049	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Brain fog (n/a - Unknown - Caused/Prolonged Hospitalisation);Derealisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542054	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Swelling (n/a - Unknown - Other Medically Important Condition);Trigger finger (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [19d - n/a - n/a])	[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542062	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Melaena (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[BUDESONIDE] (C - Colitis ulcerative - n/a - [n/a - n/a - Rectal])|[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542064	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Magnetic resonance imaging abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin T increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542065	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (24h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542067	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542070	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal symptom (0d - Recovered/Resolved - );Attention deficit hyperactivity disorder (0d - Recovered/Resolved - );Autism spectrum disorder (0d - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - );Chills (n/a - Recovered/Resolved - );Gastroenteritis (0d - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Respiratory rate increased (0d - Recovered/Resolved - );Stress (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542073	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542076	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542077	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	General physical health deterioration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Polymyalgia rheumatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542095	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542100	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 400ug - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542102	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542105	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood iron decreased (n/a - Unknown - Other Medically Important Condition);Diverticulitis intestinal haemorrhagic (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Infarction - n/a - [n/a - n/a - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Abdominal discomfort - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Infarction - n/a - [n/a - n/a - Oral])|[ISOSORBIDE MONONITRATE] (C - Infarction - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Infarction - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Infarction - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Infarction - n/a - [n/a - n/a - Oral])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Arthralgia - n/a - [n/a - n/a - n/a])|[TRIMETAZIDINE, TRIMETAZIDINE DIHYDROCHLORIDE] (C - Infarction - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542106	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Non-cardiac chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542107	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Erythema (n/a - Unknown - );Livedo reticularis (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash erythematous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Skin discolouration (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542108	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Unknown - );Monocyte count increased (n/a - Unknown - );Neutrophil count decreased (n/a - Unknown - );Poor quality sleep (n/a - Not Recovered/Not Resolved - );White blood cell count decreased (n/a - Unknown - );White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010542140	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vertebral artery dissection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542142	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010542173	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pharyngitis (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010542185	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542192	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542199	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachycardia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010542211	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Hyperventilation (n/a - Recovered/Resolved - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542252	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CLONAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ELECTROLYTES NOS] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[HALOPERIDOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542255	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542267	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542276	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Musculoskeletal chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010542316	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542370	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542375	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Fatigue (13d - Recovered/Resolved - );Nasal congestion (12d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542378	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542381	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Palpitations (1d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542406	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (12h - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542414	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRIMIPRAMINE, TRIMIPRAMINE MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542416	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542419	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Unknown - Disabling, Other Medically Important Condition);Influenza (n/a - Unknown - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010542423	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542425	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TOVIAZ [FESOTERODINE, FESOTERODINE FUMARATE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[MIRABEGRON] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[SILODOSIN] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542426	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542429	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (347min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (347min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (347min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542430	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542431	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542433	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542436	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542439	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542441	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542444	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Therapeutic response unexpected (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010542450	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - );Dizziness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ABILIFY [ARIPIPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010542454	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542460	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - Other Medically Important Condition);Visual field defect (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542462	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Unknown - Life Threatening);Dizziness (n/a - Unknown - Life Threatening);Fall (n/a - Unknown - Life Threatening);Hallucination (n/a - Unknown - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Life Threatening, Other Medically Important Condition);Malaise (n/a - Unknown - Life Threatening);Musculoskeletal chest pain (n/a - Unknown - Life Threatening);Off label use (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition);Pyrexia (n/a - Unknown - Life Threatening);Rib fracture (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010542463	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anxiety (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Electric shock sensation (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Muscle spasms (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Neck pain (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nerve injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Sleep disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542476	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral venous sinus thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010542479	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Atrial fibrillation (232h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Atrial tachycardia (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Blood pressure decreased (232h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Brain natriuretic peptide increased (232h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia paroxysmal (232h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Troponin I increased (232h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010542481	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Atrial flutter (n/a - Unknown - );COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Carotid arteriosclerosis (n/a - Unknown - Other Medically Important Condition);Cerebral atrophy (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Hypoxia (n/a - Unknown - Other Medically Important Condition);Tachypnoea (n/a - Unknown - );Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GLYCEROL] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[MEMANTINE] (C - n/a - n/a - [n/a - 10mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - .4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542483	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Decapitation (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542496	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Laziness (n/a - Unknown - Disabling);Limb discomfort (n/a - Unknown - Disabling);Liver disorder (n/a - Unknown - Disabling);Liver injury (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010542499	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542503	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hypersomnia (n/a - Recovered/Resolved - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542541	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010542543	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal movement disorder (4d - Recovered/Resolved - Other Medically Important Condition);Maternal exposure during pregnancy (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[FOLIC ACID] (C - Vitamin supplementation - n/a - [n/a - 400ug - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542551	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010542552	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bone pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Gastrointestinal pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010542612	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542641	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542675	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542722	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542732	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542844	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Impaired quality of life (n/a - Unknown - );Laboratory test abnormal (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Traumatic lung injury (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010542850	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Loss of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Mobility decreased (n/a - Unknown - );Myocardial ischaemia (n/a - Fatal - Results in Death, Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX 75 MG [CLOPIDOGREL] (C - Thrombotic cerebral infarction - n/a - [n/a - n/a - Oral])|[ACETYLCYSTEINE] (C - Bronchitis chronic - n/a - [n/a - n/a - Oral])|[AMBROXOL HYDROCHLORIDE] (C - Bronchitis chronic - n/a - [n/a - n/a - Oral])|[CARBOCISTEINE] (C - Bronchitis chronic - n/a - [n/a - n/a - Oral])|[DIFLUPREDNATE] (C - Eczema - n/a - [n/a - n/a - Topical])|[ESAXERENONE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[IRBESARTAN, TRICHLORMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[KETOPROFEN] (C - Back pain - n/a - [n/a - n/a - Topical])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[NAFTOPIDIL] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[PARAFFIN WHITE SOFT] (C - Eczema - n/a - [n/a - n/a - Topical])|[VIBEGRON] (C - Hypertonic bladder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010542890	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (5min - Recovered/Resolved - Other Medically Important Condition);Ear disorder (5min - Recovered/Resolved - );Feeling abnormal (5min - Recovered/Resolved - );Syncope (5min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010542940	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - Not applicable - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - n/a - Not applicable - [n/a - 10mg - Oral])|[FOSINOPRIL] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542986	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - );Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010542997	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2wk - Recovered/Resolved - Disabling, Other Medically Important Condition);Nausea (2wk - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010542997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010543026	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010543028	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010543029	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Arrhythmia (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543031	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543032	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010543037	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543058	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543066	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Weight bearing difficulty (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543069	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Aortic aneurysm (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543076	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543097	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543127	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );Malaise (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543130	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543139	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543289	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - );Vaccination failure (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543450	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (13d - Recovered/Resolved - );Vaccination failure (13d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543453	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543456	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543458	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543459	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543529	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure systolic decreased (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Pulse abnormal (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010543534	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543538	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (6d - Recovered/Resolved - );Pyrexia (2mo - Recovered/Resolved - );Sarcoidosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543539	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010543547	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Angina unstable (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010543560	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Angiotensin converting enzyme increased (n/a - Unknown - );Haemoptysis (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary alveolar haemorrhage (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sarcoidosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[ENTEROCOCCUS FAECALIS, LACTIC ACID] (C - Enterocolitis - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, AMOXICILLIN, CLARITHROMYCIN] (C - Duodenal ulcer - n/a - [n/a - n/a - Oral])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[REBAMIPIDE] (C - Gastritis - n/a - [n/a - n/a - Oral])|[SODIUM FERROUS CITRATE] (C - Iron deficiency anaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543561	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010543565	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543671	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure systolic increased (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (10min - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (42min - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (42min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Essential hypertension - n/a - [n/a - 1{DF} - Oral])|[OMEGA-3-ACID ETHYL ESTERS] (C - Hypercholesterolaemia - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543681	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Montgomery, J.. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiology. 2021;6(10):1202-1206. doi:10.1001/jamacardio.2021.2833	Not Specified	Adult	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010543788	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010543805	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543896	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood calcium increased (n/a - Unknown - );Heart valve calcification (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - );Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition);Vocal cord paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (S - n/a - Unknown - [n/a - n/a - n/a])|[EZETIMIBE] (S - n/a - Unknown - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (S - n/a - Unknown - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010543968	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Myositis (n/a - Recovered/Resolved - );Sleep disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010543986	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - );Pericarditis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010543986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010544030	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema multiforme (9d - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ETIZOLAM] (C - Depression - n/a - [n/a - n/a - Oral])|[FLUVOXAMINE MALEATE] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544038	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544046	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Nephrotic syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544048	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544053	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544056	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Initial insomnia (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nightmare (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544057	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - n/a - Unknown - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544064	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544068	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544070	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544074	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544077	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ENALAPRIL MALEATE [ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - 2.5mg - Oral])|RISPERIDONE [RISPERIDONE] (C - n/a - n/a - [n/a - .5mg - Oral])|SILODOSIN [SILODOSIN] (C - Dysuria - n/a - [n/a - 8mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 8mg - Oral])|[CLOSTRIDIUM BUTYRICUM] (C - Gastrointestinal disorder therapy - n/a - [n/a - 3g - Oral])|[ESZOPICLONE] (C - n/a - n/a - [n/a - 2mg - Oral])|[MECOBALAMIN] (C - Vitamin B12 - n/a - [n/a - 1500ug - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - 600mg - Oral])|[POLYCARBOPHIL CALCIUM] (C - Irritable bowel syndrome - n/a - [n/a - 1.2g - Oral])|[SENNOSIDE A+B CALCIUM] (C - Constipation - n/a - [n/a - 12mg - Oral])|[TRIAZOLAM] (C - n/a - n/a - [n/a - .25mg - Oral])|[TRICHLORMETHIAZIDE] (C - Hypertension - n/a - [n/a - 1mg - Oral])|[VONOPRAZAN, VONOPRAZAN FUMARATE, VONOPRAZAN HYDROGEN FUMARATE] (C - Hypertension - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010544078	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (1mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - Cardiac fibrillation, Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544079	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544195	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544207	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site hypoaesthesia (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544217	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544224	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544225	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544286	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544300	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544304	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Oesophageal haemorrhage (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544307	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyslalia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Movement disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BROTIZOLAM] (C - Insomnia - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DIHYDROCODEINE, DIHYDROCODEINE TARTRATE BP] (C - Bronchitis - n/a - [n/a - n/a - n/a])|[LACTOBACILLUS BIFIDUS, LYOPHILIZED] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - n/a])|[METHYLEPHEDRINE] (C - Bronchitis - n/a - [n/a - n/a - n/a])|[POLYENEPHOSPHATIDYL CHOLINE] (C - Dyslipidaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544317	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cutaneous symptom (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Drug eruption (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Epidermal necrosis (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Unknown - Caused/Prolonged Hospitalisation);Neutrophil count increased (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Skin erosion (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Pain, Pyrexia - n/a - [1d - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[MECOBALAMIN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544320	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544466	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544469	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - );Confusional state (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544470	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Ocular hyperaemia (n/a - Unknown - );Purpura (n/a - Unknown - );Upper respiratory tract congestion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[EDOXABAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 30mg - Oral])|[NIFEDIPINE] (C - n/a - n/a - [n/a - 60mg - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - 1200mg - Oral])|[SENNOSIDE A+B] (C - n/a - n/a - [n/a - 48mg - Oral])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010544486	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Blister (n/a - Unknown - Life Threatening, Other Medically Important Condition);Diastolic hypotension (n/a - Unknown - Life Threatening, Other Medically Important Condition);Headache (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Transient ischaemic attack (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vaccination site mass (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010544487	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544493	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic reaction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ISOMETHEPTENE MUCATE, METAMIZOLE SODIUM, CAFFEINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544559	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544560	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544561	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye inflammation (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Neurodermatitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544564	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010544573	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544578	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544579	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544617	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544636	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544643	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544650	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (15d - Recovered/Resolved - );Dyspnoea exertional (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544653	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	FIASP FLEXTOUCH 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])|LEVEMIR 100U/ML SOLUTION FOR INJECTION [INSULIN DETEMIR] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544655	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (9d - Recovered/Resolved - );Lymphadenopathy (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544659	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544661	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1umol - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544673	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544679	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544681	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544683	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544697	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544723	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544726	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544754	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544764	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3h - Recovered/Resolved - );Hypertension (3h - Recovered/Resolved - );Immunisation reaction (3h - Recovered/Resolved - );Insomnia (3h - Recovered/Resolved - );Malaise (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - 1{DF} - Intramuscular])	[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544768	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544769	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperferritinaemia (n/a - Recovered/Resolved - );Hyperglycaemia (n/a - Recovered/Resolved - );Hypertension (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544779	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [31d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544784	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544786	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544804	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544811	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypertensive crisis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544820	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544832	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544840	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (7d - Recovered/Resolved - );Petechiae (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544929	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (6d - Not Recovered/Not Resolved - Other Medically Important Condition);Arrhythmia (6d - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (6d - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544930	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (0d - Unknown - );Headache (0d - Unknown - );Swelling of eyelid (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010544933	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544938	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (22d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544957	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544958	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Unknown - Other Medically Important Condition);Myocarditis (3d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544959	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Dyspnoea (91d - Recovering/Resolving - );Fatigue (91d - Recovering/Resolving - );Limb discomfort (91d - Recovering/Resolving - );Respiratory distress (91d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544960	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544961	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (48d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (48d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (48d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544964	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blepharospasm (n/a - Not Recovered/Not Resolved - );Dry eye (n/a - Not Recovered/Not Resolved - );Fatigue (4d - Recovered/Resolved - );Haemorrhoids thrombosed (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544969	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010544974	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (9d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544980	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition);Haematoma (n/a - Recovering/Resolving - Other Medically Important Condition);Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544981	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544988	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010544991	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010544998	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010544998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010545002	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545004	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545009	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site swelling (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545045	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epilepsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545048	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545049	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (49d - Not Recovered/Not Resolved - );Myalgia (49d - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010545055	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Embolism arterial (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545063	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545069	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune haemolytic anaemia (116d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545123	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545154	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bradycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Epilepsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545157	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Pemphigoid (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545158	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010545173	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545180	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545185	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010545297	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (10d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (10d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545309	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545327	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Unknown - );Asthenia (n/a - Unknown - );Brain oedema (n/a - Unknown - Other Medically Important Condition);Cerebral venous thrombosis (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - );Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Dependence on respirator (n/a - Unknown - Other Medically Important Condition);Factor V Leiden mutation (n/a - Unknown - );Haemorrhagic cerebral infarction (n/a - Unknown - Other Medically Important Condition);Immune thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Ischaemic stroke (n/a - Unknown - Other Medically Important Condition);Jugular vein thrombosis (n/a - Unknown - );Leukocytosis (n/a - Unknown - );Platelet count decreased (n/a - Unknown - );Pneumonia (n/a - Unknown - Other Medically Important Condition);Pneumothorax (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Rash (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition);Staphylococcal infection (n/a - Unknown - Other Medically Important Condition);Subarachnoid haemorrhage (n/a - Unknown - Other Medically Important Condition);Superficial vein thrombosis (n/a - Unknown - );Superior sagittal sinus thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	FENTANYL [FENTANYL, FENTANYL CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|KEPPRA [LEVETIRACETAM] (C - n/a - n/a - [n/a - 1500mg - Intravenous (not otherwise specified)])|VIMPAT [LACOSAMIDE] (C - n/a - n/a - [n/a - 200mg - Intravenous (not otherwise specified)])|[ACETYLCYSTEINE, ACETYLCYSTEINE SODIUM] (C - n/a - n/a - [n/a - 12mL - n/a])|[BISACODYL, DOCUSATE SODIUM, SODIUM PICOSULFATE MONOHYDRATE] (C - Constipation - n/a - [n/a - n/a - n/a])|[BUSPIRONE, BUSPIRONE HYDROCHLORIDE] (C - Chills - n/a - [n/a - 30mg - n/a])|[CASSIA, CASSIA SENNA WHOLE, HYDROXYANTHRACENE GLYCOSIDES, SENNA PODS, SENNOSIDE B, SENNOSIDES] (C - n/a - n/a - [n/a - 8.6mg - n/a])|[CELECOXIB] (C - n/a - n/a - [n/a - 130mg - Intravenous (not otherwise specified)])|[CLONAZEPAM] (C - n/a - n/a - [n/a - 1mg - n/a])|[DOCUSATE SODIUM] (C - n/a - n/a - [n/a - 200mg - n/a])|[HEPARIN, HEPARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - Blood pressure systolic - n/a - [n/a - 60mg - n/a])|[LABETALOL, LABETALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 800mg - n/a])|[MACROGOL 3350] (C - Constipation - n/a - [n/a - 17g - n/a])|[NAFCILLIN] (C - n/a - n/a - [n/a - 12g - Intravenous (not otherwise specified)])|[NYSTATIN, ZINC OXIDE] (C - n/a - n/a - [n/a - 124% - n/a])|[OMEPRAZOLE, PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 40mg - Intravenous (not otherwise specified)])|[PARACETAMOL] (C - Pyrexia - n/a - [n/a - 650mg - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 20mg - n/a])|[SALBUTAMOL SULFATE, IPRATROPIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIZANIDINE, TIZANIDINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 18mg - n/a])|[TRIMETHOPRIM LACTATE, SULFAMETHOXAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010545330	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545336	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545340	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545341	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545353	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Activated protein C resistance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545354	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545357	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peripheral vascular disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545358	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545359	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545363	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545366	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545368	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545369	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545374	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Administration site pain (2d - Recovered/Resolved - );Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545482	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545490	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Myocarditis (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545491	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545495	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545504	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010545506	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (23d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545521	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010545522	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545528	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gastrocardiac syndrome (65d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypokalaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vestibular disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545543	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Transient ischaemic attack (1min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545546	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010545551	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545553	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545565	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010545569	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545570	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545571	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545573	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545575	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Unknown - );Headache (2d - Unknown - );Injection site reaction (2d - Unknown - );Visual impairment (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - 1000mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545576	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Bradyphrenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545578	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - )|[GLICLAZIDE] (C - n/a - n/a - )|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545588	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [34d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010545595	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	Yes	Male	Essential thrombocythaemia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545596	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545600	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545606	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545609	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545643	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010545728	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis exfoliative generalised (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACICLOVIR, ACICLOVIR SODIUM] (C - Infection prophylaxis - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CICLOSPORIN] (C - Graft versus host disease - n/a - [n/a - n/a - Oral])|[FLUCONAZOLE] (C - Infection prophylaxis - n/a - [n/a - n/a - Oral])|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - Infection prophylaxis - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545730	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Unknown - );Illness (n/a - Unknown - );Sputum retention (n/a - Not Recovered/Not Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545741	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010545751	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Bronchospasm (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovered/Resolved - );Oropharyngeal discomfort (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovering/Resolving - );Throat tightness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010545795	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545817	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545819	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545821	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545822	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545823	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545825	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545827	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545829	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545831	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545834	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545836	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545837	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545838	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010545856	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010545950	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Gingival swelling (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lymph node palpable (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[TRIMETAZIDINE DIHYDROCHLORIDE] (C - Cardiovascular disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010545950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546016	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546023	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	International normalised ratio increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Not applicable - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010546047	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site erythema (11d - Recovered/Resolved - );Injection site inflammation (11d - Recovered/Resolved - );Injection site pruritus (11d - Recovered/Resolved - );Injection site swelling (11d - Recovered/Resolved - );Injection site warmth (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546140	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546141	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546176	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Hypertension (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - Dose not changed - )|[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - Hypertension - Dose not changed - )|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - Dose not changed - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546182	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (26d - Recovered/Resolved - Other Medically Important Condition);Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (26d - Recovered/Resolved - Other Medically Important Condition);Headache (12d - Recovered/Resolved - Other Medically Important Condition);Myocarditis (26d - Recovered/Resolved - Other Medically Important Condition);Palpitations (26d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546195	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546221	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546239	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546250	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (1d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546256	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Disabling);Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Ear pain (3d - Recovered/Resolved - Disabling);Hypoacusis (n/a - Recovered/Resolved With Sequelae - Disabling);Nerve injury (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010546270	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Disabling);Mental fatigue (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546273	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546288	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546292	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (15h - Recovered/Resolved - );Headache (15h - Recovered/Resolved - );Nasopharyngitis (15h - Recovered/Resolved - );Pruritus (15h - Recovered/Resolved - );Vaccination site pain (15h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - )|[DICLOFENAC SODIUM] (C - n/a - n/a - )|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - )|[PARACETAMOL, PARACETAMOL PH. EUR., CODEINE PHOSPHATE PH.EUR., PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546310	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (16d - Recovered/Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546329	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (1d - Recovered/Resolved - Life Threatening);Blindness transient (1d - Recovered/Resolved - Life Threatening);Burning sensation (1d - Recovered/Resolved - Life Threatening);Dyspnoea (1d - Recovered/Resolved - Life Threatening);Headache (1d - Recovered/Resolved - Life Threatening);Nausea (1d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|XELJANZ [TOFACITINIB, TOFACITINIB CITRATE] (S - Colitis ulcerative - Dose not changed - [n/a - n/a - Oral])|[METHOTREXATE] (S - Colitis ulcerative - Dose not changed - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010546353	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546369	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010546370	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546396	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swollen tongue (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	HUMALOG [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|JARDIANCE [EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE, ENALAPRIL, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[INSULIN HUMAN, INSULIN HUMAN (RDNA), ISOPHANE INSULIN] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546434	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546436	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Rhinorrhoea (3d - Recovering/Resolving - );Stomatitis (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ETORICOXIB] (C - Arthralgia - Dose not changed - [n/a - 90mg - Oral])|[TOLPERISONE HYDROCHLORIDE] (C - Paraparesis - Dose not changed - [n/a - 150mg - Oral])|[TRAMADOL HYDROCHLORIDE, PARACETAMOL] (C - Arthralgia - Dose not changed - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546445	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546454	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	FEBUXOSTAT [FEBUXOSTAT] (C - Gout - n/a - [n/a - n/a - Oral])|PREGABALIN [PREGABALIN] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - Oral])|[LOXOPROFEN] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - Oral])|[MECOBALAMIN] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - Oral])|[REBAMIPIDE] (C - Intervertebral disc protrusion - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546505	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010546506	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546510	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546518	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546556	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nephrolithiasis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546561	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait inability (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	RASAGILINE [RASAGILINE, RASAGILINE TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546565	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546567	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Viral infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	VICTOZA [LIRAGLUTIDE] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546573	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );COVID-19 (n/a - Unknown - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Secretion discharge (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CENTRUM SILVER ADULTS 50+ [ASCORBIC ACID, BIOTIN, BORON, CALCIUM, CALCIUM PANTOTHENATE, CHLORIDE, CHROMIUM, COLECALCIFEROL, COPPER, CYANOCOBALAMIN, FOLIC ACID, IODINE, LYCOPENE, MAGNESIUM, MANGANESE, MOLYBDENUM, NICKEL, NICOTINAMIDE, PHOSPHORUS, PHYTOMENADIONE, POTASSIUM, PYRIDOXINE HYDROCHLORIDE, RETINOL ACETATE, RIBOFLAVIN, SELENIUM, SILICON DIOXIDE, SODIUM METAVANADATE, THIAMINE MONONITRATE, TOCOPHERYL ACETATE, XANTOFYL, ZINC] (C - n/a - n/a - [n/a - n/a - n/a])|RANOLAZINE [RANOLAZINE] (C - n/a - n/a - [n/a - 2000mg - n/a])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 1000mg - n/a])|[FISH OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[GLIPIZIDE] (C - n/a - n/a - [n/a - 5mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])|[LUTEIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 2000mg - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 100mg - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 8mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010546574	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Heart rate decreased (n/a - Unknown - );Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546581	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546595	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546604	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546607	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546609	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disorientation (156d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546610	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (24d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (208d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546616	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546625	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546628	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coronary artery disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546640	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary fibrosis (108d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546653	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal discomfort (56d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (56d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546662	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546666	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546670	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Oligoarthritis (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546671	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Eye infarction (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546679	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010546692	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546715	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Cough (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010546838	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546932	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546933	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010546943	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010546966	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Blood creatine increased (n/a - Recovered/Resolved - );Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (1d - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010546992	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ischaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Migraine (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ocular vascular disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010546997	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - 2.5mg - Oral])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - 500g - n/a])|[CLARITHROMYCIN] (C - n/a - n/a - [n/a - 400mg - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010546997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010547005	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547018	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - );Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547021	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547042	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Reaction to food additive (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling face (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TESTOSTERONE [TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACRIVASTINE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TESTOSTERONE CIPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010547046	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547054	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547084	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547198	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547200	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547203	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547225	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (77d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (77d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (77d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (77d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (19d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547261	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site muscle atrophy (n/a - Not Recovered/Not Resolved - Disabling);Injection site muscle weakness (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010547290	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547293	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547306	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547307	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547315	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Drug eruption (1wk - Recovered/Resolved - );Pruritus (n/a - Recovering/Resolving - );Toxic skin eruption (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547331	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem infarction (11d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (11d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypoaesthesia (11d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Movement disorder (11d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547333	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547341	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547348	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010547353	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547355	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autonomic nervous system imbalance (n/a - Unknown - Other Medically Important Condition);Muscular weakness (n/a - Unknown - Other Medically Important Condition);Myelitis (n/a - Recovering/Resolving - Other Medically Important Condition);Neurological symptom (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Sensory level (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010547371	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebellar artery thrombosis (5d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (62d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (5d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547382	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547403	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547406	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547411	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547426	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547441	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547445	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547453	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547461	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547469	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (24d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010547492	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010547518	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (130min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010547519	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547525	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547544	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547546	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547551	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Somnolence (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	BETMIGA [MIRABEGRON] (C - n/a - n/a - [n/a - 50mg - Oral])|VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - .4mg - Oral])|[TROSPIUM CHLORIDE] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010547554	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Unknown - Life Threatening, Other Medically Important Condition);Asthenia (n/a - Unknown - );Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chest pain (n/a - Not Recovered/Not Resolved - );Cold sweat (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - );Right ventricular failure (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Vaccination site urticaria (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010547575	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010547668	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547894	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Iridocyclitis (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010547925	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010547925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010548016	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site joint erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548045	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548046	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548059	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548061	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548063	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548079	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548080	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548084	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548092	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548156	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Folliculitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lip erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lip oedema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lip pain (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mucosal infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oral discomfort (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal erythema (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pharyngitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis allergic - n/a - [n/a - n/a - n/a])|[ISOTRETINOIN] (C - Acne - n/a - [403d - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010548205	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diplopia (n/a - Unknown - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Eyelid ptosis (n/a - Unknown - Caused/Prolonged Hospitalisation);IIIrd nerve paresis (31d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010548223	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - n/a - n/a - )|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - Anxiety - Not applicable - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010548231	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548232	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548237	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548241	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548245	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548247	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548248	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548252	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pyrexia (3d - Recovered/Resolved - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548258	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548285	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548289	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548290	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548299	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548316	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	[IBUPROFEN] (C - Headache - Drug withdrawn - [1d - n/a - n/a])|[PARACETAMOL] (C - Analgesic therapy - Drug withdrawn - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548343	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Conjunctivitis allergic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erysipelas (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548471	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548478	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548493	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (2d - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (48h - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[PEPPERMINT OIL] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548521	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548543	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - Other Medically Important Condition);Back pain (1d - Recovered/Resolved - Other Medically Important Condition);Balance disorder (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Feeling jittery (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010548594	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hyperpyrexia (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548639	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548640	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548669	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548670	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548672	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548676	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548678	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548774	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (15d - Not Recovered/Not Resolved - );Red blood cell abnormality (15d - Not Recovered/Not Resolved - );White blood cell disorder (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548778	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (105d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010548790	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (29d - Not Recovered/Not Resolved - );Rash (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010548798	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoplegia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (165d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010548799	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (73d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010548800	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548810	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548812	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (157d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010548817	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548828	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (75d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010548831	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548832	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548833	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010548841	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (4d - Recovering/Resolving - );Headache (8d - Not Recovered/Not Resolved - );Nausea (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548842	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548856	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (4d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548872	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548910	Spontaneous	2021-11-03 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010548979	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010548990	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010548990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549002	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549006	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549009	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549020	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549024	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010549034	Spontaneous	2021-11-03 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Asthma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Autoimmune disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Suicidal ideation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[PROPANTHELINE BROMIDE] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010549034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507945	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (66d - Fatal - Results in Death);Pneumonia (66d - Fatal - Results in Death);Thrombosis (66d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	RETACRIT [EPOETIN ALFA, EPOETIN ZETA] (C - Plasma cell myeloma - n/a - [n/a - n/a - Subcutaneous])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010507964	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fear (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Skin burning sensation (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010507966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (88d - Fatal - Results in Death);Fatigue (88d - Fatal - Results in Death);Haemorrhagic stroke (88d - Fatal - Results in Death);Pain in extremity (88d - Fatal - Results in Death);Paraesthesia (88d - Fatal - Results in Death);Vascular pain (88d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010507981	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Carotid artery aneurysm (n/a - Not Recovered/Not Resolved - Life Threatening);Intracranial aneurysm (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010507984	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010508011	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010508148	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508151	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (45min - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (45min - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (45min - Recovered/Resolved - Other Medically Important Condition);Peripheral coldness (45min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMBROXOL HYDROCHLORIDE] (C - Asthma - n/a - [n/a - 1{DF} - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - Asthma - n/a - [n/a - 9{DF} - n/a])|[CLOSTRIDIUM BUTYRICUM] (C - Asthma - n/a - [n/a - 4g - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - 1{DF} - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508196	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508197	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508203	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pruritus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tremor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010508219	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Feeling cold (n/a - Recovering/Resolving - );Lymph node pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010508225	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Back pain (n/a - Unknown - );Bone cancer metastatic (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Interstitial lung disease (n/a - Recovered/Resolved - Other Medically Important Condition);Prostate cancer (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508242	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508247	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dizziness (n/a - Recovered/Resolved - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508486	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508509	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Apathy (n/a - Unknown - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010508510	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Muscle contracture (n/a - Recovering/Resolving - );Paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508512	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Balance disorder (1d - Recovered/Resolved - Other Medically Important Condition);Lethargy (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Antiviral prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508519	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010508593	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508622	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508626	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508631	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Serum ferritin increased (n/a - Recovered/Resolved - );Thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508633	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Abscess bacterial (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508710	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling of body temperature change (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508712	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amylase increased (n/a - Unknown - );Hepatic enzyme increased (n/a - Unknown - );Lipase increased (n/a - Unknown - );Pancreatitis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508719	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site oedema (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508722	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Anosmia (n/a - Unknown - );Chills (n/a - Unknown - );Cough (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - );Pyrexia (n/a - Unknown - );Sneezing (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010508737	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508743	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508746	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508846	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Pain (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010508848	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disorientation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010508887	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508888	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508891	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508894	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508997	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010508998	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010508998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509083	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Dyspnoea at rest (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509084	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509087	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509092	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509095	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - );Cardiac disorder (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erythema (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Near death experience (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509098	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal impairment (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ENALAPRIL, ENALAPRIL MALEATE] (C - Blood pressure abnormal - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010509102	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509106	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed mood (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509111	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509113	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Toothache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, ALUMINIUM, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, ALGELDRATE, ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, ALGELDRATE, FILAMENTOUS HAEMAGGLUTININ, DIPHTHERIA TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, TETANUS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS PERTACTIN, BORDETELLA PERTUSSIS (INACTIVATED) ADSORBED] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509114	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509116	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509121	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes pharyngitis (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Oral herpes (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[DEXLANSOPRAZOLE, LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 1{DF} - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 1{DF} - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Hyperlipidaemia - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509125	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LATUDA [LURASIDONE, LURASIDONE HYDROCHLORIDE] (C - Bipolar II disorder - n/a - [n/a - n/a - Oral])|TESTOSTERONE [TESTOSTERONE] (C - Blood testosterone decreased - n/a - [n/a - n/a - Intramuscular])|[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[BUPROPION HYDROCHLORIDE] (C - Bipolar II disorder - n/a - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509223	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509224	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509225	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509232	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Endotracheal intubation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010509233	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509277	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	Yes	Male	Asthenia (n/a - Unknown - );Asthma (n/a - Unknown - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Illness (n/a - Unknown - );Nasal congestion (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509284	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509286	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Ear swelling (n/a - Unknown - Other Medically Important Condition);Sinusitis (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509302	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509476	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Depressed mood (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509487	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010509502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Skin odour abnormal (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010509510	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition);Generalised tonic-clonic seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509522	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509523	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509537	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509554	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509556	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509560	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509562	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010509564	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509568	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509665	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dermatitis allergic (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509698	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (5d - Recovered/Resolved - Other Medically Important Condition);Cough (5d - Recovered/Resolved - Other Medically Important Condition);Infection (5d - Recovered/Resolved - Other Medically Important Condition);Oropharyngeal pain (5d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (5d - Recovered/Resolved - Other Medically Important Condition);Rhinorrhoea (5d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	AERIUS [DESLORATADINE] (C - n/a - Unknown - )|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010509719	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509722	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509726	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509729	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509731	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010509845	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509884	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509891	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509892	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	OLANZAPINE 10 MG - ORODISPERSIBLE TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|OLANZAPINE GLENMARK 5 MG TABLETS [OLANZAPINE] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509905	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509930	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010509954	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010509954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010510026	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510037	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510038	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510079	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510086	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510096	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (S - n/a - n/a - [n/a - 1{DF} - n/a])	UROREC 8 MG [SILODOSIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PITAVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510105	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Musculoskeletal disorder (n/a - Not Recovered/Not Resolved - );Vaccination site discomfort (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510115	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510149	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (2wk - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010510150	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ventricular arrhythmia (2d - Fatal - Results in Death);Ventricular tachycardia (2d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010510184	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510186	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Local anaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (1mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510187	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510192	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510193	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510210	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute sinusitis (0d - Recovered/Resolved - );Heat stroke (0d - Recovered/Resolved - );Hypersensitivity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510233	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510235	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510240	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510243	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510246	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Autoimmune disorder (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Deafness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nodule (n/a - Not Recovered/Not Resolved - Disabling);Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010510250	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510255	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510256	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510259	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Migraine - n/a - [1834d - n/a - n/a])|[TOPIRAMATE] (C - Migraine - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010510267	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510269	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510278	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510280	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510282	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Heart rate decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Respiratory disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TESTOSTERONE [TESTOSTERONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510299	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fear (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Migraine (1wk - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510300	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Type 2 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	TRAJENTA [LINAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Depression - n/a - [n/a - n/a - Oral])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510307	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyuria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510308	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510318	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Varicella (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010510321	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Fatigue (10d - Recovered/Resolved - Other Medically Important Condition);Nausea (10d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510338	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010510358	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM] (C - Gastrointestinal disorder - n/a - [n/a - n/a - Oral])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010510361	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510364	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510370	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Dysstasia (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010510461	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Back pain (n/a - Recovered/Resolved - );Chest pain (n/a - Recovered/Resolved - );Flank pain (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510466	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (2wk - Recovered/Resolved - );Herpes zoster (2wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010510493	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Diarrhoea (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510511	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510584	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510586	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510594	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510661	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Life Threatening);Administration site erythema (n/a - Not Recovered/Not Resolved - Life Threatening);Administration site pain (n/a - Not Recovered/Not Resolved - Life Threatening);Cardiac murmur (n/a - Not Recovered/Not Resolved - Life Threatening);Dysuria (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010510723	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Testicular disorder (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010510840	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510852	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cognitive disorder (n/a - Recovering/Resolving - );Mental impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010510855	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010510943	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Gastroenteritis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010510999	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010510999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010511096	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511097	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511099	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511114	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511117	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511120	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiomyopathy (162h - Recovered/Resolved - Other Medically Important Condition);Chest pain (162h - Recovered/Resolved - );Troponin T increased (162h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511123	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Axillary pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511126	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511129	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dysstasia (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511131	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	HYRIMOZ [ADALIMUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511154	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010511178	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511179	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511180	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511181	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pancreatitis acute (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511182	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511183	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511184	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511188	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511190	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511194	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - );Hypothyroidism (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - );Rectal haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511197	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511199	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511200	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511204	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511279	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Unknown - );Injection site hypersensitivity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511341	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511342	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511343	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511346	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511348	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Putamen haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010511349	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511351	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511354	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511356	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511358	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Endocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511393	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511397	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Crush injury (3d - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (2d - Recovered/Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Pain in extremity (3d - Not Recovered/Not Resolved - );Varicose vein (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511410	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (23d - Not Recovered/Not Resolved - );Cardiovascular disorder (23d - Not Recovered/Not Resolved - );Cough (23d - Not Recovered/Not Resolved - );Insomnia (23d - Not Recovered/Not Resolved - );Nasopharyngitis (23d - Not Recovered/Not Resolved - );Vomiting (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511412	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Hypersomnia (5d - Recovering/Resolving - );Nasopharyngitis (5d - Recovering/Resolving - );Pyrexia (5d - Recovering/Resolving - );Somnolence (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511414	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Movement disorder (3d - Recovered/Resolved - );Sudden onset of sleep (4d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511416	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511443	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511464	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511465	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511469	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511479	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis psoriasiform (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511480	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511485	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swollen tongue (2d - Not Recovered/Not Resolved - );Tongue blistering (2d - Not Recovered/Not Resolved - );Tongue discomfort (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511493	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (8d - Unknown - );Somnolence (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511497	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coagulopathy (4d - Recovering/Resolving - );Injection site swelling (3d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511501	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Circulatory collapse (0d - Recovered/Resolved - Other Medically Important Condition);Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511508	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Macular degeneration (2d - Recovered/Resolved - Other Medically Important Condition);Visual acuity reduced (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511509	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (64d - Not Recovered/Not Resolved - );Limb discomfort (64d - Recovered/Resolved With Sequelae - );Peripheral swelling (64d - Not Recovered/Not Resolved - );Rheumatic disorder (64d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010511524	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511556	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511558	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (14d - Not Recovered/Not Resolved - );Myositis (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511559	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (1d - Recovering/Resolving - );Musculoskeletal chest pain (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Troponin increased (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511560	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511562	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511573	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (3d - Not Recovered/Not Resolved - );Chest pain (3d - Not Recovered/Not Resolved - );Dyspnoea (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511575	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Recovering/Resolving - );Dyspnoea (0d - Recovering/Resolving - );Fatigue (12d - Not Recovered/Not Resolved - );Influenza (12d - Not Recovered/Not Resolved - );Limb discomfort (12d - Not Recovered/Not Resolved - );Malaise (12d - Not Recovered/Not Resolved - );Myalgia (3d - Recovered/Resolved - );Somnolence (12d - Not Recovered/Not Resolved - );Tachycardia (10d - Not Recovered/Not Resolved - );Tremor (12d - Not Recovered/Not Resolved - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511589	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511596	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Disorientation (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Somnolence (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511597	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511602	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (28d - Not Recovered/Not Resolved - );Joint swelling (28d - Not Recovered/Not Resolved - );Limb discomfort (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511607	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Nausea (49d - Recovered/Resolved - );Vomiting (49d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511614	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (25d - Not Recovered/Not Resolved - );Neck pain (25d - Not Recovered/Not Resolved - );Nuchal rigidity (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511649	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Oropharyngeal pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511660	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Not Recovered/Not Resolved - );Skin discolouration (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511661	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (1d - Unknown - );Rash (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511688	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (44d - Recovering/Resolving - Other Medically Important Condition);Blood pressure increased (44d - Recovering/Resolving - );Nausea (44d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511690	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Hypersensitivity (15d - Unknown - );Limb discomfort (15d - Unknown - );Seasonal allergy (15d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511700	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511702	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Myalgia (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511723	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oral herpes (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511726	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (18d - Not Recovered/Not Resolved - );Fatigue (18d - Not Recovered/Not Resolved - );Limb discomfort (18d - Not Recovered/Not Resolved - );Malaise (18d - Not Recovered/Not Resolved - );Muscle spasms (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511728	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511730	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511731	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (42d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511732	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (6d - Not Recovered/Not Resolved - );Sudden hearing loss (6d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511734	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Recovering/Resolving - );Malaise (10d - Recovering/Resolving - );Pain in extremity (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511743	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Injection site rash (n/a - Recovering/Resolving - );Pyrexia (3d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511752	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (61d - Not Recovered/Not Resolved - );Myalgia (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511754	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010511755	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511757	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (4d - Not Recovered/Not Resolved - );Paraesthesia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511765	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (43d - Recovered/Resolved With Sequelae - );Headache (1d - Not Recovered/Not Resolved - );Hypoaesthesia (44d - Not Recovered/Not Resolved - );Limb discomfort (43d - Not Recovered/Not Resolved - );Paraesthesia (44d - Not Recovered/Not Resolved - );Tinnitus (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010511784	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511785	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511789	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511790	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511798	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511807	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (9d - Recovered/Resolved - );Fatigue (9d - Recovered/Resolved - );Influenza like illness (9d - Recovered/Resolved - );Malaise (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511810	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	C-reactive protein increased (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Upper respiratory tract infection (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511813	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (2d - Not Recovered/Not Resolved - );Dermatitis bullous (1d - Recovering/Resolving - Other Medically Important Condition);Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Rash (1d - Recovering/Resolving - );Throat irritation (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010511823	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Diarrhoea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511833	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Unknown - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511835	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Unknown - );Oropharyngeal pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511842	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511847	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (3d - Not Recovered/Not Resolved - );Pruritus (3d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - );Urticaria (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511896	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511908	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010511909	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Hypoaesthesia (4d - Recovering/Resolving - );Paraesthesia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511930	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Musculoskeletal discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511940	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Sneezing (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511942	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (3d - Recovering/Resolving - );Head discomfort (3d - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511979	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (8d - Unknown - );Somnolence (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010511987	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemihypoaesthesia (12d - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (12d - Recovering/Resolving - );Muscle spasms (12d - Recovering/Resolving - );Myalgia (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010511991	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysphagia (n/a - Unknown - );Throat tightness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010511991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512016	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Nasopharyngitis (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512032	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site discolouration (0d - Recovered/Resolved With Sequelae - );Vaccination site reaction (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010512078	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512082	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (5d - Not Recovered/Not Resolved - );Exercise tolerance decreased (5d - Not Recovered/Not Resolved - );Fatigue (5d - Not Recovered/Not Resolved - );Feeling jittery (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Hyperhidrosis (5d - Not Recovered/Not Resolved - );Injection site pain (5d - Not Recovered/Not Resolved - );Malaise (5d - Not Recovered/Not Resolved - );Movement disorder (5d - Not Recovered/Not Resolved - );Pain in extremity (5d - Not Recovered/Not Resolved - );Palpitations (5d - Not Recovered/Not Resolved - );Tachycardia (5d - Not Recovered/Not Resolved - );Weight bearing difficulty (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512110	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (1d - Unknown - );Fatigue (n/a - Unknown - );Hot flush (1d - Unknown - );Influenza (1d - Unknown - );Malaise (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512129	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (12d - Recovering/Resolving - );Diarrhoea (12d - Recovering/Resolving - );Influenza (12d - Recovering/Resolving - );Myalgia (12d - Recovering/Resolving - );Pain in extremity (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512141	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Malaise (n/a - Unknown - );Nausea (1d - Not Recovered/Not Resolved - );Somnolence (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512174	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512179	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (3d - Not Recovered/Not Resolved - );Pain in extremity (3d - Not Recovered/Not Resolved - );Peripheral swelling (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512182	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paresis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512200	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (87d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Ventricular extrasystoles (87d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010512208	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Performance status decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512233	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010512236	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (82d - Recovered/Resolved - );Vomiting (82d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010512238	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010512245	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512264	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1min - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010512276	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010512277	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (1d - Not Recovered/Not Resolved - );Peripheral swelling (1d - Not Recovered/Not Resolved - );Thirst (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512279	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstruation delayed (20d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512287	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (31d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512297	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512318	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010512346	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (45d - Not Recovered/Not Resolved - );Arrhythmia (45d - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac discomfort (45d - Not Recovered/Not Resolved - );Dizziness (45d - Not Recovered/Not Resolved - );Fatigue (45d - Not Recovered/Not Resolved - );Headache (45d - Not Recovered/Not Resolved - );Malaise (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010512354	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512355	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512389	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (7d - Not Recovered/Not Resolved - );Chills (7d - Not Recovered/Not Resolved - );Diarrhoea (7d - Not Recovered/Not Resolved - );Dizziness (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - );Visual impairment (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512397	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512413	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (8d - Recovering/Resolving - );Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512421	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Myalgia (6d - Not Recovered/Not Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512427	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512452	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512470	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (43d - Recovering/Resolving - );Dysstasia (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Sensory disturbance (n/a - Recovering/Resolving - );Skin ulcer (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512475	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ileus (n/a - Unknown - Other Medically Important Condition);Intestinal ischaemia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010512480	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512491	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512498	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Hypoaesthesia (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512499	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (13d - Not Recovered/Not Resolved - );Rash (14d - Not Recovered/Not Resolved - );Retinal disorder (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512500	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dermatitis allergic (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010512509	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PRADAXA 150 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512543	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512563	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512580	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512586	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abdominal pain lower (n/a - Recovered/Resolved - );Menstruation delayed (n/a - Recovered/Resolved - );Menstruation irregular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512597	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (90d - Unknown - );Skin ulcer (90d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010512599	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (10d - Recovering/Resolving - );Injection site pain (10d - Recovered/Resolved - );Rash (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512612	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512614	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (26d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010512628	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512633	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512646	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Infection (2d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [3y - 2.5mg - Oral])|[FUROSEMIDE] (C - Cardiac failure chronic - n/a - [n/a - 40mg - n/a])|[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - Atrial fibrillation - n/a - [n/a - 2.5mg - Oral])|[SPIRONOLACTONE] (C - Cardiac failure chronic - n/a - [n/a - 25mg - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010512660	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arterial occlusive disease (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512698	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disorientation (113d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Memory impairment (113d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (113d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tremor (113d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512719	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Unknown - Caused/Prolonged Hospitalisation);Renal pain (4d - Unknown - Caused/Prolonged Hospitalisation);Testicular pain (4d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512720	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512721	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood pressure increased (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512747	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Altered state of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation);Brain stem haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Cerebral haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dysphagia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Language disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Mechanical ventilation (7d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512757	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyarthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010512760	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (138d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (138d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512829	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512832	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512834	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Unknown - );Chills (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512835	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512838	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512848	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512892	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hyperhidrosis (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010512897	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune hepatitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Liver function test increased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512899	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood pressure increased (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (31d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512912	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512935	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010512936	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010512946	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Diarrhoea (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Influenza like illness (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Malaise (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Neck pain (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (38d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512953	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Appendicitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512979	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Arthralgia (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Asthenia (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (107d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512981	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (57d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (57d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (57d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010512986	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Increased appetite (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010512986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513000	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513001	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513005	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513008	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513011	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513012	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513018	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Inflammatory marker increased (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Injection site induration (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Liver disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Respiratory distress (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vaccination site reaction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Weight bearing difficulty (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (9d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513055	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic vein thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010513059	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513064	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Breast pain (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513075	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (72d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (72d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513096	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	International normalised ratio decreased (0d - Not Recovered/Not Resolved - );Transient ischaemic attack (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513107	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (42d - Not Recovered/Not Resolved - );Visual impairment (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513131	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513135	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513139	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Malaise (4d - Not Recovered/Not Resolved - );Tension headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513145	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513146	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Status epilepticus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513150	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Auditory disorder (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Parosmia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Psychotic disorder (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sensory disturbance (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sleep disorder (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Toothache (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Visual impairment (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513196	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (1d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513208	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cerebrovascular accident (77d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513217	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure fluctuation (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Presyncope (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513218	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Hypersensitivity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513220	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513231	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513233	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Angina pectoris (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513235	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513246	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (27d - Not Recovered/Not Resolved - );Rash (27d - Not Recovered/Not Resolved - );Rash pruritic (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513252	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513261	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coordination abnormal (143d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Glioblastoma (143d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (143d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513265	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertensive crisis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513271	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Injection site pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Maternal exposure during pregnancy (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Premature labour (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513279	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuritis (63d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513280	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sarcoidosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513283	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Recovering/Resolving - );Vaccination site reaction (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513294	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Fatigue (2d - Recovered/Resolved - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513297	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (0d - Unknown - );Hyposmia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513315	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Middle insomnia (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (5d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513318	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (12d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling hot (15d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (31d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Injection site pain (27d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (36d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (32d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (33d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (12d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (32d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (12d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513320	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Body temperature increased (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza like illness (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513324	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (n/a - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Colitis ischaemic (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Intestinal haemorrhage (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Intestinal ischaemia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513364	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (29d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Back pain (24d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (29d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypotonia (29d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Muscle twitching (29d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (29d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain (24d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Sensory disturbance (24d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Weight bearing difficulty (24d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513396	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Arrhythmia (127d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (6d - Unknown - Caused/Prolonged Hospitalisation);Fatigue (140d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocardial necrosis marker increased (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513424	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Apathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hot flush (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Inflammatory marker increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Night sweats (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sleep disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513426	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513429	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513451	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Unknown - Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation);Cyanosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513460	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Lacrimation increased (n/a - Not Recovered/Not Resolved - );Seasonal allergy (n/a - Not Recovered/Not Resolved - );Sneezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513461	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (7d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (7d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (7d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513494	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest discomfort (25d - Not Recovered/Not Resolved - );Dizziness (25d - Not Recovered/Not Resolved - );Dyspnoea (25d - Not Recovered/Not Resolved - );Fatigue (25d - Not Recovered/Not Resolved - );Hypotonia (25d - Not Recovered/Not Resolved - );Musculoskeletal discomfort (25d - Not Recovered/Not Resolved - );Palpitations (25d - Not Recovered/Not Resolved - );Platelet count abnormal (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513516	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Salivary gland enlargement (1d - Not Recovered/Not Resolved - );Salivary gland pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513518	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (10d - Not Recovered/Not Resolved - );Rash (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513535	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513557	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (8d - Not Recovered/Not Resolved - );Nasopharyngitis (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513562	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Haematoma (0d - Unknown - );Headache (0d - Recovering/Resolving - );Rash (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513567	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (2d - Not Recovered/Not Resolved - );Vaccination site joint movement impairment (2d - Not Recovered/Not Resolved - );Vaccination site swelling (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513577	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513579	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (18d - Recovered/Resolved With Sequelae - );Paraesthesia (18d - Recovered/Resolved With Sequelae - );Vaccination site paraesthesia (18d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010513591	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Constipation (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513618	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010513620	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Keratitis (28d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513625	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (8d - Not Recovered/Not Resolved - Other Medically Important Condition);Oral herpes (8d - Not Recovered/Not Resolved - );Rash (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513641	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Paraesthesia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513648	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Breast pain (38d - Not Recovered/Not Resolved - );Lymphadenopathy (38d - Not Recovered/Not Resolved - );Pain in extremity (38d - Not Recovered/Not Resolved - );Vaccination site pain (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513652	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (29d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513654	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513657	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (42d - Not Recovered/Not Resolved - );Eye pain (42d - Not Recovered/Not Resolved - );Fatigue (42d - Not Recovered/Not Resolved - );Trigeminal nerve disorder (42d - Not Recovered/Not Resolved - );Visual impairment (42d - Not Recovered/Not Resolved - );Visual pathway disorder (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513690	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling cold (55d - Recovering/Resolving - );Paraesthesia (55d - Recovering/Resolving - );Poor peripheral circulation (45d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513704	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (8d - Recovering/Resolving - );Lymphadenopathy (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513705	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bursitis (n/a - Recovered/Resolved - );Cellulitis (n/a - Recovered/Resolved - Other Medically Important Condition);Injection site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513716	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (12d - Unknown - );Pain in extremity (12d - Unknown - );Peripheral swelling (12d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513718	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513727	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513736	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513743	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (5d - Not Recovered/Not Resolved - );Heart rate increased (2d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Painful respiration (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513750	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513752	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (17d - Recovered/Resolved - );Blood pressure increased (17d - Recovered/Resolved - );Disturbance in attention (17d - Recovered/Resolved - );Fatigue (17d - Recovered/Resolved - );Feeling jittery (17d - Recovered/Resolved - );Heart rate increased (17d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513758	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Restlessness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513764	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513791	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Hypoacusis (3d - Recovering/Resolving - );Sudden hearing loss (3d - Recovering/Resolving - Other Medically Important Condition);Tinnitus (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513793	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513800	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Palpitations (3d - Recovering/Resolving - );Pruritus (3d - Recovering/Resolving - );Rash erythematous (3d - Recovering/Resolving - );Sleep disorder (3d - Recovering/Resolving - );Somnolence (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513821	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (12d - Recovered/Resolved - );Dyspnoea (12d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Migraine (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513864	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Recovering/Resolving - );Body temperature increased (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Joint effusion (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513869	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010513872	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513874	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513881	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Prothrombin time prolonged (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010513902	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (33d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513906	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513912	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513916	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513917	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513921	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Local reaction (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513924	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010513932	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513933	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513946	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513947	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Unevaluable event (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513961	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513970	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513972	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513984	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest pain (1d - Unknown - );Dyspnoea (1d - Unknown - );Malaise (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010513993	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (1wk - Recovered/Resolved - );Urticaria (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[LITHIUM] (C - n/a - n/a - )|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010513999	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010513999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514028	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514046	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514051	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Mobility decreased (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514058	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514061	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514062	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514065	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514068	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514071	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514085	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514087	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Head discomfort (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514089	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514114	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Weight decreased (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514119	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (18d - Unknown - Other Medically Important Condition);Disturbance in attention (18d - Unknown - );Memory impairment (18d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514128	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010514132	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Epistaxis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Platelet count decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514146	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (2d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514148	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010514156	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514165	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514167	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514172	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514179	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Heavy menstrual bleeding (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514187	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514190	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514191	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (47d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Restlessness (47d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (47d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514233	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514236	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010514272	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disturbance in attention (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514279	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514305	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Mesenteric vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514317	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dermatitis bullous (4d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514319	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute myocardial infarction (4d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514321	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (2d - Not Recovered/Not Resolved - );Balance disorder (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Hyperacusis (2d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Movement disorder (2d - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - );Nausea (0d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - );Sensorimotor disorder (2d - Not Recovered/Not Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010514324	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	International normalised ratio decreased (0d - Not Recovered/Not Resolved - );Transient ischaemic attack (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514325	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (39d - Not Recovered/Not Resolved - );Cough (39d - Not Recovered/Not Resolved - );Headache (39d - Not Recovered/Not Resolved - );Hypopnoea (39d - Not Recovered/Not Resolved - );Myalgia (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010514348	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Parotid gland enlargement (8d - Recovered/Resolved - );Swelling face (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514353	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (132d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (132d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (132d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia oral (132d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (132d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514388	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514391	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514392	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514395	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514404	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovering/Resolving - Other Medically Important Condition);Confusional state (2d - Not Recovered/Not Resolved - );Memory impairment (2d - Not Recovered/Not Resolved - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514428	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Optic ischaemic neuropathy (14d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010514433	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514445	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (105d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint stiffness (105d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint swelling (105d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (105d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514448	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral artery thrombosis (n/a - Unknown - );Peripheral vein thrombosis (n/a - Unknown - );Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514471	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diplopia (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514473	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514477	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010514481	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Flank pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514489	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514490	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Appendicitis (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514491	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Injection site pain (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vascular pain (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514511	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (24d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (24d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (24d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (24d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514529	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514535	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Decreased appetite (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Epistaxis (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haematuria (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Liver disorder (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Weight decreased (49d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514536	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Movement disorder (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514553	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Presyncope (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	COMTAN [ENTACAPONE] (C - Parkinson's disease - n/a - [n/a - 200mg - n/a])|NEUPRO [ROTIGOTINE] (C - Parkinson's disease - n/a - [n/a - 8mg - Transdermal])|[AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE, AMILORIDE, HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE DIHYDRATE, HYDROCHLOROTHIAZIDE, ANHYDROUS AMILORIDE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 55mg - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - 40mg - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - 250mg - n/a])|[CITALOPRAM, CITALOPRAM HYDROCHLORIDE] (C - Depression - n/a - [n/a - 40mg - n/a])|[CLONAZEPAM] (C - Depression - n/a - [n/a - 2mg - n/a])|[MANIDIPINE DIHYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - 850mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514559	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Swelling face (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514575	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (38d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514578	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Angina pectoris (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514595	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514596	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Multiple sclerosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514597	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Campylobacter gastroenteritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Epstein-Barr virus infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514598	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (245d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pain in extremity (245d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Paraesthesia (245d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514601	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type 1 diabetes mellitus (42d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514602	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myasthenia gravis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514643	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Small fibre neuropathy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514644	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - );Blood pressure increased (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Unknown - );Hypoaesthesia (n/a - Recovering/Resolving - );Hypoaesthesia oral (n/a - Recovering/Resolving - );Malaise (n/a - Unknown - );Pallor (n/a - Recovering/Resolving - );Paraesthesia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination complication (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514648	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Dizziness postural (2d - Recovered/Resolved - Other Medically Important Condition);Insomnia (2d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (4d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514652	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Unknown - );Tendonitis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Oesophagitis - n/a - [n/a - n/a - Oral])|[BRIMONIDINE, BRIMONIDINE TARTRATE] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010514654	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lip oedema (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ANORO ELLIPTA [UMECLIDINIUM BROMIDE, VILANTEROL, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE, UMECLIDINIUM, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLURAZEPAM, FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM MONOHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514669	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514671	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Vertigo positional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514675	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - );Chest discomfort (n/a - Unknown - );Fatigue (n/a - Unknown - );Inflammatory marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Leukocytosis (n/a - Unknown - );Malaise (n/a - Unknown - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Polymyalgia rheumatica (n/a - Unknown - Disabling);Polyneuropathy (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - );Red blood cell sedimentation rate increased (n/a - Unknown - );Vasculitis (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	HUMALOG [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Diabetes mellitus - n/a - [n/a - 100mg - Oral])|JARDIANCE [EMPAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - 25mg - Oral])|LANTUS [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral - More in ICSR])|SHINGRIX [RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E, STIMULON, MONOPHOSPHORYL LIPID A] (C - n/a - n/a - [n/a - .5mL - Intramuscular])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypocholesterolaemia - n/a - [n/a - 10mg - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 1mg - Oral])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 12.5mg - Oral])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - Hypertension - n/a - [n/a - 15mg - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - 1000mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514679	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Epilepsy (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition);Wound (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514682	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514688	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea exertional (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Limb discomfort (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Paraparesis (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Urosepsis (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514695	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (77d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514698	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Neuritis (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Performance status decreased (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vertigo (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (20d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514702	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Splenomegaly (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514709	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Dyspepsia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514724	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514734	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paresis (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemoptysis (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Language disorder (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Monoparesis (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonitis (10d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514770	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal infarct (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514776	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bladder discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514778	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Unknown - Caused/Prolonged Hospitalisation);Palpitations (1d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514781	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Blood pressure increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Performance status decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sense of oppression (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514782	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (48d - Unknown - Caused/Prolonged Hospitalisation);Rash (48d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514788	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Coronary artery dissection (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514812	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514816	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514823	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ANTIHYPERTENSIVUM (BLOEDDRUKVERLAGER) [NOT AVAILABLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|JANUVIA 25 MG FILM-COATED TABLETS [SITAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|METFORMIN HYDROCHLORIDE 1000MG TABLET, ERTUGLIFLOZIN 2.5MG TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|ORAAL ANTIDIABETICUM [NOT AVAILABLE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514825	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514863	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514870	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514877	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514881	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514883	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514884	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dysphoria (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514885	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514888	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010514896	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514901	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514904	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514906	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514908	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514909	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (1d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514912	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514919	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010514948	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blister (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neuralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Unevaluable event (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514963	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral coldness (n/a - Unknown - );Peripheral vascular disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010514967	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Oral allergy syndrome (78d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514973	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lumbosacral radiculopathy (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514974	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling hot (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Joint swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Walking disability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514976	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (0d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514988	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010514992	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (128d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Atrioventricular block complete (128d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Blood glucose increased (8d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (8d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010514992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515006	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (167d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (167d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (167d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (167d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515033	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (1d - Recovering/Resolving - );Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515038	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (0d - Unknown - Caused/Prolonged Hospitalisation);Syncope (0d - Unknown - Caused/Prolonged Hospitalisation);Visual impairment (0d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515044	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Unknown - );Polyneuropathy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010515045	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515062	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515067	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515068	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (83d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (83d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (83d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (74d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515081	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Injection site pain (3d - Not Recovered/Not Resolved - );Pain in extremity (3d - Not Recovered/Not Resolved - );Swelling (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515083	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Head discomfort (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Muscular weakness (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nuchal rigidity (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vertigo (98d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515093	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (49d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010515113	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (120d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombosis (120d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515137	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (16d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster meningitis (16d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (16d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515141	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (100d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Disturbance in attention (100d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral swelling (100d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sleep disorder (100d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515144	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (54d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Medical induction of coma (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vascular stent occlusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515145	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gastrointestinal inflammation (155d - Unknown - Caused/Prolonged Hospitalisation);Vomiting (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515170	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal failure (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515184	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (17d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Portal vein thrombosis (17d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515185	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515199	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515204	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Meningoradiculitis (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (14d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515213	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Unknown - Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Unknown - Caused/Prolonged Hospitalisation);Cyanosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515216	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (1d - Unknown - Caused/Prolonged Hospitalisation);Facial paresis (154d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Language disorder (154d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgia (154d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tongue paralysis (154d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (1d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515221	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515236	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cyanosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Retinal artery occlusion (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515239	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Asthma (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Respiratory distress (74d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Respiratory (inhalation)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515240	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515248	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (42d - Not Recovered/Not Resolved - );Lacrimation increased (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010515263	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515266	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515267	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (114d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Spondylitis (114d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515270	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral venous thrombosis (36d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515281	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (71d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fall (71d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515300	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515301	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumothorax (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515304	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (34d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (34d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515306	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sarcoidosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515322	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Renal failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010515344	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010515351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515354	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (5d - Recovered/Resolved - Disabling);Fatigue (5d - Recovered/Resolved - Disabling);Mobility decreased (5d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010515359	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010515361	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010515373	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (13d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515384	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine with aura (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010515406	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515409	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood creatinine increased (n/a - Unknown - );Bronchospasm (n/a - Unknown - );Cardiac failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cough (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Hypoxia (n/a - Unknown - Other Medically Important Condition);Joint swelling (n/a - Unknown - );Oedema (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation abnormal (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (4015h - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Renal failure (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tachypnoea (n/a - Unknown - );Vasculitis (4015h - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Wheezing (n/a - Unknown - );Wound (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ANORO [UMECLIDINIUM BROMIDE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - 5mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation, Coronary artery disease - n/a - [n/a - n/a - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral - More in ICSR])|[INDAPAMIDE, INDAPAMIDE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral - More in ICSR])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - Coronary artery disease - n/a - [n/a - 60mg - n/a])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - Oral])|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMIN MONOHYDRATE, PERINDOPRIL TERT-BUTYLAMINE] (C - Coronary artery disease - n/a - [n/a - n/a - Oral])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010515410	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diabetic ketoacidosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010515450	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (30d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (30d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515455	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dysphonia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515464	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Type 1 diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515475	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Erythema nodosum (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - );Sarcoidosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515476	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (14d - Recovered/Resolved - Other Medically Important Condition);Muscle disorder (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515480	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pleurisy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary resection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515575	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (131d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (131d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515583	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (7d - Unknown - );Menstrual disorder (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515608	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphangitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515619	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515623	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515631	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Dyspnoea (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Pain in extremity (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515641	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (34d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (34d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Facial paresis (34d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (n/a - Unknown - Caused/Prolonged Hospitalisation);Somnolence (34d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515646	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Cerebrovascular accident (137d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Herpes zoster (137d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Rash (137d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515666	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diplopia (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515685	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic stroke (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515688	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (64d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (64d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (64d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515691	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Palpitations (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Tachycardia (0d - Unknown - );Vaccination site pain (1d - Recovering/Resolving - );Vaccination site reaction (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling cold (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515703	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (9d - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (9d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515734	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in jaw (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515740	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Not Specified	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010515762	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Post herpetic neuralgia (38d - Recovering/Resolving - );Rash (38d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010515764	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Rash (19d - Recovered/Resolved - );Skin discolouration (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515772	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (4d - Unknown - );Rash (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515781	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (4h - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010515791	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515792	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Fatal - Results in Death);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Neoplasm progression (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CASSIA] (C - Constipation - n/a - [n/a - .5g - Oral])|[FAMOTIDINE] (C - Gastric pH decreased - n/a - [n/a - 20mg - Oral])|[LUBIPROSTONE] (C - Constipation - n/a - [n/a - 48ug - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - 990mg - Oral])|[MOSAPRIDE, MOSAPRIDE CITRATE] (C - Abdominal discomfort - n/a - [n/a - 15mg - Oral])|[VALSARTAN] (C - Hypertension - n/a - [n/a - 40mg - Oral])|[ZOLPIDEM TARTRATE] (C - Insomnia - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010515802	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac dysfunction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ejection fraction decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010515821	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515823	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515848	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Groin pain (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515852	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (5d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515887	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515895	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (4d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Vaccination site pruritus (5d - Not Recovered/Not Resolved - );Vaccination site reaction (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515896	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515905	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (9d - Not Recovered/Not Resolved - );Pain (9d - Not Recovered/Not Resolved - );Pyrexia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515912	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Unknown - );Injection site swelling (1d - Recovering/Resolving - );Muscle tightness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515918	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Night sweats (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515924	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515927	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (0d - Recovered/Resolved - );Pruritus (0d - Recovered/Resolved - );Rash (0d - Recovered/Resolved - );Urticaria (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515944	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515958	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010515962	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515963	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010515988	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Insomnia (5d - Not Recovered/Not Resolved - );Restlessness (5d - Not Recovered/Not Resolved - );Tachycardia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010515992	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010515997	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (4d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010515997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516000	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Nervousness (6d - Not Recovered/Not Resolved - );Restlessness (6d - Not Recovered/Not Resolved - );Somnolence (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516025	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516030	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - );Syncope (0d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516066	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516069	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (4d - Not Recovered/Not Resolved - );Breast pain (4d - Not Recovered/Not Resolved - );Chest discomfort (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516071	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Ocular hyperaemia (3d - Recovering/Resolving - );Scleral haemorrhage (3d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516160	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Ear pain (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Nasal congestion (6d - Not Recovered/Not Resolved - );Pustule (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516163	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Disturbance in attention (1d - Recovering/Resolving - );Eczema (3d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Hyperaesthesia (3d - Recovered/Resolved - );Influenza (1d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Pain in extremity (3d - Recovered/Resolved - );Rash (3d - Not Recovered/Not Resolved - );Sluggishness (1d - Recovering/Resolving - );Somnolence (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516194	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516200	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Oropharyngeal pain (1d - Recovered/Resolved - );Restlessness (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516207	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516217	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstrual disorder (n/a - Unknown - );Premenstrual pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516229	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516236	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (42d - Not Recovered/Not Resolved - );Shoulder injury related to vaccine administration (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516239	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516260	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010516264	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonia bacterial (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010516265	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - );Fall (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516280	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516287	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibromyalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010516288	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (7d - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (4d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Malaise (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516302	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516303	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516309	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010516333	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (2d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516346	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (3d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Initial insomnia (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Insomnia (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Middle insomnia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516369	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516382	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovering/Resolving - );Oropharyngeal pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516399	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear infection (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010516452	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry skin (42d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Rash (42d - Recovered/Resolved - );Skin hyperpigmentation (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516453	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (2d - Not Recovered/Not Resolved - );Hyperhidrosis (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - );Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516507	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Epistaxis (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516521	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010516524	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516534	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516545	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (47d - Not Recovered/Not Resolved - );Headache (47d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516583	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes simplex (29d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516585	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Petechiae (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516590	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516594	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516612	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site induration (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516617	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516622	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (4d - Recovered/Resolved - );Flushing (4d - Recovered/Resolved - );Hypersensitivity (4d - Recovered/Resolved - );Swelling face (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516637	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Muscle spasms (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516638	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Orchitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516639	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Unevaluable event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516647	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516649	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Diarrhoea (10d - Recovering/Resolving - );Fatigue (10d - Recovering/Resolving - );Malaise (10d - Recovering/Resolving - );Myalgia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516677	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exposure to vaccinated person (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516689	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (7d - Unknown - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nodule (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516693	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010516695	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516696	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (42d - Recovering/Resolving - );Myalgia (42d - Recovering/Resolving - );Paraesthesia (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516700	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516701	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516762	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved With Sequelae - );Injection site pain (4d - Recovered/Resolved With Sequelae - );Limb discomfort (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010516767	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematochezia (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010516776	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - );Tendon pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516806	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Amnesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516817	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Macular degeneration (2d - Recovered/Resolved - Other Medically Important Condition);Visual acuity reduced (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010516827	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoaesthesia (55d - Not Recovered/Not Resolved - );Ill-defined disorder (55d - Not Recovered/Not Resolved - );Pain in extremity (55d - Not Recovered/Not Resolved - );Paraesthesia (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516838	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516843	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalopathy (14d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010516847	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (28d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010516852	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516873	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peritonitis (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinary tract infection (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010516879	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Deafness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516881	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Parosmia (28d - Not Recovered/Not Resolved - );Sinus pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516886	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune hepatitis (7d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010516892	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Feeling hot (0d - Not Recovered/Not Resolved - );Pruritus (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516893	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Hypotonia (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516896	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperacusis (4d - Not Recovered/Not Resolved - );Tinnitus (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516924	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Unknown - );Myalgia (1d - Unknown - );Nuchal rigidity (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516925	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovering/Resolving - );Breast pain (1d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Hot flush (1d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Pain in extremity (1d - Recovering/Resolving - );Skin burning sensation (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516926	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516944	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516949	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Night sweats (2d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516957	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (23d - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (23d - Not Recovered/Not Resolved - );Dizziness (23d - Not Recovered/Not Resolved - );Drug hypersensitivity (23d - Not Recovered/Not Resolved - );Dyspnoea (23d - Not Recovered/Not Resolved - );Feeling hot (23d - Not Recovered/Not Resolved - );Gastrointestinal pain (23d - Not Recovered/Not Resolved - );Lymphadenopathy (23d - Not Recovered/Not Resolved - );Malaise (23d - Not Recovered/Not Resolved - );Nausea (23d - Not Recovered/Not Resolved - );Oesophagitis (23d - Not Recovered/Not Resolved - );Tachycardia (23d - Not Recovered/Not Resolved - );Visual impairment (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516959	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (44d - Not Recovered/Not Resolved - );Dizziness (44d - Not Recovered/Not Resolved - );Rash (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516961	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010516964	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516965	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthritis (96d - Not Recovered/Not Resolved - );Asthenia (96d - Not Recovered/Not Resolved - );Dizziness (96d - Not Recovered/Not Resolved - );Myalgia (96d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010516975	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Unknown - );Malaise (1d - Unknown - );Nausea (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010516983	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (24d - Unknown - Other Medically Important Condition);Chest pain (23d - Unknown - );Dizziness (24d - Unknown - );Fatigue (23d - Unknown - );Headache (24d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010516999	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Asthma (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010516999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517011	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517015	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Recovered/Resolved - );Prostatitis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517020	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Recovering/Resolving - );Herpes zoster (8d - Recovering/Resolving - );Myalgia (8d - Recovering/Resolving - );Pruritus (8d - Recovering/Resolving - );Pustule (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517042	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (5d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Fatigue (32d - Not Recovered/Not Resolved - );Headache (12d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Spinal pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517049	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Muscle twitching (4d - Recovered/Resolved - );Swelling face (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517065	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517077	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Mood swings (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517081	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Dry throat (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Nasopharyngitis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517085	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517129	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (0d - Recovered/Resolved - );Haematoma (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517158	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517166	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (12d - Unknown - );Pain in extremity (12d - Unknown - );Peripheral swelling (12d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517167	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Seasonal allergy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517171	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Paraesthesia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517175	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517176	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Unknown - );Fatigue (1d - Unknown - );Influenza like illness (1d - Unknown - );Injection site pain (1d - Unknown - );Injection site swelling (1d - Unknown - );Nasopharyngitis (1d - Unknown - );Oropharyngeal pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517186	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517191	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (4d - Not Recovered/Not Resolved - );Injection site swelling (4d - Not Recovered/Not Resolved - );Motor dysfunction (2d - Not Recovered/Not Resolved - );Paraesthesia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517217	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Syncope (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517218	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (14d - Not Recovered/Not Resolved - );Herpes zoster reactivation (14d - Not Recovered/Not Resolved - );Pyrexia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517223	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (1d - Recovered/Resolved - );Blood pressure increased (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517226	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517227	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphonia (48d - Not Recovered/Not Resolved - );Throat clearing (48d - Not Recovered/Not Resolved - );Vocal cord disorder (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010517228	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (13d - Recovering/Resolving - );Head discomfort (13d - Recovering/Resolving - );Headache (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517230	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pruritus (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517244	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Nausea (n/a - Unknown - );Oedema peripheral (n/a - Unknown - );Pain (n/a - Unknown - );Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ACEBUTOLOL, ACEBUTOLOL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 400mg - n/a])|[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - n/a - Unknown - )|[ALLOPURINOL] (C - n/a - Unknown - [n/a - 100mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - Unknown - )|[CITALOPRAM HYDROBROMIDE] (C - n/a - Unknown - )|[FUROSEMIDE] (C - n/a - Unknown - [n/a - 40mg - n/a])|[GLIQUIDONE] (C - n/a - Unknown - )|[PERINDOPRIL ARGININE] (C - n/a - Unknown - [n/a - 5mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - 20mg - n/a])|[ZOLPIDEM TARTRATE] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010517248	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517292	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517296	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517310	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517312	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (5d - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517316	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517323	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517325	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517329	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Not Recovered/Not Resolved - );Injection site pain (4d - Not Recovered/Not Resolved - );Pain in extremity (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517348	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Migraine (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517362	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Typical aura without headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517364	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (0d - Recovered/Resolved - );Body temperature increased (1d - Recovering/Resolving - );Chest discomfort (1d - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Cough (1d - Recovering/Resolving - );Diarrhoea (1d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517388	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517395	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (59d - Not Recovered/Not Resolved - );Tinnitus (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010517398	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Headache (10d - Recovered/Resolved - );Influenza (10d - Recovered/Resolved - );Limb discomfort (10d - Recovered/Resolved - );Nausea (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517417	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Influenza (6d - Unknown - );Nausea (6d - Not Recovered/Not Resolved - );Retching (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517449	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517463	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (63d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517465	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (2d - Recovering/Resolving - );Paraesthesia (2d - Recovering/Resolving - );Peripheral swelling (2d - Recovering/Resolving - );Vaccination site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517466	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517482	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Dizziness (7d - Recovered/Resolved - );Influenza (7d - Recovered/Resolved - );Nausea (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517486	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Device expulsion (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010517489	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (4d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517493	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517517	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Allergy to arthropod sting (10d - Not Recovered/Not Resolved - );Eczema nummular (10d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Rash (10d - Not Recovered/Not Resolved - );Urticaria (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517521	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (2d - Not Recovered/Not Resolved - );Diarrhoea (2d - Not Recovered/Not Resolved - );Flatulence (2d - Not Recovered/Not Resolved - );Gastrointestinal sounds abnormal (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517558	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chest pain (22d - Recovering/Resolving - );Feeling hot (59d - Recovered/Resolved - );Limb discomfort (n/a - Unknown - );Nightmare (22d - Recovering/Resolving - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517561	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517581	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (12d - Not Recovered/Not Resolved - );Cardiovascular disorder (12d - Not Recovered/Not Resolved - );Dizziness (7d - Recovered/Resolved - );Fatigue (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517582	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (18d - Not Recovered/Not Resolved - );Dizziness (18d - Not Recovered/Not Resolved - );Headache (18d - Not Recovered/Not Resolved - );Tachycardia (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517595	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517596	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517602	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual field defect (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517610	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dry mouth (19d - Not Recovered/Not Resolved - );Oral discomfort (19d - Not Recovered/Not Resolved - );Stomatitis (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517629	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (31d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010517642	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Unknown - );Flushing (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517648	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517665	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (33d - Unknown - );Night sweats (33d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010517669	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (11d - Recovering/Resolving - );Fatigue (11d - Recovering/Resolving - );Limb discomfort (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517677	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Hypotonia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517681	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (36d - Not Recovered/Not Resolved - );Disturbance in attention (36d - Not Recovered/Not Resolved - );Headache (36d - Not Recovered/Not Resolved - );Memory impairment (36d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517716	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Not Recovered/Not Resolved - Other Medically Important Condition);Nodal rhythm (0d - Not Recovered/Not Resolved - );Sinus arrest (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517718	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517720	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - );Dyspepsia (n/a - Recovering/Resolving - );Eructation (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517721	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517732	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517738	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010517742	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Recovering/Resolving - );Hypotonia (7d - Recovering/Resolving - );Malaise (7d - Recovering/Resolving - );Pain in extremity (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517747	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517758	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010517797	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood urine present (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517801	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anosmia (5d - Not Recovered/Not Resolved - );Cough (5d - Not Recovered/Not Resolved - );Decreased appetite (3d - Not Recovered/Not Resolved - );Dysphagia (5d - Not Recovered/Not Resolved - );Influenza (5d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Nasopharyngitis (5d - Not Recovered/Not Resolved - );Pharyngitis (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010517805	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (4d - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517807	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (1d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Hyperhidrosis (2d - Not Recovered/Not Resolved - );Injection site pain (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517810	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517815	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517832	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Apathy (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517836	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517842	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impetigo (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517846	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (4d - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure decreased (4d - Not Recovered/Not Resolved - );Dizziness (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Somnolence (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517848	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - );Therapeutic response unexpected (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517850	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517853	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (44d - Not Recovered/Not Resolved - );Fatigue (44d - Not Recovered/Not Resolved - );Headache (44d - Not Recovered/Not Resolved - );Limb discomfort (44d - Not Recovered/Not Resolved - );Localised infection (44d - Not Recovered/Not Resolved - );Myalgia (44d - Not Recovered/Not Resolved - );Pain (44d - Not Recovered/Not Resolved - );Pain in extremity (44d - Not Recovered/Not Resolved - );Peripheral swelling (44d - Not Recovered/Not Resolved - );Pyrexia (44d - Not Recovered/Not Resolved - );Tendon pain (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010517855	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocarditis (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010517856	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517861	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pleuritic pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517864	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010517873	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010517882	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Fall (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Inappropriate schedule of product administration (n/a - Unknown - );International normalised ratio abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Motor dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Seizure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Speech disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010517884	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517886	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010517892	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010517898	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea at rest (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010517903	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Flatulence (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Ileus paralytic (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Myelitis transverse (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - );Paraplegia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pulmonary function test decreased (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Urinary retention (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010517904	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Weight bearing difficulty (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010517905	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute disseminated encephalomyelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of bladder sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myelitis transverse (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensory loss (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urinary incontinence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010517911	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphonia (n/a - Not Recovered/Not Resolved - Disabling);Dysphagia (n/a - Not Recovered/Not Resolved - Disabling);Dysphonia (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Unknown - );Heart rate decreased (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Liver disorder (n/a - Unknown - );Malaise (n/a - Unknown - );Muscle tightness (n/a - Unknown - );Nervous system disorder (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vocal cord disorder (n/a - Not Recovered/Not Resolved - Disabling);Vocal cord paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010517916	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517922	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (1d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517930	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphthous ulcer (32d - Recovered/Resolved - );Tongue discomfort (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010517931	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517934	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Localised infection (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517937	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517948	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Muscle twitching (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517951	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517954	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site swelling (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517956	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (11d - Not Recovered/Not Resolved - );Nasopharyngitis (11d - Not Recovered/Not Resolved - );Sneezing (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517958	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517965	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphagia (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517990	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010517999	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Epistaxis (5d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Haematoma (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010517999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518009	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010518019	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (0d - Recovering/Resolving - );Foreign body sensation in eyes (0d - Recovering/Resolving - );Photophobia (0d - Recovering/Resolving - );Somnolence (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518039	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518045	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abnormal dreams (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Feeling cold (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Sleep disorder (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518053	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Unknown - );Injection site swelling (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518070	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness unilateral (24d - Recovering/Resolving - Other Medically Important Condition);Fatigue (24d - Recovering/Resolving - );Tinnitus (24d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518079	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cough (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nasopharyngitis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518087	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Asthenia (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518097	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518110	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovering/Resolving - );Cardiovascular disorder (2d - Recovering/Resolving - );Dizziness (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Heart rate increased (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Paraesthesia (2d - Recovering/Resolving - );Somnolence (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518112	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (59d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518169	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (25d - Not Recovered/Not Resolved - );Rash (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518178	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Recovering/Resolving - );Headache (6d - Recovering/Resolving - );Somnolence (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518179	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abnormal faeces (36d - Not Recovered/Not Resolved - );Flatulence (36d - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518181	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518183	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - );Nasopharyngitis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518194	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518204	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518208	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Asthma (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518210	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (2d - Recovering/Resolving - );Dizziness (2d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518216	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (25d - Not Recovered/Not Resolved - );Nasopharyngitis (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518241	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Unknown - );Seasonal allergy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518243	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute vestibular syndrome (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Ear pain (2d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Tinnitus (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518252	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518258	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (11d - Recovering/Resolving - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (4d - Recovering/Resolving - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovered/Resolved - );Lymphadenopathy (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518260	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (0d - Unknown - );Lymphadenopathy (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518273	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518277	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518280	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518285	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Intermenstrual bleeding (36d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518293	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Glossitis (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Swollen tongue (1d - Recovered/Resolved - );Vaccination site warmth (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518294	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518296	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovered/Resolved - );Rash (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518297	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (36d - Not Recovered/Not Resolved - );Disturbance in attention (36d - Not Recovered/Not Resolved - );Headache (36d - Not Recovered/Not Resolved - );Memory impairment (36d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518302	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (5d - Recovering/Resolving - );Lymphadenopathy (5d - Recovering/Resolving - );Oropharyngeal pain (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518303	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518315	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518316	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (25d - Recovering/Resolving - );Rash (25d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518324	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518337	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518352	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Vaccination site joint movement impairment (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518353	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (1d - Recovered/Resolved - );Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518354	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Recovering/Resolving - );Hypotonia (7d - Recovering/Resolving - );Limb discomfort (7d - Recovering/Resolving - );Malaise (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518356	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (5d - Recovered/Resolved With Sequelae - );Fatigue (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010518371	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (30d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010518372	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518376	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518390	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518392	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518397	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Muscle spasms (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518403	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cyanosis (0d - Recovered/Resolved - Life Threatening);Dyspnoea (0d - Recovered/Resolved - Life Threatening);Hyperhidrosis (0d - Recovered/Resolved - Life Threatening);Hypotension (0d - Recovered/Resolved - Life Threatening);Pallor (0d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010518409	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle spasms (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518410	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis ulcerative (2d - Recovered/Resolved - Other Medically Important Condition);Rectal haemorrhage (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518411	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Headache (43d - Recovering/Resolving - );Visual impairment (43d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518413	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Recovering/Resolving - );Chills (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518414	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518419	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Oropharyngeal pain (1d - Recovering/Resolving - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518420	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518427	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518431	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Unknown - );Injection site pain (2d - Recovered/Resolved - );Malaise (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518451	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Troponin increased (n/a - Recovered/Resolved - );Ventricular tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518460	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymph node pain (3d - Recovering/Resolving - );Lymphadenopathy (3d - Recovering/Resolving - );Orbital cyst (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010518462	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Dizziness (14d - Recovered/Resolved - );Malaise (14d - Recovered/Resolved - );Paraesthesia (7d - Recovered/Resolved - );Tachycardia (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518465	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010518466	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - );Mental impairment (0d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518479	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010518480	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (9d - Not Recovered/Not Resolved - );Dizziness (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Limb discomfort (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518489	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint stiffness (11d - Recovering/Resolving - );Limb discomfort (11d - Recovering/Resolving - );Myalgia (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518490	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Piloerection (0d - Not Recovered/Not Resolved - );Somnolence (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518495	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518499	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure increased (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518504	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Lymph node pain (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010518510	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (10d - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - );Delirium (10d - Recovered/Resolved - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved - );Loss of personal independence in daily activities (10d - Recovered/Resolved - );Nausea (10d - Recovered/Resolved - );Pain (10d - Recovered/Resolved - );Weight decreased (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Seizure - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - Joint swelling - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Bladder disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010518528	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Recovered/Resolved - Other Medically Important Condition);Liver function test abnormal (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518540	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518541	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518557	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (7d - Not Recovered/Not Resolved - );Dyspnoea (7d - Not Recovered/Not Resolved - );Influenza (7d - Not Recovered/Not Resolved - );Oropharyngeal pain (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518583	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518613	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518624	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Haemangioma (43d - Not Recovered/Not Resolved - );Haemorrhage subcutaneous (43d - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - );Prothrombin time shortened (43d - Not Recovered/Not Resolved - );Pulse abnormal (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518628	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518632	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518633	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Haemangioma (43d - Not Recovered/Not Resolved - );Haemorrhage subcutaneous (43d - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - );Prothrombin time shortened (43d - Not Recovered/Not Resolved - );Pulse abnormal (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518645	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Depressed level of consciousness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Negative thoughts (n/a - Not Recovered/Not Resolved - );Psychiatric symptom (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010518649	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (30d - Not Recovered/Not Resolved - );Headache (30d - Not Recovered/Not Resolved - );Hyperacusis (30d - Not Recovered/Not Resolved - );Hyperaesthesia (30d - Not Recovered/Not Resolved - );Pain in jaw (30d - Not Recovered/Not Resolved - );Toothache (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518661	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypoacusis (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010518673	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518684	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Vision blurred (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518725	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518753	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518758	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518762	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518774	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518845	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518846	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518865	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hordeolum (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518866	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Petechiae (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518867	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518904	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518907	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory level abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518954	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010518957	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Noninfective encephalitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010518958	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518959	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010518969	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Macular oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010518969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519002	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Photosensitivity reaction (0d - Recovered/Resolved - );Sunburn (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519005	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519018	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral mucosal erythema (39d - Not Recovered/Not Resolved - );Oral mucosal exfoliation (39d - Not Recovered/Not Resolved - );Tongue discomfort (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010519022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519030	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519038	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eye irritation (3d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Pain in extremity (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010519051	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519073	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519083	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519116	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (8d - Recovering/Resolving - );Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519118	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519120	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519121	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519126	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519129	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (42d - Recovered/Resolved - );Myalgia (42d - Recovered/Resolved - );Pain in extremity (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010519150	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coronary artery disease (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519161	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519182	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Ataxia (n/a - Not Recovered/Not Resolved - );Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Not Recovered/Not Resolved - );Trigeminal neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519189	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519191	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovering/Resolving - Other Medically Important Condition);Bradycardia (2d - Recovering/Resolving - Other Medically Important Condition);Hypotension (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519194	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Oropharyngeal pain (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519214	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519216	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519222	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - );Ataxia (n/a - Unknown - );Multiple sclerosis relapse (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Performance status decreased (n/a - Unknown - );Trigeminal neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519223	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519226	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Altered state of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Dizziness (0d - Recovered/Resolved - );Illusion (0d - Recovered/Resolved - );Time perception altered (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519227	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hypersensitivity vasculitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519228	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519251	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (2d - Not Recovered/Not Resolved - );Memory impairment (2d - Not Recovered/Not Resolved - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519257	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscle twitching (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgia (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paralysis (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519260	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Altered state of consciousness (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Amnesia (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Anosmia (155d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (123d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519266	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site swelling (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519284	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519285	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Unknown - Caused/Prolonged Hospitalisation);Renal pain (4d - Unknown - Caused/Prolonged Hospitalisation);Testicular pain (4d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519287	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519290	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleurisy (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonitis (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (21d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519306	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Axillary pain (10d - Recovered/Resolved - );Lymphadenopathy (10d - Recovered/Resolved - );Pain (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519322	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (11d - Recovered/Resolved - );Oesophageal spasm (11d - Recovered/Resolved - );Vomiting (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519329	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immune thrombocytopenia (9d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519336	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519337	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519338	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dysgeusia (1d - Recovered/Resolved - );Feeling of body temperature change (1d - Recovered/Resolved - );Hypoaesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519347	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519350	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mobility decreased (119d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Osteonecrosis (119d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519359	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	No adverse event (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519361	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (68d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519378	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Atrioventricular block complete (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Head injury (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ventricular tachycardia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [77d - n/a - n/a])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[PREDNISOLONE] (C - Myalgia - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[WARFARIN SODIUM] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519406	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519409	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519417	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519442	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519444	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chills (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Ocular hyperaemia (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519447	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519452	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519455	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disease progression (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Parkinson's disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519475	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - Dose not changed - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - Dose not changed - [n/a - n/a - n/a])|[PYRIDOSTIGMINE BROMIDE] (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519476	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arterial disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Venous thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	GREPID 75 MG FILM-COATED TABLETS [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519495	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519497	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash macular (n/a - Recovered/Resolved - );Vertigo (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[CARBASALATE CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519519	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling face (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519523	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sinusitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519530	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (n/a - Unknown - );Heavy menstrual bleeding (n/a - Recovered/Resolved - );Injection site pain (n/a - Unknown - );Oligomenorrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519534	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Unevaluable event (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519539	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519542	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519543	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seasonal allergy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519555	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovering/Resolving - Other Medically Important Condition);Reaction to excipient (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling face (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[MACROGOL, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519570	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peroneal nerve palsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519574	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519580	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (60d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (60d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519582	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519585	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519587	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Limb discomfort (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Myalgia (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Nausea (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Rash (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (131d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519612	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519613	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Therapeutic response unexpected (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519620	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atonic seizures (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519625	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Mesenteric vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519657	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Unknown - Caused/Prolonged Hospitalisation);Renal pain (4d - Unknown - Caused/Prolonged Hospitalisation);Testicular pain (4d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519661	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519664	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (16d - Recovered/Resolved - );Intermenstrual bleeding (16d - Recovered/Resolved - );Polymenorrhoea (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519671	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deafness (128d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (128d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519674	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis infective (58d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (58d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Limb discomfort (58d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519677	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (62d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Atrial fibrillation (62d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardioversion (62d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (62d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519680	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519688	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypokalaemia (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (24d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519689	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519712	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Muscle atrophy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519713	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dysuria (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Retching (n/a - Not Recovered/Not Resolved - );Vaccination site joint pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519715	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (11d - Unknown - Other Medically Important Condition);Libido decreased (11d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519721	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Flushing (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519724	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhoids thrombosed (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519726	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519752	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519759	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dysmenorrhoea (4d - Recovering/Resolving - );Vaginal haemorrhage (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519760	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519765	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse event (12d - Not Recovered/Not Resolved - );Pruritus (13d - Not Recovered/Not Resolved - );Retinal disorder (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519770	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010519777	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (n/a - Unknown - Other Medically Important Condition);Partial seizures (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519782	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (54d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010519819	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519821	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Hypersensitivity (19d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519823	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Periarthritis (69d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010519830	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519841	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Red blood cell abnormality (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519845	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519848	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Mental impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519853	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (1min - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (1min - Recovered/Resolved - Other Medically Important Condition);Syncope (1min - Recovered/Resolved - Other Medically Important Condition);Visual impairment (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519862	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain (n/a - Unknown - Other Medically Important Condition);Appendicitis (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519863	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519872	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519874	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Cheilitis (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Cough (n/a - Recovered/Resolved - );Diarrhoea (n/a - Unknown - );Dizziness (n/a - Unknown - );Erythema (n/a - Unknown - Other Medically Important Condition);Flatulence (n/a - Unknown - );Glossitis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Recovering/Resolving - );Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Rash (n/a - Unknown - );Somnolence (n/a - Unknown - );Varicose vein (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519875	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519882	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Erythema (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pruritus (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Urticaria (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519884	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519887	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519898	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519901	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/BRISBANE/60/2008-LIKE VIRUS, A/BRISBANE/59/2007 (H1N1)-LIKE STRAIN (A/BRISBANE/59/2007 REASS. IVR-148), A/BRISBANE/10/2007 (H3N2)-LIKE STRAIN (A/URUGUAY/716/2007 REASS. NYMC X-175C), B/FLORIDA/4/2006-LIKE STRAIN (B/FLORIDA/4/2006), A/NEW CALEDONIA/20/99 (H1N1) - LIKE STRAIN (A/NEW CALEDONIA/20/99 REASS. IVR-116), B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/HIROSHIMA/52/2005 REASS. IVR-142), ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09, ANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS, ANTIGENS OF THE INFLUENZA VIRUS B/WISCONSIN/1/2010-LIKE VIRUS, B/BRISBANE/60/2008-LIKE VIRUS, A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187), A/CALIFORNIA/7/2009 (H1N1)-DERIVED STRAIN USED NYMC X-181, B/MALAYSIA/2506/2004 - LIKE STRAIN (B/MALAYSIA/2506/2004), A/WISCONSIN/67/2005 (H3N2) - LIKE STRAIN (A/WISCONSIN/67/2005 REASS. NYMC X-161-B), A/SOLOMON ISLANDS/3/2006 (H1N1) - LIKE STRAIN (A/SOLOMON ISLANDS/3/2006 REASS. IVR-145), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, CITRIC ACID, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/HONG KONG/2671/2019 (H3N2) - LIKE VIRUS (A/HONG KONG/2671/2019, IVR-208), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/GUANDONG-MAONAN/SWL1536/2019 (H1N1)PDM09-LIKE VIRUS (A/VICTORIA/2454/2019 IVR-207), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, A/SWITZERLAND/9715293/2013 (H3N2)-LIKE STRAIN (A/SWITZERLAND/9715293/2013, NIB-88), B/BRISBANE/9/2014 (WILD TYPE), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/COLORADO/06/2017-LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) (B/MARYLAND/15/2016, NYMC BX-69A), A/BRISBANE/02/2018 (H1N1)PDM09-LIKE VIRUS (A/BRISBANE/02/2018, IVR-190), A/KANSAS/14/2017 (H3N2)-LIKE VIRUS (A/KANSAS/14/2017, NYMC X-327), SQUALENE, SORBITAN TRIOLEATE, POLYSORBATE 80, SODIUM CITRATE, CITRIC ACID ANHYDROUS, B/MASSACHUSETTS/2/2012-LIKE STRAIN USED B/MASSACHUSETTS/2/2012 WILD TYPE, A/TEXAS/50/2012 (H3N2) – DERIVED STRAIN USED (NYMC X-223), SQUALENE, A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181)] (C - Vaccination site bruising - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519902	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010519915	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519917	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519951	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Nasal congestion (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519955	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac death (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010519958	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypoaesthesia (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Monoparesis (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (7d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519959	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	CSF cell count increased (93d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Erectile dysfunction (128d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (105d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (44d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (91d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (93d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (69d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neuralgia (93d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Night sweats (44d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (91d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (93d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vision blurred (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010519981	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Trigeminal palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519983	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Therapeutic response unexpected (38d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010519984	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010519991	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010519994	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Swelling of eyelid (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010519994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520012	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520023	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520041	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520042	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Urinary incontinence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520045	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Not Recovered/Not Resolved - );Oropharyngeal pain (3d - Not Recovered/Not Resolved - );Pain of skin (3d - Not Recovered/Not Resolved - );Somnolence (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520051	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paresis (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520056	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - );Dry mouth (0d - Recovered/Resolved - );Hypersensitivity (0d - Recovered/Resolved - );Oropharyngeal discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520059	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Encephalitis (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520060	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Sudden hearing loss (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520061	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Pain in extremity (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520064	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520068	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520069	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Personality disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520070	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chest discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520074	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520078	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sensory disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520081	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Altered state of consciousness (18d - Unknown - Other Medically Important Condition);Disturbance in attention (18d - Unknown - );Memory impairment (18d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520082	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520085	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Breast pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520086	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Extrasystoles (31d - Not Recovered/Not Resolved - );Heart rate decreased (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520116	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Mobility decreased (176d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal pain (176d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520139	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520141	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520143	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Performance status decreased (3d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520152	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (137d - Unknown - Caused/Prolonged Hospitalisation);Migraine (137d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520174	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (1d - Recovering/Resolving - );Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520179	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520215	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520222	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520232	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (8d - Recovered/Resolved - );Myalgia (8d - Recovered/Resolved - );Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520234	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysphagia (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscular weakness (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myositis (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rhabdomyolysis (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tendonitis (9d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520249	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic shock (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood pressure decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520259	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (73d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (73d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520266	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520304	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520313	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Retinal detachment (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520323	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520324	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Not Recovered/Not Resolved - );Joint swelling (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520326	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520327	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid function disorder (8d - Recovered/Resolved - );Fatigue (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520333	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (2d - Recovered/Resolved - );Memory impairment (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520335	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes virus infection (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520347	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (3d - Recovered/Resolved - );Visual impairment (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520363	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520368	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (10d - Recovered/Resolved - Other Medically Important Condition);Hot flush (10d - Recovered/Resolved - );Injection site pain (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520370	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (19d - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (17d - Not Recovered/Not Resolved - );Myalgia (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520372	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (4d - Recovering/Resolving - );Polymenorrhoea (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520374	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Tremor (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010520377	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Oropharyngeal pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520378	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (2d - Not Recovered/Not Resolved - );Peripheral swelling (2d - Not Recovered/Not Resolved - );Vaccination site joint movement impairment (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520398	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual impairment (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520406	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520423	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apathy (9d - Recovered/Resolved - );Diarrhoea (9d - Recovered/Resolved - );Fatigue (9d - Recovered/Resolved - );Headache (9d - Recovered/Resolved - );Malaise (9d - Recovered/Resolved - );Nausea (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520427	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Hyperhidrosis (1d - Recovering/Resolving - );Insomnia (1d - Recovering/Resolving - );Irritability (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520430	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Night sweats (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520433	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520437	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520440	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520452	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520454	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - );General physical health deterioration (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - );Somnolence (n/a - Unknown - );Swelling (n/a - Recovering/Resolving - );Tenderness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520479	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site joint movement impairment (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520500	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010520567	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520573	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Throat tightness (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520580	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Lethargy (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520583	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520584	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520585	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Haemoptysis (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520587	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520597	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - Other Medically Important Condition);Haemoglobin decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Vaccination site bruising (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520599	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash papular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[TRIMETHOPRIM] (C - Acne - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520603	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520609	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Focal segmental glomerulosclerosis (n/a - Unknown - );Headache (n/a - Unknown - );Hypertensive crisis (n/a - Unknown - Other Medically Important Condition);Nephrotic syndrome (n/a - Unknown - Other Medically Important Condition);Parainfluenzae virus infection (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520613	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520616	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520665	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520709	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - n/a - )|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - )|[ATORVASTATIN CALCIUM, EZETIMIBE, ATORVASTATIN, EZETIMIBE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520733	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (16d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520737	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	COVID-19 pneumonia (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - .3mL - Intramuscular])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - )|SITAGLIPTIN [SITAGLIPTIN] (C - n/a - n/a - )|VIREAD [TENOFOVIR DISOPROXIL, TENOFOVIR DISOPROXIL FUMARATE] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID, D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - )|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - )|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[SULFAMETHOXAZOLE, TRIMETHOPRIM] (C - n/a - n/a - )|[TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - n/a - )|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520739	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])|EVEROLIMUS [EVEROLIMUS] (S - Organ transplant - n/a - [n/a - 1.5mg - Oral])|TACROLIMUS MONOHYDRATE [TACROLIMUS MONOHYDRATE] (S - Organ transplant - n/a - [n/a - 1mg - Oral])|[PREDNISONE] (S - Organ transplant - n/a - [n/a - 5mg - Oral])	VILDAGLIPTIN [VILDAGLIPTIN] (C - n/a - n/a - )|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - )|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520754	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520755	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520774	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520775	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520785	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin oedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520787	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	0-1 Month	Infant	Yes	Male	Metabolic syndrome (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010520792	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Artery dissection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Splenic artery thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Splenic infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520800	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neutropenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520801	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[FENOFIBRATE] (C - Dyslipidaemia - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Migraine - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520808	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520811	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520823	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Disabling);Lacunar stroke (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010520827	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520828	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Meningitis aseptic (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520830	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520831	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (3d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520835	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520842	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arrhythmia supraventricular (n/a - Recovered/Resolved - Other Medically Important Condition);Orchitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520849	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520852	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520853	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520862	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520869	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520874	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [52d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010520881	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[BETAMETHASONE, BETAMETHASONE DIPROPIONATE] (C - n/a - Dose not changed - [n/a - n/a - Cutaneous])|[LITHIUM, LITHIUM GLUCONATE] (C - n/a - Dose not changed - [n/a - n/a - Cutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520892	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Herpes zoster (26d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520905	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea exertional (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520949	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Herpes zoster oticus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520952	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Electrocardiogram T wave inversion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epistaxis (n/a - Not Recovered/Not Resolved - );Haematemesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520957	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Depressed level of consciousness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010520959	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010520964	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (15min - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Cyanosis (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (15min - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010520964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010521011	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Spondylitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521012	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521019	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521030	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Unknown - );Neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521044	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521045	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521046	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Injected limb mobility decreased (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [249d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521054	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521056	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521066	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Uveitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521068	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521077	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site lymphadenopathy (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521083	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (12h - Recovered/Resolved - );Ear pain (12h - Recovered/Resolved - );Headache (3wk - Recovered/Resolved - );Influenza like illness (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521087	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[LOSARTAN POTASSIUM] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521115	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521119	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521123	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521132	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521133	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521137	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (3d - Recovered/Resolved - );Pruritus (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521141	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521160	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521164	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Testicular pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521167	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521174	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521175	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Agitation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521175&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521184	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Musculoskeletal chest pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521185	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute vestibular syndrome (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521189	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521207	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521212	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (S - Product used for unknown indication - Dose not changed - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521220	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521252	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521269	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521326	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Aphasia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521335	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521336	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521337	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521338	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Vaccination failure - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521342	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521348	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[PRAVASTATIN SODIUM] (S - Hypercholesterolaemia - Dose not changed - [n/a - 20mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521352	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521362	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521375	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521376	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521378	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521379	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521383	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521389	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521390	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521397	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521401	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521402	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amyotrophy (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Sensorimotor disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521408	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash erythematous (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521410	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521412	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nausea (1d - Recovered/Resolved - );Urticaria (n/a - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521424	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epstein-Barr virus infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521432	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521432&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521453	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCORTISONE ACETATE, MEFENIDRAMIUM METILSULFATE, LIDOCAINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521455	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521465	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	[CITALOPRAM HYDROBROMIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[LOPRAZOLAM, LOPRAZOLAM MESILATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[LOXAPINE SUCCINATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[TROPATEPINE HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521514	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521517	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521658	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Brachial plexopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010521659	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521660	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune myositis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010521673	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Myalgia (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521691	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Unknown - );Myalgia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521700	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521704	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521708	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521737	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521739	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521741	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521743	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Malaise (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521744	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521745	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (47d - Recovering/Resolving - );Headache (47d - Recovering/Resolving - );Vomiting (47d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521747	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521749	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521750	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (47d - Recovering/Resolving - );Headache (47d - Recovering/Resolving - );Vomiting (47d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521752	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (37d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521753	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521756	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521764	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (11d - Recovering/Resolving - );Feeling hot (11d - Recovering/Resolving - );Headache (12d - Recovering/Resolving - );Influenza (12d - Recovering/Resolving - );Limb discomfort (12d - Recovering/Resolving - );Pyrexia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521779	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Not Recovered/Not Resolved - );Injection site erythema (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521782	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521789	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521791	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521800	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521821	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521830	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Tachycardia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521831	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521837	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521839	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521844	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521853	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521866	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521874	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Recovered/Resolved - );Rash (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521876	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521878	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Tachycardia (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521879	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521881	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521883	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521885	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521887	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521889	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521913	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521921	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521922	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (102d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521926	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521932	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521934	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521937	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521939	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521963	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521964	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521965	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Influenza (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521974	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521975	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010521978	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (25d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010521979	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521980	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010521988	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010521988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522016	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (6d - Recovered/Resolved - );Cough (6d - Recovered/Resolved - );Nasopharyngitis (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522018	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522026	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522030	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522061	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522065	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522073	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (13d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522075	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovered/Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522080	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522105	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522106	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522110	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010522112	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Not Recovered/Not Resolved - );Dizziness (1d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522117	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522120	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522123	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (43d - Recovered/Resolved - );Malaise (43d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522127	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (30d - Not Recovered/Not Resolved - );Dyspnoea (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522128	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522129	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Unknown - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522148	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Formication (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522153	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aneurysm (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010522155	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010522165	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Transient ischaemic attack (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010522169	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010522220	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522223	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522227	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522231	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522232	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522234	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522238	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522241	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (27d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522245	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522247	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522272	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522273	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522289	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522311	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysarthria (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Eyelid sensory disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Loss of personal independence in daily activities (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010522315	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - );Injection site pain (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522320	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (54d - Not Recovered/Not Resolved - );Influenza (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522327	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522328	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (3d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522331	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522333	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522334	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522335	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522338	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522340	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522363	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (4d - Recovering/Resolving - );Fatigue (4d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522368	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Feeling hot (1d - Recovered/Resolved - );Injection site erythema (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - );Myalgia (0d - Recovered/Resolved - );Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522377	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (28d - Recovering/Resolving - );Pain in extremity (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522388	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (20d - Not Recovered/Not Resolved - );Limb discomfort (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522400	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522418	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522420	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (4d - Not Recovered/Not Resolved - );Dizziness (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - );Malaise (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522448	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (42d - Recovered/Resolved - );Headache (42d - Recovered/Resolved - );Injection site pain (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522450	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522454	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - );Limb discomfort (8d - Recovered/Resolved - );Myalgia (8d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Not Recovered/Not Resolved - );Disturbance in attention (4d - Not Recovered/Not Resolved - );Dysuria (4d - Not Recovered/Not Resolved - );Ear pain (4d - Not Recovered/Not Resolved - );Feeling abnormal (4d - Not Recovered/Not Resolved - );Flank pain (4d - Not Recovered/Not Resolved - );Hepatic pain (4d - Not Recovered/Not Resolved - );Influenza (4d - Not Recovered/Not Resolved - );Nausea (4d - Not Recovered/Not Resolved - );Sensitive skin (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522458	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522461	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522464	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Not Recovered/Not Resolved - );Neuralgia (6d - Not Recovered/Not Resolved - );Rash (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522490	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (65d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522491	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (2d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522492	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522494	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522507	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522509	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522511	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522512	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522536	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522538	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522543	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522544	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522545	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522554	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522561	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010522562	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (n/a - Recovered/Resolved - Other Medically Important Condition);Suicidal behaviour (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010522568	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Gait inability (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Inappropriate schedule of product administration (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Sensory loss (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010522592	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522598	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522599	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522607	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (23d - Not Recovered/Not Resolved - );Dyspnoea (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522609	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (15d - Not Recovered/Not Resolved - );Tachycardia (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522614	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522636	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522642	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522643	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522649	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522650	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522651	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522652	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522655	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522659	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522660	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522661	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522679	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522680	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522681	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522684	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (4d - Recovered/Resolved - );Fatigue (5d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Paraesthesia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522689	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522701	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522722	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522729	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522731	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (11d - Not Recovered/Not Resolved - );Vaccination site reaction (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522736	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522738	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522739	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522740	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522744	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522804	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010522806	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010522811	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522827	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522837	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522838	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522839	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522845	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (7d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010522846	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (10d - Recovering/Resolving - );Headache (10d - Recovering/Resolving - );Limb discomfort (10d - Recovering/Resolving - );Myalgia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522850	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522865	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522868	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Hypotonia (1d - Recovered/Resolved - );Muscular weakness (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522871	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522876	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - );Pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522886	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (13d - Not Recovered/Not Resolved - );Muscle tightness (13d - Not Recovered/Not Resolved - );Myalgia (13d - Not Recovered/Not Resolved - );Pain in extremity (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522898	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (10d - Recovering/Resolving - );Insomnia (10d - Recovering/Resolving - );Limb discomfort (11d - Not Recovered/Not Resolved - );Malaise (10d - Recovering/Resolving - );Myalgia (11d - Not Recovered/Not Resolved - );Tachycardia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522904	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Respiratory tract irritation (2d - Recovered/Resolved - );Sleep disorder (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522909	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye inflammation (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522920	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (10d - Not Recovered/Not Resolved - );Rash pruritic (10d - Not Recovered/Not Resolved - );Urticaria (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522959	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522961	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (0d - Recovered/Resolved - );Chills (0d - Recovering/Resolving - );Dyspnoea (0d - Recovered/Resolved - );Feeling hot (0d - Recovering/Resolving - );Hallucination (0d - Recovered/Resolved - );Limb discomfort (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522965	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010522966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypogeusia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010522993	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Sudden hearing loss (12d - Not Recovered/Not Resolved - );Tinnitus (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010522993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523014	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (19d - Not Recovered/Not Resolved - );Arrhythmia (19d - Not Recovered/Not Resolved - );Chest pain (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523036	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depressed mood (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523039	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Unknown - );Eye pain (1d - Recovering/Resolving - );Fatigue (1d - Unknown - );Injection site pain (2d - Recovering/Resolving - );Ocular hyperaemia (1d - Recovering/Resolving - );Swelling of eyelid (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523040	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (21d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523041	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4d - Not Recovered/Not Resolved - );Peripheral swelling (4d - Not Recovered/Not Resolved - );Swelling face (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523051	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cardiovascular disorder (4d - Recovered/Resolved With Sequelae - );Dizziness (4d - Recovered/Resolved With Sequelae - );Fatigue (4d - Recovered/Resolved With Sequelae - );Headache (4d - Recovered/Resolved With Sequelae - );Nausea (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523082	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (17d - Unknown - );Fatigue (17d - Unknown - );Headache (17d - Unknown - );Malaise (17d - Unknown - );Pain in extremity (17d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523086	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523088	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523097	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (35d - Recovering/Resolving - );Dizziness (30d - Recovering/Resolving - );Fatigue (64d - Recovering/Resolving - );Injection site pain (65d - Recovered/Resolved - );Insomnia (3d - Recovered/Resolved - );Limb discomfort (35d - Recovering/Resolving - );Lymphadenopathy (37d - Not Recovered/Not Resolved - );Malaise (41d - Recovering/Resolving - );Myalgia (35d - Recovering/Resolving - );Pain in extremity (35d - Recovering/Resolving - );Paraesthesia (35d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010523128	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523139	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - );Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - );Paraesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523146	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes simplex (30d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010523157	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523180	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523187	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523192	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (13d - Recovered/Resolved - );Limb discomfort (13d - Recovered/Resolved - );Pain in extremity (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523198	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (12d - Recovering/Resolving - );Myalgia (12d - Recovering/Resolving - );Rash (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523201	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523204	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523242	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (12h - Recovering/Resolving - Other Medically Important Condition);Dysgeusia (12h - Recovering/Resolving - );Pain in extremity (12h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523250	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Recovered/Resolved With Sequelae - );Hypoaesthesia (10d - Recovered/Resolved With Sequelae - );Paraesthesia (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523252	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523258	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis bullous (2d - Not Recovered/Not Resolved - );Influenza like illness (2d - Not Recovered/Not Resolved - );Rash (2d - Not Recovered/Not Resolved - );Skin discolouration (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523263	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523267	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear swelling (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Eye swelling (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - );Tongue discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523271	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	RIVASTIGMINE [RIVASTIGMINE, RIVASTIGMINE HYDROGEN TARTRATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Transdermal])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010523288	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal pain (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523293	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Diarrhoea (1d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523295	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hereditary motor and sensory neuropathy (7d - Recovered/Resolved With Sequelae - );Loss of control of legs (7d - Recovered/Resolved With Sequelae - );Myalgia (7d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523300	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Tinnitus (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523301	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (5d - Recovering/Resolving - );Hypertension (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523317	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523331	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (27d - Recovering/Resolving - );Rash (27d - Recovering/Resolving - );Sarcoidosis (27d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010523339	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Renal pain (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - );Malaise (0d - Not Recovered/Not Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523358	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523390	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Iritis (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523393	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - );Vaccination site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523397	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Vaccination site pain (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523434	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523445	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523451	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip oedema (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010523463	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523467	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523469	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Head discomfort (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523476	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523484	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Arrhythmia (5d - Recovered/Resolved - );Atrial fibrillation (5d - Recovered/Resolved - );Hyperthyroidism (5d - Recovered/Resolved - );Pruritus (5d - Recovered/Resolved - );Tachycardia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523487	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (0d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523505	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523506	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (30d - Unknown - );Sensory disturbance (30d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010523509	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Myalgia (6d - Recovering/Resolving - );Palpitations (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523512	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523513	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (5d - Recovering/Resolving - );Dizziness (5d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - );Peripheral vascular disorder (1d - Recovering/Resolving - );Throat tightness (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523519	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523541	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523542	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Seasonal allergy (8d - Recovered/Resolved With Sequelae - );Sneezing (8d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523543	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Tachycardia (39d - Not Recovered/Not Resolved - );Tinnitus (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523554	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (69d - Not Recovered/Not Resolved - );Headache (69d - Recovered/Resolved With Sequelae - );Malaise (69d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010523564	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rash (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523573	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Middle ear inflammation (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523578	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thirst (16d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523580	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Rhinorrhoea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523583	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (18d - Not Recovered/Not Resolved - );Bone pain (18d - Not Recovered/Not Resolved - );Fatigue (18d - Not Recovered/Not Resolved - );General physical health deterioration (18d - Not Recovered/Not Resolved - );Limb discomfort (18d - Not Recovered/Not Resolved - );Myalgia (18d - Not Recovered/Not Resolved - );Somnolence (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523589	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - );Muscle spasms (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523590	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (31d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010523591	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523592	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (1d - Unknown - );Photophobia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523653	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523690	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523720	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Metastases to lymph nodes (n/a - Recovering/Resolving - );Night sweats (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523730	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523732	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523735	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Gastrointestinal disorder (4d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Pyrexia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523749	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010523751	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010523758	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - );Pain in jaw (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523773	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523778	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523791	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Drug ineffective (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523794	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (18d - Recovered/Resolved - Life Threatening);Subarachnoid haemorrhage (n/a - Unknown - Life Threatening);Vomiting (3d - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010523798	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010523818	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tricuspid valve incompetence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010523822	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523825	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523826	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523838	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523868	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (11d - Recovered/Resolved - );Rash (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523873	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523883	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site oedema (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523889	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523903	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523924	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010523925	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Lymphadenitis (n/a - Recovering/Resolving - );Lymphangitis (n/a - Recovering/Resolving - );Lymphoedema (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523928	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry eye (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Ocular discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523937	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Diarrhoea (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pain in extremity (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523955	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Contusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010523968	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Demyelinating polyneuropathy (n/a - Unknown - Other Medically Important Condition);Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010523978	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (3d - Recovered/Resolved - Disabling);Pyrexia (1d - Recovered/Resolved - Disabling);Somnolence (1d - Recovered/Resolved - Disabling);Vaccination site pain (4d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010523991	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (7d - Unknown - );Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523992	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Feeling hot (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523993	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523995	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Recovered/Resolved - );Performance status decreased (14d - Recovered/Resolved - );Pre-existing condition improved (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010523999	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (4d - Recovering/Resolving - );Influenza (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010523999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524017	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [38d - .3mL - Intramuscular])	FEBUXOSTAT [FEBUXOSTAT] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|LEVODOPA [LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - Oral])|RASAGILINE [RASAGILINE, RASAGILINE TARTRATE] (C - Parkinson's disease - n/a - [n/a - n/a - Oral])|[HYDROXYCHLOROQUINE SULFATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[PREDNISOLONE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[SULFASALAZINE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Parkinson's disease - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010524020	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Vasculitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	EXFORGE [VALSARTAN, AMLODIPINE, VALSARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[CARVEDILOL] (C - Hypertension - n/a - [n/a - .5{DF} - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010524025	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524042	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [3y - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [8y - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - n/a - n/a - [560d - n/a - n/a])|[CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM), COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [3y - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [560d - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [784d - n/a - n/a])|[LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MESALAZINE] (C - n/a - n/a - [3y - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [4y - n/a - n/a])|[PRAVASTATIN SODIUM] (C - n/a - n/a - [550d - n/a - n/a])|[RETINOL PALMITATE] (C - n/a - n/a - [224d - n/a - n/a])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [3y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524055	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (26d - Not Recovered/Not Resolved - );Hyperhidrosis (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010524068	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Unknown - );Rash pruritic (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524071	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524087	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524097	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524102	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Visual impairment (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524109	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524110	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - );Tinnitus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010524121	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );No adverse event (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Vaccination site movement impairment (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524126	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - );Toothache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524151	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524158	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (2mo - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010524173	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cutaneous vasculitis (n/a - Unknown - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (3d - Recovered/Resolved - Other Medically Important Condition);Somnolence (1d - Recovered/Resolved - Other Medically Important Condition);Taste disorder (3d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - 1{DF} - Intramuscular])	ISENTRESS [RALTEGRAVIR, RALTEGRAVIR POTASSIUM] (C - HIV infection - n/a - [n/a - n/a - n/a])|TRUVADA [EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE] (C - HIV infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010524188	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524194	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524201	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010524202	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - );Limb discomfort (9d - Not Recovered/Not Resolved - );Malaise (9d - Not Recovered/Not Resolved - );Muscle discomfort (9d - Not Recovered/Not Resolved - );Muscle spasms (9d - Not Recovered/Not Resolved - );Somnolence (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524232	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (12h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524246	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524247	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524249	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524255	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes ophthalmic (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524274	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524297	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524301	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524316	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (7d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524318	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (39d - Not Recovered/Not Resolved - );Chills (39d - Not Recovered/Not Resolved - );Cough (39d - Not Recovered/Not Resolved - );Tachycardia (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524322	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524332	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Diarrhoea haemorrhagic (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524346	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524354	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (15d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	HYDROCHLOROTHIAZIDE, TELMISARTAN [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|HYDROXYCARBAMIDE [HYDROXYCARBAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010524362	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524372	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatic enzyme increased (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524376	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (0d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Tinnitus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524387	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524388	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Hyperhidrosis (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524392	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (68d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010524394	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotonia (10d - Not Recovered/Not Resolved - );Influenza (10d - Not Recovered/Not Resolved - );Muscle discomfort (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524423	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (38d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010524438	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524440	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (10d - Recovering/Resolving - );Heart rate increased (10d - Recovering/Resolving - );Musculoskeletal chest pain (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524443	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524444	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Body temperature increased (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Panic attack (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524446	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524492	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524498	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombophlebitis (3mo - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	AZARGA [BRINZOLAMIDE, TIMOLOL, TIMOLOL MALEATE, BRINZOLAMIDE] (C - Product used for unknown indication - n/a - [n/a - 1{DF} - Ophthalmic])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 5mg - Oral])|[HYDROCHLOROTHIAZIDE, RAMIPRIL] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[LATANOPROST] (C - Product used for unknown indication - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010524512	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (53d - Recovering/Resolving - );Dyspnoea (53d - Recovering/Resolving - );Fatigue (53d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524524	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (8d - Not Recovered/Not Resolved - );Lymphadenopathy (8d - Not Recovered/Not Resolved - );Parotid gland enlargement (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524568	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (3d - Not Recovered/Not Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524583	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - );Influenza like illness (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Oral herpes (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524584	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	C-reactive protein increased (45d - Recovered/Resolved With Sequelae - );Chills (45d - Recovered/Resolved With Sequelae - );Cough (45d - Recovered/Resolved With Sequelae - );Dyspnoea (45d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010524585	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pruritus (36d - Recovering/Resolving - );Rash (36d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010524587	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524588	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524605	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524608	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (3d - Not Recovered/Not Resolved - );Dizziness (3d - Recovering/Resolving - );Dyspnoea (3d - Recovering/Resolving - );Epigastric discomfort (3d - Not Recovered/Not Resolved - );Feeling hot (4d - Not Recovered/Not Resolved - );Hot flush (4d - Not Recovered/Not Resolved - );Hyperhidrosis (4d - Not Recovered/Not Resolved - );Injection site pain (5d - Not Recovered/Not Resolved - );Malaise (5d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - );Pain in extremity (5d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - );Vaccination site movement impairment (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524609	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Illusion (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524615	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524616	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Musculoskeletal discomfort (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524626	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (15d - Not Recovered/Not Resolved - );Dizziness (15d - Not Recovered/Not Resolved - );Headache (15d - Not Recovered/Not Resolved - );Palpitations (15d - Not Recovered/Not Resolved - );Tachycardia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524634	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amaurosis fugax (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Decreased appetite (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Fatigue (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Giant cell arteritis (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Headache (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Intermittent claudication (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Weight decreased (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010524659	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524666	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (1d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524667	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Not Recovered/Not Resolved - );Breast pain (3d - Not Recovered/Not Resolved - );Dysphagia (3d - Recovered/Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Heart rate irregular (3d - Not Recovered/Not Resolved - );Hyperhidrosis (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Pain in extremity (3d - Recovered/Resolved - );Paraesthesia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524701	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Haematochezia (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524730	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Migraine (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524736	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524740	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oral herpes (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524765	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010524768	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pancreatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010524770	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010524784	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010524799	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Eczema (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524816	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Abdominal pain lower (4d - Recovered/Resolved - );Arthralgia (4d - Recovered/Resolved - );Body temperature increased (4d - Recovered/Resolved - );Chills (4d - Recovered/Resolved - );Diarrhoea (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524850	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524852	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524856	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524857	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (4d - Recovering/Resolving - );Rash (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524859	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524870	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure (1min - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dilated cardiomyopathy (1mo - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010524888	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (6d - Recovering/Resolving - );Rash (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524896	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (85d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010524929	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524937	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524938	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5d - Not Recovered/Not Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - );Neck pain (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524969	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524975	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (5d - Not Recovered/Not Resolved - );Paraesthesia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524977	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (10d - Recovered/Resolved - );Migraine (10d - Recovered/Resolved - );Sinusitis (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010524978	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Muscle tightness (4d - Not Recovered/Not Resolved - );Muscle twitching (4d - Not Recovered/Not Resolved - );Tremor (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010524989	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (38d - Not Recovered/Not Resolved - );Influenza (38d - Not Recovered/Not Resolved - );Limb discomfort (38d - Not Recovered/Not Resolved - );Myalgia (38d - Not Recovered/Not Resolved - );Night sweats (38d - Not Recovered/Not Resolved - );Rheumatic disorder (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010524989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010525010	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Listless (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525012	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Hypoaesthesia (16d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Paraesthesia (16d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525018	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (2d - Not Recovered/Not Resolved - );Chills (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525047	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Not Recovered/Not Resolved - );Oedema peripheral (1d - Not Recovered/Not Resolved - );Peripheral swelling (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525077	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palpitations (0d - Recovering/Resolving - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525083	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525086	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Pain in extremity (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525099	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Diarrhoea (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525117	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525124	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (1d - Not Recovered/Not Resolved - );Rash (1d - Not Recovered/Not Resolved - );Rash morbilliform (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525126	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oral herpes (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525160	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Breast pain (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525163	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (32d - Recovering/Resolving - );Injection site pain (32d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010525170	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525174	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525183	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (2d - Recovered/Resolved - );Taste disorder (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525205	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (2d - Not Recovered/Not Resolved - );Gout (2d - Recovering/Resolving - );Joint swelling (2d - Recovering/Resolving - );Pruritus (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - );Urticaria (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525211	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (5d - Recovered/Resolved - );Dizziness (5d - Recovered/Resolved - );Dyspnoea (5d - Recovered/Resolved - );Influenza like illness (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525221	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525221&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525225	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525237	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525241	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525252	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (51d - Not Recovered/Not Resolved - );Fatigue (51d - Not Recovered/Not Resolved - );Hypoaesthesia (51d - Not Recovered/Not Resolved - );Myalgia (51d - Not Recovered/Not Resolved - );Pain in extremity (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010525259	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525263	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Supraventricular extrasystoles (2wk - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ventricular extrasystoles (2wk - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010525278	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastritis (9d - Recovered/Resolved - );Mucosal inflammation (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525280	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Menstruation irregular (n/a - Recovered/Resolved - );Oligomenorrhoea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525285	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovering/Resolving - );Dyspnoea (4d - Not Recovered/Not Resolved - );Fatigue (11d - Recovering/Resolving - );Headache (9d - Recovered/Resolved - );Injection site pain (5d - Not Recovered/Not Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Palpitations (5d - Recovering/Resolving - );Tachycardia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525349	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Encephalitis (n/a - Recovering/Resolving - Life Threatening);Seizure (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - .3mL - Intramuscular])	MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - Unknown - [n/a - 500mg - Oral])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - Unknown - [n/a - 1mg - Oral])|[CARVEDILOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - Unknown - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010525359	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Flushing (0d - Recovered/Resolved - );Peripheral swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525370	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525396	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010525415	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010525426	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Bone pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeding disorder (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[FLUTICASONE PROPIONATE, SALMETEROL] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010525427	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Other Medically Important Condition);Anosmia (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Sensation of foreign body (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010525430	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Nasopharyngitis (1d - Recovering/Resolving - );Paranasal sinus hyposecretion (1d - Recovering/Resolving - );Throat irritation (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525433	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysarthria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525434	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (3d - Unknown - );Headache (3d - Unknown - );Limb discomfort (3d - Unknown - );Nausea (3d - Unknown - );Neck pain (3d - Unknown - );Pyrexia (3d - Unknown - );Somnolence (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525443	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525447	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525453	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - );Injection site pain (3d - Recovering/Resolving - );Myalgia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010525468	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (8d - Not Recovered/Not Resolved - );Dizziness (10d - Not Recovered/Not Resolved - );Fatigue (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525474	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Infection (19d - Recovered/Resolved - );Myalgia (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525477	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525483	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Palpitations (0d - Not Recovered/Not Resolved - );Tachycardia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525484	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525534	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Parkinson's disease (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525541	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Rhinorrhoea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525549	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Not Recovered/Not Resolved - );Feeling hot (6d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525551	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525555	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blindness (0d - Recovered/Resolved - );Feeling hot (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525584	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525620	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (15d - Not Recovered/Not Resolved - );Hypoaesthesia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525623	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Flatulence (1d - Recovered/Resolved - );Gastrointestinal pain (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525625	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525641	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Circulatory collapse (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525644	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depressed mood (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymph node pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525663	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525690	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Mobility decreased (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525699	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Malaise (5d - Recovering/Resolving - );Nausea (4d - Recovered/Resolved - );Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525700	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (3d - Not Recovered/Not Resolved - );Injection site discomfort (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525704	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (5d - Recovering/Resolving - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525711	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010525716	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010525717	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Feeling cold (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010525720	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Iliotibial band syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Infectious disease carrier (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Vertigo positional (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LATANOPROST [LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - 25ug - n/a])|[LISINOPRIL, LISINOPRIL ANHYDROUS, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - .4mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010525727	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Generalised bullous fixed drug eruption (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525730	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525734	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (1d - Not Recovered/Not Resolved - );Cough (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525752	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (11d - Not Recovered/Not Resolved - );Tenderness (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525774	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525778	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525793	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (15d - Recovered/Resolved - );Rash (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525794	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Lip swelling (0d - Recovered/Resolved - );Palpitations (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Paraesthesia oral (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525830	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Swelling face (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525832	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525842	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525844	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Cough (2d - Not Recovered/Not Resolved - );Dizziness (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525869	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (14d - Not Recovered/Not Resolved - );Paraesthesia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525891	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525915	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (3d - Recovering/Resolving - );Chills (3d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Vomiting (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525917	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525934	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - );Influenza (4d - Not Recovered/Not Resolved - );Insomnia (4d - Not Recovered/Not Resolved - );Musculoskeletal chest pain (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525940	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Muscle tightness (1d - Recovering/Resolving - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525956	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (0d - Not Recovered/Not Resolved - );Abnormal faeces (0d - Not Recovered/Not Resolved - );Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Hyperaesthesia (1d - Not Recovered/Not Resolved - );Injection site movement impairment (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525960	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525961	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525972	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010525973	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (11d - Recovering/Resolving - );Influenza (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525978	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (52d - Unknown - );Paraesthesia (52d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010525992	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Abdominal discomfort (0d - Recovering/Resolving - );Abnormal faeces (0d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Feeling cold (1d - Recovering/Resolving - );Mobility decreased (1d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Pain in extremity (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010525995	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (6d - Recovered/Resolved With Sequelae - );Tendon rupture (6d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010525995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010526015	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (15d - Recovering/Resolving - );Panic attack (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526029	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (60d - Recovered/Resolved With Sequelae - );Rheumatic disorder (60d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010526048	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526067	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526082	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Recovered/Resolved With Sequelae - );Breast pain (n/a - Recovered/Resolved With Sequelae - );Cough (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Nausea (n/a - Recovered/Resolved With Sequelae - );Oropharyngeal pain (n/a - Recovered/Resolved With Sequelae - );Pain (n/a - Recovered/Resolved With Sequelae - );Palpitations (n/a - Recovered/Resolved With Sequelae - );Pruritus (n/a - Recovered/Resolved With Sequelae - );Visual impairment (n/a - Recovered/Resolved With Sequelae - );Vomiting (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010526086	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Back pain (1d - Recovered/Resolved - );Headache (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526104	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Panic attack (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526107	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (5d - Recovered/Resolved - );Palpitations (5d - Recovered/Resolved - );Tachycardia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526119	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526126	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (32d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010526127	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (10d - Recovering/Resolving - );Petechiae (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526152	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|PRADAXA 110 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526154	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010526161	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526179	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010526212	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526220	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526229	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pruritus (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526244	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (28d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Insomnia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010526258	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (55d - Not Recovered/Not Resolved - );Fatigue (55d - Not Recovered/Not Resolved - );Headache (55d - Not Recovered/Not Resolved - );Hot flush (55d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovering/Resolving - );Pyrexia (55d - Not Recovered/Not Resolved - );Somnolence (55d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010526276	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526282	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010526296	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cyanosis (13d - Not Recovered/Not Resolved - );Influenza (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526326	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (4d - Fatal - Results in Death);Haematemesis (n/a - Fatal - Results in Death);Vomiting (4d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010526331	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (53d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526335	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (19d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526354	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Vomiting (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526369	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526372	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010526378	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010526381	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lip injury (n/a - Recovered/Resolved - );Syncope (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526388	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526389	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526391	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526400	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (27d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010526402	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dissociation (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526403	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526439	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526471	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526484	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (7d - Not Recovered/Not Resolved - );Diarrhoea (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526504	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526510	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526516	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ear pruritus (n/a - Recovered/Resolved With Sequelae - );Eye pruritus (n/a - Recovered/Resolved With Sequelae - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Recovered/Resolved With Sequelae - );Rash (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010526531	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526541	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526550	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526551	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Influenza (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526554	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526565	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526599	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526603	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (10d - Recovering/Resolving - );Pyrexia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526604	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526612	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Nausea (3d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526613	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526621	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526635	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526647	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526653	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526657	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526663	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Injection site pain (3d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526664	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Influenza (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526672	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526685	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526694	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526695	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526708	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526709	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (5d - Recovering/Resolving - );Influenza (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526710	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526735	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526736	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526741	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (6d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526748	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526749	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526766	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526773	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526777	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526778	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526786	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (3d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - );Injection site swelling (1d - Recovered/Resolved - );Lymphadenopathy (2d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526789	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526790	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526797	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526804	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526827	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Feeling hot (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Nausea (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526829	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (61d - Recovered/Resolved - );Injection site swelling (43d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010526836	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (22d - Unknown - );Fatigue (15d - Unknown - );Malaise (22d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010526838	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526847	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526856	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526862	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526863	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526867	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526872	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526873	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526874	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526876	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526878	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526886	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526887	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526893	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526901	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526907	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526909	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526912	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Not Recovered/Not Resolved - );Dizziness (7d - Not Recovered/Not Resolved - );Fatigue (7d - Not Recovered/Not Resolved - );Headache (7d - Not Recovered/Not Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Malaise (7d - Not Recovered/Not Resolved - );Myalgia (7d - Not Recovered/Not Resolved - );Nausea (7d - Not Recovered/Not Resolved - );Tachycardia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010526921	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526923	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526942	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526944	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526945	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526946	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526952	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526955	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526958	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526959	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526965	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526967	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526970	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526990	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010526991	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Injection site swelling (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010526991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527011	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527013	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527016	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527027	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527035	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527037	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527038	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527041	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (32d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010527044	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527052	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527058	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527061	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527068	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527070	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527074	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527090	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527093	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527128	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527132	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527138	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (3d - Not Recovered/Not Resolved - );Influenza (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527143	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527144	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527147	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - );Feeling hot (6d - Not Recovered/Not Resolved - );Injection site pain (6d - Recovering/Resolving - );Limb discomfort (6d - Recovering/Resolving - );Lymphadenopathy (6d - Recovering/Resolving - );Malaise (6d - Not Recovered/Not Resolved - );Pyrexia (7d - Recovering/Resolving - );Tachycardia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527153	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Vaccination site reaction (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527157	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010527159	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527173	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527177	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527182	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527186	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527187	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527190	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (21d - Recovering/Resolving - );Tachycardia (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527196	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (24d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010527198	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527200	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527206	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527214	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527219	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527220	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527237	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cough (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527244	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527247	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527249	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527255	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527258	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527259	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527264	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527269	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527280	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527282	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527287	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Injection site pain (3d - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527289	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527298	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527313	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527321	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Dyspnoea (30d - Unknown - );Pyrexia (30d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527362	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527366	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovering/Resolving - );Fatigue (5d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Influenza (5d - Recovering/Resolving - );Myalgia (4d - Not Recovered/Not Resolved - );Nausea (3d - Recovered/Resolved - );Rash (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527368	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527370	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527373	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527381	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527386	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527393	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527399	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527406	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527409	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527412	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527414	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527424	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527429	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527445	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Unknown - Life Threatening);Myocardial infarction (1d - Recovered/Resolved With Sequelae - Life Threatening);Skin irritation (n/a - Unknown - Life Threatening);Thrombosis (n/a - Unknown - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010527455	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010527457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527460	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527467	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Not Recovered/Not Resolved - );Glomerulonephritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Unknown - );Protein urine present (n/a - Not Recovered/Not Resolved - );Renal disorder (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010527487	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527495	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527506	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527509	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527510	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527522	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (6d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (6d - Recovered/Resolved - );Nausea (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527534	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527546	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527554	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527555	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527556	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527559	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527571	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527572	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527576	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527580	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010527607	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527612	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527613	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527614	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527615	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527623	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527624	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site erythema (n/a - Unknown - );Injection site pain (n/a - Unknown - );Injection site swelling (n/a - Unknown - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527628	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527630	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527638	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527646	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527647	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527687	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527688	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527697	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527720	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527740	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527753	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010527756	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527763	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527770	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527797	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site erythema (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527798	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (1d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010527810	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527815	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527823	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Influenza (5d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527832	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527836	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (5d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527849	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527863	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527876	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527877	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527887	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527894	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527909	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527917	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527928	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527932	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527941	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Injection site erythema (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Lymphadenopathy (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527951	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527973	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527979	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527983	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site erythema (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Paraesthesia (10d - Recovering/Resolving - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010527987	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010527987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528001	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528002	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528004	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site erythema (7d - Recovered/Resolved - );Injection site pain (8d - Recovered/Resolved - );Injection site swelling (8d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site reaction (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528015	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528017	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528021	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528046	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528070	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528077	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528079	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528084	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528088	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528090	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528091	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528107	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528122	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (0d - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010528162	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528167	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528168	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528184	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528185	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (41d - Not Recovered/Not Resolved - );Fatigue (42d - Not Recovered/Not Resolved - );Injection site pain (11d - Recovered/Resolved - );Paraesthesia (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010528208	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528213	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528216	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528224	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528230	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528255	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site erythema (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528268	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Nausea (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528270	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528275	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528279	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528285	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528290	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (5d - Recovering/Resolving - );Limb discomfort (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528293	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528298	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528324	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (0d - Recovering/Resolving - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528327	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528361	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528364	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (13d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528379	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (4d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528387	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528396	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (23d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528399	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528408	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528430	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528435	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528455	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (43d - Recovered/Resolved - );Myalgia (43d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528459	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovering/Resolving - );Dyspnoea (1d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010528463	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528464	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528470	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovered/Resolved - );Limb discomfort (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528478	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528489	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528490	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528510	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528523	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528537	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Corneal dystrophy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dry eye (n/a - Unknown - );Injury corneal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010528552	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528554	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528581	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010528584	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528586	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528596	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528598	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site erythema (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528615	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528631	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528646	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (42d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528647	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528650	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528654	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528670	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528676	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528677	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528684	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528689	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528704	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010528709	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lethargy (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528711	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528716	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528719	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Nausea (21d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528722	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528723	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528739	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528743	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528747	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (40d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528748	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528761	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528775	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528778	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved With Sequelae - );Feeling hot (0d - Recovered/Resolved - );Headache (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved With Sequelae - );Paraesthesia (0d - Recovered/Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010528788	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528790	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528798	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528807	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528818	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528829	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528830	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528840	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010528853	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (57d - Recovered/Resolved - );Fatigue (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528860	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528863	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528864	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528873	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528875	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528889	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528898	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Unknown - );Injection site pain (42d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010528907	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Malaise (8d - Not Recovered/Not Resolved - );Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010528908	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010528924	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528927	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010528930	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528931	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (1d - Recovered/Resolved - );Lymphadenopathy (2d - Recovering/Resolving - );Muscle tightness (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - );Paraesthesia oral (1d - Recovered/Resolved - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528939	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528959	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528967	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528975	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528982	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528992	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528994	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010528998	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010528998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529004	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529008	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529024	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	SILODOSIN [SILODOSIN] (C - n/a - n/a - [n/a - n/a - Oral])|TRELEGY ELLIPTA [UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - Oral])|[ADENOSINE 5' TRIPHOSPHATE, DISODIUM SALT] (C - Dizziness - n/a - [n/a - n/a - Oral])|[ALLERGENS, POLLEN & PLANT EXTRACT, CERNITIN GBX] (C - n/a - n/a - [n/a - n/a - Oral])|[AMBROXOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ASCORBIC ACID, RIBOFLAVIN, DEXTRIN] (C - Nutritional supplementation - n/a - [n/a - n/a - Oral])|[BETAHISTINE MESILATE] (C - Dizziness - n/a - [n/a - n/a - Oral])|[CILOSTAZOL] (C - n/a - n/a - [n/a - n/a - Oral])|[CLARITHROMYCIN] (C - n/a - n/a - [n/a - n/a - Oral])|[VIBEGRON] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010529035	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529042	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529055	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529057	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529061	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529063	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010529069	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529070	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529080	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Fatal - Results in Death);Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010529115	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529121	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529124	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529128	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Fatigue (1d - Recovering/Resolving - );Injection site swelling (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529134	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529139	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529142	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529147	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529150	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529151	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529155	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529201	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529203	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529213	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529219	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529238	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010529240	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529243	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529244	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529251	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529253	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529256	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529257	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529271	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529275	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529279	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Vaccination site reaction (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529280	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529284	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529298	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529313	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529317	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529322	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (7d - Unknown - );Dizziness (10d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - );Headache (10d - Not Recovered/Not Resolved - );Limb discomfort (5d - Recovered/Resolved - );Malaise (10d - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529324	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010529330	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529344	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529348	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Malaise (2d - Not Recovered/Not Resolved - );Tachycardia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010529355	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529359	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529381	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529385	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (27d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010529386	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (54d - Unknown - );Influenza (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010529398	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529419	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529421	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529425	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529431	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529434	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529438	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529446	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (35d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010529462	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (37d - Not Recovered/Not Resolved - );Headache (4d - Recovering/Resolving - );Injection site pain (30d - Recovered/Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - );Myalgia (4d - Not Recovered/Not Resolved - );Pyrexia (37d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010529468	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529474	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529500	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529505	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (2d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529527	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529536	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529539	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529547	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - );Premenstrual pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529549	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529552	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529555	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529558	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Odynophagia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529584	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529587	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529593	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529594	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529605	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuritis cranial (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pachymeningitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyneuropathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010529607	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529609	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529611	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - );Vaccination site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529615	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529618	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529623	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529625	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529631	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Ataxia (n/a - Unknown - Caused/Prolonged Hospitalisation);Burning sensation (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fear of death (n/a - Unknown - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Painful respiration (n/a - Unknown - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Unknown - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010529643	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529664	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529668	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529686	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - );Rash (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529772	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Injection site erythema (3d - Recovering/Resolving - );Lymphadenopathy (0d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529794	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529798	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529804	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529805	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (8d - Unknown - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529817	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529818	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529822	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529834	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529837	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529872	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Penile oedema (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (7d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombocytopenia (14d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Urinary hesitation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010529878	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529882	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529882&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529886	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529890	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529908	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529920	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529934	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529940	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (4d - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (4d - Recovering/Resolving - );Malaise (3d - Not Recovered/Not Resolved - );Myalgia (3d - Recovering/Resolving - );Nausea (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010529949	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529953	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529962	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529966	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529967	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529979	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010529986	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010529986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530005	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530016	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010530023	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Feeling hot (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530029	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site erythema (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010530037	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530038	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530047	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530053	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530059	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530114	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530119	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530121	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530125	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Injection site pain (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530128	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovering/Resolving - );Influenza (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530129	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530135	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530165	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530170	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Paraesthesia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530172	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530190	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530206	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (4d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530211	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530238	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530247	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (8d - Recovering/Resolving - );Pyrexia (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530248	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (15d - Not Recovered/Not Resolved - );Feeling hot (15d - Not Recovered/Not Resolved - );Headache (15d - Not Recovered/Not Resolved - );Influenza (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530263	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530284	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530285	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530286	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530290	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530296	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530302	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530309	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Injection site pain (7d - Recovering/Resolving - );Lymphadenopathy (7d - Recovering/Resolving - );Malaise (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530311	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (6d - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530312	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530315	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovering/Resolving - );Nausea (4d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530318	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530319	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530323	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530324	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530328	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010530329	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530333	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530348	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530366	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530368	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530379	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530384	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530399	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530406	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Influenza (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530407	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530420	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (3d - Not Recovered/Not Resolved - );Dizziness (3d - Not Recovered/Not Resolved - );Headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010530429	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530436	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530443	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530467	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530481	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530485	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530486	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530539	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530541	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530545	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530549	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530558	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530580	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530591	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530596	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530602	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010530610	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (33d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010530615	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530616	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530623	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530625	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530639	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010530667	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530679	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010530681	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530687	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (2d - Recovered/Resolved - );Fatigue (4d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530698	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010530703	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530733	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530734	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530740	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530746	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530766	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530770	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530789	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovering/Resolving - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530819	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530820	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530826	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530856	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (6d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530869	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530870	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530877	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530878	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530923	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530926	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530928	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530935	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530941	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530952	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530958	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530964	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530976	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530987	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530988	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (41d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010530989	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010530992	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010530992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531004	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531020	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531028	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531039	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531053	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531064	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (8d - Recovering/Resolving - );Limb discomfort (4d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531079	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - );Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531093	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531112	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531114	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531145	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531158	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531168	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010531180	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531194	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Fatigue (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531201	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531231	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	Yes	Not Specified	Congenital central nervous system anomaly (n/a - Fatal - Results in Death, Congenital Anomaly);Foetal exposure during pregnancy (n/a - Unknown - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010531271	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (7d - Not Recovered/Not Resolved - );Rash (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531274	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531282	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531317	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Night sweats (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531325	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531330	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531335	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531343	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531345	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (n/a - Recovered/Resolved - );Peripheral swelling (20min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531347	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site hypoaesthesia (1d - Not Recovered/Not Resolved - );Sensory disturbance (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531352	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531354	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (32d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovering/Resolving - );Limb discomfort (3d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010531357	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531358	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531361	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531369	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531370	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (2d - Recovering/Resolving - );Eye pain (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Periorbital swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531379	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Not Recovered/Not Resolved - );Urticaria (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531381	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Skin exfoliation (n/a - Not Recovered/Not Resolved - );Wound (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531396	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531401	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531414	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531419	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531427	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (12d - Not Recovered/Not Resolved - );Limb discomfort (12d - Not Recovered/Not Resolved - );Myalgia (12d - Not Recovered/Not Resolved - );Pyrexia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531433	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531439	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (12d - Not Recovered/Not Resolved - );Dyspnoea (11d - Recovering/Resolving - );Fatigue (11d - Recovering/Resolving - );Headache (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531450	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531458	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (8d - Recovering/Resolving - );Injection site pain (8d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531459	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531475	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531489	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531494	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (10h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	HIZENTRA 200 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION [HUMAN NORMAL IMMUNOGLOBULIN] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531495	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531499	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Injection site pain (1d - Recovered/Resolved - );Menstrual disorder (n/a - Unknown - );Polymenorrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531500	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (4d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Influenza (5d - Not Recovered/Not Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531505	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Headache (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531513	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531526	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531534	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphonia (n/a - Recovering/Resolving - );Lung carcinoma cell type unspecified stage IV (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SOLIFENACIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010531545	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mesenteric vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Portal vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010531550	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531557	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug eruption (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531557&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010531569	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531573	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531579	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531593	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (4d - Recovering/Resolving - );Nausea (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531596	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010531599	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovering/Resolving - );Fatigue (5d - Recovered/Resolved - );Feeling hot (5d - Recovering/Resolving - );Headache (6d - Recovering/Resolving - );Malaise (5d - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - );Tachycardia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531609	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (49d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010531610	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010531614	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531615	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Recovered/Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531624	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531633	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Not Recovered/Not Resolved - );Malaise (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531636	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531647	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531648	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Herpes zoster (4wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531649	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531666	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531706	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010531714	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531730	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531739	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531744	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531746	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Malaise (7d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531751	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531774	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (15d - Recovered/Resolved - );Headache (15d - Recovered/Resolved - );Myalgia (32d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010531775	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531800	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531808	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (14d - Recovering/Resolving - );Headache (12d - Not Recovered/Not Resolved - );Limb discomfort (3d - Recovered/Resolved - );Nausea (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531812	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531817	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531850	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (7d - Recovered/Resolved - );Vomiting (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531851	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531865	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531866	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531868	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531871	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovering/Resolving - );Influenza (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531873	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531876	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovering/Resolving - );Bone pain (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531889	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531896	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010531900	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (3d - Not Recovered/Not Resolved - );Injection site erythema (2d - Not Recovered/Not Resolved - );Injection site pain (4d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531906	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (3d - Unknown - );Headache (3d - Unknown - );Limb discomfort (3d - Unknown - );Nausea (3d - Unknown - );Neck pain (3d - Unknown - );Pyrexia (3d - Unknown - );Somnolence (3d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531918	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531922	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531928	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531937	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531942	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531952	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531956	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (2d - Recovering/Resolving - );Feeling hot (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531957	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531965	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531970	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Injection site pain (3d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010531985	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010531993	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010531993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532023	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (4d - Not Recovered/Not Resolved - );Myalgia (4d - Not Recovered/Not Resolved - );Pain in extremity (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532030	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010532050	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532052	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (3mo - Not Recovered/Not Resolved - );Joint swelling (3mo - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532095	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532106	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532117	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Headache (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532131	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532132	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532137	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532138	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532141	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Vaccination site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532142	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532161	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - );Cough (2d - Recovered/Resolved - );Fatigue (2d - Recovering/Resolving - );Limb discomfort (4d - Recovered/Resolved - );Vaccination site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532170	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532174	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532182	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532186	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532189	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532191	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532192	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532204	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532206	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532207	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532228	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532237	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532239	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (123d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532243	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532245	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532249	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532259	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site erythema (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532265	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532272	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Trigeminal neuralgia (162d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532275	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010532276	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532282	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532287	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Narcolepsy (12d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532290	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010532294	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Soft tissue infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532307	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532310	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532340	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrioventricular block (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Gout (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010532341	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010532356	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532360	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532361	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532370	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mesenteric vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Portal vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vena cava thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010532380	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MESALAZINE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Colitis ulcerative - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532382	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532385	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532392	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Influenza (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532397	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532407	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532452	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532453	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Influenza (5d - Not Recovered/Not Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532457	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (57d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532464	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532472	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532475	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Limb discomfort (1d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532489	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532490	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532492	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532494	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532505	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532510	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532513	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532516	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Fatigue (5d - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Injection site erythema (5d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532518	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Nausea (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532521	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532522	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532524	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532528	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532543	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Migraine with aura (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Photophobia (n/a - Not Recovered/Not Resolved - );Photopsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010532551	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Photophobia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532552	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532573	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532582	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [22d - 1{DF} - Unknown - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532589	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532611	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532611&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532627	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532631	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532655	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532660	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532665	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532672	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532675	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (10d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532676	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532691	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532694	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532695	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010532699	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dyspnoea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532758	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532765	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Unknown - );Feeling hot (2d - Unknown - );Headache (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532774	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Injection site swelling (5d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532782	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532785	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532802	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532810	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532813	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Influenza (2d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532815	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532829	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532840	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532846	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532848	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Injection site swelling (4d - Recovering/Resolving - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532857	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532859	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532866	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532871	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532878	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532879	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Rash (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010532880	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532883	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532884	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532889	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Unknown - );Headache (1d - Unknown - );Injection site pain (1d - Unknown - );Nausea (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532894	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532895	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532898	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532899	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532901	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532904	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010532906	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (68d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010532913	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (44d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010532925	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532950	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532951	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (25d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010532962	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532973	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (35d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532974	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (0d - Recovering/Resolving - );Chills (2d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Fall (0d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010532976	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532978	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532980	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (140d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010532988	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (4d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532990	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Not Recovered/Not Resolved - );Swelling face (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010532996	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010532996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010533054	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533067	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533077	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533080	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533082	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533083	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533085	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533092	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pleurisy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533104	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - );Headache (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533106	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533111	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010533118	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Visual impairment (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533122	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533123	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533127	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533153	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533169	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533177	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533194	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533225	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533245	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010533256	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533260	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533275	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533316	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Microscopic polyangiitis (n/a - Recovering/Resolving - Other Medically Important Condition);Tenderness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533319	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533348	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (17d - Not Recovered/Not Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533349	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533353	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533362	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533375	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533376	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - );Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533378	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Increased viscosity of upper respiratory secretion (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533380	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533383	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533401	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Dermatitis allergic (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533402	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533404	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533409	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (3d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533417	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Type 1 diabetes mellitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533453	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533470	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010533478	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533536	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Feeling hot (4d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533541	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533542	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533555	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533575	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (2d - Recovering/Resolving - );Injection site erythema (1d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533576	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533582	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533614	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (40d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010533632	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (15d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010533667	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533671	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (21d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Myalgia (14d - Recovered/Resolved - );Paraesthesia (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010533678	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533688	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533694	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533722	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533749	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533750	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533753	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533763	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533765	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Rectal haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010533807	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533821	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Rash (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010533834	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010533835	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyarthritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533839	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010533844	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Memory impairment (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010533847	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eating disorder (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010533852	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (0d - Unknown - );Influenza (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533874	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533878	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533881	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533887	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533904	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (51d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010533905	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533907	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533912	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533913	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (39d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010533925	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (37d - Recovering/Resolving - );Vomiting (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010533930	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533950	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533952	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533964	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533969	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010533975	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010533991	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010533995	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010533995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534002	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534006	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534010	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (0d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534014	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534017	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (4d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534020	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534020&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534022	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534025	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (45d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534033	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534034	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534036	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534042	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010534048	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534050	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534060	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534071	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534073	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (23d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534078	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Headache (9d - Recovered/Resolved - );Limb discomfort (9d - Recovered/Resolved - );Nausea (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534080	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Not Recovered/Not Resolved - );Dyspnoea (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - );Tachycardia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534091	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534095	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534102	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site mass (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534103	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534104	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Myopericarditis (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010534107	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovering/Resolving - );Headache (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534111	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (11d - Not Recovered/Not Resolved - );Dizziness (5d - Not Recovered/Not Resolved - );Dyspnoea (9d - Not Recovered/Not Resolved - );Fatigue (11d - Not Recovered/Not Resolved - );Feeling hot (9d - Not Recovered/Not Resolved - );Headache (6d - Unknown - );Malaise (5d - Not Recovered/Not Resolved - );Myalgia (8d - Not Recovered/Not Resolved - );Vaccination site reaction (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534138	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534141	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534170	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534176	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534179	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534182	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534188	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534190	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534192	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - );Lymphadenopathy (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534193	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (9d - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534199	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534203	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534206	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534225	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Cough (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534260	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534261	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (2d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534268	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chronic obstructive pulmonary disease (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extra dose administered (n/a - Unknown - );Fatigue (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - );Hypoxia (n/a - Recovering/Resolving - Life Threatening, Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza - Not applicable - [1d - n/a - n/a])	[DICLOXACILLIN] (C - Wound treatment - n/a - [n/a - 500mg - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 18mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010534269	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534271	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010534281	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534288	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534294	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534301	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Not Recovered/Not Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - );Pyrexia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534302	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (1d - Unknown - );Malaise (1d - Unknown - );Paraesthesia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534309	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010534323	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Feeling hot (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534332	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010534339	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010534340	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534345	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534351	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534363	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534364	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534365	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral artery embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Cerebral artery thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Monoparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010534371	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534375	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534383	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534385	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534392	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534409	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534417	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534421	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534428	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534430	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534434	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Injection site erythema (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534435	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534438	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (38d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534442	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534444	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534454	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534459	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534464	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534475	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (0d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534476	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534482	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Influenza (3d - Recovering/Resolving - );Malaise (4d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534484	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Cough (0d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534498	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534506	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534510	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010534516	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534521	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (2d - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Recovering/Resolving - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534525	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534533	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534538	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534540	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534550	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534572	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534590	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534595	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534599	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (3d - Not Recovered/Not Resolved - );Dizziness (2d - Recovering/Resolving - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534604	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534606	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534615	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010534630	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Influenza (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534631	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534636	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534637	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534641	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534654	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534656	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534657	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Headache (4d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534658	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534662	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534665	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534692	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534695	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534715	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534721	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534723	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (9d - Not Recovered/Not Resolved - );Feeling hot (9d - Not Recovered/Not Resolved - );Headache (9d - Not Recovered/Not Resolved - );Limb discomfort (9d - Not Recovered/Not Resolved - );Lymphadenopathy (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534751	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Head discomfort (1d - Recovered/Resolved - );Hypotonia (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534767	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534769	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534770	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (1d - Unknown - );Photophobia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534771	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534780	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534781	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534801	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (9d - Recovering/Resolving - );Rash (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534805	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (2d - Not Recovered/Not Resolved - );Neuralgia (2d - Not Recovered/Not Resolved - );Respiratory muscle weakness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534824	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534838	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (30d - Recovering/Resolving - );Gastrointestinal pain (30d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534841	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Rheumatoid nodule (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534876	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Sudden onset of sleep (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534879	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (4d - Recovering/Resolving - );Oropharyngeal pain (4d - Recovering/Resolving - );Productive cough (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534885	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Poor quality sleep (n/a - Recovered/Resolved - );Vaccination site bruising (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN PH. EUR., IBUPROFEN SODIUM, IBUPROFEN SODIUM DIHYDRATE] (C - Headache - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534888	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534906	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534909	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534923	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534924	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010534930	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534964	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (60d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010534967	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cognitive disorder (48h - Unknown - );Fatigue (48h - Unknown - );Fibromyalgia (48h - Unknown - );Pain (48h - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - )|DULOXETINE [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - )|LYRICS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|VALDOXAN [AGOMELATINE] (C - n/a - n/a - )|[ALPRAZOLAM] (C - n/a - n/a - )|[DESOGESTREL] (C - n/a - n/a - )|[ESOMEPRAZOLE, ESOMEPRAZOLE, NAPROXEN, NAPROXEN, NAPROXEN, ESOMEPRAZOLE MAGNESIUM] (C - n/a - n/a - )|[PARACETAMOL] (C - n/a - n/a - )|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010534983	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534985	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534986	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534989	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cyanosis (13d - Not Recovered/Not Resolved - );Influenza (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010534993	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010534999	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010534999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010535006	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Malaise (9d - Not Recovered/Not Resolved - );Nasopharyngitis (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535025	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535026	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blister (39d - Not Recovered/Not Resolved - );Pustule (39d - Not Recovered/Not Resolved - );Rash (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010535042	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Illness (n/a - Recovering/Resolving - );Plasma cell myeloma (n/a - Recovering/Resolving - Other Medically Important Condition);Ventricular extrasystoles (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010535046	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535047	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535048	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535052	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535055	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Headache (4d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (4d - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535058	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535063	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535067	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535089	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (19d - Not Recovered/Not Resolved - );Headache (18d - Not Recovered/Not Resolved - );Injection site erythema (14d - Recovered/Resolved - );Injection site swelling (13d - Recovered/Resolved - );Tachycardia (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010535101	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535103	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535127	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535129	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (27d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010535140	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535146	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiomegaly (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Epiploic appendagitis (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010535162	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535174	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535203	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535211	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovering/Resolving - );Lymphadenopathy (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535237	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535239	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535253	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535256	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535276	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535310	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (6d - Not Recovered/Not Resolved - );Dizziness (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Feeling hot (6d - Not Recovered/Not Resolved - );Headache (6d - Not Recovered/Not Resolved - );Injection site swelling (1d - Recovered/Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Myalgia (6d - Not Recovered/Not Resolved - );Pyrexia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535329	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535333	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535352	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Feeling hot (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535366	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535373	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535390	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535393	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Cough (2d - Not Recovered/Not Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Influenza (2d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535395	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535399	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535403	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535408	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535425	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535436	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535437	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dizziness (9d - Recovered/Resolved - );Nausea (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535440	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535444	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535445	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535454	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Headache (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Recovering/Resolving - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535465	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535476	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535477	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling hot (2d - Not Recovered/Not Resolved - );Headache (0d - Recovering/Resolving - );Influenza (0d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (2d - Not Recovered/Not Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535482	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535484	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535486	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535501	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535502	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535506	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash (8d - Recovering/Resolving - );Tachycardia (4d - Recovered/Resolved - );Vaccination site reaction (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010535513	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535522	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535536	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (43d - Not Recovered/Not Resolved - );Fatigue (43d - Not Recovered/Not Resolved - );Headache (43d - Not Recovered/Not Resolved - );Injection site pain (42d - Recovered/Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - );Paraesthesia (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010535561	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010535562	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535564	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Malaise (2d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535568	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Body temperature increased (1d - Not Recovered/Not Resolved - );Muscular weakness (1d - Not Recovered/Not Resolved - );Musculoskeletal pain (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535573	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (84d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (84d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (57d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (84d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (84d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (84d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535581	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (8d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (16d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (16d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (8d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535588	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535613	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chills (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Injection site pain (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535629	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (26d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Chest discomfort (26d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Somnolence (26d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535637	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535651	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535654	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Incomplete course of vaccination (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010535656	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535658	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535661	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010535665	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535667	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemoptysis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010535671	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (25d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (25d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oedema peripheral (25d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535707	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010535714	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535719	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual acuity reduced (25d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535722	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Renal pain (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535724	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535734	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (9d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535738	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010535739	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (110d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (109d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Weight decreased (69d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535741	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coronary artery stenosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535748	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Vitreous haemorrhage (18d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535753	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010535775	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombosis (0d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535787	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epilepsy (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535794	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nephrotic syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535795	Spontaneous	2021-11-02 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Glomerulonephritis (75d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535815	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010535956	Spontaneous	2021-11-02 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Arrhythmia (n/a - Fatal - Results in Death);Cardiac failure acute (n/a - Fatal - Results in Death);Hypoventilation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Pulmonary oedema (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010535956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010498390	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pulmonary artery thrombosis (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Post-traumatic stress disorder - n/a - [n/a - 50mg - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - 400mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498616	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498704	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Disabling);Chest pain (n/a - Recovered/Resolved - Disabling);Dizziness (n/a - Recovered/Resolved - Disabling);Dyspnoea (n/a - Recovered/Resolved - Disabling);Fatigue (n/a - Recovered/Resolved - Disabling);Heart rate increased (n/a - Recovered/Resolved - Disabling);Myocarditis (n/a - Recovered/Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010498709	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Asthenia (24h - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498729	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010498744	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [83d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498747	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ventricular enlargement (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010498751	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctival haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498759	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498793	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498870	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5d - Recovered/Resolved - );Dyspnoea (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Myositis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010498871	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Ventricular fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010499030	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aneurysm (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|SILODYX 4 MG HARD CAPSULES [SILODOSIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010499080	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ophthalmic vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010499083	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010499109	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Platelet count decreased (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010499274	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010499291	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (7d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (7d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Resuscitation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010499294	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010499435	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Hypertensive crisis (n/a - Unknown - );Panic attack (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010499837	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (1wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010499841	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010499853	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gynaecomastia (101d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Incarcerated umbilical hernia (n/a - Recovering/Resolving - );Mood altered (83d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010499856	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010499857	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diverticulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Gastrointestinal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010499859	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010499864	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Central nervous system inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010499864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010500613	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rhinitis (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010500633	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010500726	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	FIASP [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - 60mL - n/a])|TRESIBA [INSULIN DEGLUDEC] (C - Type 1 diabetes mellitus - n/a - [n/a - 60mL - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010500743	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (S - Product used for unknown indication - Unknown - [n/a - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010500749	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010500753	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Hypoacusis (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [57d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010500821	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling);Weight bearing difficulty (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010500845	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500845&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010500873	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010500888	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hyperkeratosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010500890	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Flank pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Insomnia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Muscular weakness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010500911	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010500996	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - );Swelling face (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010500996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501003	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (11d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010501025	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Muscle twitching (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010501026	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Increased bronchial secretion (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (7d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501029	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal pain (n/a - Not Recovered/Not Resolved - );Gastrointestinal wall thickening (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Varicose vein (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501035	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501071	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501075	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501080	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (4d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010501081	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501098	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501111	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Suspected COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501118	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010501124	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501140	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - )|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010501166	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501172	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	APROVEL 300 MG TABLETS [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501183	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010501186	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Joint swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501193	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (2d - Fatal - Results in Death);Drug ineffective (2d - Fatal - Results in Death);Vaccination failure (2d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010501198	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501238	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Tenderness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501249	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501252	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Nausea (n/a - Unknown - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - )|[COD-LIVER OIL] (C - n/a - n/a - )|[DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[METOCLOPRAMIDE HYDROCHLORIDE] (C - Impaired gastric emptying, Nausea - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - Back pain, Sciatica - n/a - [n/a - n/a - n/a])|[RHODIOLA ROSEA] (C - n/a - n/a - )|[TRAMADOL HYDROCHLORIDE] (C - Back pain, Sciatica - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501259	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501273	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501282	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - );Abdominal pain upper (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Face oedema (n/a - Unknown - );Fatigue (n/a - Unknown - );Insomnia (n/a - Unknown - );Malaise (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - );Night sweats (n/a - Unknown - );Oedema peripheral (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pruritus (n/a - Unknown - );Pyrexia (n/a - Unknown - );Sneezing (n/a - Unknown - );Weight increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID, COLECALCIFEROL, MAGNESIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010501289	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Unknown - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501292	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Hospitalisation (n/a - Unknown - );Varicella (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010501295	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Malaise (n/a - Unknown - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501298	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (66d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501300	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (13d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501301	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Coronary artery stenosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Delirium (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[LEVOTHYROXINE] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501304	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Angioedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Throat irritation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Angina unstable - n/a - [n/a - 75mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501308	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501353	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Scarlet fever (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501372	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501385	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (9d - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[LOSARTAN] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010501386	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010501408	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Feeling drunk (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010501409	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501411	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (48h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501474	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle discomfort (n/a - Not Recovered/Not Resolved - );Muscle strain (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501475	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Vaccination site hypertrophy (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - );Vaccination site warmth (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501476	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[OLMESARTAN MEDOXOMIL, AMLODIPINE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010501480	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501571	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Neck pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501572	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501575	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - );Inner ear disorder (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501584	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501596	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fear of injection (n/a - Recovered/Resolved - );Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Neurosis (n/a - Recovered/Resolved - );Oropharyngeal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Stress (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501620	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (106d - Recovered/Resolved - );Testicular pain (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010501626	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501628	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac dysfunction (15d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Chest pain (15d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (15d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010501636	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diabetes mellitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501719	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Gynaecomastia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|XARELTO 10 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501725	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Exposure during pregnancy (n/a - Unknown - );Trisomy 21 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501744	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diplopia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dysphagia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Ischaemic cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010501765	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (3d - Recovered/Resolved - );Puncture site oedema (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501795	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Contusion (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - );Joint swelling (n/a - Unknown - Disabling);Off label use (n/a - Unknown - );Rash (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010501798	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Altered state of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501805	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Eructation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - );Respiratory distress (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachypnoea (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501807	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysarthria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	TREMFYA [GUSELKUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501816	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501826	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyskinesia (n/a - Recovered/Resolved - );Gaze palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Joint ankylosis (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - Oral])|[POLAPREZINC] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501827	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501829	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Rash (n/a - Recovered/Resolved - );Throat irritation (n/a - Recovered/Resolved - );Type I hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501830	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (19d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Mediastinal mass (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 180ug - Intramuscular])	LINAGLIPTIN [LINAGLIPTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDRALAZINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501831	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Glomerulonephritis (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Pain (n/a - Unknown - );Peripheral swelling (n/a - Recovering/Resolving - );Proteinuria (n/a - Recovering/Resolving - );Thyroid function test abnormal (n/a - Unknown - );Urine abnormality (n/a - Recovering/Resolving - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - .125ug - n/a - More in ICSR])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501832	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LOXOPROFEN] (C - n/a - n/a - [n/a - n/a - Oral])|[REBAMIPIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[URSODEOXYCHOLIC ACID] (C - Cholelithiasis, Hepatic function abnormal - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501833	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest X-ray abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Interstitial lung disease (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (26d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[ETIZOLAM] (C - Tension headache - n/a - [n/a - n/a - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501852	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovering/Resolving - );Vaccination failure (11d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501859	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovering/Resolving - );Haemoglobin decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	BRILIQUE [TICAGRELOR] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501866	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Adverse reaction (n/a - Unknown - );Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - );Genital pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[OMEPRAZOLE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501867	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010501870	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010501887	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501888	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|PROBIOTICS NOS [PROBIOTICS NOS] (C - n/a - n/a - [n/a - n/a - n/a])|TADALAFIL [TADALAFIL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501890	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501900	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (4d - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501905	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501906	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501915	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Unknown - Disabling, Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Psychiatric symptom (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Weight decreased (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010501929	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Inflammation (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Soft tissue infection (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010501939	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Epilepsy (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010501943	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	DUPILUMAB [DUPILUMAB] (C - Eczema - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010501943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010502016	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast pain (n/a - Unknown - Other Medically Important Condition);Breast swelling (7d - Recovered/Resolved - Other Medically Important Condition);Contusion (12d - Recovered/Resolved - Other Medically Important Condition);Dermatitis (n/a - Unknown - Other Medically Important Condition);Erythema (3d - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Pain (7d - Recovered/Resolved - Other Medically Important Condition);Swelling (7d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502017	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pulmonary pain (n/a - Unknown - Other Medically Important Condition);Urinary retention (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE PH. EUR.] (C - Addison's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502028	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Primary headache associated with sexual activity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010502031	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502038	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - );Depression (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate variability increased (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - );Suicidal ideation (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502039	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Weight increased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502041	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502046	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502047	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502054	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Breast tenderness (n/a - Unknown - Other Medically Important Condition);Dysmenorrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502056	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Condition aggravated (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502063	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502066	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Guttate psoriasis (n/a - Unknown - Other Medically Important Condition);Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502082	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - Other Medically Important Condition);Chills (4d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502083	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Dysphonia (n/a - Unknown - Disabling, Other Medically Important Condition);Muscle atrophy (n/a - Unknown - Disabling, Other Medically Important Condition);Musculoskeletal discomfort (n/a - Unknown - Disabling, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Disabling, Other Medically Important Condition);Radiculitis brachial (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010502166	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502167	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502169	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Localised infection (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010502176	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Gender dysphoria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502187	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COVID-19 VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502195	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502200	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Epistaxis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Mast cell activation syndrome - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502202	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling cold (1d - Recovered/Resolved - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Somnolence (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502205	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart rate abnormal - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Heart rate abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502208	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Productive cough (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Prophylaxis - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502216	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502220	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Increased appetite (10d - Recovered/Resolved - Other Medically Important Condition);Lymph node pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Tonsillitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502273	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram ST segment elevation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010502274	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502283	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (0d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502287	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Abdominal distension (n/a - Recovering/Resolving - Other Medically Important Condition);Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Coeliac disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Other Medically Important Condition);Flatulence (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Irritability (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502293	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502301	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502366	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502392	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition)	ENBREL [ETANERCEPT] (S - n/a - Drug withdrawn - [n/a - n/a - Unknown])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502397	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502531	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010502532	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Amnesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Febrile convulsion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nystagmus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rhinitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);SARS-CoV-2 test negative (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Suffocation feeling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010502541	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug eruption (n/a - Unknown - Other Medically Important Condition);Toxic skin eruption (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502546	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502547	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010502560	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Adverse event (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Product administered to patient of inappropriate age (n/a - Unknown - );Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010502570	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010502573	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - Life Threatening);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010502581	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502582	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Psoriasis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010502584	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	HEFIYA [ADALIMUMAB] (C - n/a - n/a - )|[COLECALCIFEROL] (C - n/a - n/a - )|[RISEDRONATE MONOSODIUM, RISEDRONATE SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010502600	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Thalamic infarction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502703	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (2mo - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010502897	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM, OLODATEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010502912	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac failure (n/a - Recovered/Resolved With Sequelae - Disabling);Cellulitis staphylococcal (n/a - Recovered/Resolved With Sequelae - Disabling);Pain in extremity (n/a - Recovered/Resolved With Sequelae - Disabling);Pneumonia (n/a - Recovered/Resolved With Sequelae - Disabling);Skin graft (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010502912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010503348	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010503360	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010503764	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash erythematous (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010503863	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010503887	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anaphylactic shock (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Bronchitis (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Initial insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010503888	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Monoclonal gammopathy (n/a - Unknown - );Waldenstrom's macroglobulinaemia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010503973	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (23d - Recovered/Resolved - Disabling);Dysstasia (n/a - Recovered/Resolved With Sequelae - Disabling);Fatigue (25d - Recovered/Resolved - Disabling);Heart rate increased (n/a - Recovering/Resolving - Disabling);Joint swelling (n/a - Recovering/Resolving - Disabling);Myalgia (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010503981	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010503986	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010503995	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure fluctuation (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Panic reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010503998	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pancreatitis acute (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010503998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010504002	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010504009	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Ligament rupture (n/a - Unknown - Other Medically Important Condition);Muscle strain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (13d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010504019	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait inability (n/a - Unknown - Other Medically Important Condition);Hemiparesis (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - );Viral infection (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	MELATONIN [MELATONIN] (C - Insomnia - n/a - [n/a - n/a - Oral])|PRAMIPEXOLE [PRAMIPEXOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - n/a - [n/a - n/a - Oral])|ZALEPLON [ZALEPLON] (C - Insomnia - n/a - [n/a - 10mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[CLONAZEPAM] (C - Insomnia - n/a - [n/a - n/a - Oral])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[DUTASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[FAMOTIDINE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[GABAPENTIN] (C - Radiculopathy - n/a - [n/a - n/a - Oral])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Radiculopathy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010504036	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010504123	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NON SPECIFIED ANTICOAGULANS [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010504124	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Hyperventilation (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - );Thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010504129	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Unknown - );Vitreous floaters (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010504136	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Heart rate increased (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Periorbital oedema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Speech disorder (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010504376	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthropathy (n/a - Unknown - Disabling);Fatigue (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010504693	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (0d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (0d - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperventilation (n/a - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition);Hyporesponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Recovered/Resolved - Other Medically Important Condition);Physical deconditioning (n/a - Recovered/Resolved - Other Medically Important Condition);Respiratory failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010504693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010505042	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010505062	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010505065	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - );Oral mucosal blistering (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010505069	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ABASAGLAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010505073	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010505088	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505094	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010505122	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tonsillar erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Tonsillitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505181	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505215	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010505255	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Lip swelling (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Skin abrasion (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010505261	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiovascular disorder (2d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Choking sensation (2d - Recovered/Resolved - );Dizziness (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Muscular weakness (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010505263	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010505273	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010505282	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010505413	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Injection site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010505614	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[TOLTERODINE TARTRATE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[TOLTERODINE TARTRATE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505773	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sensitive skin (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505775	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010505782	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Unknown - );Papule (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Unknown - );Skin reaction (n/a - Unknown - );Toxic skin eruption (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505784	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505796	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Epigastric discomfort (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Movement disorder (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Physical deconditioning (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - );Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010505804	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010505805	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010505953	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Painful respiration (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010505953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010506062	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Back pain (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010506433	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	ABASAGLAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])|DESLORATADINE 5 MG - ORODISPERSIBLE TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|TELMISARTAN 80 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010506502	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Poor quality sleep (n/a - Recovering/Resolving - Other Medically Important Condition);Torticollis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010506508	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010506700	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010506709	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010506729	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010506798	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010506805	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasal congestion (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010506981	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (2d - Unknown - );Haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition);Traumatic haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - 1{DF} - n/a])|[OCTOCOG ALFA] (S - n/a - Dose increased - [n/a - 2{DF} - Intravenous (not otherwise specified) - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010506981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010507000	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood creatine phosphokinase MB increased (n/a - Recovering/Resolving - Other Medically Important Condition);C-reactive protein increased (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);N-terminal prohormone brain natriuretic peptide increased (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin I increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010507007	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010507015	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Migraine (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010507027	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arterial occlusive disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - );Bone pain (n/a - Unknown - );Chest pain (n/a - Unknown - );Dysphagia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Enzyme abnormality (n/a - Unknown - );Fatigue (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Imperforate oesophagus (n/a - Unknown - Other Medically Important Condition);Muscle spasms (n/a - Unknown - );Muscular weakness (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Unknown - );Tenderness (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[ALPHA-TOCOPHEROL] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 25mg - n/a])|[BACLOFEN] (C - n/a - n/a - [n/a - 10mg - n/a])|[CIMETIDINE, CIMETIDINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 800mg - n/a])|[CLONAZEPAM] (C - Anxiety - n/a - [n/a - 3g - n/a])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL, CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUCOSAMINE, CHONDROITIN] (C - n/a - n/a - [n/a - n/a - n/a])|[KRILL OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LINSEED OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507031	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dysstasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Gait inability (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Stress (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507086	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Disabling);Enthesopathy (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Unknown - Disabling);Muscular weakness (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010507088	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis allergic - n/a - [n/a - n/a - Nasal])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[CLOBETASOL PROPIONATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[HYDROCORTISONE BUTYRATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[IBUPROFEN] (C - Pain - n/a - [25d - n/a - Oral])|[MIRTAZAPINE] (C - Insomnia - n/a - [n/a - n/a - Oral])|[MOMETASONE FUROATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507097	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	CIRCADIN [MELATONIN] (C - Insomnia - n/a - [n/a - n/a - Oral])|JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Type 2 diabetes mellitus - n/a - [601d - n/a - Oral])|LYRICA [PREGABALIN] (C - Pain - n/a - [n/a - n/a - Oral])|SEEBRI BREEZHALER [GLYCOPYRRONIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[BENZALKONIUM CHLORIDE, HYDROCORTISONE ACETATE, BENZOCAINE, AMYLOCAINE, ESCULIN, BENZALKONIUM CHLORIDE, HYDROCORTISONE ACETATE, BENZOCAINE, ESCULIN, CINCHOCAINE HYDROCHLORIDE, FRAMYCETIN SULFATE, HYDROCORTISONE, CINCHOCAINE HYDROCHLORIDE, FRAMYCETIN SULFATE, HYDROCORTISONE, AESCULUS, CINCHOCAINE HYDROCHLORIDE, FRAMYCETIN SULFATE, HYDROCORTISONE, ESCULIN, CINCHOCAINE HYDROCHLORIDE, FRAMYCETIN, HYDROCORTISONE, ESCULIN, CINCHOCAINE HYDROCHLORIDE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE PH. EUR., CINCHOCAINE HYDROCHLORIDE BP] (C - Haemorrhoids - n/a - [n/a - n/a - Rectal])|[CLOBETASOL PROPIONATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[GABAPENTIN] (C - Pain - n/a - [n/a - n/a - Oral])|[KETOCONAZOLE, KETOCONAZOLE PH. EUR.] (C - Dandruff - n/a - [n/a - n/a - Cutaneous])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - Oral])|[OXYCODONE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[POTASSIUM CHLORIDE] (C - Mineral supplementation - n/a - [n/a - n/a - Oral])|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - Oral])|[PYRIDOXINE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - Vitamin supplementation - n/a - [n/a - n/a - Oral])|[PYRIDOXINE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[TERBUTALINE SULFATE] (C - Bronchospasm - n/a - [n/a - n/a - Respiratory (inhalation)])|[VITAMIN D, CALCIUM] (C - Vitamin supplementation - n/a - [n/a - n/a - Oral])|[VITAMIN D, CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507100	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	ELIQUIS [APIXABAN] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[CARBOMER, CARBOMER 974P] (C - Dry eye - n/a - [n/a - n/a - Subconjunctival])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - Diuretic therapy - n/a - [n/a - n/a - Oral])|[GLYCERYL TRINITRATE, GLYCERYL TRINITRATE SOLUTION] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[POTASSIUM CHLORIDE] (C - Mineral supplementation - n/a - [n/a - n/a - Oral])|[QUININE HYDROCHLORIDE] (C - Muscle spasms - n/a - [n/a - n/a - Oral])|[RAMIPRIL] (C - Cardiac failure - n/a - [n/a - n/a - Oral])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Bronchospasm - n/a - [n/a - n/a - Respiratory (inhalation)])|[SPIRONOLACTONE] (C - Cardiac failure - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507112	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain upper (n/a - Unknown - Caused/Prolonged Hospitalisation);Mesenteric vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507114	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cold sweat (3h - Recovered/Resolved - );Dyspepsia (3h - Recovered/Resolved - );Gastrooesophageal reflux disease (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	INSULATARD FLEXPEN [INSULIN HUMAN, INSULIN HUMAN (RDNA), INSULIN HUMAN ISOPHANE (RDNA)] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|INSUMAN RAPID SOLOSTAR [INSULIN HUMAN] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|TRAJENTA [LINAGLIPTIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|XARELTO [RIVAROXABAN] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypometabolism - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[GLYCERYL TRINITRATE] (C - Chest pain - n/a - [n/a - n/a - n/a])|[OXYCODONE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Diuretic therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507157	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Alopecia areata (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010507244	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[PHENOXYMETHYLPENICILLIN POTASSIUM] (C - Pneumonia - n/a - [n/a - n/a - Oral])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - Oral])|[RAMIPRIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[TERBUTALINE SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[VITAMIN D, CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010507276	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010507289	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Facial pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507296	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	CLOPIDOGREL KRKA [CLOPIDOGREL, CLOPIDOGREL HYDROCHLORIDE] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])|[CYANOCOBALAMIN] (C - Vitamin B12 deficiency - n/a - [n/a - n/a - Oral])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507301	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - Osteoporosis - n/a - [n/a - n/a - n/a])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Dysuria - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010507331	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[FORMOTEROL FUMARATE DIHYDRATE] (C - Lung disorder - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507334	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperglycaemia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[ALLOPURINOL] (C - Gouty arthritis - n/a - [n/a - n/a - Oral])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE, ENALAPRIL, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[KETOCONAZOLE, KETOCONAZOLE PH. EUR.] (C - Dandruff - n/a - [n/a - n/a - Cutaneous])|[MACROGOL 400, OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507335	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	[HYDROCHLOROTHIAZIDE, LOSARTAN] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[LERCANIDIPINE, LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507361	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	AVAMYS [FLUTICASONE FUROATE] (C - Rhinitis allergic - n/a - [n/a - n/a - Nasal])|RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[CLOBETASOL PROPIONATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[HYDROCORTISONE BUTYRATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[MIRTAZAPINE] (C - Insomnia - n/a - [n/a - n/a - Oral])|[MOMETASONE FUROATE] (C - Eczema - n/a - [n/a - n/a - Cutaneous])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507365	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[CLONAZEPAM] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[DIAZEPAM] (C - Muscle spasms - n/a - [n/a - n/a - Rectal])|[DONEPEZIL, DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE, LOSARTAN, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[IBUPROFEN] (C - Myalgia - n/a - [n/a - n/a - Oral])|[LAMOTRIGINE] (C - Epilepsy - n/a - [n/a - n/a - Oral])|[MIANSERIN HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - Oral])|[OXAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - Oral])|[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[VENLAFAXINE] (C - Depression - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507388	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Hyperhidrosis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507405	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - );Temperature difference of extremities (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010507427	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Extra dose administered (n/a - Unknown - );Illness (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - );Photopsia (n/a - Unknown - );Pulmonary congestion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010507428	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Herpes zoster (19d - Recovered/Resolved - );Herpes zoster meningitis (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010507433	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Autonomic nervous system imbalance (n/a - Unknown - Disabling);Illness (n/a - Unknown - );Myocardial injury (n/a - Unknown - Disabling, Other Medically Important Condition);Postural orthostatic tachycardia syndrome (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010507454	Spontaneous	2021-11-01 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Recovered/Resolved - Disabling);White blood cell count decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010507608	Spontaneous	2021-11-01 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010507608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010497504	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Asthenia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497510	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Periorbital swelling (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497564	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (30min - Recovered/Resolved - );Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Injection site reaction (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010497566	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497788	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497853	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497855	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497860	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497861	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497870	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497872	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497879	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497885	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497888	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497896	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497992	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498042	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Skin lesion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498074	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010498082	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498095	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498113	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Phlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [15min - 1{DF} - Intramuscular])	[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498114	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498116	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498117	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Application site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498131	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (28d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010498134	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (2wk - Fatal - Results in Death);Sepsis (2wk - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010498135	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498137	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Haemorrhoids (4d - Recovered/Resolved - );Rectal haemorrhage (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010498141	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (14d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498155	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (8d - Recovered/Resolved - );Decreased appetite (8d - Recovered/Resolved - );Dysphagia (8d - Recovered/Resolved - );Dysphonia (8d - Recovered/Resolved - );Hyperhidrosis (8d - Recovered/Resolved - );Influenza like illness (8d - Recovered/Resolved - );Insomnia (8d - Recovered/Resolved - );Oropharyngeal pain (8d - Recovered/Resolved - );Puncture site pain (8d - Recovered/Resolved - );Rhinorrhoea (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498213	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Unknown - );Myalgia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [21y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498236	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498259	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498267	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498270	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498271	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498274	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498278	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (1mo - Fatal - Results in Death);Sepsis (1mo - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010498279	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498281	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498291	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498292	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498293	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498294	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498298	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010498299	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498305	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498318	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498321	Spontaneous	2021-10-31 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (105d - Recovered/Resolved - );Fatigue (95d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010498329	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498334	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498340	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498341	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498350	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498352	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498356	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498357	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498361	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498364	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010498365	Spontaneous	2021-10-31 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010498365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010494150	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Flushing (n/a - Not Recovered/Not Resolved - );Lip blister (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494154	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Muscle spasms (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494208	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494253	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Balance disorder (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494269	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494301	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494460	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494468	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494537	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Flushing (n/a - Not Recovered/Not Resolved - );Injection site rash (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494545	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494570	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494572	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	KARVEZIDE [HYDROCHLOROTHIAZIDE, IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494600	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (3d - Recovered/Resolved - );Discomfort (3d - Recovered/Resolved - );Hyperhidrosis (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Panic attack (3d - Recovered/Resolved - );Paraesthesia mucosal (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ALPRAZOLAM] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494609	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Catarrh (5d - Recovered/Resolved - );Cough (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494630	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (S - Antiviral prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494646	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494662	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Skin reaction (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ATENOLOL, ATENOLOL BP] (C - Hypertension - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494734	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494736	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site joint pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494825	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494827	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypertensive crisis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Presyncope (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494851	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494860	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia oral (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010494865	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010494869	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Photopsia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual field defect (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vitreous detachment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vitreous floaters (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494881	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494883	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494884	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010494885	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494886	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010494887	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN, EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010494893	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494899	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494901	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494902	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494915	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494921	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494925	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperpyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494929	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494932	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494936	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ecchymosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010494937	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494947	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Glioblastoma (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010494949	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010494951	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010494958	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494958&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494961	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010494963	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - .3mL - Intramuscular])	[METHADONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494968	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494970	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494971	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Disabling);Eye haemorrhage (n/a - Not Recovered/Not Resolved - Disabling);Retinal oedema (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010494973	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010494979	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pneumonitis (24d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010494980	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010494981	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertensive crisis (n/a - Unknown - Caused/Prolonged Hospitalisation);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494984	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010494988	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494989	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchospasm (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Ear infection (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010494990	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010494997	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Blood glucose increased (n/a - Not Recovered/Not Resolved - Disabling);Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - Disabling);Tremor (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010494997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010495001	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dermatitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495008	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010495009	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (0d - Recovered/Resolved - Other Medically Important Condition);Paralysis (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	TYSABRI [NATALIZUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010495016	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010495157	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Insomnia (n/a - Recovered/Resolved With Sequelae - );Malaise (n/a - Recovered/Resolved With Sequelae - );Myalgia (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010495165	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Hyperpyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495166	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495183	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495194	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495206	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])|FLUAD TETRA [B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, BVR-1B), B/WASHINGTON/02/2019-LIKE VIRUS (B/VICTORIA/705/2018 BVR-11), A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/2570/2019, IVR-215), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/CAMBODIA/E0826360/2020 IVR-224), MF59C.1] (S - Influenza immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495212	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	OCRELIZUMAB [OCRELIZUMAB] (C - Multiple sclerosis - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495224	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Joint effusion (n/a - Not Recovered/Not Resolved - Disabling);Oedema (n/a - Not Recovered/Not Resolved - Disabling);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Disabling);Synovitis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Cerebrovascular accident - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - 20mg - n/a])|[FOLIC ACID] (C - Hyperhomocysteinaemia - n/a - [n/a - 5mg - n/a])|[OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010495225	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010495227	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	EUCREAS [METFORMIN HYDROCHLORIDE, VILDAGLIPTIN] (C - Diabetes mellitus - n/a - [n/a - 50mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[ATENOLOL, ATENOLOL BP] (C - Myocardial ischaemia - n/a - [n/a - 25mg - Oral])|[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - 20mg - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010495228	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle contractions involuntary (n/a - Recovering/Resolving - );Muscle twitching (n/a - Recovering/Resolving - );Ocular discomfort (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495231	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010495245	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495246	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495260	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bone pain (5d - Recovered/Resolved - );Diarrhoea (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495266	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495291	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495299	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Life Threatening);Blood pressure increased (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Insomnia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010495302	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495332	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495346	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010495347	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010495348	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Taste disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010495361	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Haemoptysis (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495361&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010495373	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010495391	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495397	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastroenteritis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495402	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis (n/a - Not Recovered/Not Resolved - );Irritable bowel syndrome (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495436	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495451	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|ORTHICA C-1000 SR TABL [NOT AVAILABLE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010495479	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010495493	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPHENIDATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495577	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495615	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495624	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site inflammation (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Injection site warmth (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495650	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Increased upper airway secretion (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495660	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye haemorrhage (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010495683	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose increased (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495713	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495729	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495739	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[MINERALS NOS, VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495759	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495915	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010495952	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Antibody test negative (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|POLIVY [POLATUZUMAB VEDOTIN] (S - Diffuse large B-cell lymphoma - Unknown - [n/a - n/a - Unknown])|RITUXIMAB [RITUXIMAB] (S - Diffuse large B-cell lymphoma - Unknown - [n/a - n/a - Intravenous drip])|[BENDAMUSTINE, BENDAMUSTINE HYDROCHLORIDE] (S - Diffuse large B-cell lymphoma - Unknown - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010495961	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010495962	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010495962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496133	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496140	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496145	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496146	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496149	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496216	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496217	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496222	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496233	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496284	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496288	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496289	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496291	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496454	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496455	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496510	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496511	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010496733	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010496886	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010496911	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Conjunctivitis (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010496915	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Injection site discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LEVETIRACETAM 500 MG - FILM-COATED TABLET  (C - n/a - Dose not changed - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010496931	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea exertional (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010496931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010497041	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Hypersensitivity (n/a - Recovering/Resolving - );Malaise (1d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497044	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497046	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497126	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (20min - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497135	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497138	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497162	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypogeusia (4d - Recovered/Resolved - );Influenza like illness (4d - Recovered/Resolved - );Laryngeal oedema (4d - Recovered/Resolved - );Nasopharyngitis (4d - Recovered/Resolved - );Puncture site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497177	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling hot (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497201	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497202	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497256	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497259	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497262	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497271	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497277	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Choking (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010497278	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497280	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497282	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497284	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497291	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497297	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (22d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALPRAZOLAM] (C - Anxiety - n/a - [15y - .5mg - Oral])|[FLUOXETINE HYDROCHLORIDE] (C - Anxiety, Depression - n/a - [10y - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010497299	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site warmth (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497302	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Toothache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497303	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenopia (n/a - Recovering/Resolving - );Eye pain (n/a - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Injected limb mobility decreased (5d - Recovered/Resolved - );Lacrimation increased (n/a - Recovering/Resolving - );Muscular weakness (5d - Recovered/Resolved - );Ocular hyperaemia (n/a - Recovering/Resolving - );Ocular icterus (n/a - Recovering/Resolving - );Puncture site pain (5d - Recovered/Resolved - );Pyrexia (9d - Recovered/Resolved - );Visual acuity reduced (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497305	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497310	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497314	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497317	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497319	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Bradykinesia (1d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Disturbance in attention (1d - Recovered/Resolved - );Formication (1d - Recovered/Resolved - );Hallucination (0d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Influenza like illness (4d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nasopharyngitis (1d - Recovered/Resolved - );Night sweats (0d - Recovered/Resolved - );Pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Restless legs syndrome (2d - Recovered/Resolved - );Restlessness (1d - Recovered/Resolved - );Vertigo (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497321	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Circulatory collapse (1min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497324	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497331	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - );Lymphadenopathy (4d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497335	Spontaneous	2021-10-30 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (16h - Recovered/Resolved - );Pyrexia (16h - Recovered/Resolved - );Tremor (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010497461	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL ANHYDROUS, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010497463	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010497476	Spontaneous	2021-10-30 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010497476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481620	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Malaise (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481658	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481694	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481702	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481708	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	IRBESARTAN [IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481725	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Induration (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481732	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481734	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481746	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481747	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481779	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481781	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Photopsia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481783	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid oedema (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481816	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481827	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481842	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481865	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis allergic (n/a - Not Recovered/Not Resolved - );Flushing (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Skin discolouration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481884	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoacusis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID, ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, ACETYLSALICYLIC ACID, MAGNESIUM HYDROXIDE, ALGELDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BROMAZEPAM, PROPANTHELINE BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481891	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481897	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481900	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481917	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481937	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481956	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481981	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Peripheral swelling (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481984	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disorientation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual brightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual field defect (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010482047	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010482076	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482083	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482100	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010482106	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482109	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482136	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482147	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482151	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Torticollis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482205	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cyst (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482224	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482225	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mouth haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Mucosal haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010482230	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482238	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Breast tenderness (n/a - Recovered/Resolved With Sequelae - );Dyspnoea (n/a - Recovered/Resolved With Sequelae - );Hypertension (n/a - Recovered/Resolved With Sequelae - );Movement disorder (n/a - Recovered/Resolved With Sequelae - );Musculoskeletal chest pain (n/a - Recovered/Resolved With Sequelae - );Pain in extremity (n/a - Recovered/Resolved With Sequelae - );Tachycardia (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010482239	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482242	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482247	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482258	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482261	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482273	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010482287	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Disabling);Ataxia (n/a - Not Recovered/Not Resolved - Disabling);Bronchitis (n/a - Not Recovered/Not Resolved - Disabling);Confusional state (n/a - Not Recovered/Not Resolved - Disabling);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010482310	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482313	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site lymphadenopathy (3d - Recovered/Resolved - );Lymphadenitis (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	FLUCELVAX TETRA [A/BRISBANE/02/2018 (H1N1)PDM09 - LIKE STRAIN (A/IDAHO/07/2018), A/KANSAS/14/2017 (H3N2) - LIKE STRAIN (A/INDIANA/08/2018), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/COLORADO/06/2017 - LIKE STRAIN (B/IOWA/06/2017), B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/WASHINGTON/02/2019-LIKE VIRUS (B/DARWIN/7/2019, WILD TYPE), A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE STRAIN (A/WASHINGTON/19/2020, WILD TYPE), A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN (A/TASMANIA/503/2020, WILD TYPE)] (C - Influenza immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482343	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010482360	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Optic ischaemic neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010482366	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperpyrexia (4d - Recovered/Resolved - Other Medically Important Condition);Oedema mouth (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010482376	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (7d - Recovered/Resolved - );Pain in extremity (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482549	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OCREVUS [OCRELIZUMAB] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010482563	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Cerebral haemorrhage (n/a - Unknown - Other Medically Important Condition);Cerebral thrombosis (n/a - Unknown - Other Medically Important Condition);Coma (n/a - Unknown - Other Medically Important Condition);Death (n/a - Fatal - Results in Death);Dysarthria (n/a - Unknown - );Fatigue (n/a - Unknown - );Insomnia (n/a - Unknown - );Malaise (n/a - Unknown - );Neck pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010482582	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);White blood cell count decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	MICARDIS [TELMISARTAN] (C - Cardiac disorder - n/a - [n/a - 80mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Cardiac disorder - n/a - [n/a - 2.5mg - Oral])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - 1500mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010482612	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Lazaros, G.. A case series of acute pericarditis following COVID-19 vaccination in the context of recent reports from Europe and the United States.. Vaccine. 2021;10.1016/j.vaccine.2021.09.078. doi:10.1016/j.vaccine.2021.09.078	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010482630	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diplegia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482630&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010482803	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Somnolence (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482806	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482806&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010482833	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (354h - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (354h - Recovered/Resolved - );Dyspnoea exertional (n/a - Unknown - );Fatigue (114h - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pericarditis (n/a - Unknown - Other Medically Important Condition);Somnolence (114h - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010482850	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010482857	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Back pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010482857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483006	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Keratitis (n/a - Not Recovered/Not Resolved - );Lid sulcus deepened (3wk - Recovered/Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483010	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - 40mg - n/a])|[DUTASTERIDE] (C - n/a - n/a - [80d - .5mg - n/a])|[EDOXABAN] (C - n/a - n/a - [63d - 30mg - n/a])|[MECOBALAMIN] (C - n/a - n/a - [63d - 1000ug - n/a])|[RISEDRONATE SODIUM] (C - n/a - n/a - [2d - 75mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [63d - 2.5mg - n/a])|[SILODOSIN] (C - n/a - n/a - [80d - 8mg - n/a])|[VIBEGRON] (C - n/a - n/a - [80d - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010483014	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Delirium (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010483021	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483025	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010483028	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Recovering/Resolving - );Pain in extremity (n/a - Unknown - );Rash macular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483073	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematemesis (4d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (4d - Recovered/Resolved - );Vomiting (4d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMOXICILLIN SODIUM, POTASSIUM CLAVULANATE, AMOXICILLIN, CLAVULANIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAMETHASONE VALERATE, GENTAMICIN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAMETHASONE, BETAMETHASONE BUTYRATE PROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLATE SODIUM, BIOTIN, CALCIUM PANTOTHENATE, COLECALCIFEROL, CYANOCOBALAMIN, CASEIN, MANGANESE SULFATE, POTASSIUM CARBONATE, PYRIDOXINE HYDROCHLORIDE, MAGNESIUM CHLORIDE, TRISODIUM CITRATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PARAFFIN WHITE SOFT] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE, SODIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZONISAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010483077	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483161	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (5wk - Recovered/Resolved - );Disturbance in attention (5wk - Recovered/Resolved - );Dizziness (5wk - Recovered/Resolved - );Feeling jittery (5wk - Recovered/Resolved - );Hypoaesthesia (5wk - Recovered/Resolved - Other Medically Important Condition);Hypotension (5wk - Recovered/Resolved - );Paraesthesia (5wk - Recovered/Resolved - Other Medically Important Condition);Somnolence (5wk - Recovered/Resolved - );Troponin increased (5wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010483162	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483167	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cholecystitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010483216	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Not Recovered/Not Resolved - Life Threatening);Feeling hot (n/a - Not Recovered/Not Resolved - Life Threatening);Head discomfort (n/a - Not Recovered/Not Resolved - Life Threatening);Presyncope (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010483231	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010483277	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483282	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (0d - Unknown - Life Threatening, Other Medically Important Condition);Dizziness (n/a - Unknown - Life Threatening, Other Medically Important Condition);Fall (n/a - Unknown - Life Threatening, Other Medically Important Condition);Haemodynamic instability (n/a - Unknown - Life Threatening, Other Medically Important Condition);Head injury (n/a - Unknown - Life Threatening, Other Medically Important Condition);Heart rate irregular (n/a - Unknown - Life Threatening, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Pallor (n/a - Unknown - Life Threatening, Other Medically Important Condition);Vomiting (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010483328	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chest pain (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483373	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483396	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gout (8d - Recovered/Resolved - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483435	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010483436	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrioventricular block complete (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lyme carditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010483522	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010483534	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Skin disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483757	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphoedema (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (7wk - Recovered/Resolved - );Rash morbilliform (7wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010483892	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010483906	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Monoparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010483906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010484027	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitated depression (n/a - Recovering/Resolving - );Asthma (n/a - Recovering/Resolving - );Myocardial bridging (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484080	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484297	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cold agglutinins (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484298	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484299	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010484341	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - );Infection (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484346	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484356	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484358	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (153d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010484362	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (4d - Recovered/Resolved - );Musculoskeletal pain (3d - Recovered/Resolved - );Nausea (4d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484368	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484370	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484381	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Condition aggravated (n/a - Recovering/Resolving - );Sleep apnoea syndrome (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484382	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rheumatoid arthritis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484383	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Muscle spasticity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010484394	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal discomfort (n/a - Recovering/Resolving - );COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484395	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Fatal - Results in Death);Myocardial infarction (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010484410	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (0d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484411	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thirst (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010484415	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010484421	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010484428	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hot flush (n/a - Not Recovered/Not Resolved - Life Threatening);Pruritus (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010484459	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Respiratory rate decreased (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010484464	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Product administered at inappropriate site (n/a - Unknown - Disabling);Product administration error (n/a - Unknown - Disabling);Shoulder injury related to vaccine administration (n/a - Unknown - Disabling);Vaccination site movement impairment (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010484465	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484469	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484473	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - Transient ischaemic attack - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484485	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Arteriosclerosis (n/a - Fatal - Results in Death);Cardiac failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Mitral valve incompetence (n/a - Fatal - Results in Death);Papillary muscle disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[PITAVASTATIN] (C - Dyslipidaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010484493	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484532	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010484546	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - );Oropharyngeal pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484552	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484558	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Eye swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010484562	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484595	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484602	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484978	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010484982	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Application site pain (n/a - Recovered/Resolved - );Arthralgia (n/a - Recovered/Resolved - );Menstruation irregular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010484982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485041	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - );Urticaria (3d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485085	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485086	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485090	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Lower respiratory tract infection (0d - Recovered/Resolved - Other Medically Important Condition);Sensation of foreign body (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485097	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (2d - Recovered/Resolved - Other Medically Important Condition);Feeling cold (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010485101	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Feeling cold (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485107	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Brain fog (n/a - Not Recovered/Not Resolved - Disabling);Memory impairment (n/a - Not Recovered/Not Resolved - Disabling);Quality of life decreased (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010485115	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485120	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Recovered/Resolved - );COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - );Decubitus ulcer (n/a - Recovering/Resolving - );Fatigue (n/a - Recovered/Resolved - );Illness (n/a - Recovered/Resolved - );Lung disorder (n/a - Recovered/Resolved - Other Medically Important Condition);Osteomyelitis (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - );Pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Renal failure (2mo - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	XIGDUO [METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN] (C - Weight decreased - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485131	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Encephalitis autoimmune (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Gait inability (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mutism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thinking abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485153	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Recovering/Resolving - );Dysgeusia (n/a - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010485183	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Decreased appetite (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485207	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Cough (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Rhinitis (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010485234	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemiparaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nerve compression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	RELVAR ELLIPTA [FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010485241	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - );Drug interaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[BUDESONIDE] (I - Colitis microscopic - Dose increased - [n/a - 3mg - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485248	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[BARNIDIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE MAGNESIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485400	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010485434	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (14d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[METOPROLOL, METOPROLOL TARTRATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010485613	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485713	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485714	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485715	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010485716	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (180d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485719	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pruritus (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485741	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485742	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Myalgia (242d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485745	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485747	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Varicella zoster virus infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485750	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485751	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (54d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485756	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485757	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485761	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485767	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485771	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (90d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485772	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (36d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485775	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485777	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dyspnoea (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485779	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485782	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (27d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485783	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (4d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485784	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485788	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (18d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485789	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485790	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485791	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (14d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485799	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (24d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485802	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (3d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485804	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485808	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485811	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (55d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485813	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (90d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485814	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485818	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (56d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (56d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (56d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza (56d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Malaise (57d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (57d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (56d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (56d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site reaction (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (56d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485819	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485822	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485823	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (29d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485846	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485848	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485850	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485851	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010485852	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485854	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485855	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485876	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485887	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485888	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485889	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485890	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485893	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485894	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010485897	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485922	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485931	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485941	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (42d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010485967	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010485967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010486056	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (21d - Fatal - Results in Death);Fatigue (21d - Fatal - Results in Death);Malaise (21d - Fatal - Results in Death);Nausea (21d - Fatal - Results in Death);Pyrexia (21d - Fatal - Results in Death);Respiratory failure (21d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010486124	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Therapeutic response unexpected (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010486417	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Muscle fatigue (5d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010486553	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010486691	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (0d - Recovered/Resolved - Other Medically Important Condition);Urticaria (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010486711	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010486712	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Skin induration (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010486716	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010486717	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010486717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010487060	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010487258	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Rash vesicular (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487259	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010487261	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487265	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Life Threatening, Disabling, Other Medically Important Condition);Atrial fibrillation (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Atrial flutter (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Atrioventricular block (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Bradycardia (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition);Supraventricular extrasystoles (n/a - Unknown - Life Threatening, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BIMATOPROST [BIMATOPROST] (C - Ocular hypertension - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[URSODEOXYCHOLIC ACID] (C - Cholelithiasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Life Threatening	Hospitalisation
EU-EC-10010487266	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Feeding disorder (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Neck pain (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in jaw (n/a - Recovering/Resolving - Other Medically Important Condition);Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - n/a - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487277	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CLONAZEPAM] (C - Mental disorder - n/a - [n/a - n/a - Oral])|[CLOZAPINE] (C - Mental disorder - n/a - [n/a - n/a - Oral])|[DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - Mental disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010487287	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487289	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Mobility decreased (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487299	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[BICALUTAMIDE] (C - Prostate cancer - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - Gastritis - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487307	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (3d - Recovered/Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - n/a - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010487308	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010487352	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure measurement (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487357	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487358	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (59d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487362	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (29d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487382	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487383	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487399	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487440	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Suspected COVID-19 (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487442	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487445	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487446	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487447	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487455	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487460	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487466	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487476	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487479	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Cardiac disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487480	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cold sweat (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487482	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (6d - Recovered/Resolved - Other Medically Important Condition);Back pain (7d - Recovered/Resolved - Other Medically Important Condition);Cold sweat (2d - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Lymphadenopathy (6d - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (3d - Recovered/Resolved - Other Medically Important Condition);Night sweats (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487487	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Head injury (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487491	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010487506	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487507	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Asthenia (48d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (48d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487509	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487510	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487511	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (96d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487518	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (110d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487520	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgia (56d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487531	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487532	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487541	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (38d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (38d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487550	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuralgia (6d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487556	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487587	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (93d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487588	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Hemiparesis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010487592	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (61d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487593	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487595	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487598	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cardiac failure acute (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Influenza (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487607	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Dizziness (141d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487610	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mobility decreased (48d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487614	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487640	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487644	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Weight increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010487651	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Influenza (136d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010487653	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010487710	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487716	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (33d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487727	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (47d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487742	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487745	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (38d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Influenza (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (12d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487752	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487754	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Paraesthesia (25d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487757	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (43d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (74d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (71d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487761	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (133d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487762	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487772	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Joint swelling (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Limb discomfort (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Malaise (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010487775	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	BRINTELLIX 10 MG FILM-COATED TABLETS [VORTIOXETINE] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|[RISPERIDONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010487786	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010487796	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Aphthous ulcer (n/a - Recovered/Resolved - );Gastrointestinal inflammation (10d - Recovered/Resolved - );Pulmonary embolism (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010487814	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487816	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487822	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Feeling hot (1d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487824	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (47d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487826	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (41d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487829	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (23d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487830	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (12d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487831	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (28d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487838	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487853	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Tachycardia (42d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487854	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487869	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (70d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487874	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (2d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487875	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (65d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (5d - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (0d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487881	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487883	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lymph node pain (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487898	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death);Drug ineffective (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010487914	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (28d - Recovered/Resolved - Other Medically Important Condition);Basal ganglia haemorrhage (29d - Recovered/Resolved - Other Medically Important Condition);Blood pressure systolic increased (n/a - Recovered/Resolved - Other Medically Important Condition);Cerebral haemorrhage (16d - Recovered/Resolved - Other Medically Important Condition);Dizziness (29d - Recovered/Resolved - Other Medically Important Condition);Dysstasia (29d - Recovered/Resolved - Other Medically Important Condition);Fall (27d - Recovered/Resolved - Other Medically Important Condition);Haemorrhage (27d - Recovered/Resolved - Other Medically Important Condition);Neck pain (28d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (28d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (30d - Recovered/Resolved - Other Medically Important Condition);Vomiting (36d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLOSTRIDIUM BUTYRICUM] (C - n/a - n/a - [n/a - 8{DF} - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 4{DF} - Oral])|[POLYCARBOPHIL] (C - n/a - n/a - [n/a - 4{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487925	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lacrimation increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487938	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Sensory disturbance (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487951	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myocarditis (5d - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487964	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Chills (1d - Recovered/Resolved - );Inflammation (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010487968	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - );Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CYANOCOBALAMIN, VITAMIN B12] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROXOCOBALAMIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE] (C - Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010487981	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (14d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487985	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (58d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010487988	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010487988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488003	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (0d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488008	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (89d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Malaise (89d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488011	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (8d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[MORPHINE, MORPHINE HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010488012	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Delirium (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Ventricular fibrillation (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[FOLIC ACID] (C - Anaemia - n/a - [n/a - 15mg - Oral])|[FUROSEMIDE] (C - Oedema due to cardiac disease - n/a - [n/a - 20mg - Oral])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 30mg - Oral])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Dementia - n/a - [n/a - 12.5mg - Oral])|[THEOPHYLLINE] (C - Bronchitis chronic - n/a - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010488015	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010488061	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488090	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488093	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site reaction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488101	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (51d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488102	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Haematochezia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488103	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488135	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488139	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (241d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (241d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488142	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (35d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488143	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488144	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Respiratory distress (137d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488145	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (20d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488149	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (103d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488196	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dyspnoea (14d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488281	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488283	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Breath sounds abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyskinesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Laboratory test abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - );Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Product use issue (n/a - Unknown - );Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Vasculitis - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - Vasculitis - n/a - [n/a - n/a - n/a])|[CYANOCOBALAMIN] (C - Vasculitis - n/a - [n/a - n/a - n/a])|[ISOSORBIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Vasculitis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Myocardial infarction - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488443	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488474	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - 1mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488476	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488482	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Hypoaesthesia (1d - Recovered/Resolved - );Pain in extremity (4d - Recovering/Resolving - );Vaccination site movement impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488485	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - 125ug - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 10mg - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488486	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010488488	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488509	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488514	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Peripheral swelling (24h - Recovered/Resolved - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488516	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Night sweats (1d - Recovered/Resolved - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488528	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Parkinson's disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Tremor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	[CLONIDINE HYDROCHLORIDE] (C - Hypertension - n/a - )|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488541	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CALCIUM FOLINATE, FOLIC ACID, FOLINIC ACID] (C - Rectal cancer metastatic - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[FLUOROURACIL] (C - Rectal cancer metastatic - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE TRIHYDRATE] (C - Rectal cancer metastatic - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488564	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Unknown - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488567	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488622	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010488640	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash macular (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488646	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488709	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488710	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488715	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hospitalisation (47d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Osteomyelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sepsis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010488719	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488720	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488726	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488727	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010488802	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Coagulopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[IBUPROFEN] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PERINDOPRIL ARGININE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010488879	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Wrong product administered (n/a - Unknown - )	CABLIVI [CAPLACIZUMAB] (S - n/a - Not applicable - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010488879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489127	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (2d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Hiccups (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|OLANZAPINE 5 MG - TABLET  (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010489128	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[CITALOPRAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010489135	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010489166	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489174	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bedridden (n/a - Unknown - Disabling, Other Medically Important Condition);Disturbance in attention (n/a - Unknown - Disabling, Other Medically Important Condition);Ear pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Slow speech (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010489179	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Splenectomy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489188	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Head injury (n/a - Recovered/Resolved - Other Medically Important Condition);Neck pain (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489198	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - );Diarrhoea (1d - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Pallor (n/a - Unknown - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010489260	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (2wk - Recovered/Resolved - );COVID-19 (2wk - Recovered/Resolved - Other Medically Important Condition);Cough (2wk - Recovered/Resolved - );Rhinorrhoea (2wk - Recovered/Resolved - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2s - 1{DF} - Intramuscular - More in ICSR])	[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - n/a - Unknown - )|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - Unknown - )|[NITRENDIPINE] (C - n/a - Unknown - )|[TELMISARTAN] (C - n/a - Unknown - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010489271	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489272	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489277	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489281	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489450	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489457	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010489464	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010489471	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Investigation abnormal (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010489478	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489479	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Neck pain (n/a - Unknown - Disabling, Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Disabling, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010489873	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amnesia (8h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489885	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489887	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Sensorimotor disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489892	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Formication (n/a - Not Recovered/Not Resolved - );Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489893	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Adult failure to thrive (n/a - Fatal - Results in Death);Melaena (1d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010489896	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489911	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vascular purpura (26d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010489932	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Multisystem inflammatory syndrome in children (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489935	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010489940	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489962	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [30d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010489966	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Spina bifida (n/a - Not Recovered/Not Resolved - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [91d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010489970	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010489982	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebellar stroke (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010489991	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010489991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010490012	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490012&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010490100	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[COLCHICINE, OPIUM, STANDARDIZED POWDERED, TIEMONIUM METHYLSULPHATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490105	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490105&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490111	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490130	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Colitis (14d - Recovered/Resolved - );Condition aggravated (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490146	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490156	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490157	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490183	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Musculoskeletal chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010490187	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Eye irritation (n/a - Unknown - );Fatigue (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Headache (n/a - Unknown - );Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490189	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490208	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - Factor V Leiden mutation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490209	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (5d - Recovered/Resolved - );SARS-CoV-2 test positive (2d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN CALCIUM] (C - Hypercholesterolaemia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010490211	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490222	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490232	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010490268	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490269	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490290	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490310	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cystitis bacterial (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490315	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490340	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - )|[AMOXICILLIN, CLAVULANIC ACID] (C - n/a - n/a - )|[BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[DIAZEPAM] (C - n/a - n/a - )|[ENOXAPARIN, ENOXAPARIN SODIUM] (C - n/a - n/a - )|[OXAZEPAM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490358	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (1wk - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Sciatica (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	DESLORATADINE [DESLORATADINE] (C - Antiallergic therapy - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490364	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490384	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash macular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - 2{DF} - Intramuscular])|TEMODAL [TEMOZOLOMIDE] (S - Glioblastoma - Dose not changed - [n/a - 380mg - Oral])|[ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE DIHYDRATE] (S - Prophylaxis of nausea and vomiting - Dose not changed - [n/a - 4mg - Oral])	ANORO ELLIPTA 55 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED [UMECLIDINIUM BROMIDE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - 1{DF} - Respiratory (inhalation)])|KEPPRA 500 MG FILM-COATED TABLETS [LEVETIRACETAM] (C - Glioblastoma - n/a - [n/a - 1000mg - Oral])|[MONTELUKAST] (C - Chronic obstructive pulmonary disease - n/a - [n/a - 10mg - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Gastric ulcer - n/a - [n/a - 40mg - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490387	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490388	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperthyroidism (63d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010490423	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Lymphopenia (4d - Recovered/Resolved - );Neutropenia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ENOXAPARIN SODIUM] (C - Thrombosis prophylaxis - n/a - [27d - 4000[iU] - Subcutaneous])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - 1{DF} - Oral])|[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490438	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Accommodation disorder (3d - Recovered/Resolved - );Heterophoria (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490443	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490446	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Phlebitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490448	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fall (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490450	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490463	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490465	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Back pain (1d - Recovered/Resolved - );Visceral pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490466	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchial obstruction (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490480	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490482	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490483	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490484	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490492	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490506	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490510	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490511	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490522	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[FLECAINIDE ACETATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[NEBIVOLOL] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])|[OLMESARTAN MEDOXOMIL, AMLODIPINE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490525	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490530	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490538	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490543	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490553	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490555	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490567	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ISOTRETINOIN] (C - n/a - n/a - [n/a - n/a - n/a])|[VENLAFAXINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490575	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490580	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490582	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490600	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490629	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaesthesia (n/a - Recovering/Resolving - );Paraesthesia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490641	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490658	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cytomegalovirus hepatitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490662	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Depression (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490663	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Therapeutic response unexpected (116d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010490669	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thirst (n/a - Recovered/Resolved - );Vision blurred (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490685	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctival haemorrhage (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490690	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490693	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490701	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490710	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490710&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010490719	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490722	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490726	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Formication (86d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[RAMIPRIL] (C - Hypertension - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010490732	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490742	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490745	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [43d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490767	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid oedema (n/a - Recovering/Resolving - );Lip swelling (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Cutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490787	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Post herpetic neuralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490853	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490862	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Unknown - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Recovered/Resolved With Sequelae - Disabling);Limb discomfort (n/a - Recovered/Resolved With Sequelae - Disabling);Mobility decreased (n/a - Recovered/Resolved - Disabling);Muscle spasms (n/a - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010490865	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010490877	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Nipple disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010490885	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490891	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010490893	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - );Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010490917	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Constipation (n/a - Unknown - );Flatulence (n/a - Unknown - );Portal vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[CLARITHROMYCIN, OMEPRAZOLE, OMEPRAZOLE SODIUM] (C - n/a - n/a - )|[INDAPAMIDE, PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010490917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010491033	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Unknown - );Infection (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2s - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491161	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myositis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491220	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010491223	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010491224	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491225	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491228	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Unknown - Other Medically Important Condition);Nonspecific reaction (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Sensitive skin (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491241	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMINS NOS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491246	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Loss of personal independence in daily activities (2d - Recovered/Resolved - Other Medically Important Condition);Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (2d - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BENDROFLUMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, FLUTICASONE PROPIONATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR.] (C - Asthma - n/a - [n/a - n/a - n/a])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010491248	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491251	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [4d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010491384	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testicular infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010491403	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491404	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491458	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eye irritation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Influenza like illness (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - );Tachypnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 100mg - n/a])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - 25mg - n/a])|[LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491463	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491490	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (8h - Recovered/Resolved - );Influenza like illness (8h - Recovered/Resolved - );Myalgia (8h - Recovered/Resolved - );Nausea (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491533	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Retching (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[CARBOHYDRATES NOS] (C - n/a - n/a - )|[FAT] (C - n/a - n/a - )|[GLUCOSE, ANHYDROUS, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CITRIC ACID, POTASSIUM CHLORIDE, SODIUM CHLORIDE, GLUCOSE, DISODIUM HYDROGEN CITRATE, SODIUM CHLORIDE] (C - n/a - n/a - )|[LAMOTRIGINE] (C - n/a - n/a - )|[LANSOPRAZOLE] (C - n/a - n/a - )|[LEVOCARNITINE] (C - n/a - n/a - )|[MINERALS NOS] (C - n/a - n/a - )|[POTASSIUM, SODIUM, MACROGOL 3350, CHLORIDE ION, HYDROGEN CARBONATE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - n/a - n/a - )|[SODIUM VALPROATE] (C - n/a - n/a - )|[TOPIRAMATE] (C - n/a - n/a - )|[VITAMINS NOS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491535	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - );Vomiting (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491593	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491679	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491701	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491707	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010491719	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Tremor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491720	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[CHLORTALIDONE] (C - n/a - n/a - [n/a - 12.5mg - n/a])|[QUINAPRIL, QUINAPRIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010491725	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mobility decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010491731	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	DESLORATADINE [DESLORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010491736	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Ear pain (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypersomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Osteomyelitis (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in jaw (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010491886	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010491887	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010491890	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Atrial fibrillation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010491893	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010491899	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010491901	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010491925	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010491925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492015	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010492026	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010492028	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010492036	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492146	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - );Constipation (n/a - Not Recovered/Not Resolved - );Diverticulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspepsia (n/a - Not Recovered/Not Resolved - );Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ZONISAMIDE [ZONISAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LAMOTRIGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492216	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010492266	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (2d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (2d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492292	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492324	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood creatine phosphokinase increased (n/a - Unknown - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Decreased appetite (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dehydration (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Disease progression (n/a - Unknown - Caused/Prolonged Hospitalisation);Fluid intake reduced (n/a - Unknown - Caused/Prolonged Hospitalisation);Movement disorder (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rhabdomyolysis (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (15d - Recovered/Resolved - Caused/Prolonged Hospitalisation);White blood cells urine positive (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010492358	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pityriasis rosea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492360	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear infection (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Influenza (5d - Recovered/Resolved - );Ocular discomfort (n/a - Not Recovered/Not Resolved - );Vestibular neuronitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492363	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (10d - Recovered/Resolved - );Diarrhoea (10d - Recovered/Resolved - );Vision blurred (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492373	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492386	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492411	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492472	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Contusion (6d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492473	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492482	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492486	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Furuncle (55d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010492488	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (26d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyslalia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Monoparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Putamen haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010492514	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010492521	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010492522	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Fatigue (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492523	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (0d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Tinnitus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492533	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Oxygen saturation decreased (n/a - Unknown - );Peripheral circulatory failure (n/a - Unknown - );Pyelonephritis acute (n/a - Fatal - Results in Death);Sepsis (n/a - Fatal - Results in Death);Septic shock (n/a - Fatal - Results in Death);Urinary tract infection (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[AMBROXOL, AMBROXOL HYDROCHLORIDE] (C - Bronchitis chronic - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - Cardiac failure - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - Cardiac failure - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[PILSICAINIDE] (C - Cardiac failure - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Cardiac failure - n/a - [n/a - n/a - Oral])|[VERAPAMIL, VERAPAMIL HYDROCHLORIDE] (C - Cardiac failure - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010492543	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492544	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Genital pain (n/a - Unknown - );Mass (n/a - Unknown - );Penile vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010492549	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash pruritic (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010492653	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Cardiac arrest (n/a - Unknown - Life Threatening);Cardiac failure (n/a - Fatal - Results in Death);Haematuria (n/a - Fatal - Results in Death);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Respiratory arrest (n/a - Unknown - Life Threatening);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ETIZOLAM] (C - Anxiety - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010492666	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Altered visual depth perception (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - );Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Gait inability (n/a - Not Recovered/Not Resolved - );Visual field defect (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010492717	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ischaemic cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010492914	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010492930	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[BOTULINUM TOXIN TYPE A] (S - Skin wrinkling - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010492992	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Neonate (Preterm and Term newborns)	Yes	Male	Maternal exposure during pregnancy (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Premature baby (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Premature delivery (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[AMPICILLIN] (C - n/a - n/a - [n/a - n/a - Transplacental])|[BETAMETHASONE, BETAMETHASONE SODIUM PHOSPHATE] (C - n/a - n/a - [2d - n/a - Transplacental])|[ERYTHROMYCIN, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE PH. EUR., ERYTHROMYCIN STEARATE] (C - n/a - n/a - [n/a - n/a - Transplacental])|[RITODRINE] (C - n/a - n/a - [3d - n/a - Transplacental])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010492992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010493000	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010493006	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abdominal pain (n/a - Unknown - );Angina pectoris (n/a - Unknown - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - );Brain fog (n/a - Unknown - );Eye irritation (n/a - Unknown - );Head discomfort (n/a - Unknown - );Headache (n/a - Unknown - );Oral discomfort (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010493011	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Fatal - Results in Death);Pyrexia (n/a - Unknown - );Respiratory disorder (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[FUROSEMIDE] (C - Pleural effusion - n/a - [20d - n/a - Intravenous (not otherwise specified)])|[MEROPENEM, MEROPENEM ANHYDROUS] (C - Pneumonia - n/a - [12d - n/a - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010493228	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	INVOKANA [CANAGLIFLOZIN] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|LIXIANA [EDOXABAN, EDOXABAN TOSYLATE] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[EPROSARTAN, EPROSARTAN MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FLECAINIDE ACETATE] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|[GLICLAZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[METFORMIN HYDROCHLORIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493272	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010493275	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493278	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493355	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	GLYCOPYRRONIUM BROMIDE [GLYCOPYRRONIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493362	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemoptysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, VONOPRAZAN FUMARATE] (C - Carotid artery stenosis - n/a - [n/a - n/a - Oral])|[AMBROXOL HYDROCHLORIDE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Oral])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ITRACONAZOLE] (C - Aspergilloma - n/a - [n/a - n/a - Oral])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010493415	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Activated partial thromboplastin time prolonged (n/a - Recovered/Resolved - Other Medically Important Condition);Petechiae (n/a - Recovered/Resolved - );Prothrombin time prolonged (n/a - Recovered/Resolved - Other Medically Important Condition);Rash maculo-papular (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010493418	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493421	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493425	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493431	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493436	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 11{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493439	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493450	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493473	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovering/Resolving - );Vaccination site lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493474	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Sudden death (1d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010493482	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coccydynia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493516	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Aphthous ulcer (n/a - Recovered/Resolved - Other Medically Important Condition);Vulval ulceration (36d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010493518	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493524	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493539	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493610	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysstasia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscular weakness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010493615	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493750	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Diarrhoea (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493752	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493758	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493780	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abnormal loss of weight (123d - Recovered/Resolved - );Appetite disorder (n/a - Recovered/Resolved - );Haematochezia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010493784	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tachycardia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010493801	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010493802	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (28d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010493804	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010493890	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cluster headache (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - );Loss of personal independence in daily activities (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RETINOL] (C - n/a - n/a - [n/a - n/a - Topical])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493890&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493897	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	General physical health deterioration (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Transaminases increased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	FORXIGA [DAPAGLIFLOZIN] (C - n/a - n/a - [n/a - 10mg - n/a])|LANTUS SOLOSTAR [INSULIN GLARGINE] (C - n/a - n/a - [n/a - 40[iU] - n/a])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[METAMIZOLE SODIUM, METAMIZOLE SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - n/a - n/a - [n/a - 50mg - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - 50mg - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010493899	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Furuncle (n/a - Recovering/Resolving - Other Medically Important Condition);Hair disorder (n/a - Not Recovered/Not Resolved - );Mental disorder (n/a - Recovering/Resolving - );Scar (n/a - Not Recovered/Not Resolved - );Self esteem decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493916	Spontaneous	2021-10-29 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - );Hypopnoea (n/a - Unknown - );Palpitations (n/a - Unknown - );Presyncope (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010493939	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	Non European Economic Area	Kant, S.. Impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with anti-neutrophil cytoplasmic antibody vasculitis. Kidney international. 2021;100(5):1124-1127. doi:10.1016/j.kint.2021.08.020	65-85 Years	Not Specified	No	Male	B-lymphocyte count decreased (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	RITUXIMAB [RITUXIMAB] (S - Granulomatosis with polyangiitis - Unknown - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010493972	Spontaneous	2021-10-29 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010493972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468458	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Herpes zoster (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468487	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Tonsillitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468487&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468490	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468493	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468499	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468524	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468590	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468777	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468814	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Conjunctivitis (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468820	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468831	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468874	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468909	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Eye irritation (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Regurgitation (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	VICTOZA 6 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN [LIRAGLUTIDE] (C - Diabetes mellitus - n/a - [n/a - 1{DF} - Subcutaneous])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - Essential hypertension - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468920	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468921	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematuria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468934	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Life Threatening);Heart rate increased (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010468936	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468954	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010468977	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468985	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Migraine (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010468990	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hemiparesis (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010468993	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010469010	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Balance disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	LEVETIRACETAM [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - 3g - Oral])|VIMPAT 50 MG FILM-COATED TABLETS [LACOSAMIDE] (C - Epilepsy - n/a - [n/a - 400mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469023	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010469030	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Infarction (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 5000{DF} - Oral])|[ENOXAPARIN] (C - n/a - n/a - [n/a - 4000{DF} - Subcutaneous])|[FOLIC ACID] (C - n/a - n/a - [n/a - 15mg - n/a])|[ZOLPIDEM, ZOLPIDEM TARTRATE] (C - n/a - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010469031	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Retinal detachment (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010469035	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperpyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interstitial lung disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469046	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (5d - Recovered/Resolved - );Photophobia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469048	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010469063	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo positional (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469065	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Suffocation feeling (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	HUMALOG 100 U/ML KWIKPEN, SOLUTION FOR INJECTION [INSULIN LISPRO] (C - n/a - n/a - [n/a - n/a - n/a])|LANTUS [INSULIN GLARGINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469068	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010469078	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (41d - Recovered/Resolved - Disabling);Headache (41d - Recovered/Resolved - Disabling);Hepatic enzyme increased (41d - Recovered/Resolved - Disabling);Hiccups (41d - Recovered/Resolved - Disabling);Myalgia (41d - Recovered/Resolved - Disabling);Nausea (41d - Recovered/Resolved - Disabling);Pain in extremity (41d - Recovered/Resolved - Disabling);Pyrexia (41d - Recovered/Resolved - Disabling);Tachycardia (41d - Recovered/Resolved - Disabling);Troponin increased (41d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	FIASP 100 UNITS/ML [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010469079	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469112	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depersonalisation/derealisation disorder (n/a - Not Recovered/Not Resolved - );Depression (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469125	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transverse sinus thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010469126	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Unknown - );Periorbital swelling (n/a - Unknown - );Swelling face (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010469145	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469150	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (6d - Recovered/Resolved - );Dyspnoea (6d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Neck pain (6d - Recovered/Resolved - );Pain in extremity (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010469153	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Torticollis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469157	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469158	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469161	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010469176	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Vasodilatation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469178	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469188	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469191	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Vaccination site joint pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469201	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469204	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469207	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469232	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010469238	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469250	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469252	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469253	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469280	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469282	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010469313	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (10d - Recovered/Resolved - );Dyspnoea (10d - Recovered/Resolved - );Malaise (10d - Recovered/Resolved - );Oropharyngeal pain (10d - Recovered/Resolved - );Pyrexia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010469447	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469448	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal hypokinesia (n/a - Recovered/Resolved - Other Medically Important Condition);Maternal exposure timing unspecified (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010469450	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469451	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Tension (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469457	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Aortic valve sclerosis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Aphasia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Cerebral atrophy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Diastolic dysfunction (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypokinesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Mental impairment (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Tricuspid valve incompetence (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - 20mg - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - 10mg - Oral])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - 5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010469517	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Coordination abnormal (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Diplopia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemoptysis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypersensitivity (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Influenza like illness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Miller Fisher syndrome (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oropharyngeal pain (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Rhinorrhoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Speech disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010469521	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Seizure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469522	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Extra dose administered (n/a - Unknown - );Off label use (n/a - Unknown - );Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469543	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469568	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010469570	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sinus node dysfunction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TELMISARTAN [TELMISARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [80d - .5mg - n/a])|[EDOXABAN] (C - n/a - n/a - [63d - 30mg - n/a])|[MECOBALAMIN] (C - n/a - n/a - [63d - 1000ug - n/a])|[RISEDRONATE SODIUM] (C - n/a - n/a - [2d - 75mg - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [63d - 2.5mg - n/a])|[SILODOSIN] (C - n/a - n/a - [80d - 8mg - n/a])|[VIBEGRON] (C - n/a - n/a - [80d - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010469732	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Fibrin D dimer increased (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010469734	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Silent thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010469741	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysuria (n/a - Unknown - );Fall (n/a - Unknown - );Hypotension (n/a - Unknown - );Incontinence (n/a - Unknown - );Injury (n/a - Unknown - );Physical deconditioning (n/a - Unknown - Caused/Prolonged Hospitalisation);Presyncope (n/a - Unknown - );Tachycardia (n/a - Unknown - );Urinary tract infection (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	XARELTO [RIVAROXABAN] (C - Atrial fibrillation - n/a - [n/a - 20mg - Oral])|[ALUMINUM MAGNESIUM HYDROXIDE] (C - Dyspepsia - n/a - [n/a - 20mL - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[BACITRACIN] (C - n/a - n/a - [n/a - n/a - Topical])|[BACLOFEN, BACLOFEN PH. EUR.] (C - Muscle spasms - n/a - [n/a - 20mg - Oral])|[BUPROPION HYDROCHLORIDE] (C - Depression - n/a - [n/a - 200mg - Oral])|[CALCIUM CARBONATE] (C - Dyspepsia - n/a - [n/a - 1000mg - Oral])|[CASSIA, CASSIA SENNA WHOLE, HYDROXYANTHRACENE GLYCOSIDES, SENNA PODS, SENNOSIDE B, SENNOSIDES] (C - Constipation - n/a - [n/a - 17.2mg - Oral])|[CEFALEXIN, CEFALEXIN MONOHYDRATE] (C - n/a - n/a - [n/a - 2000mg - Oral])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - 2000[iU] - Oral])|[DICLOFENAC, DICLOFENAC DIETHYLAMINE, DICLOFENAC EPOLAMINE, DICLOFENAC POTASSIUM, DICLOFENAC RESINATE, DICLOFENAC SODIUM] (C - Pain - n/a - [n/a - 1% - Topical])|[DOCUSATE CALCIUM] (C - Constipation - n/a - [n/a - 240mg - Oral])|[FISH OIL] (C - n/a - n/a - [n/a - 1000mg - Oral])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - 4{DF} - Nasal])|[GUAIFENESIN] (C - n/a - n/a - [n/a - 1200mg - Oral])|[LISINOPRIL, LISINOPRIL ANHYDROUS, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - 40mg - Oral])|[LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE OXIDE] (C - Diarrhoea - n/a - [n/a - 2mg - Oral])|[LORATADINE] (C - n/a - n/a - [n/a - 10mg - Oral])|[MACROGOL 3350] (C - n/a - n/a - [n/a - 17g - Oral])|[MENTHOL, ZINC OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - 100mg - Oral])|[NEOMYCIN] (C - n/a - n/a - [n/a - n/a - Topical])|[NYSTATIN, NYSTATIN, ZINC OXIDE] (C - Fungal infection - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - Back pain, Osteoarthritis, Pain - n/a - [n/a - 1000mg - Oral])|[PARAFFIN WHITE SOFT, ZINC OXIDE] (C - Skin irritation - n/a - [n/a - 2{DF} - Topical])|[POLYCARBOPHIL CALCIUM, PSYLLIUM HUSK] (C - n/a - n/a - [n/a - 4{DF} - Oral])|[POLYMYXIN B] (C - n/a - n/a - [n/a - n/a - Topical])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - 2{DF} - Respiratory (inhalation)])|[TRAZODONE HYDROCHLORIDE] (C - Insomnia - n/a - [n/a - 150mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010469767	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010469775	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010469775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010470108	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Joint stiffness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - Other Medically Important Condition);Persistent postural-perceptual dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470111	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hangover (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[TICK-BORNE ENCEPHALITIS VACCINE] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470113	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Unknown - Other Medically Important Condition);Ligament sprain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[NAPROXEN] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZOPICLONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470118	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Polyneuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470118&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010470124	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness neurosensory (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010470125	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Disabling, Other Medically Important Condition);Pollakiuria (n/a - Unknown - Disabling, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010470183	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Cataract (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470204	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010470251	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - Disabling);Impaired work ability (n/a - Unknown - Disabling);Influenza like illness (n/a - Unknown - Disabling);Muscle spasms (n/a - Unknown - Disabling);Myalgia (n/a - Unknown - Disabling);Upper respiratory tract infection (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010470323	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Fatigue (n/a - Unknown - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[PARACETAMOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470326	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470343	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470345	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470346	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470348	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470349	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470416	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Disabling);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Disabling);Sneezing (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010470424	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myeloid leukaemia (79d - Fatal - Results in Death);Face oedema (79d - Fatal - Results in Death);Neutropenia (79d - Fatal - Results in Death);Pulmonary embolism (79d - Fatal - Results in Death);Thrombophlebitis (79d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[COLECALCIFEROL] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PHENYTOIN SODIUM] (C - n/a - Unknown - [n/a - 200mg - n/a])|[VALPROIC ACID, SODIUM VALPROATE] (C - n/a - Unknown - [n/a - 2250mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010470472	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470474	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470521	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010470529	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010470568	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Lymph node pain (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470747	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling of body temperature change (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Sinus pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470749	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	AERIUS [DESLORATADINE] (C - Hypersensitivity - n/a - [n/a - 5mg - Oral])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010470758	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470766	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved With Sequelae - );Migraine (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010470783	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470784	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470790	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010470800	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470866	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rhinitis (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010470900	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Burning sensation (6d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010470932	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010470932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471065	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471066	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471068	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471099	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471104	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Condition aggravated (n/a - Unknown - Disabling);Pain in extremity (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010471117	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (5d - Recovered/Resolved - );Asthenia (n/a - Unknown - );Chills (3h - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471168	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471190	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471212	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471213	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010471214	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010471220	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Disabling);Nasopharyngitis (n/a - Recovering/Resolving - Disabling);SARS-CoV-2 test negative (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [60d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010471272	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471280	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471284	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471285	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471285&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471308	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471318	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471319	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (n/a - Not Recovered/Not Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010471323	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471336	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471339	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Visual acuity reduced (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471340	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471341	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471345	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral vein thrombosis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471346	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Diabetes mellitus (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypertension (31d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471347	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombophlebitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471356	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471360	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (6wk - Not Recovered/Not Resolved - );Herpes zoster (6wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010471433	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471445	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471446	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471458	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Unknown - );Locked-in syndrome (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Product use issue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010471459	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Hallucination (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - );Muscle twitching (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Tourette's disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471470	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cognitive disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (3d - Recovered/Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471473	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Incontinence (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Cerebrovascular accident - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAMADOL, TRAMADOL HYDROCHLORIDE] (C - Pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471477	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Areflexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diplopia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extraocular muscle disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Miller Fisher syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ophthalmoplegia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);VIth nerve disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471490	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Epistaxis (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471498	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Bladder irritation (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Bladder pain (n/a - Unknown - Disabling, Other Medically Important Condition);Joint range of motion decreased (n/a - Unknown - Disabling, Other Medically Important Condition);Musculoskeletal stiffness (n/a - Unknown - Disabling, Other Medically Important Condition);Pollakiuria (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010471499	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471505	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Waheed, R.. Guillain-Barre syndrome presenting with bilateral facial nerve palsy following Pfizer- BioNTech COVID-19 vaccination (late breaking abstract). Journal of the Peripheral Nervous System. 2021;26 (3):436. doi:10.1111/jns.12460	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471508	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471513	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Pulse waveform abnormal (n/a - Unknown - );Respiration abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471538	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);SARS-CoV-2 test positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471553	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dyspnoea exertional (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010471659	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471720	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (205d - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LYRICA 75 MG [PREGABALIN] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[ALLOPURINOL] (C - n/a - Unknown - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 3{DF} - n/a])|[NALOXONE HYDROCHLORIDE, TILIDINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[OMEPRAZOLE] (C - n/a - Unknown - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010471739	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (8h - Recovered/Resolved - );Chills (8h - Recovered/Resolved - );Headache (8h - Recovered/Resolved - );Malaise (8h - Recovered/Resolved - );Pyrexia (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471914	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471915	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010471917	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Rodriguez, c.. Vaccine-induced immune thrombotic thrombocytopenia after the BNT162b2 mRNA Covid-19 vaccine: A case study. Thrombosis Research. 2021;208:1-3. doi:10.1016/j.thromres.2021.10.002	65-85 Years	Not Specified	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471918	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Anxiety (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Asthenia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Constipation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyschezia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fear of eating (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Feeling abnormal (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Flatulence (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Impaired work ability (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Panic reaction (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Suicidal ideation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010471920	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471929	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Bedridden (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Paralysis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471936	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010471945	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Skin warm (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471947	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471949	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471959	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Lazaros, G.. A case series of acute pericarditis following COVID-19 vaccination in the context of recent reports from Europe and the United States.. Vaccine. 2021;10.1016/j.vaccine.2021.09.078. doi:10.1016/j.vaccine.2021.09.078	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471962	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010471972	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Discomfort (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471973	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471977	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Peripheral vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010471983	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010471990	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010471995	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition);Essential tremor (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Congenital Anomaly, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010471995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472040	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Head discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472049	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472052	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472061	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472068	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010472073	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pneumonia (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472075	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Dizziness (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472075&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472085	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472111	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Skin disorder (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472143	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Autoimmune disorder (n/a - Not Recovered/Not Resolved - Disabling);Blood creatine phosphokinase increased (n/a - Not Recovered/Not Resolved - Disabling);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Disabling);Gait inability (n/a - Not Recovered/Not Resolved - Disabling);Gamma-glutamyltransferase increased (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pelvic girdle pain (n/a - Not Recovered/Not Resolved - Disabling);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Disabling);Red blood cell sedimentation rate increased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])|[RAMIPRIL, FELODIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010472145	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoacusis (n/a - Recovering/Resolving - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site discomfort (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [57d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472158	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis transverse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472161	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);COVID-19 pneumonia (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472167	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Death (n/a - Fatal - Results in Death)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010472170	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (2d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Gait inability (n/a - Unknown - Other Medically Important Condition);Headache (2d - Recovered/Resolved - Other Medically Important Condition);Illness (2d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472187	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])|TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	[POTASSIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010472261	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472309	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ANTIBIOTICA [NOT AVAILABLE] (C - Inflammation - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472313	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - Pain - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[BECLOMETASONE DIPROPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010472364	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472420	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site inflammation (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010472460	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472461	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472467	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472476	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010472567	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Trigger finger (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472756	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Infection (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[WARFARIN, WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010472757	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Endocarditis (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Not Recovered/Not Resolved - );Swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010472762	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash follicular (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC SODIUM, MISOPROSTOL] (C - n/a - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, TRIAMTERENE] (C - n/a - n/a - [n/a - n/a - n/a])|[LORAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE, RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TRAZODONE, TRAZODONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472763	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Drug eruption (n/a - Unknown - Other Medically Important Condition);Eczema (n/a - Unknown - );Erythema (n/a - Unknown - );Gamma-glutamyltransferase increased (n/a - Unknown - );Liver disorder (n/a - Unknown - Other Medically Important Condition);Pigmentation disorder (n/a - Unknown - );Pruritus (n/a - Unknown - );Rash (n/a - Recovered/Resolved - );Rash erythematous (n/a - Recovering/Resolving - );Toxic skin eruption (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - );Vaccination site swelling (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472764	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Dyslipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472765	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010472788	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Shock (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (0d - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010472818	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010472823	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010472879	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010472981	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemorrhagic diathesis (163d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Petechiae (163d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Thrombocytopenia (163d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010472986	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Atrioventricular block (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac dysfunction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac pacemaker insertion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010472986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010473045	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Bladder irritation (n/a - Recovering/Resolving - );Chills (1d - Recovered/Resolved - );Constipation (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Seasonal allergy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473058	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Cardiac discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010473065	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cerebral venous sinus thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010473079	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Abdominal pain lower (n/a - Not Recovered/Not Resolved - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473080	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dilated cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010473088	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473092	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010473094	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (48d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Thrombophlebitis (48d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473094&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010473104	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473104&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010473161	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010473166	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Prostatic specific antigen increased (57d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010473170	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster oticus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 2mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010473172	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473178	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473197	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473200	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coronary artery disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010473208	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473241	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010473254	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473255	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473256	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473257	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473262	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473263	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473264	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473304	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Superficial vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010473456	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (6h - Recovered/Resolved - );Fatigue (6h - Recovered/Resolved - );Headache (6h - Recovered/Resolved - );Myalgia (6h - Recovered/Resolved - );Pyrexia (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLCYSTEINE] (C - COVID-19 - Dose not changed - [n/a - 600mg - Oral])|[ACETYLSALICYLIC ACID] (C - COVID-19 - Dose not changed - [n/a - 400mg - Oral])|[AZITHROMYCIN, AZITHROMYCIN DIHYDRATE] (C - COVID-19 - Dose not changed - [n/a - 500mg - Oral])|[FAMOTIDINE] (C - COVID-19 - Dose not changed - [n/a - 40mg - Oral])|[IVERMECTIN] (C - COVID-19 - Dose not changed - [n/a - 12mg - Oral - More in ICSR])|[PARACETAMOL] (C - COVID-19 - Dose not changed - [n/a - 2g - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473590	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473592	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010473593	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473595	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473597	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473600	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473602	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (2d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473603	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473606	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Unknown - );Nausea (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473607	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473608	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473653	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473727	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis transverse (56d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010473795	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Muscular weakness (38d - Recovered/Resolved - );Musculoskeletal pain (38d - Recovered/Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (38d - Recovered/Resolved - );Paraesthesia (38d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010473807	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473817	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473833	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010473949	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010473950	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010473950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474112	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - );Vaccination failure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474308	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Skin disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010474339	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010474395	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474401	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474472	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Anaphylactic shock (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);COVID-19 immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vaccination complication (3d - Recovered/Resolved - )	CIMZIA [CERTOLIZUMAB PEGOL] (S - Rheumatoid arthritis - Drug withdrawn - [157d - 400mg - Subcutaneous])|COMIRNATY [TOZINAMERAN] (S - Immunisation - Unknown - [n/a - n/a - n/a])	KEVZARA [SARILUMAB] (C - Rheumatoid arthritis - n/a - [n/a - 400mg - Subcutaneous])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 5mg - Oral])|[FAMOTIDINE] (C - Chronic gastritis - n/a - [n/a - 20mg - Oral])|[IGURATIMOD] (C - Rheumatoid arthritis - n/a - [n/a - 50mg - Oral])|[LOXOPROFEN, LOXOPROFEN SODIUM] (C - Rheumatoid arthritis - n/a - [n/a - 120mg - Oral])|[REBAMIPIDE] (C - Chronic gastritis - n/a - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474488	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474489	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474490	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474496	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site haematoma (9d - Recovered/Resolved - );Application site pain (4d - Recovered/Resolved - );Application site reaction (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010474499	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474616	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle rigidity (n/a - Recovering/Resolving - );Musculoskeletal stiffness (n/a - Recovering/Resolving - );Near death experience (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474618	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474632	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (3d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vision blurred (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	BUDESONIDE [BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FORMOTEROL, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474643	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chills (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474645	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (0d - Recovered/Resolved - Other Medically Important Condition);Laryngeal oedema (0d - Recovered/Resolved - Other Medically Important Condition);Throat tightness (0d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[METAMIZOLE SODIUM, METAMIZOLE SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474646	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - );Immunisation (n/a - Unknown - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - );Off label use (n/a - Unknown - );Paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474650	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010474656	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - );Respiratory tract congestion (n/a - Recovering/Resolving - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474673	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474674	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010474682	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral haemorrhage (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Immune thrombocytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pancytopenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474682&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010474683	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Coronary artery disease (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474683&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010474684	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (15d - Recovered/Resolved - );Glossodynia (19d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010474693	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dialysis (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Hepatic failure (9d - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Renal failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010474705	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Somnolence (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474742	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474744	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Depression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - );Immunisation (n/a - Unknown - );Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Trigger finger (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[VARICELLA VACCINE (LIVE)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474749	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474759	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	FIASP [INSULIN ASPART] (C - Type 1 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474763	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474769	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474771	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Muscle spasms (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474774	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Heart rate irregular (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Joint range of motion decreased (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Loss of consciousness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Poor quality sleep (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474780	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Peptic ulcer haemorrhage (n/a - Recovering/Resolving - Other Medically Important Condition);Salivary hypersecretion (n/a - Unknown - );Urinary tract disorder (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474789	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Euphoric mood (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Left ventricular dysfunction (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474791	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Iridocyclitis (n/a - Recovering/Resolving - Other Medically Important Condition);Uveitis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474801	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - );Epididymitis (n/a - Unknown - Other Medically Important Condition);Orchitis (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474808	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474811	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474812	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary congestion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[THYROID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474817	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Musculoskeletal stiffness (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474821	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Eyelid ptosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Unknown - );Pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[HYDROCODONE BITARTRATE, PARACETAMOL] (C - Nephrolithiasis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474823	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Haematuria (3d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Renal impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010474826	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Unknown - Other Medically Important Condition);Frequent bowel movements (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Secretion discharge (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474827	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain stem haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Cerebral haemorrhage (n/a - Fatal - Results in Death, Other Medically Important Condition);Cerebral ventricular rupture (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010474843	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dry throat (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [91d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010474898	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474900	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474903	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474904	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474905	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474908	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474909	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474911	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474940	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site reaction (n/a - Unknown - );Localised oedema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010474976	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010474979	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010474983	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DESLORATADINE [DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010474985	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - );Headache (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Palpitations (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010474996	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arrhythmia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010474996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475000	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475002	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475024	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adolescent	No	Male	Abnormal loss of weight (n/a - Unknown - Caused/Prolonged Hospitalisation);Type 1 diabetes mellitus (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010475029	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Face injury (n/a - Unknown - Other Medically Important Condition);Fall (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - );Presyncope (n/a - Unknown - );Urinary incontinence (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475054	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dependence on oxygen therapy (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Physical deconditioning (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AMLODIPINE, OLMESARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010475057	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Lung disorder (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475112	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary mass (n/a - Unknown - );Fatigue (n/a - Not Recovered/Not Resolved - );Renal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010475114	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Joint effusion (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010475235	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Cyanosis (n/a - Recovered/Resolved - );Fall (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Pulse abnormal (n/a - Recovered/Resolved - );Snoring (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475238	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475239	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Adverse food reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Blister (n/a - Unknown - Other Medically Important Condition);Fibromyalgia (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Photophobia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition);Scrotal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin burning sensation (n/a - Unknown - Other Medically Important Condition);Skin exfoliation (14d - Recovered/Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475251	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475252	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - Other Medically Important Condition);Muscle strain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475263	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Enteritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010475336	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475337	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475342	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475343	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475345	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475346	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475348	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475373	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Thrombosis (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475382	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475477	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - );Vaccination failure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475528	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash vesicular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475578	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475591	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - n/a - Not applicable - [n/a - 15mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475599	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Connor, B.. Monoclonal Antibody Therapy in a Vaccine Breakthrough SARS-CoV-2 Hospitalized Delta (B.1.617.2) Variant Case. International Journal of Infectious Diseases. 2021;110:232-234. doi:10.1016/j.ijid.2021.07.029	18-64 Years	Not Specified	No	Male	COVID-19 (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010475608	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Blood potassium decreased (n/a - Unknown - );Insomnia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010475610	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Inflammatory marker increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Troponin increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	AZATHIOPRINE [AZATHIOPRINE] (C - Crohn's disease - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010475643	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010475729	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition);Vaccination site pruritus (n/a - Unknown - Other Medically Important Condition);Vaccination site warmth (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACRIVASTINE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ANHYDROUS AZITHROMYCIN, AZITHROMYCIN, AZITHROMYCIN DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])|[MINOCYCLINE, MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PROPYLENE GLYCOL, SODIUM CHLORIDE, MACROGOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475730	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475793	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475798	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010475805	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010475805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476068	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Coagulopathy (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476127	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved With Sequelae - );Vaccination failure (11d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010476135	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476136	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476200	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Type 1 diabetes mellitus (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476201	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476207	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476213	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - );Rheumatoid arthritis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476217	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Unknown - );Rash (5d - Recovered/Resolved - Other Medically Important Condition);Rash pruritic (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476219	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cellulitis (n/a - Unknown - Other Medically Important Condition);Folliculitis (n/a - Unknown - Other Medically Important Condition);Furuncle (n/a - Unknown - Other Medically Important Condition);Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476371	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476379	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476384	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476390	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abortion spontaneous (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010476393	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476395	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476403	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476418	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010476427	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Allergic hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	BIKTARVY 50 MG/200 MG/25 MG FILM-COATED TABLETS [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, BICTEGRAVIR] (C - n/a - Not applicable - )|[ROSUVASTATIN] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476452	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Autoimmune hepatitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476456	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476462	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [29d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010476464	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Facial paralysis (2wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476479	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [37d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476482	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476484	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476495	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [39d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476511	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vestibular neuronitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	[NEBIVOLOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476522	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epstein-Barr virus infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hepatitis acute (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476523	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476532	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sinus tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476537	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476540	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476542	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476551	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Febrile convulsion (n/a - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	AERIUS 2.5 MG ORODISPERSIBLE TABLETS [DESLORATADINE] (C - n/a - n/a - )|[BUDESONIDE] (C - n/a - n/a - )|[ESOMEPRAZOLE] (C - n/a - n/a - )|[FLUTICASONE PROPIONATE, SALMETEROL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476553	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [18d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476554	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476555	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010476566	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral coldness (n/a - Not Recovered/Not Resolved - );Peripheral swelling (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010476577	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Recovered/Resolved - Other Medically Important Condition);Decreased appetite (2d - Recovered/Resolved - Other Medically Important Condition);Dysgeusia (2d - Recovered/Resolved - Other Medically Important Condition);Paraesthesia (2d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010476640	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476652	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476653	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dissociation (10d - Recovered/Resolved - );Malaise (10d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Restlessness (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476658	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Unknown - );Gastrointestinal disorder (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476659	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476662	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Vertigo (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476671	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476675	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eczema (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476678	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476691	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (2wk - Recovering/Resolving - );Oral dysaesthesia (2wk - Recovering/Resolving - );Swollen tongue (2wk - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476695	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Lymphoedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476699	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476701	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476748	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Tension headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476766	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradyphrenia (2d - Recovered/Resolved - );Hypokinesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476767	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476770	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476777	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476789	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Hypertension (2d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476791	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5d - Recovered/Resolved - );Vertigo (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476795	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (5s - Recovered/Resolved - );Malaise (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476798	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (15min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476808	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476814	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476820	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epistaxis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476827	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476836	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476848	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (10d - Recovering/Resolving - );Muscle twitching (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476859	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476860	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	HUMIRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [ADALIMUMAB] (C - Arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476875	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476880	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476885	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476886	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476889	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (45d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010476891	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476896	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[CETIRIZINE DIHYDROCHLORIDE] (C - Urticaria chronic - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476902	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastroenteritis (3d - Recovered/Resolved - );Speech disorder (3d - Recovered/Resolved - );Tetany (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476904	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Herpes zoster (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - Arrhythmia - n/a - [n/a - n/a - n/a])|[FLECAINIDE ACETATE] (C - Arrhythmia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476908	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[NEBIVOLOL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[POTASSIUM CHLORIDE] (C - Hypokalaemia - n/a - [n/a - n/a - n/a])|[PRAVASTATIN SODIUM] (C - Cardiovascular event prophylaxis - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476909	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site paraesthesia (90min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476912	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476915	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476932	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476932&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476935	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes simplex (n/a - Recovering/Resolving - );Impetigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476938	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476956	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476960	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urethral haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010476965	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476967	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476968	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (60h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476981	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476984	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lip oedema (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476988	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010476998	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010476998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477002	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477003	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477026	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACEBUTOLOL HYDROCHLORIDE] (C - n/a - n/a - )|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[INDAPAMIDE, PERINDOPRIL ARGININE] (C - n/a - n/a - )|[SOLIFENACIN, SOLIFENACIN SUCCINATE] (C - n/a - n/a - )|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477030	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LERCANIDIPINE HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477031	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477032	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477037	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477038	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477039	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477044	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477050	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477052	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [26d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477057	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ENTRESTO [VALSARTAN, SACUBITRIL] (C - n/a - n/a - )|SILODOSIN [SILODOSIN] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - )|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - )|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477061	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477067	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477068	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477070	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477071	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477074	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477084	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477085	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477091	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477103	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477106	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477107	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477110	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477111	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477117	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477119	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Recovering/Resolving - );Neuralgia (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477121	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477122	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477127	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (4h - Recovered/Resolved - );Palpitations (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477134	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477138	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477140	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477143	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477146	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477148	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovered/Resolved - );Anosmia (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010477150	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477152	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MOMETASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477158	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [40d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477164	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477167	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477174	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Musculoskeletal pain (n/a - Not Recovered/Not Resolved - );Sleep disorder (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477184	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477189	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - );Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[PAROXETINE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477196	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - );Insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477546	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis allergic (6d - Recovering/Resolving - );Diarrhoea (6d - Recovering/Resolving - );Erythema (6d - Recovering/Resolving - );Nausea (6d - Recovering/Resolving - );Pruritus (6d - Recovering/Resolving - );Skin disorder (6d - Recovering/Resolving - );Vomiting (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 50mg - n/a])|[PARACETAMOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010477559	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010477760	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[PREDNISOLONE] (S - Nephrotic syndrome - Unknown - [n/a - 5mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010477793	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010477795	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - );Contusion (n/a - Unknown - );Fall (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010477819	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Petrescu, E.. It hurts with tears. VIATA MEDICALA. 2021;41 (1653):7	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010477827	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Petrescu, E.. It hurts with tears. VIATA MEDICALA. 2021;41 (1653):7	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010477829	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - );Near death experience (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010477836	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010477839	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - );Formication (n/a - Unknown - );Headache (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Mood swings (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - );Skin mass (1d - Recovered/Resolved - );Suicidal ideation (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[PALIPERIDONE PALMITATE] (C - Bipolar disorder - n/a - [n/a - 900mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010477844	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010477852	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010477859	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010477879	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (n/a - Unknown - Other Medically Important Condition);Haemorrhage (n/a - Unknown - Other Medically Important Condition);Head injury (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010477917	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adolescent	No	Not Specified	Injury (n/a - Unknown - Other Medically Important Condition);Physical deconditioning (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010477931	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010477998	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (11d - Not Recovered/Not Resolved - );Dyspnoea (11d - Not Recovered/Not Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010477998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010478048	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010478054	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Asthenia (n/a - Unknown - Other Medically Important Condition);Atrial flutter (n/a - Recovered/Resolved - Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (115d - Recovered/Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|CANAGLIFLOZIN [CANAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|RANOLAZINE [RANOLAZINE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - Depression - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - Angina pectoris - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010478083	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Drug ineffective (n/a - Unknown - Other Medically Important Condition);SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478088	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myelitis transverse (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010478089	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478124	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010478144	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Unknown - );Injection site pruritus (n/a - Unknown - );Injection site swelling (n/a - Unknown - );Injection site warmth (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010478163	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Arrhythmia (3wk - Recovered/Resolved - );Arthralgia (3wk - Recovered/Resolved - );Body temperature increased (13d - Recovered/Resolved - );Chills (3wk - Recovered/Resolved - );Fatigue (3wk - Recovered/Resolved - );Headache (3wk - Recovered/Resolved - );Malaise (3wk - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010478199	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - );Paraesthesia (2h - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ARIPIPRAZOLE [ARIPIPRAZOLE] (C - Anxiety - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010478202	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ETORICOXIB] (C - Arthritis - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010478208	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Testicular torsion (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[COLCHICINE] (C - Myocarditis - n/a - [274d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010478251	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Photopsia (n/a - Recovered/Resolved - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478272	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Parosmia (131d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010478281	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Decreased appetite (1d - Recovered/Resolved - );Fluid intake reduced (1d - Recovered/Resolved - );Lethargy (1d - Recovered/Resolved - );Refusal of treatment by patient (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[CARBIDOPA, LEVODOPA, LEVODOPA, ANHYDROUS CARBIDOPA, LEVODOPA, CARBIDOPA MONOHYDRATE] (C - Essential tremor - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[MORPHINE SULFATE, MORPHINE SULFATE PENTAHYDRATE] (C - Pain - n/a - [n/a - n/a - n/a])|[SODIUM PICOSULFATE] (C - Constipation - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010478289	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478588	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (n/a - Unknown - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478590	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concussion (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478593	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Sensitivity to weather change (6d - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site erythema (6d - Recovered/Resolved - Other Medically Important Condition);Vaccination site swelling (6d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478661	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute kidney injury (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nephritis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010478692	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin erosion (n/a - Recovering/Resolving - Other Medically Important Condition);Skin exfoliation (n/a - Recovering/Resolving - Other Medically Important Condition);Skin swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Skin weeping (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478694	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (1d - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vomiting (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - Depression - n/a - [153d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478706	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010478717	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010478721	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010478722	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Coma (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010478738	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain upper (n/a - Unknown - Other Medically Important Condition);Anal incontinence (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Postmenopausal haemorrhage (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010478740	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Carrasco, L.. A rapidly progressive and rare illness: Autoantibodies against melanoma differentiation-associated protein 5 (Anti-MDA5) amyopathic dermatomyositis with progressive interstitial lung disease that developed after COVID-19 vaccine. Chest. 2021;160 (4suppl):A680-A681. doi:10.1016/j.chest.2021.07.646	18-64 Years	Not Specified	No	Male	Dermatomyositis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interstitial lung disease (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010478774	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010478776	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010478921	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness postural (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Headache (n/a - Unknown - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Influenza like illness (n/a - Unknown - Disabling, Other Medically Important Condition);Off label use (n/a - Unknown - );Orthostatic hypotension (n/a - Unknown - Disabling, Other Medically Important Condition);Pain (n/a - Unknown - Disabling, Other Medically Important Condition);Palpitations (n/a - Unknown - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010478953	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010478979	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010478979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479096	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010479109	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479181	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479207	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479222	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - );Hypoaesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479302	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479304	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Nausea (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010479319	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	[AZITHROMYCIN] (C - Pneumonia mycoplasmal - n/a - [n/a - n/a - Oral])|[CODEINE PHOSPHATE SESQUIHYDRATE] (C - Headache - n/a - [n/a - n/a - Oral])|[DOMPERIDONE MALEATE] (C - Nausea - n/a - [n/a - n/a - Oral])|[IBUPROFEN] (C - Pain - n/a - [n/a - n/a - Oral])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Migraine prophylaxis - n/a - [n/a - n/a - Oral])|[PHENOXYMETHYLPENICILLIN POTASSIUM] (C - Pneumonia - n/a - [n/a - n/a - Oral])|[SUMATRIPTAN] (C - Migraine - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010479336	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haemoptysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Non-cardiac chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Chronic obstructive pulmonary disease - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479340	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010479341	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vestibular neuronitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479343	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	DESLORATADINE [DESLORATADINE] (C - Seasonal allergy - n/a - [n/a - n/a - Oral])|[FORMOTEROL FUMARATE DIHYDRATE] (C - Bronchospasm - n/a - [n/a - n/a - Respiratory (inhalation)])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - Seasonal allergy - n/a - [n/a - n/a - Nasal])|[SALBUTAMOL, SALBUTAMOL MICRONIZED, SALBUTAMOL SULFATE] (C - Bronchospasm - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479345	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (27d - Recovered/Resolved - );Neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010479350	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Facial paresis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479362	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	LEVETIRACETAM [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479366	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Photophobia (n/a - Unknown - Caused/Prolonged Hospitalisation);Subarachnoid haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479369	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paresis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479376	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479379	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chronic obstructive pulmonary disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Respiratory acidosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479392	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Arthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010479401	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479414	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479416	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebellar haemorrhage (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Facial paralysis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010479422	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479426	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (15d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479508	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Unknown - Other Medically Important Condition);Renal pain (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010479528	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspepsia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479543	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479547	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Night sweats (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479558	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lumbosacral radiculopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479565	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479693	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010479725	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010479768	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Ear disorder (n/a - Unknown - );Ear pain (n/a - Not Recovered/Not Resolved - );Ear swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Eye movement disorder (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Joint lock (n/a - Unknown - );Ocular hyperaemia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	PRASUGREL [PRASUGREL] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010479968	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Unknown - Other Medically Important Condition);Tachycardia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010479968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010480164	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Injection site reaction (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480181	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bedridden (3wk - Recovered/Resolved - );COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (12d - Recovered/Resolved - );Disorientation (n/a - Unknown - );Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (12d - Recovered/Resolved - );Illness (3wk - Recovered/Resolved - );Immune system disorder (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Muscle spasms (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010480189	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480234	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	XARELTO 15 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480250	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fall (0d - Recovered/Resolved - );Heart rate decreased (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010480261	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiparesis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mutism (n/a - Unknown - Caused/Prolonged Hospitalisation);Vertigo (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010480264	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480287	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480290	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480298	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480300	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480301	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480431	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480435	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [2d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480436	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Adverse reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480441	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Temperature regulation disorder (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480442	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480443	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480445	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480449	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Delirium febrile (0d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480468	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480469	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480493	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480498	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480543	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema (n/a - Unknown - Other Medically Important Condition);Pruritus (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480552	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a - More in ICSR])	LYRICA 150 MG HARD CAPSULES [PREGABALIN] (C - n/a - n/a - [n/a - 150mg - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - 6mg - n/a])|[ESCITALOPRAM] (C - n/a - n/a - [n/a - 10mg - n/a])|[FLURAZEPAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 30mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010480556	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480576	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );COVID-19 pneumonia (n/a - Fatal - Results in Death, Other Medically Important Condition);Cough (n/a - Unknown - );Dyspnoea (n/a - Fatal - Results in Death, Other Medically Important Condition);Pyrexia (n/a - Unknown - );Vaccination failure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010480583	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480596	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - );Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010480602	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480608	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480609	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Recovered/Resolved - );Somnolence (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480619	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute hepatic failure (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010480647	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Unknown - Other Medically Important Condition);Anxiety (n/a - Unknown - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Memory impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - Lower respiratory tract infection - n/a - [3d - n/a - n/a])|[CODEINE] (C - n/a - n/a - [n/a - 30mg - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - Panic attack - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[PARACETAMOL, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - n/a - n/a - [n/a - 500mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480652	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (1410min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010480718	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Confusional state (n/a - Unknown - );Epistaxis (n/a - Unknown - );Fatigue (n/a - Unknown - );Incoherent (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Irritability (n/a - Unknown - );Malaise (n/a - Unknown - );Memory impairment (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010480764	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Dysphoria (0d - Recovered/Resolved - );Heart rate decreased (0d - Recovered/Resolved - );Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010480777	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010480800	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480802	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480804	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480811	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480894	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480896	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480922	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480924	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010480979	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010480979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481002	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (0d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010481006	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (30d - Recovered/Resolved - );Neuralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010481013	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481015	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481018	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481025	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481027	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481029	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481034	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481042	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481048	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Unknown - );Tachyarrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010481050	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Encephalitis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010481052	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Orthostatic hypotension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481055	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481125	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010481248	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481276	Spontaneous	2021-10-28 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain oedema (n/a - Unknown - Other Medically Important Condition);Encephalitis autoimmune (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Fatigue (n/a - Unknown - );Gait inability (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Mental impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Speech disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010481343	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010481345	Spontaneous	2021-10-28 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010481345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454334	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454337	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454358	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454359	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454364	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454372	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010454375	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Oxygen saturation decreased (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454376	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Purulence (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454385	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling cold (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454386	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454405	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454416	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454450	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010454613	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Confusional state (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Flank pain (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Photosensitivity reaction (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010454621	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (20d - Recovered/Resolved - Other Medically Important Condition);Migraine (20d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (20d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010454623	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraparesis (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010454639	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mg - Intramuscular])	[THIAMAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454643	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454695	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (2d - Recovered/Resolved - );Urticaria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454700	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010454737	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454738	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454741	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454746	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454762	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Somnolence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454763	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454765	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature increased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454767	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (0d - Recovered/Resolved - );Pruritus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454796	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pallor (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454798	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - );Pyrexia (n/a - Recovered/Resolved With Sequelae - );Vertigo (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010454799	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site oedema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454883	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454889	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454889&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454895	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454900	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Platelet aggregation increased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454908	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - );Skin exfoliation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454910	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454912	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454915	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Inflammation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454916	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454921	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erythema (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454953	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454956	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454957	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454972	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010454978	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Atrial fibrillation (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Immunisation reaction (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|RIVAROXABAN [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLECAINIDE, FLECAINIDE ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010454980	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454985	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455010	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	IDELVION [ALBUTREPENONACOG ALFA] (C - Factor IX deficiency - n/a - [n/a - 2000k[iU] - Intravenous bolus])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455030	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	ELIQUIS [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010455042	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (n/a - Unknown - );Visual impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010455047	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Capillary fragility (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral venous disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010455068	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455077	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (41d - Fatal - Results in Death);Asthenia (41d - Fatal - Results in Death);Blood creatine phosphokinase increased (41d - Fatal - Results in Death);Choluria (41d - Fatal - Results in Death);Decreased appetite (41d - Fatal - Results in Death);Hypokinesia (41d - Fatal - Results in Death);Malaise (41d - Fatal - Results in Death);Myalgia (41d - Fatal - Results in Death);Respiratory failure (41d - Fatal - Results in Death);Rhabdomyolysis (41d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (S - Carotid artery occlusion - Drug withdrawn - [n/a - 80mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010455092	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Not Recovered/Not Resolved - Life Threatening);Hodgkin's disease (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	CELLCEPT [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - 500mg - n/a])|[ALFUZOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISONE] (C - n/a - n/a - [n/a - 7.5mg - n/a])|[TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - n/a - [n/a - 3mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010455110	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Ear discomfort (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455117	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - );Epistaxis (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Tremor (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010455121	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Musculoskeletal pain (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455131	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455133	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455139	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455164	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cyst (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455168	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455184	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pollakiuria (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010455229	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455231	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455232	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455235	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455237	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455241	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455243	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455263	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455270	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455332	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	3-11 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Product administered to patient of inappropriate age (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010455335	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Recovering/Resolving - );Hallucination (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455339	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - );Troponin increased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[CLOZAPINE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010455343	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010455344	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mucosal haemorrhage (n/a - Not Recovered/Not Resolved - );Petechiae (n/a - Not Recovered/Not Resolved - );Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010455345	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010455346	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disease recurrence (n/a - Unknown - );Lyme disease (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010455348	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (2wk - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010455513	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysphonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypotonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010455514	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010455544	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010455558	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Bronchospasm (n/a - Recovered/Resolved - Other Medically Important Condition);Burning sensation (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling hot (n/a - Recovered/Resolved - Other Medically Important Condition);Gait disturbance (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (n/a - Recovered/Resolved - Other Medically Important Condition);Pharyngeal swelling (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - Other Medically Important Condition);Wheezing (n/a - Recovered/Resolved - Other Medically Important Condition)	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (S - Product used for unknown indication - Drug withdrawn - [28d - n/a - Unknown])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010455579	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[ALLOPURINOL] (C - Gout - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - Gout - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010455595	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010455606	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial asymmetry (10min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Speech disorder (10min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010455732	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CANDESARTAN CILEXETIL] (C - Cluster headache - n/a - [n/a - 16mg - Oral])|[SUMATRIPTAN, SUMATRIPTAN SUCCINATE] (C - n/a - n/a - [n/a - 50mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010455753	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Muscle spasms (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition);Vasculitis (n/a - Recovered/Resolved - Other Medically Important Condition)	APIXABAN [APIXABAN] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])|[TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010455753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456185	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456190	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456193	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456194	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456195	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Oedema peripheral (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Venous thrombosis (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456365	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010456366	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456376	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemihypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Muscle tightness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010456386	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Poor quality sleep (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010456411	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010456415	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010456442	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010456455	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010456456	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovered/Resolved - );Dry eye (n/a - Recovered/Resolved - );Erythema nodosum (n/a - Unknown - Caused/Prolonged Hospitalisation);Oedema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sarcoidosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010456493	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010456495	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - Disabling);Hypoaesthesia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010456501	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456650	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	TYSABRI [NATALIZUMAB] (C - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])|[DOCONEXENT, ICOSAPENT, FISH OIL, OMEGA-3-ACID ETHYL ESTERS 90] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456650&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010456663	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Unknown - );Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[ISOSORBIDE 5 MONONITRATE, ISOSORBIDE MONONITRATE] (C - Arteriosclerosis - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - Dyspepsia - n/a - [n/a - n/a - n/a])|[LISINOPRIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010456675	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lichen sclerosus (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010456678	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Petechiae (n/a - Recovering/Resolving - );Skin haemorrhage (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010456713	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456714	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010456721	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (90min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Unknown - );Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Troponin increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456729	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myopericarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE SODIUM] (C - Hiatus hernia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456734	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Autoimmune haemolytic anaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010456737	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Lip swelling (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - );Swollen tongue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456742	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456744	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456780	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Neoplasm malignant (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010456791	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (510min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Blood pressure decreased (505min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Confusional state (505min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal disorder (505min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (505min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (505min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peripheral circulatory failure (505min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456793	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved With Sequelae - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456794	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pelvic fluid collection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Pleurisy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456797	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Concomitant disease aggravated (n/a - Not Recovered/Not Resolved - );Exercise tolerance decreased (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - );Mental impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - );Testicular pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456801	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Hallucination, visual (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456808	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Chest pain (n/a - Unknown - );Chills (n/a - Unknown - );Dyspnoea exertional (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Myopericarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010456814	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Pericardial effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[LISDEXAMFETAMINE DIMESYLATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MIRTAZAPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456815	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Electrocardiogram ST segment elevation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456819	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood urine present (n/a - Unknown - );Headache (n/a - Unknown - );Pain (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456831	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Drug ineffective (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456832	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injury (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456838	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Menstruation irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456841	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456846	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010456847	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456852	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Necrotising retinitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Varicella zoster virus infection (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456856	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Death (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010456861	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Head discomfort (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Hypotension (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456863	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diverticulum (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	VARENICLINE [VARENICLINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010456866	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - );Vaccination site erythema (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456866&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010456987	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010456987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457000	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Autonomic nervous system imbalance (n/a - Recovering/Resolving - );Blood pressure decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Dehydration (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Feeling abnormal (n/a - Recovering/Resolving - );Pallor (n/a - Recovering/Resolving - );Presyncope (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010457001	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cystitis noninfective (n/a - Unknown - );Sepsis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010457026	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash pruritic (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010457036	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010457126	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010457143	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457151	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457153	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - );Somnolence (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457154	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (n/a - Not Recovered/Not Resolved - );Haemorrhagic urticaria (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010457158	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010457181	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Recovered/Resolved - Life Threatening);Blood pressure decreased (n/a - Recovered/Resolved - Life Threatening);Confusional state (n/a - Recovered/Resolved - Life Threatening);Pallor (n/a - Recovered/Resolved - Life Threatening);Peripheral coldness (n/a - Recovered/Resolved - Life Threatening);Pulse abnormal (n/a - Recovered/Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010457185	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Facial paralysis (12d - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010457187	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid rash (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457191	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010457200	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Renal infarct (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010457205	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010457222	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Arrhythmia (28d - Recovering/Resolving - );Arthralgia (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010457223	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza like illness (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457238	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood immunoglobulin G decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457240	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010457312	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010457391	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling);Cardiac arrest (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010457436	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (S - Influenza immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457495	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Disabling);Malaise (7d - Recovered/Resolved - Disabling);Pyrexia (7d - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010457498	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Palpitations (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010457539	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010457545	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010457709	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Blister (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010457846	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010457997	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Axillary pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010457997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458011	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertonia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458015	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458042	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening);Dyspnoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010458064	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458070	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458083	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458098	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458100	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458101	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458103	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aortic valve incompetence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiac failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cardiomyopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Mitral valve incompetence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Prinzmetal angina (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular extrasystoles (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ventricular hypokinesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458109	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fear of injection (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral coldness (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458109&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458111	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Immunisation (n/a - Unknown - );Loss of consciousness (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|BUMETANIDE [BUMETANIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - n/a])|[TIOTROPIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010458127	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chills (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate irregular (7d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypotension (7d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Infection (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Lymphadenopathy (5d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Swelling (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Tonsillar hypertrophy (5d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458150	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pseudodementia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Psychotic disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CELECOXIB [CELECOXIB] (C - n/a - n/a - [n/a - 40mg - n/a])|[CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458153	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458161	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Other Medically Important Condition);Fatigue (n/a - Unknown - Life Threatening, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Myocarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Off label use (n/a - Unknown - );Palpitations (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pericarditis (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010458165	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458168	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bundle branch block (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458174	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Gingival pain (n/a - Unknown - );Headache (n/a - Unknown - );Hypertensive crisis (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (n/a - Unknown - );Neuralgia (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Unknown - );Tooth disorder (n/a - Unknown - );Toothache (n/a - Unknown - );Trigeminal nerve disorder (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458176	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal distension (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Faeces soft (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458178	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Contusion (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458198	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010458204	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood cholesterol increased (n/a - Unknown - );Cerebrovascular accident (n/a - Recovering/Resolving - Other Medically Important Condition);Emotional disorder (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Mental fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Stress (n/a - Not Recovered/Not Resolved - );Transient ischaemic attack (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458205	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Illness (n/a - Recovered/Resolved - Other Medically Important Condition);Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458208	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Cerebrovascular disorder (n/a - Unknown - );Death (n/a - Fatal - Results in Death);Dyspnoea (n/a - Recovered/Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	DARBEPOETIN ALFA [DARBEPOETIN ALFA] (C - Nephrogenic anaemia - n/a - [11mo - n/a - Intravenous (not otherwise specified)])|EPOETIN ALFA [EPOETIN ALFA] (C - Nephrogenic anaemia - n/a - [1d - n/a - Intravenous (not otherwise specified)])|[ACETYLSALICYLIC ACID] (C - Prophylaxis - n/a - [n/a - n/a - Oral])|[ALCLOMETASONE DIPROPIONATE] (C - Dermatitis contact - n/a - [n/a - n/a - Topical])|[ALFACALCIDOL] (C - Chronic kidney disease-mineral and bone disorder - n/a - [n/a - n/a - Oral])|[BROTIZOLAM] (C - Insomnia - n/a - [n/a - n/a - Oral])|[CALCIUM CARBONATE] (C - Chronic kidney disease-mineral and bone disorder - n/a - [n/a - n/a - Oral])|[CARVEDILOL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FERRIC CITRATE] (C - Chronic kidney disease-mineral and bone disorder - n/a - [n/a - n/a - Oral])|[IRBESARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[LANSOPRAZOLE] (C - Prophylaxis - n/a - [n/a - n/a - Oral])|[LIDOCAINE, PRILOCAINE, PRILOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE] (C - Local anaesthesia - n/a - [n/a - 2g - Topical])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[SENNOSIDE A+B] (C - Constipation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010458209	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458224	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458232	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac arrest (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458233	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458236	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458237	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Foetal distress syndrome (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly);Foetal exposure during pregnancy (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly);Premature baby (n/a - Fatal - Results in Death, Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Congenital Anomaly)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010458239	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458240	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alopecia (n/a - Recovered/Resolved With Sequelae - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010458245	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458257	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Disorientation (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Hallucination (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Peripheral coldness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458266	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458277	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (20min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458280	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458318	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458324	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Inappropriate schedule of product administration (n/a - Unknown - );Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Psoriasis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458325	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Acute respiratory failure (204h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chronic obstructive pulmonary disease (348h - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (9d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Oxygen saturation decreased (9d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory acidosis (9d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ALFACALCIDOL] (C - Osteoporosis - n/a - [n/a - 1{DF} - Oral])|[AMBROXOL, AMBROXOL HYDROCHLORIDE] (C - Bronchitis chronic - n/a - [n/a - 9{DF} - Oral])|[BISOPROLOL FUMARATE] (C - Cardiac failure chronic - n/a - [n/a - 2{DF} - Oral])|[CARBOCISTEINE] (C - Bronchitis chronic - n/a - [n/a - 18{DF} - n/a])|[LANSOPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 1{DF} - Oral])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - 4{DF} - n/a])|[SARPOGRELATE] (C - Peripheral arterial occlusive disease - n/a - [n/a - 4{DF} - Oral])|[SUVOREXANT] (C - Insomnia - n/a - [n/a - 1{DF} - Oral])|[TULOBUTEROL, TULOBUTEROL HYDROCHLORIDE] (C - Bronchitis chronic - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458327	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458344	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458349	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458355	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Unknown - );Headache (n/a - Recovered/Resolved - );Leukocytosis (n/a - Unknown - );Musculoskeletal stiffness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Subarachnoid haemorrhage (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting projectile (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458355&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458374	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Death (n/a - Fatal - Results in Death);Fall (n/a - Not Recovered/Not Resolved - );Guillain-Barre syndrome (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010458378	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458379	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458391	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Nausea (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458395	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458406	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (41min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458409	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458417	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - );Muscle strain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Thrombosis (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ARMODAFINIL] (C - Sleep apnoea syndrome - n/a - [n/a - n/a - Oral])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - Oral])|[ROPINIROLE] (C - Restless legs syndrome - n/a - [n/a - n/a - Oral])|[TESTOSTERONE ENANTATE] (C - Blood testosterone decreased - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010458425	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Deafness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458436	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458451	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458456	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458460	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Troponin I increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458465	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[IBUPROFEN, IBUPROFEN SODIUM DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010458488	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458491	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458492	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458495	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458501	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458504	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458507	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458526	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Erythema (n/a - Unknown - );Joint swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458582	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood testosterone decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TESTOSTERONE [TESTOSTERONE] (S - Klinefelter's syndrome - Unknown - [n/a - n/a - Unknown])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Unknown])	[TESTOSTERONE] (C - Klinefelter's syndrome - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010458591	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010458620	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458629	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Unknown - );Hepatic cancer metastatic (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])|ELIQUIS 5 MG FILM-COATED TABLETS [APIXABAN] (S - Anticoagulant therapy - Dose not changed - [n/a - n/a - Unknown])|KEPPRA [LEVETIRACETAM] (S - Epilepsy - Dose not changed - [n/a - n/a - Unknown])|ULTIBRO BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER HARD CAPSULES [GLYCOPYRRONIUM BROMIDE, INDACATEROL MALEATE] (S - Chronic obstructive pulmonary disease - Dose not changed - [n/a - n/a - Unknown])|[AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE, AMILORIDE, HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE DIHYDRATE, HYDROCHLOROTHIAZIDE, ANHYDROUS AMILORIDE HYDROCHLORIDE] (S - Hypertension - Dose not changed - [n/a - n/a - Unknown])|[BISOPROLOL FUMARATE] (S - Hypertension - Dose not changed - [n/a - n/a - Unknown])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (S - Hypertension - Dose not changed - [n/a - n/a - Unknown])|[DUTASTERIDE] (S - Benign prostatic hyperplasia - Dose not changed - [n/a - n/a - Unknown])|[LANSOPRAZOLE] (S - Prophylaxis against gastrointestinal ulcer - Dose not changed - [n/a - n/a - Unknown])|[ROSUVASTATIN CALCIUM] (S - Dyslipidaemia - Dose not changed - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010458648	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Joint swelling (4d - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458697	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pleural effusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458719	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010458740	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458741	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458743	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458745	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458748	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458749	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458752	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458760	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458761	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458765	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010458770	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site hypersensitivity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458771	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458824	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458901	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - );Peripheral coldness (n/a - Recovering/Resolving - );Vasoconstriction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [148d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458910	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Upper respiratory tract irritation (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458934	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Photosensitivity reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	APROVEL 300 MG FILM-COATED TABLETS [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458938	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Unknown - );Sperm analysis abnormal (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458946	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Musculoskeletal pain (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010458950	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010458966	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010458966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010459058	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	REMICADE [INFLIXIMAB] (C - n/a - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010459092	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010459096	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010459100	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010459156	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	DIABETES TYPE 2 MEDICATIONS [NOT AVAILABLE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459168	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Dizziness (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[FORMOTEROL FUMARATE, BUDESONIDE] (C - n/a - n/a - )|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - )|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459178	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (0d - Recovered/Resolved - );Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459178&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459180	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Guillain-Barre syndrome (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459185	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Photophobia (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459194	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye inflammation (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459220	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (7d - Recovering/Resolving - );Urticaria (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459224	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459229	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459236	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal operation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459262	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459278	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459282	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gingival pain (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459303	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Not Recovered/Not Resolved - );Injection site swelling (1d - Recovering/Resolving - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459305	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010459314	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Heavy menstrual bleeding (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459319	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (14d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459332	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459339	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (0d - Unknown - );Disturbance in attention (0d - Unknown - );Dizziness (0d - Unknown - );Fatigue (0d - Unknown - );Headache (0d - Unknown - );Injection site pain (0d - Unknown - );Pain in extremity (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459350	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (2d - Not Recovered/Not Resolved - );Musculoskeletal chest pain (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Pulmonary pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459378	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation);Staphylococcal sepsis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Tachypnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[DIPYRIDAMOLE] (C - n/a - n/a - [n/a - 50mg - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 2mg - n/a])|[DRIED FERROUS SULFATE, FERROUS SULFATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - 5mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 40mg - n/a])|[OXYBUTYNIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - 20mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 20mg - n/a])|[TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 2mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010459389	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010459390	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - );Painful respiration (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010459391	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Trismus (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010459394	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hereditary spherocytosis (n/a - Fatal - Results in Death);Malaise (n/a - Fatal - Results in Death);Pulmonary hypertension (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010459446	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Unknown - );Fatigue (3d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pruritus (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459455	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Facial paresis (8d - Recovered/Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459568	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459573	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459581	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459589	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Thirst (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459593	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ruptured cerebral aneurysm (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010459594	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459605	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459615	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - );Dysgeusia (n/a - Unknown - );Fatigue (n/a - Unknown - );Feeling hot (n/a - Unknown - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459616	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459619	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (7d - Recovering/Resolving - );Malaise (7d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459621	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (12d - Unknown - );Nasopharyngitis (12d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459638	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Facial paresis (8d - Recovered/Resolved - );Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010459639	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459667	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hypersomnia (n/a - Recovered/Resolved - );Illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459688	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (32d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - );Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010459721	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chillblains (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	[PARACETAMOL] (C - Product used for unknown indication - n/a - [0mo - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459739	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459771	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Constipation (n/a - Recovered/Resolved - );Feeling cold (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - );Peripheral coldness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010459825	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010459826	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010459830	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010459868	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459869	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (0d - Recovered/Resolved - Other Medically Important Condition);Hypoaesthesia oral (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010459870	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010459900	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010459900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010460042	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010460120	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010460122	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyskinesia (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010460125	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010460128	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bursitis (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010460129	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site infection (14d - Recovered/Resolved - );Injection site inflammation (14d - Recovered/Resolved - );Injection site swelling (14d - Recovered/Resolved - );Injection site warmth (14d - Recovered/Resolved - );Malaise (14d - Recovered/Resolved - );Myalgia (14d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010460257	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Abnormal behaviour (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);COVID-19 immunisation (n/a - Unknown - );COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extra dose administered (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pancreatic failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tracheal disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urinary tract infection (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|SPIKEVAX [ELASOMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLCYSTEINE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[ASCORBIC ACID] (C - Product used for unknown indication - n/a - [n/a - 500mg - Unknown])|[FLUFENAMIC ACID] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])|[PARACETAMOL] (C - Product used for unknown indication - n/a - [n/a - 500mg - Unknown])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Product used for unknown indication - n/a - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010460320	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460322	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460329	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460330	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460643	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460687	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (20d - Not Recovered/Not Resolved - );Cough (20d - Not Recovered/Not Resolved - );Dyspnoea (20d - Not Recovered/Not Resolved - );Fatigue (20d - Not Recovered/Not Resolved - );Pyrexia (20d - Not Recovered/Not Resolved - );Sneezing (20d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010460712	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460713	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460717	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460720	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460729	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460732	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460735	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010460842	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Dizziness (3d - Recovered/Resolved - );Hot flush (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - );Night sweats (3d - Recovered/Resolved - );Palpitations (3d - Recovered/Resolved - );Reversed hot-cold sensation (3d - Recovered/Resolved - );Somnolence (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010460885	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cold sweat (0d - Recovered/Resolved - );Pallor (0d - Recovered/Resolved - );Presyncope (0d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010460903	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - );Asthenia (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Puncture site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010460906	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Recovering/Resolving - Life Threatening);Confusional state (n/a - Recovering/Resolving - Life Threatening);Dizziness (n/a - Recovering/Resolving - Life Threatening);Fatigue (n/a - Recovering/Resolving - Life Threatening);Palpitations (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010460951	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Insomnia (30h - Recovered/Resolved - );Pruritus (30h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[METOPROLOL, METOPROLOL TARTRATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010460951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461001	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010461029	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461030	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461031	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461032	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461037	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461041	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461044	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461046	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461053	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Myasthenia gravis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010461081	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Blood pressure decreased (13min - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Heart rate decreased (13min - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461083	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (68min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461085	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461086	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461087	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ankylosing spondylitis (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461106	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461114	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Gait inability (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Loss of bladder sensation (n/a - Not Recovered/Not Resolved - Disabling);Loss of control of legs (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010461117	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Depressed mood (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461122	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461130	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461130&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461136	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Incoherent (n/a - Recovered/Resolved - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - Other Medically Important Condition);Unresponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	CARBIDOPA, LEVODOPA [CARBIDOPA, LEVODOPA] (C - n/a - n/a - [n/a - n/a - n/a])|IRBESARTAN [IRBESARTAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461141	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461144	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Erythema (n/a - Unknown - );Musculoskeletal pain (n/a - Unknown - );Swelling (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	LINAGLIPTIN [LINAGLIPTIN] (C - n/a - n/a - [n/a - 5mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[FLUCLOXACILLIN, FLUCLOXACILLIN SODIUM, FLUCLOXACILLIN SODIUM MONOHYDRATE] (C - n/a - n/a - [n/a - 500mg - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - 80mg - n/a])|[LORATADINE] (C - n/a - n/a - [n/a - 10mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - 80mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461162	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461168	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461182	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461185	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - );Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - );Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461186	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Fatal - Results in Death);Chest pain (n/a - Fatal - Results in Death);Vomiting (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010461192	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Thrombophlebitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461194	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Unknown - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Lymph node pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Night sweats (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatic adenoma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461197	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Santiago, J.. RARE EXPRESSION OF SYSTEMIC SARCOIDOSIS AFTER A NOVEL RNA VACCINE. Chest. 2021;160 (4 Suppl):A1233-A1234. doi:10.1016/j.chest.2021.07.1134	18-64 Years	Not Specified	No	Male	Iridocyclitis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461203	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Disorientation (n/a - Unknown - );Dizziness (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Swelling (n/a - Unknown - Other Medically Important Condition);Urticaria (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VACCINE] (S - n/a - Not applicable - [1d - n/a - n/a])	[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TERAZOSIN, TERAZOSIN HYDROCHLORIDE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461213	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Drug ineffective (n/a - Unknown - Other Medically Important Condition);Herpes zoster (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Pruritus (n/a - Unknown - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461214	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Drug ineffective (n/a - Fatal - Results in Death, Other Medically Important Condition);Suspected COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010461222	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461235	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Disease recurrence (10min - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Epilepsy (10min - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010461246	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461250	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Ischaemic cardiomyopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Coronary artery disease - n/a - [n/a - 75mg - Oral])|[ACETYLSALICYLIC ACID] (C - Coronary artery disease - n/a - [n/a - 81mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - Coronary artery disease - n/a - [n/a - 80mg - Oral])|[ATORVASTATIN] (C - Blood cholesterol abnormal - n/a - [n/a - 80mg - n/a])|[CARVEDILOL] (C - Cardiac disorder - n/a - [n/a - 12.5mg - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - Coronary artery disease - n/a - [n/a - 25mg - Oral])|[TICAGRELOR] (C - Cardiac disorder - n/a - [n/a - 180mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010461304	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, BUDESONIDE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461340	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Balance disorder (n/a - Unknown - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010461374	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (5d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461377	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin burning sensation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461406	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461407	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Chronic obstructive pulmonary disease (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461408	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461410	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumonia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461417	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461420	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461424	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461428	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Peripheral vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombophlebitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461439	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Vasculitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461444	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010461455	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461456	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (1d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Chills (11d - Recovered/Resolved With Sequelae - );Pyrexia (11d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461528	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);COVID-19 pneumonia (n/a - Unknown - Caused/Prolonged Hospitalisation);Fibrin D dimer increased (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Thyroid gland scan abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Tracheal deviation (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LIXIANA 60 MG [EDOXABAN, EDOXABAN TOSYLATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[BUMETANIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[LORMETAZEPAM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - n/a - Unknown - [n/a - .5{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461531	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461537	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461537&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461540	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (3mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010461548	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Recovered/Resolved - );Feeling cold (3d - Recovered/Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461552	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angioedema (n/a - Not Recovered/Not Resolved - );Blood immunoglobulin E (n/a - Not Recovered/Not Resolved - );Cough (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461574	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461637	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (4d - Recovered/Resolved - );Hypoaesthesia (5d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	OZEMPIC SOLUTION FOR INJECTION IN PRE-FILLED PEN [SEMAGLUTIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461689	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461691	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461693	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461695	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461698	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461705	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461799	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461855	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (24h - Recovering/Resolving - );Headache (24h - Recovering/Resolving - );Myalgia (24h - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461860	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461861	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461870	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010461871	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Epigastric discomfort (n/a - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Oropharyngeal discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461874	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461875	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved - );C-reactive protein increased (n/a - Recovering/Resolving - );Joint swelling (n/a - Recovering/Resolving - );Neck pain (n/a - Recovered/Resolved - );Polyarthritis (n/a - Recovering/Resolving - Other Medically Important Condition);Swelling (n/a - Recovering/Resolving - );White blood cell count increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461878	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Depressed mood (n/a - Unknown - );Lymph node pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461898	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461907	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discomfort (n/a - Unknown - );Lymphadenitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010461913	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Fatal - Results in Death, Other Medically Important Condition);Back pain (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Decreased appetite (n/a - Fatal - Results in Death, Other Medically Important Condition);Dehydration (n/a - Fatal - Results in Death, Other Medically Important Condition);Depressed level of consciousness (n/a - Fatal - Results in Death, Other Medically Important Condition);Malaise (n/a - Fatal - Results in Death, Other Medically Important Condition);Pupillary reflex impaired (n/a - Fatal - Results in Death, Other Medically Important Condition);Unresponsive to stimuli (n/a - Fatal - Results in Death, Other Medically Important Condition);Vomiting (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	CELECOXIB [CELECOXIB] (C - Back pain - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[CARBOCISTEINE] (C - Bronchitis chronic, Interstitial lung disease - n/a - [n/a - 500mg - Oral])|[ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ESOMEPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[MIROGABALIN BESILATE] (C - Neuralgia - n/a - [n/a - n/a - Oral])|[TELMISARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[TIZANIDINE, TIZANIDINE HYDROCHLORIDE] (C - Back pain, Cervicobrachial syndrome - n/a - [n/a - 1mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010461916	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461920	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (1h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010461969	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (8d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccination failure (8d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - [n/a - 1g - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - 130mg - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - Unknown - [n/a - 80mg - n/a])|[BACLOFEN] (C - n/a - Unknown - [n/a - .5{DF} - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE] (C - n/a - Unknown - [n/a - 2.5mg - n/a])|[FENOFIBRATE] (C - n/a - Unknown - [n/a - 200mg - n/a])|[GABAPENTIN] (C - n/a - Unknown - [n/a - 200mg - n/a])|[OMEPRAZOLE] (C - n/a - Unknown - [n/a - 40mg - n/a])|[PROPIVERINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 15mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010461982	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010461985	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Cyanosis (n/a - Recovered/Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Radial pulse abnormal (0d - Recovered/Resolved - Other Medically Important Condition);Somnolence (0d - Recovered/Resolved - Other Medically Important Condition);Tachycardia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010461988	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Contusion (n/a - Unknown - );Fall (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010461994	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (110min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010461994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462084	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Obesity (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010462085	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hallucination, auditory (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])|VALSARTAN, AMLODIPINE [VALSARTAN, AMLODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMFETAMINE SULFATE, DEXAMFETAMINE SULFATE, AMFETAMINE ASPARTATE, DEXAMFETAMINE SACCHARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462183	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462187	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462188	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Application site reaction (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462191	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462199	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462202	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462205	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462205&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462206	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462240	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (20min - Unknown - );Haematemesis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462242	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling cold (n/a - Recovered/Resolved - );Hypotension (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010462245	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462256	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	COVID-19 (n/a - Fatal - Results in Death, Other Medically Important Condition);Cough (n/a - Unknown - );Decreased appetite (n/a - Unknown - );Dysphagia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );General physical health deterioration (n/a - Unknown - );Immobile (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010462258	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - );Blood pressure increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462288	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462323	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010462359	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Burning sensation (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Movement disorder (n/a - Not Recovered/Not Resolved - );Neuralgia (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462392	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - );Hypoxia (n/a - Unknown - Other Medically Important Condition);Respiratory failure (n/a - Unknown - Other Medically Important Condition);Tachypnoea (n/a - Unknown - );Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BUMETANIDE [BUMETANIDE] (C - n/a - n/a - [n/a - 9mg - n/a])|ENOXAPARIN SODIUM [ENOXAPARIN SODIUM] (C - n/a - n/a - [n/a - 20mg - n/a])|[DIGOXIN] (C - n/a - n/a - [n/a - .062mg - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 4mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010462395	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Gaze palsy (n/a - Recovered/Resolved - Other Medically Important Condition);Moaning (n/a - Recovered/Resolved - Other Medically Important Condition);Respiratory distress (n/a - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010462422	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle tightness (n/a - Recovering/Resolving - Disabling);Pain (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010462436	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Unknown - );Cardiac failure acute (n/a - Fatal - Results in Death, Life Threatening, Disabling, Other Medically Important Condition);Decreased appetite (n/a - Unknown - );Insomnia (n/a - Unknown - );Pericarditis (n/a - Fatal - Results in Death, Life Threatening, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462436&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010462473	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arrhythmia (n/a - Fatal - Results in Death);Cardiovascular disorder (n/a - Fatal - Results in Death);Coronary artery disease (n/a - Fatal - Results in Death);Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[BACILLUS SUBTILIS, LACTOMIN, BIFIDOBACTERIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[ISOSORBIDE DINITRATE] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[LAFUTIDINE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[MAGNESIUM OXIDE] (C - Constipation - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010462481	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral ischaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Glomerular filtration rate decreased (n/a - Unknown - );Haematocrit decreased (n/a - Unknown - );Hypoaesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Monoplegia (43530min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paralysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);White blood cell count decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - Gout - n/a - [n/a - 1{DF} - Oral])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - Epilepsy - n/a - [n/a - 9{DF} - Oral])|[LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - Thyroiditis chronic - n/a - [n/a - 1{DF} - Oral])|[NAFTOPIDIL] (C - Benign prostatic hyperplasia - n/a - [n/a - 1{DF} - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462504	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (18min - Recovered/Resolved - Other Medically Important Condition);Heart rate increased (18min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010462505	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (61min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - 75mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462511	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Insomnia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462518	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Unknown - );Cardiac disorder (n/a - Not Recovered/Not Resolved - );Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	BUDESONIDE [BUDESONIDE] (C - Hypertension, Sinusitis, Small airways disease - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462764	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Balance disorder (n/a - Unknown - );Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - );Vertigo positional (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462782	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID, GLYCINE, ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[CLOPIDOGREL] (C - n/a - n/a - [n/a - n/a - Periarticular])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[GLIMEPIRIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010462790	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Tinnitus (10d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462791	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462794	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash macular (6wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462797	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (7d - Recovered/Resolved - );Insomnia (3d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462803	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010462807	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epistaxis (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462808	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain lower (1d - Recovering/Resolving - );Diarrhoea (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462810	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (2d - Not Recovered/Not Resolved - );Dizziness exertional (2d - Not Recovered/Not Resolved - );Dyspnoea exertional (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Peripheral vascular disorder (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462811	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462820	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462823	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Memory impairment (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462824	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462826	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462832	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462836	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Hypoaesthesia (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Panic reaction (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462837	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462859	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462903	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Alopecia (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462906	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010462909	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiparesis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462909&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462913	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010462927	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462980	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Parapsoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462981	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010462983	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010462987	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chronic obstructive pulmonary disease (n/a - Recovered/Resolved - Other Medically Important Condition);Condition aggravated (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010462988	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradycardia (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010462989	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrioventricular block complete (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462992	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462994	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010462999	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	TRELEGY ELLIPTA 92 MICROGRAMS/55 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED [UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[BILASTINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010462999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463005	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463007	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Retinal artery occlusion (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463011	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Other Medically Important Condition);Hypertension (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463017	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463026	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010463027	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute motor-sensory axonal neuropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	[ESCITALOPRAM] (C - n/a - n/a - [n/a - n/a - n/a])|[VERAPAMIL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463041	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Eczema (n/a - Recovering/Resolving - Other Medically Important Condition);Eosinophilia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])|[BICALUTAMIDE] (S - Prostate cancer - Drug withdrawn - [91d - n/a - Oral])|[LEUPRORELIN] (S - Prostate cancer - Drug withdrawn - [3mo - 5mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463042	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463047	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pneumothorax (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463049	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (24h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (3mo - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463058	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	AVAMYS [FLUTICASONE FUROATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463067	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash maculo-papular (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|[CELECOXIB] (S - Analgesic therapy - Drug withdrawn - [11d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Myocardial ischaemia - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE] (C - Myocardial ischaemia - n/a - )|[ATORVASTATIN CALCIUM, EZETIMIBE, ATORVASTATIN, EZETIMIBE] (C - Ischaemic heart disease prophylaxis - n/a - )|[BISOPROLOL FUMARATE] (C - Myocardial ischaemia - n/a - )|[LANSOPRAZOLE] (C - Product used for unknown indication - n/a - )|[PARACETAMOL] (C - Pain - n/a - )|[RAMIPRIL] (C - Myocardial ischaemia - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463070	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463071	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac ventricular thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ejection fraction decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463072	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Hot flush (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - );Visual acuity reduced (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463077	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463087	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden death (n/a - Fatal - Results in Death, Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010463088	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463089	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463091	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463097	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463115	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463137	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	XARELTO 20 MG FILM-COATED TABLETS [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 7.5mg - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 2mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463140	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463141	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Henoch-Schonlein purpura (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463141&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463162	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [32d - 1{DF} - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463163	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463170	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463176	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Exfoliative rash (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - );Skin ulcer (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE, AMLODIPINE, PERINDOPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 2.5mg - n/a])|[D,L-LYSINE ACETYLSALICYLATE] (C - n/a - n/a - [n/a - 75mg - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1000mg - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 40mg - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - n/a - n/a - [n/a - .5mg - n/a])|[TRAMADOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 150mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463179	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463180	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463181	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Transient ischaemic attack (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463185	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463192	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haemolytic anaemia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 2{DF} - Intramuscular])	[ATOVAQUONE] (C - n/a - Dose not changed - [n/a - 1.5mg - Oral])|[FOLIC ACID] (C - n/a - Dose not changed - [n/a - 10mg - Oral])|[HYDROXYCHLOROQUINE SULFATE] (C - n/a - Dose not changed - [n/a - 400mg - Oral])|[PHENOXYMETHYLPENICILLIN] (C - n/a - Dose not changed - [n/a - 2M[iU] - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010463219	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463224	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Odynophagia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463226	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463228	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463229	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Migraine (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463231	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463243	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Neuropathy peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463253	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463257	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Eczema nummular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463269	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463278	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463279	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Stereotypy (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463299	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [153d - .3mL - Intramuscular])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463308	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463313	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463316	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463323	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Dyspnoea exertional (n/a - Recovered/Resolved - );Gait disturbance (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [25d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463324	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Flat affect (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Hypogammaglobulinaemia (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463333	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Loss of consciousness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463340	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erythema multiforme (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463343	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463345	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463346	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463367	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463369	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epilepsy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	KEPPRA 100 MG/ML ORAL SOLUTION [LEVETIRACETAM] (C - Epilepsy - Dose not changed - [n/a - n/a - Oral])|[AMITRIPTYLINE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Oral])|[CLOBAZAM] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Oral])|[LOXAPINE, LOXAPINE SUCCINATE] (C - Product used for unknown indication - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463370	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463371	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463382	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463384	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463388	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Trismus (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463399	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disease recurrence (n/a - Recovered/Resolved - );Transient acantholytic dermatosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463413	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Oropharyngeal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463424	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463427	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463429	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463430	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463438	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [38d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463451	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463456	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (48h - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463458	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463466	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463468	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463476	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (2h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463478	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463484	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463484&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463488	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463490	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463500	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	C-reactive protein increased (n/a - Unknown - );International normalised ratio increased (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])|[FLUINDIONE] (S - n/a - n/a - [n/a - n/a - Oral])	LANTUS [INSULIN GLARGINE] (C - n/a - n/a - )|TRULICITY [DULAGLUTIDE] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - )|[DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - )|[FUROSEMIDE] (C - n/a - n/a - )|[LAMOTRIGINE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )|[PERINDOPRIL, PERINDOPRIL ARGININE, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - )|[SOLIFENACIN, SOLIFENACIN SUCCINATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463501	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Head discomfort (n/a - Recovered/Resolved - );Sudden hearing loss (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010463509	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463510	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Recovered/Resolved - );Rash pruritic (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463515	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463516	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010463528	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (15d - Recovered/Resolved - );Myalgia (15d - Recovered/Resolved - );Nausea (15d - Recovered/Resolved - );Pyrexia (15d - Recovered/Resolved - );Vomiting (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010463828	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - Disabling);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Recovered/Resolved - Disabling);Vaccination site pain (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010463829	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010463835	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463839	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Yesilkaya, U.. A novel adverse effect of the BNT162b2 mRNA vaccine: First episode of acute mania with  psychotic features. Brain, Behavior, &amp; Immunity - Health. 2021;18:10.1016/j.bbih.2021.100363. doi:10.1016/j.bbih.2021.100363	18-64 Years	Not Specified	No	Male	Mania (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Psychotic behaviour (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463850	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sepsis (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010463856	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);COVID-19 (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - );Drug ineffective (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysstasia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Encephalopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Fall (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Jaundice (n/a - Unknown - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular - More in ICSR])	KEPPRA [LEVETIRACETAM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010463860	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463869	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463879	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Grip strength decreased (n/a - Unknown - );Hypersensitivity (n/a - Unknown - );Hypertension (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - );Rash (n/a - Unknown - );Rash erythematous (n/a - Unknown - );Skin depigmentation (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010463891	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diplegia (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463978	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - Other Medically Important Condition);Initial insomnia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010463984	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010463984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010464070	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464153	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010464158	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464160	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Respiration abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464167	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Fatal - Results in Death, Other Medically Important Condition);Neoplasm malignant (n/a - Fatal - Results in Death, Other Medically Important Condition);Portal vein thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010464169	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cough (n/a - Unknown - );Haemoptysis (n/a - Unknown - );Immune thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Interstitial lung disease (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lung opacity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	REVOLADE [ELTROMBOPAG] (C - Immune thrombocytopenia - n/a - [n/a - n/a - n/a])|[FAMOTIDINE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE, PREDNISOLONE ACETATE] (C - Immune thrombocytopenia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010464220	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dementia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Transient ischaemic attack - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010464228	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464283	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010464298	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye inflammation (12d - Recovered/Resolved - );Oral herpes (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[DILTIAZEM, DILTIAZEM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464346	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Meningitis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010464371	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Epistaxis (n/a - Unknown - );Optic neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Somnolence (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464375	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464380	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[LINAGLIPTIN] (C - Diabetes mellitus - n/a - [43d - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464384	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464494	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464494&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464525	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Atrioventricular block (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cardiac disorder (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Multiple organ dysfunction syndrome (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010464529	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Endocrine ophthalmopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Graves' disease (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperthyroidism (n/a - Recovered/Resolved - Other Medically Important Condition);Toxic goitre (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464558	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Mobility decreased (n/a - Not Recovered/Not Resolved - Disabling);Periarthritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010464570	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464578	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Blood pressure increased (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Hypersensitivity (n/a - Unknown - );Hypoaesthesia oral (n/a - Unknown - );Lip pruritus (n/a - Not Recovered/Not Resolved - );Oropharyngeal discomfort (n/a - Unknown - );Pain (n/a - Recovering/Resolving - );Paraesthesia oral (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Rhinorrhoea (n/a - Unknown - );Swelling (n/a - Recovering/Resolving - );Tachycardia (n/a - Unknown - Other Medically Important Condition);Tension headache (n/a - Unknown - );Throat irritation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464579	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464582	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Unknown - );Peripheral swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ATENOLOL, ATENOLOL HYDROCHLORIDE, ATENOLOL PH. EUR.] (C - Hypertension - n/a - [n/a - n/a - n/a])|[AZILSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[BENZBROMARONE] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Hyperuricaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464646	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Nasopharyngitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR.] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[DUTASTERIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464656	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (62d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010464707	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464743	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Back pain (n/a - Unknown - );Musculoskeletal pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464748	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arthralgia (24h - Recovered/Resolved - );Fatigue (24h - Recovered/Resolved - );Headache (24h - Recovered/Resolved - );Insomnia (24h - Recovered/Resolved - );Pain in extremity (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464752	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010464757	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition);Eye movement disorder (n/a - Unknown - Other Medically Important Condition);Eye pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - );Hemiparesis (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia oral (n/a - Unknown - Other Medically Important Condition);Hypokinesia (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Migraine (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - );Paraesthesia (n/a - Unknown - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - Other Medically Important Condition);Sleep terror (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464758	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deafness (n/a - Unknown - Other Medically Important Condition);Tinnitus (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[GABAPENTIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464770	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010464787	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010464828	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010464898	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010464978	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010464979	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010464981	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010464981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010465000	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010465180	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465181	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010465214	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465287	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Foetus	Yes	Male	Congenital musculoskeletal disorder of limbs (n/a - Fatal - Results in Death, Congenital Anomaly, Other Medically Important Condition);Limb reduction defect (n/a - Fatal - Results in Death, Congenital Anomaly, Other Medically Important Condition);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transplacental])	[CYANOCOBALAMIN, FOLIC ACID, POTASSIUM IODIDE, POTASSIUM IODIDE] (C - Pregnancy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010465306	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Monoplegia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010465311	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden hearing loss (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010465331	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute febrile neutrophilic dermatosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cellulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Erythema nodosum (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - );Vasculitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010465442	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 10mg - n/a])|[CLONIDINE] (C - n/a - n/a - [n/a - 200mg - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 100mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465444	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Nausea (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Vertigo (n/a - Unknown - Other Medically Important Condition);Vertigo positional (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19) [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	[FINASTERIDE] (C - Prostatomegaly - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465461	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465462	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465469	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465471	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465471&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465473	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465475	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465561	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465565	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Other Medically Important Condition);Sinus bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	GILENYA [FINGOLIMOD] (C - n/a - n/a - [n/a - .5g - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM TRIHYDRATE] (C - n/a - n/a - [n/a - 5mg - Oral])|[CARVEDILOL] (C - n/a - n/a - [n/a - 1.25mg - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - Oral])|[RIBOFLAVIN] (C - n/a - n/a - [n/a - 100mg - Oral])|[TELMISARTAN, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - Oral])|[THIAMINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 100mg - Oral])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010465566	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaemia (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010465568	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (15min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465618	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (3h - Recovered/Resolved - );Nausea (3h - Recovered/Resolved - );Taste disorder (3h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465622	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465629	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465645	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465646	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465656	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash pruritic (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465668	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Periarthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465717	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Condition aggravated (3d - Recovered/Resolved - );Gout (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - Gout - n/a - [3y - n/a - n/a])|[CANDESARTAN] (C - Hypertension - n/a - [4y - n/a - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - Hypertension - n/a - [3y - n/a - n/a])|[EPLERENONE] (C - Hypertension - n/a - [3y - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465726	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465727	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465823	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010465946	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Giant cell arteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010465951	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	GANFORT [TIMOLOL MALEATE, BIMATOPROST] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])|[AZELAIC ACID] (C - Hidradenitis - n/a - [n/a - n/a - Cutaneous])|[DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE] (C - Glaucoma - n/a - [n/a - n/a - Ophthalmic])|[KETOCONAZOLE, KETOCONAZOLE PH. EUR.] (C - Dandruff - n/a - [n/a - n/a - Cutaneous])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - Oral])|[SILDENAFIL] (C - Erectile dysfunction - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010465954	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diplopia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465978	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (1d - Recovered/Resolved - );Arthralgia (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465981	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010465989	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[WARFARIN, WARFARIN SODIUM, WARFARIN SODIUM BP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010465989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466001	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cardiac fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466003	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466015	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	XIGDUO [METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - Oral])|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[GLYCERYL TRINITRATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METOPROLOL SUCCINATE, METOPROLOL TARTRATE] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010466017	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466029	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466032	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Brain stem thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466061	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cyanosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	NIMVASTID [RIVASTIGMINE] (C - n/a - n/a - [n/a - n/a - Oral])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - Parkinson's disease - n/a - [n/a - n/a - Oral])|[CETRIMIDE, HYPROMELLOSE] (C - Eye lubrication therapy - n/a - [n/a - n/a - Ophthalmic])|[DRIED FERROUS SULFATE, FERROUS SULFATE] (C - Iron deficiency - n/a - [n/a - n/a - Oral])|[FLUORIDE, SODIUM FLUORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE, MAGNESIUM OXIDE, LIGHT] (C - Constipation - n/a - [n/a - n/a - Oral])|[MICONAZOLE, MICONAZOLE NITRATE, MICONAZOLE NITRATE, HYDROCORTISONE] (C - Fungal infection - n/a - [n/a - n/a - Cutaneous])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[QUETIAPINE, QUETIAPINE HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[SODIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[SODIUM PICOSULFATE] (C - Constipation - n/a - [n/a - n/a - Oral])|[TOBRAMYCIN] (C - Eye infection - n/a - [n/a - n/a - Ophthalmic])|[VITAMIN D, CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466061&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466062	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466067	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466087	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebral thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466095	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	INSULIN DEGLUDEC [INSULIN DEGLUDEC] (C - n/a - n/a - [n/a - n/a - Subcutaneous])|NOVORAPID FLEXPEN [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|OZEMPIC [SEMAGLUTIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|VIZARSIN [SILDENAFIL, SILDENAFIL CITRATE] (C - Erectile dysfunction - n/a - [n/a - n/a - Oral])|[ACICLOVIR] (C - Herpes virus infection - n/a - [n/a - n/a - Oral])|[ACICLOVIR] (C - n/a - n/a - [n/a - n/a - Oral])|[ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, SODIUM CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, ALUMINIUM HYDROXIDE GEL, DRIED USP, SODIUM HYDROGEN CARBONATE, ALGINIC ACID, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, ALUMINIUM HYDROXIDE GEL, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN CARBONATE, CALCIUM CARBONATE, SODIUM ALGINATE, ALUMINIUM HYDROXIDE, SODIUM HYDROGEN CARBONATE, SODIUM ALGINATE] (C - Gastrooesophageal reflux disease - n/a - [n/a - n/a - Oral])|[BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - Respiratory (inhalation)])|[FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE HYDRATE] (C - Bronchospasm - n/a - [n/a - n/a - Respiratory (inhalation)])|[MESALAZINE] (C - n/a - n/a - [n/a - n/a - Rectal])|[METFORMIN HYDROCHLORIDE] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - Oral])|[MOMETASONE FUROATE, MOMETASONE FUROATE MONOHYDRATE] (C - Nasal congestion - n/a - [n/a - n/a - Nasal])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Prophylaxis against gastrointestinal ulcer - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[PREDNISOLONE] (C - n/a - n/a - [n/a - n/a - Rectal])|[TADALAFIL] (C - Erectile dysfunction - n/a - [n/a - n/a - Oral])|[VITAMIN D, CALCIUM] (C - Mineral supplementation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466102	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Erythema (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - Oral])|PRADAXA [DABIGATRAN ETEXILATE, DABIGATRAN ETEXILATE MESILATE] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - Gouty arthritis - n/a - [n/a - n/a - Oral])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - Oral])|[ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[GLYCERYL TRINITRATE] (C - Angina pectoris - n/a - [n/a - n/a - n/a])|[ISOSORBIDE MONONITRATE] (C - Angina pectoris - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Pain - n/a - [n/a - n/a - Oral])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466103	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eyelid function disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466116	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Electric shock sensation (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466116&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466122	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466176	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466213	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466220	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466222	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466226	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466274	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site movement impairment (4d - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466289	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466291	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466298	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466301	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	HUMALOG KWIKPEN 100 U/ML SOLUTION FOR INJECTION [INSULIN LISPRO] (C - Diabetes mellitus - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010466302	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovered/Resolved - );Depressed mood (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466306	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	HYRIMOZ 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN [ADALIMUMAB] (C - Crohn's disease - Dose not changed - [n/a - n/a - Subcutaneous])|[COLECALCIFEROL, CALCIUM CARBONATE] (C - Crohn's disease - Dose not changed - [n/a - n/a - Oral])|[METRONIDAZOLE] (C - Crohn's disease - Dose not changed - [n/a - n/a - Oral])|[PREDNISONE] (C - Crohn's disease - Dose not changed - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466312	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466318	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466336	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466387	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466424	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pancreatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466438	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466439	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Oxygen saturation decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466446	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Arthralgia (n/a - Unknown - );Electrocardiogram abnormal (2d - Recovered/Resolved - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	BUDESONIDE [BUDESONIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[HYDROCHLOROTHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Cardiac disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010466448	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (194h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (194h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (218h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Erythema (218h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (218h - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (218h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[CROTAMITON] (S - n/a - Unknown - [n/a - n/a - n/a])|[DIPHENHYDRAMINE HYDROCHLORIDE] (S - n/a - Unknown - [n/a - n/a - n/a])|[DIPOTASSIUM GLYCYRRHIZATE] (S - n/a - Unknown - [n/a - n/a - n/a])|[LEVOMENTHOL] (S - n/a - Unknown - [n/a - n/a - n/a])|[LIDOCAINE, LIDOCAINE HYDROCHLORIDE] (S - n/a - Unknown - [n/a - n/a - n/a])|[ZINC OXIDE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466449	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466454	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (30min - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466513	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466521	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[METOCLOPRAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL SULFATE, IPRATROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466521&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466523	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	FIASP 100 UNITS/ML PENFILL SOLUTION FOR INJECTION IN CARTRIDGE [INSULIN ASPART] (C - n/a - n/a - [n/a - n/a - n/a])|[SELENIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466538	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010466547	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Hordeolum (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466636	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466637	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466638	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466643	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466645	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466762	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010466766	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal growth restriction (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	[FOLIC ACID] (C - n/a - n/a - [n/a - 400ug - Transplacental])|[ONDANSETRON HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466768	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - 1800mg - n/a])|[COLCHICINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 2g - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466770	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Enterocolitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (450min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010466818	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Blood pressure diastolic increased (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466883	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466885	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466891	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466895	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010466911	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Altered state of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Dysphoria (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypotension (n/a - Recovered/Resolved - Other Medically Important Condition);Poor quality product administered (n/a - Unknown - );Pulse abnormal (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010466911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010467007	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Foetal death (n/a - Fatal - Results in Death, Disabling);Foetal hypokinesia (n/a - Fatal - Results in Death, Congenital Anomaly);Maternal exposure during pregnancy (n/a - Fatal - Results in Death, Congenital Anomaly);Umbilical cord abnormality (n/a - Fatal - Results in Death, Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010467047	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467050	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467051	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467069	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467142	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Yesilkaya, U.. A novel adverse effect of the BNT162b2 mRNA vaccine: First episode of acute mania with  psychotic features. Brain, Behavior, &amp; Immunity - Health. 2021;18:10.1016/j.bbih.2021.100363. doi:10.1016/j.bbih.2021.100363	18-64 Years	Not Specified	No	Male	Mania (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Psychotic behaviour (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010467144	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alanine aminotransferase increased (n/a - Unknown - Other Medically Important Condition);Arthralgia (3150min - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Gamma-glutamyltransferase increased (n/a - Unknown - );Headache (3150min - Recovered/Resolved - );Lymphocyte count decreased (n/a - Unknown - );Malaise (n/a - Unknown - );Mean cell volume abnormal (n/a - Unknown - );Muscular weakness (n/a - Recovered/Resolved - );Neutrophil count increased (n/a - Unknown - );Pyrexia (3150min - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site swelling (3150min - Recovered/Resolved - );White blood cell count increased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467251	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - Other Medically Important Condition);Lymphadenopathy (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	KEPPRA [LEVETIRACETAM] (C - Epilepsy - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Immunisation - n/a - [n/a - n/a - n/a])|[CODEINE] (C - Analgesic therapy - n/a - [n/a - n/a - n/a])|[SODIUM VALPROATE, VALPROIC ACID, SODIUM VALPROATE] (C - Epilepsy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467291	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Migraine (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467302	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ageusia (n/a - Recovering/Resolving - Disabling);Bell's palsy (20d - Recovered/Resolved - Disabling);Facial paralysis (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010467309	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467310	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467346	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (14d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467357	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Sudden hearing loss (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467360	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intestinal ischaemia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010467389	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoglycaemia (n/a - Unknown - );Hypotension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467393	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Seizure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467402	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Skin haemorrhage (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467403	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (16d - Not Recovered/Not Resolved - );Headache (16d - Not Recovered/Not Resolved - );Influenza like illness (16d - Not Recovered/Not Resolved - );Laryngopharyngitis (16d - Not Recovered/Not Resolved - );Sinusitis (16d - Not Recovered/Not Resolved - );Sleep apnoea syndrome (16d - Not Recovered/Not Resolved - );Sleep disorder (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467404	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467408	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467410	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467419	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467422	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467433	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467445	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467447	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	SARS-CoV-2 test positive (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467455	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467462	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Language disorder (n/a - Recovered/Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467469	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467472	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood fibrinogen abnormal (n/a - Unknown - );Fibrin D dimer increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467474	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute myocardial infarction (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467485	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (107d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010467491	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467492	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467503	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Lichen planus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467506	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chronic kidney disease (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010467536	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Disseminated intravascular coagulation (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010467538	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467542	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010467545	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010467546	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Somnolence (0d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Visual impairment (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467554	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467558	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467559	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Dyspnoea (n/a - Fatal - Results in Death);Pyrexia (n/a - Fatal - Results in Death);Tachycardia (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010467563	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467566	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (53d - Recovered/Resolved - );Dizziness (53d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010467567	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disseminated intravascular coagulation (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010467586	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Bronchitis (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467590	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467596	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467605	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute generalised exanthematous pustulosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467613	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (63d - Unknown - );Hypoaesthesia (63d - Unknown - );Tension headache (63d - Unknown - );Visual field defect (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010467619	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (0d - Recovered/Resolved - );Memory impairment (n/a - Not Recovered/Not Resolved - );Movement disorder (0d - Recovered/Resolved - );Paralysis (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467621	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467622	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (1d - Unknown - );Hemiparesis (3d - Unknown - );Vomiting (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467626	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ischaemic cerebral infarction (0d - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467643	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Unknown - Caused/Prolonged Hospitalisation);Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Cardiac arrest (n/a - Fatal - Results in Death);Cardiac ventricular thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nasopharyngitis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010467647	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467651	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Shoulder injury related to vaccine administration (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467653	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rheumatic disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467653&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467660	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polyneuropathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467661	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (0d - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010467662	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467664	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467668	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Epstein-Barr virus antibody positive (n/a - Not Recovered/Not Resolved - );Hepatosplenomegaly (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467671	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eosinophilic oesophagitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467680	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diabetes mellitus inadequate control (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467681	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nervous system disorder (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467685	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467690	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467692	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467696	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467698	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Exercise tolerance decreased (n/a - Unknown - );Organic erectile dysfunction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])|COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467705	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467717	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467720	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467721	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination failure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467722	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Child	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467728	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chest pain (n/a - Unknown - );Exercise tolerance decreased (n/a - Unknown - );Neuritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467734	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal vein occlusion (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - Intervertebral disc protrusion - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010467746	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467755	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sinus tachycardia (2d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010467759	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467762	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010467763	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467766	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467768	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Acute kidney injury (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010467775	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Thyroiditis acute (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467781	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Atrial fibrillation (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Cardioversion (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010467782	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	SARS-CoV-2 test positive (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 2{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467786	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467787	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea exertional (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010467794	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467798	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertonia (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467804	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467805	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467821	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467829	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467830	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (11d - Recovered/Resolved - );Hyperhidrosis (11d - Recovered/Resolved - );Sleep attacks (11d - Recovered/Resolved - );Somnolence (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467833	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute vestibular syndrome (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467835	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467839	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010467878	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467883	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010467896	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pharyngeal swelling (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010467999	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010467999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010468002	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrioventricular block (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cerebral infarction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Feeling abnormal (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[CELECOXIB] (C - Neck pain - n/a - [n/a - n/a - Oral])|[EPERISONE HYDROCHLORIDE] (C - Neck pain - n/a - [n/a - n/a - Oral])|[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - Oral])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - Oral])|[THIAMINE HYDROCHLORIDE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE] (C - Neck pain - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010468039	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468208	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010468216	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010468261	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (4d - Recovered/Resolved - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468269	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468277	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468279	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Body temperature increased (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010468284	Spontaneous	2021-10-27 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anosmia (n/a - Recovering/Resolving - );Body temperature increased (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010468349	Spontaneous	2021-10-27 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010468349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010430975	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Sensory disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010430994	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dry mouth (3d - Recovered/Resolved - );Dysphagia (3d - Recovered/Resolved - );Gingival pain (3d - Recovered/Resolved - );Tongue discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431043	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Feeling cold (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431054	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431067	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Coagulopathy (n/a - Not Recovered/Not Resolved - );Deep vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431069	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431103	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Oropharyngeal pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431106	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431117	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431117&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431129	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431133	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431159	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (5d - Not Recovered/Not Resolved - );Arrhythmia (5d - Not Recovered/Not Resolved - );Blood pressure increased (5d - Not Recovered/Not Resolved - );Dyspnoea (5d - Not Recovered/Not Resolved - );Headache (5d - Recovering/Resolving - );Nausea (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431163	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Blood pressure increased (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431165	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431171	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Not Recovered/Not Resolved - );Decreased appetite (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431190	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431194	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Gait disturbance (n/a - Unknown - );Nervous system disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431196	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Influenza like illness (0d - Recovered/Resolved - );Performance status decreased (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431199	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (3d - Recovering/Resolving - );Chills (3d - Recovering/Resolving - );Diarrhoea (3d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - );Vaccination site pain (3d - Recovering/Resolving - );Vomiting (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431202	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (23d - Not Recovered/Not Resolved - );Lymphadenopathy (23d - Not Recovered/Not Resolved - );Myalgia (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010431215	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovering/Resolving - );Rash (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431225	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (13d - Not Recovered/Not Resolved - );Headache (13d - Not Recovered/Not Resolved - );Restlessness (2d - Not Recovered/Not Resolved - );Sleep disorder (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431239	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431253	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431266	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - );Tachycardia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431270	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (3d - Recovering/Resolving - );Pain in extremity (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431276	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431298	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431330	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (4d - Not Recovered/Not Resolved - );Dizziness (4d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Nausea (0d - Recovered/Resolved - );Tachycardia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431360	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431369	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (16d - Not Recovered/Not Resolved - );Vision blurred (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431374	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Pain in extremity (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431377	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood immunoglobulin A (19d - Not Recovered/Not Resolved - );Blood immunoglobulin G increased (19d - Not Recovered/Not Resolved - );Herpes zoster (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431392	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431393	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431411	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Contusion (13d - Recovering/Resolving - );Headache (31d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010431422	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Joint swelling (1d - Recovered/Resolved - );Lip swelling (1d - Recovered/Resolved - );Peripheral swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431429	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (128d - Not Recovered/Not Resolved - );Tachycardia (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431429&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431469	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dermatitis allergic (0d - Not Recovered/Not Resolved - );Rash (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431503	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovered/Resolved - );Diarrhoea (2d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Nasal congestion (2d - Recovered/Resolved - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431510	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431519	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Confusional state (2d - Not Recovered/Not Resolved - );Diarrhoea (2d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - );Movement disorder (2d - Not Recovered/Not Resolved - );Muscle spasms (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - );Renal pain (2d - Not Recovered/Not Resolved - );Somnolence (2d - Not Recovered/Not Resolved - );Toothache (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431522	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (0d - Recovering/Resolving - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431527	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431536	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Not Recovered/Not Resolved - );Hypoaesthesia (4d - Not Recovered/Not Resolved - );Injection site pain (4d - Not Recovered/Not Resolved - );Myalgia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431541	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431541&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431552	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (5d - Not Recovered/Not Resolved - );Chills (5d - Not Recovered/Not Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Oropharyngeal pain (5d - Not Recovered/Not Resolved - );Pyrexia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431565	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Unknown - );Limb discomfort (1d - Unknown - );Myalgia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431622	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431635	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (20d - Recovered/Resolved - );Chest discomfort (20d - Recovered/Resolved - );Dizziness (20d - Recovered/Resolved - );Flushing (20d - Recovered/Resolved - );Head discomfort (20d - Recovered/Resolved - );Tachycardia (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431642	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Limb discomfort (n/a - Not Recovered/Not Resolved - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431647	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved - );Influenza (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431674	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - );Sleep disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431712	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431722	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431757	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphasia (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Eye pain (n/a - Not Recovered/Not Resolved - );Flank pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431784	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (3d - Not Recovered/Not Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431788	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (15d - Not Recovered/Not Resolved - );Myalgia (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431789	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010431849	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431853	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (24d - Not Recovered/Not Resolved - );Vaccination site pain (24d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010431893	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431896	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431900	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Insomnia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432017	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (4d - Recovering/Resolving - );Nasal congestion (4d - Recovering/Resolving - );Oropharyngeal discomfort (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432029	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432046	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (10d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Muscle spasms (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Nervousness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432063	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432067	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Injection site pain (5d - Not Recovered/Not Resolved - );Vaccination site discomfort (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432084	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Local reaction (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432085	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432119	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cyanosis (4d - Recovering/Resolving - );Disturbance in attention (5d - Recovering/Resolving - );Fatigue (4d - Recovering/Resolving - );Feeling hot (5d - Not Recovered/Not Resolved - );Injection site pain (4d - Recovered/Resolved - );Limb discomfort (5d - Not Recovered/Not Resolved - );Pain in extremity (4d - Recovered/Resolved - );Sensory disturbance (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432140	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Hypersensitivity (0d - Recovered/Resolved - );Pruritus (0d - Recovered/Resolved - );Restlessness (0d - Recovered/Resolved - );Tremor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432155	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovered/Resolved - );Pruritus (10d - Recovered/Resolved - );Vaccination site reaction (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432162	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432172	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Injection site erythema (1d - Not Recovered/Not Resolved - );Injection site pruritus (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Not Recovered/Not Resolved - );Pain (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432190	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Energy increased (1d - Recovering/Resolving - );Euphoric mood (1d - Recovering/Resolving - );Exercise tolerance increased (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432191	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial pain (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432194	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Hypertensive crisis (35d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010432202	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432223	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432250	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (10d - Recovered/Resolved - );Nausea (10d - Recovered/Resolved - );Vestibular neuronitis (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432253	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (14d - Recovered/Resolved - );Dyspnoea (14d - Recovered/Resolved - );Fatigue (14d - Recovered/Resolved - );Nausea (14d - Recovered/Resolved - );Oligomenorrhoea (14d - Recovered/Resolved - );Palpitations (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432255	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432270	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Recovering/Resolving - );Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432282	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432305	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432313	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (22d - Not Recovered/Not Resolved - );Dyspnoea (22d - Not Recovered/Not Resolved - );Fatigue (22d - Not Recovered/Not Resolved - );Pulmonary embolism (22d - Not Recovered/Not Resolved - );Troponin increased (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432318	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - );Vomiting (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432360	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Muscular weakness (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432372	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (8d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432391	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hallucination (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432400	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432413	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - );Somnolence (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432420	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphonia (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432424	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Circadian rhythm sleep disorder (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Sleep disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432447	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (12d - Recovered/Resolved - );Haematoma (12d - Recovered/Resolved - );Headache (12d - Recovered/Resolved - );Neuritis (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432451	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (2d - Recovered/Resolved - );Lip swelling (2d - Recovered/Resolved - );Stomatitis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432463	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disorientation (1d - Recovered/Resolved - );Disturbance in attention (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432467	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432469	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Asthenia (1d - Recovering/Resolving - );Chills (0d - Recovered/Resolved - );Dizziness (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Hot flush (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432472	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (7d - Recovered/Resolved - );Paraesthesia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432483	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432524	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (3d - Not Recovered/Not Resolved - );Influenza like illness (3d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432528	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Movement disorder (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432636	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Tinnitus (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432679	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433760	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010433764	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433796	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Vaccination site oedema (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433838	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433940	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010433943	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Optic neuritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433943&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010433949	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010433957	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010433960	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood homocysteine increased (n/a - Recovering/Resolving - Other Medically Important Condition);Fibrin D dimer increased (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Petechiae (n/a - Recovering/Resolving - Other Medically Important Condition);Phlebitis (n/a - Recovering/Resolving - Other Medically Important Condition);Red blood cell sedimentation rate increased (n/a - Recovering/Resolving - Other Medically Important Condition);White blood cell count increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010433965	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoxia (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 20mg - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 1.25mg - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - 75mg - Oral])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - 4mg - Oral])|[WARFARIN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010433974	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010433976	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hepatitis acute (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010433981	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Unknown - Other Medically Important Condition);Purpura (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010433984	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433992	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010433993	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010434000	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010434005	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010434013	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434987	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434988	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Axillary pain (28d - Recovering/Resolving - );Chest pain (28d - Recovering/Resolving - );Fatigue (28d - Recovering/Resolving - );Gait disturbance (28d - Recovering/Resolving - );Labile blood pressure (28d - Recovering/Resolving - );Malaise (28d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010434990	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Hypoaesthesia (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434995	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperaesthesia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434999	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (3d - Recovering/Resolving - );Chills (3d - Recovering/Resolving - );Diarrhoea (3d - Recovering/Resolving - );Dizziness (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Pyrexia (3d - Recovering/Resolving - );Vaccination site pain (3d - Recovering/Resolving - );Vomiting (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435003	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (3d - Not Recovered/Not Resolved - );Diarrhoea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435003&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435004	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (10d - Recovering/Resolving - );Pain in extremity (10d - Recovering/Resolving - );Somnolence (10d - Recovering/Resolving - );Tachycardia (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435007	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Dysgeusia (2d - Recovered/Resolved - );Dyspnoea (6d - Not Recovered/Not Resolved - );Fatigue (7d - Not Recovered/Not Resolved - );Headache (1d - Recovering/Resolving - );Influenza (7d - Not Recovered/Not Resolved - );Limb discomfort (6d - Not Recovered/Not Resolved - );Lymphadenopathy (4d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Myalgia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435031	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chronic obstructive pulmonary disease (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435056	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Not Recovered/Not Resolved - );Cough (3d - Not Recovered/Not Resolved - );Dizziness (2d - Recovering/Resolving - );Erythema (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Headache (4d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Nausea (2d - Recovering/Resolving - );Night sweats (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435091	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (5d - Recovering/Resolving - );Pain in extremity (5d - Recovering/Resolving - );Paraesthesia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435093	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Blood pressure increased (1d - Not Recovered/Not Resolved - );Chills (1d - Not Recovered/Not Resolved - );Dizziness (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - );Ocular discomfort (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435096	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mucosal inflammation (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435107	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Not Recovered/Not Resolved - );Headache (3d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435143	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435146	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (26d - Not Recovered/Not Resolved - );Malaise (26d - Not Recovered/Not Resolved - );Nausea (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010435157	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435160	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (0d - Recovered/Resolved - );Visual impairment (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435165	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Breast pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435169	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435190	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Testis discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435192	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (28d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010435199	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Hyperhidrosis (2d - Not Recovered/Not Resolved - );Nausea (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435204	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435204&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435215	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435227	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypogeusia (56d - Not Recovered/Not Resolved - );Parosmia (56d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010435228	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Herpes zoster reactivation (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435244	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Unknown - );Feeling hot (1d - Unknown - );Headache (1d - Unknown - );Hypoaesthesia oral (1d - Unknown - );Hypogeusia (1d - Unknown - );Malaise (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435249	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435249&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435251	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435252	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (0d - Not Recovered/Not Resolved - );Dyspnoea (0d - Not Recovered/Not Resolved - );Head discomfort (0d - Not Recovered/Not Resolved - );Hot flush (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435257	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diaphragmalgia (10d - Not Recovered/Not Resolved - );Odynophagia (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435264	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Vaccination site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435272	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (2d - Not Recovered/Not Resolved - );Heart rate increased (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Limb discomfort (0d - Recovering/Resolving - );Myalgia (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435274	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Not Specified	Dyspnoea (4d - Unknown - );Fatigue (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435275	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - );Fatigue (2d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435278	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Unknown - );Lymphadenopathy (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435286	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (12d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435286&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435296	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dysphagia (2d - Not Recovered/Not Resolved - );Feeling hot (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435297	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435302	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435303	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435305	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435322	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435328	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Injection site pain (3d - Recovering/Resolving - );Nausea (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435332	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435341	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435344	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435345	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435347	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood glucose increased (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435353	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435358	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435360	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Injection site swelling (3d - Not Recovered/Not Resolved - );Limb discomfort (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435366	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435374	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovering/Resolving - );Hot flush (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435385	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anxiety (6d - Recovered/Resolved - );Blood pressure increased (6d - Recovered/Resolved - );Chest discomfort (6d - Recovered/Resolved - );Chest pain (6d - Recovered/Resolved - );Dizziness (6d - Recovered/Resolved - );Malaise (6d - Recovered/Resolved - );Performance status decreased (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435390	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435394	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Hypotension (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435394&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435398	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Neck pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435405	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (6d - Unknown - );Malaise (6d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435418	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435421	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (2d - Not Recovered/Not Resolved - );Myalgia (2d - Not Recovered/Not Resolved - );Vaccination site pain (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435422	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain upper (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435434	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435438	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (3d - Recovering/Resolving - );Dyspnoea (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Hot flush (3d - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - );Nausea (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435442	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (10d - Recovering/Resolving - );Fatigue (10d - Recovering/Resolving - );Heart rate increased (10d - Recovering/Resolving - );Influenza like illness (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435442&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435445	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435448	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - );Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435455	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435456	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (20d - Recovered/Resolved - );Chest discomfort (20d - Recovered/Resolved - );Dizziness (20d - Recovered/Resolved - );Flushing (20d - Recovered/Resolved - );Head discomfort (20d - Recovered/Resolved - );Tachycardia (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435463	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - );Vaccination site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435468	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (16d - Not Recovered/Not Resolved - );Influenza (9d - Not Recovered/Not Resolved - );Tonsillar inflammation (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435478	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovering/Resolving - );Dizziness (0d - Not Recovered/Not Resolved - );Gastrointestinal pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435486	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (1d - Recovered/Resolved - );Abnormal faeces (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435489	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435491	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (34d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435492	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematoma (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435495	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Depressed mood (0d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Gastrointestinal pain (0d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - );Malaise (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435499	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Visual impairment (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435505	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (14d - Not Recovered/Not Resolved - );Cough (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (14d - Not Recovered/Not Resolved - );Limb discomfort (14d - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Pyrexia (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435516	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling abnormal (3d - Recovering/Resolving - );Influenza like illness (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435520	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (2d - Not Recovered/Not Resolved - );Pruritus (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435534	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435536	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435545	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthma (1d - Recovering/Resolving - );Dyspnoea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435548	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear discomfort (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435550	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site movement impairment (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435552	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435553	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435558	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Injection site pain (n/a - Recovered/Resolved With Sequelae - );Rotator cuff syndrome (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010435560	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435565	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (13d - Recovering/Resolving - );Limb discomfort (13d - Recovering/Resolving - );Pain in extremity (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435573	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Muscle tightness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (2d - Recovered/Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435574	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (0d - Unknown - );Rash (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435586	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Not Recovered/Not Resolved - );Muscle spasms (0d - Not Recovered/Not Resolved - );Myalgia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435589	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Choroidal effusion (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435591	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (21d - Not Recovered/Not Resolved - );Blood pressure increased (21d - Not Recovered/Not Resolved - );Headache (21d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435596	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired healing (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435598	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (6d - Not Recovered/Not Resolved - );Dizziness (7d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Nausea (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435602	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435607	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Hallucination (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435613	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435618	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Walking disability (32d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010435624	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Not Recovered/Not Resolved - );Dyspnoea (8d - Not Recovered/Not Resolved - );Muscle tightness (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435627	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Lymphadenopathy (1d - Not Recovered/Not Resolved - );Malaise (1d - Recovering/Resolving - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435645	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Seizure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010435658	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (25d - Not Recovered/Not Resolved - );Fatigue (25d - Not Recovered/Not Resolved - );Headache (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010435684	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovering/Resolving - );Feeling hot (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Hyperhidrosis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435684&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435690	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - );Vaccination site pruritus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435704	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site discomfort (16d - Not Recovered/Not Resolved - );Limb discomfort (16d - Not Recovered/Not Resolved - );Pain (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435716	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Musculoskeletal discomfort (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435743	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - );Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435745	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysaesthesia (1d - Not Recovered/Not Resolved - );Sensory disturbance (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435752	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435759	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Dizziness (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Insomnia (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Somnolence (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435779	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Influenza (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435782	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435789	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiovascular disorder (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Somnolence (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435796	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site discomfort (1d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435801	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (14d - Not Recovered/Not Resolved - );Malaise (13d - Not Recovered/Not Resolved - );Oropharyngeal pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435811	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (46d - Not Recovered/Not Resolved - );Headache (46d - Not Recovered/Not Resolved - );Limb discomfort (46d - Not Recovered/Not Resolved - );Tinnitus (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010435819	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling hot (42d - Not Recovered/Not Resolved - );Headache (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010435832	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Feeling of despair (2d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Muscle tightness (1d - Not Recovered/Not Resolved - );Musculoskeletal discomfort (1d - Not Recovered/Not Resolved - );Myalgia (2d - Recovering/Resolving - );Sleep disorder (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010435912	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Hypotonia (2d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010435912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436072	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436212	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Haematoma (3d - Recovered/Resolved - );Influenza like illness (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436212&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010436229	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Anosmia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (6d - Recovered/Resolved - );Thirst (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010436313	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lip swelling (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Skin discolouration (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436383	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436396	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Subcutaneous])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436418	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436424	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site nodule (n/a - Recovering/Resolving - );Pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436467	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010436491	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Neck pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Sciatic nerve neuropathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436496	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010436501	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertension (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436501&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436503	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Retinal tear (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010436526	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (5d - Recovered/Resolved - );Pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436526&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436530	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (7d - Recovered/Resolved - );Eye pain (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Pain (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436543	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436548	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436550	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, RILPIVIRINE] (C - HIV test positive - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436558	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010436562	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010436563	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebellar haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Cognitive disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010436575	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bronchospasm (n/a - Recovering/Resolving - );Dysphonia (n/a - Recovering/Resolving - );Palatal oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010436613	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436622	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (31d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010436635	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436636	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436643	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436742	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436743	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436745	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pollakiuria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436764	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436776	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Orchitis noninfective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436780	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436893	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - );Injection site oedema (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436899	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Confusional state (n/a - Recovering/Resolving - );Peripheral swelling (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010436931	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010436949	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010436951	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Deafness (n/a - Not Recovered/Not Resolved - Disabling);Dry skin (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010436983	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Joint swelling (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Quality of life decreased (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010436989	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness transient (n/a - Recovered/Resolved - Other Medically Important Condition);Disorientation (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Scintillating scotoma (n/a - Recovered/Resolved - Other Medically Important Condition);Sensory loss (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010436989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010437000	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010437006	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Life Threatening);Monoparesis (n/a - Not Recovered/Not Resolved - Life Threatening);Myosclerosis (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010437007	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Supraventricular extrasystoles (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010437024	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute lung injury (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Haemoptysis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Otitis media (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010437026	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Life Threatening);Palpitations (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010437028	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Libido decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Xerophthalmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010437030	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010437034	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Food refusal (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010437043	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Disorientation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hospitalisation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[CARBAMAZEPINE] (C - n/a - n/a - [n/a - n/a - n/a])|[PAROXETINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, ANHYDROUS] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010437054	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010437119	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010437119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010438742	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010438742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010438858	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010438858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010438874	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (6d - Recovering/Resolving - );Fatigue (6d - Recovering/Resolving - );Headache (4d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (6d - Recovering/Resolving - );Myalgia (2d - Recovered/Resolved - );Tachycardia (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010438874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010439114	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010439114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010439373	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010439373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440547	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440548	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440558	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440590	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440595	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (7d - Recovered/Resolved - );Vaccination site reaction (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440626	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440643	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440736	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (11d - Recovering/Resolving - );Fatigue (16d - Recovering/Resolving - );Influenza (11d - Recovered/Resolved - );Myalgia (13d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440743	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440751	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (40d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010440757	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440783	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440793	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440830	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440907	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (8d - Recovering/Resolving - );Rash (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010440914	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440914&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440923	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440925	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Vaccination site paraesthesia (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440929	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Epistaxis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440930	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (13d - Not Recovered/Not Resolved - );Somnolence (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440935	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Thirst (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440937	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (30d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010440942	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Musculoskeletal chest pain (18d - Recovering/Resolving - );Tachycardia (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010440946	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anxiety (6d - Recovering/Resolving - );Dizziness (6d - Recovering/Resolving - );Influenza (6d - Recovering/Resolving - );Malaise (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440948	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Influenza (5d - Recovering/Resolving - );Influenza like illness (5d - Recovering/Resolving - );Injection site pain (6d - Recovering/Resolving - );Limb discomfort (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440954	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (20d - Recovered/Resolved - );Chest discomfort (20d - Recovered/Resolved - );Dizziness (20d - Recovered/Resolved - );Flushing (20d - Recovered/Resolved - );Head discomfort (20d - Recovered/Resolved - );Tachycardia (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010440957	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440966	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Biliary colic (0d - Recovered/Resolved With Sequelae - );Bladder pain (0d - Recovered/Resolved With Sequelae - );Facial paralysis (0d - Recovered/Resolved With Sequelae - );Headache (0d - Recovered/Resolved With Sequelae - );Myalgia (0d - Recovered/Resolved With Sequelae - );Pollakiuria (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010440970	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastric haemangioma (n/a - Not Recovered/Not Resolved - );Haemangioma of breast (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440970&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440971	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (14d - Not Recovered/Not Resolved - );Rash (14d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010440972	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010440984	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - );Pruritus (3d - Not Recovered/Not Resolved - );Rash (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010440996	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010440997	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure increased (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010440997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441002	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Cardiovascular disorder (2d - Not Recovered/Not Resolved - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Hypotension (2d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441008	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Chills (19d - Not Recovered/Not Resolved - );Dyspnoea (19d - Not Recovered/Not Resolved - );Increased bronchial secretion (19d - Not Recovered/Not Resolved - );Pyrexia (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010441010	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (3d - Recovering/Resolving - );Cough (3d - Recovering/Resolving - );Dermatitis allergic (3d - Recovering/Resolving - );Dyspnoea (3d - Recovering/Resolving - );Eye pain (3d - Recovering/Resolving - );Fatigue (3d - Recovering/Resolving - );Feeling hot (1d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Hot flush (3d - Recovering/Resolving - );Hyperhidrosis (3d - Recovering/Resolving - );Myalgia (3d - Recovering/Resolving - );Tachycardia (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010441014	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Injection site pain (5d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441031	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441036	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441040	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Joint swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441044	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood potassium decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebral haemorrhage (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441045	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441050	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Somnolence (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441059	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441062	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441070	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441087	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Periorbital oedema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Photophobia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441088	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441089	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441091	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Rash (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441092	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441124	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Painful respiration (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441126	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pelvic venous thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441126&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441306	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441309	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441313	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hyperhidrosis (n/a - Recovering/Resolving - );Hypotension (0d - Recovered/Resolved - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441313&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441318	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (809min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cough (809min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (1d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tachycardia (809min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Tachypnoea (809min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Wheezing (809min - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010441328	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Life Threatening, Other Medically Important Condition);Pulmonary embolism (96d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010441333	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441334	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441336	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441340	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gastroenteritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Sepsis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441348	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Infectious mononucleosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Respiratory rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Viral infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441348&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441350	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441352	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441368	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Seizure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441368&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441374	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Injected limb mobility decreased (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Tremor (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010441384	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Feeling abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441386	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Haematoma (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Myocarditis (n/a - Not Recovered/Not Resolved - Disabling);Swelling (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site bruising (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site haematoma (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010441393	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441396	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Musculoskeletal stiffness (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441399	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441400	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebellar infarction (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441402	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441410	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Herpes zoster (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441411	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeling of body temperature change (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441555	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441560	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - );Tenderness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441563	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441565	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (54h - Recovered/Resolved - Other Medically Important Condition);Urticaria (54h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441568	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441569	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441575	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Orthostatic hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441576	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash erythematous (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash maculo-papular (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Rash pruritic (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vasculitic rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441582	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Drooling (30min - Unknown - );Hemiparesis (n/a - Unknown - Other Medically Important Condition);Speech disorder (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441584	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441584&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441587	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441590	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441601	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleurisy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441613	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441619	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441620	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441625	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Tremor (1d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Parenteral])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PERINDOPRIL, PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010441629	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441637	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (10d - Recovered/Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441638	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chronic fatigue syndrome (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disease progression (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Disturbance in attention (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010441662	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441663	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cyanosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Generalised tonic-clonic seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (15min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nightmare (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441665	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Muscular weakness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	MICARDIS [TELMISARTAN] (C - Hypertension - n/a - [n/a - 80mg - Oral])|PLAVIX [CLOPIDOGREL, CLOPIDOGREL HYDROGEN SULFATE] (C - Cardiovascular disorder - n/a - [n/a - 75mg - Oral])|[ACETYLSALICYLIC ACID] (C - Cardiovascular disorder - n/a - [n/a - 100mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441668	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Muscle twitching (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Unresponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010441672	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gingival pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Toothache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441672&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010441695	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia areata (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441701	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - );Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hospitalisation (n/a - Unknown - Caused/Prolonged Hospitalisation);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Tenderness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010441713	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010441961	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Oedema peripheral (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010441961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442017	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010442021	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Infarction (n/a - Unknown - Other Medically Important Condition);Pleural effusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442024	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Recovered/Resolved - );Pericardial effusion (n/a - Recovered/Resolved - Other Medically Important Condition);Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442029	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442030	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442031	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - Disabling);Lethargy (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010442038	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442040	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in jaw (n/a - Not Recovered/Not Resolved - );Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442044	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442045	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Delirium (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442048	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bradycardia (n/a - Recovering/Resolving - Other Medically Important Condition);Extrasystoles (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442049	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442070	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442073	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Troponin I increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442074	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442079	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442080	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442082	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442084	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (25d - Recovered/Resolved - );Vaccination site discomfort (25d - Recovered/Resolved - );Vaccination site pain (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010442086	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442088	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	No	Not Specified	Fracture (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010442100	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Anaemia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Laboratory test abnormal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Troponin increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442364	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442376	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthma (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442380	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Unknown - );Immunisation (n/a - Unknown - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - );Sluggishness (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ATORVASTATIN] (C - n/a - n/a - [n/a - 10mg - n/a])|[LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 50mg - n/a])|[PROPRANOLOL, PROPRANOLOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 40mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010442393	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442393&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442414	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE] (C - Blood pressure abnormal - n/a - [n/a - 2.5mg - n/a])|[OXYCODONE HYDROCHLORIDE, PARACETAMOL] (C - Arthralgia, Back pain - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442422	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442424	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - );Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Unknown - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition);Tunnel vision (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442425	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442428	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chromaturia (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442446	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442449	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Overdose (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .5mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010442454	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442456	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442457	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442486	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442518	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - );Vaccination site discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010442565	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442566	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442570	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Uveitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442613	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Depression (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442614	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010442755	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010442775	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (13d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442794	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (n/a - Recovering/Resolving - );Decreased appetite (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010442815	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Loose tooth (n/a - Recovering/Resolving - );Mouth haemorrhage (n/a - Recovering/Resolving - );Mouth swelling (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Recovering/Resolving - );Oral pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Sleep disorder (n/a - Not Recovered/Not Resolved - );Vitamin C deficiency (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - Unknown - [n/a - 300mg - n/a])|[AMLODIPINE MALEATE] (C - n/a - Unknown - [n/a - 10mg - n/a])|[ATENOLOL] (C - n/a - Unknown - [n/a - 25mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010442835	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Diarrhoea (0d - Recovered/Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010442901	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010442915	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Unknown - );Fatigue (n/a - Unknown - );Influenza (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010442922	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Facial paralysis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Herpes zoster oticus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442956	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (18d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (18d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010442957	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Prostatitis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010442976	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010442976&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010443010	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Feeling cold (76d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site swelling (19d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010443120	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (0d - Unknown - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Unknown - );Pyrexia (1d - Not Recovered/Not Resolved - );Somnolence (1d - Not Recovered/Not Resolved - );Vomiting (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010443124	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010443138	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [3mo - n/a - n/a])|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - Hypertension - n/a - [3mo - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010443272	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (6d - Not Recovered/Not Resolved - );Malaise (6d - Not Recovered/Not Resolved - );Peripheral swelling (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010443276	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Not Recovered/Not Resolved - );Rash morbilliform (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010443278	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Recovering/Resolving - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Peripheral swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010443362	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Coagulopathy (n/a - Recovering/Resolving - );Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Gait disturbance (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ALPRAZOLAM] (C - n/a - Unknown - [n/a - n/a - n/a])|[LORMETAZEPAM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[PERINDOPRIL ARGININE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010443465	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010443556	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (6d - Recovering/Resolving - );Anosmia (6d - Recovering/Resolving - );Asthenia (6d - Recovering/Resolving - );Ear infection (6d - Recovering/Resolving - );Fatigue (6d - Recovering/Resolving - );Pyrexia (6d - Recovering/Resolving - );Vertigo (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010443791	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Monoplegia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Spinal cord ischaemia (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010443792	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Herpes zoster meningitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010443793	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrioventricular block complete (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010443839	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ophthalmic herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010443841	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blood pressure measurement (9d - Recovered/Resolved - );Dizziness (9d - Recovered/Resolved - );Headache (9d - Recovered/Resolved - );Hyperhidrosis (9d - Recovered/Resolved - );Palpitations (9d - Recovered/Resolved - );Paraesthesia (9d - Recovered/Resolved - );Tachycardia (9d - Recovered/Resolved - );Thirst (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010443899	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010443934	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - );Menstruation irregular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LEVONORGESTREL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010443934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010444015	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (28d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444049	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010444199	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Diabetes mellitus (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - )|[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - )|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - n/a - )|[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE PROPIONATE, FORMOTEROL FUMARATE HYDRATE, FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE PH.EUR., BECLOMETHASONE DIPROPIONATE PH. EUR., FORMOTEROL FUMARATE DIHYDRATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - )|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - )|[PERINDOPRIL, PERINDOPRIL ARGININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010444280	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypercalcaemia (n/a - Recovering/Resolving - );Hyperkalaemia (n/a - Recovering/Resolving - Other Medically Important Condition);Interstitial lung disease (15d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Non-small cell lung cancer (n/a - Fatal - Results in Death, Other Medically Important Condition);Renal impairment (n/a - Recovering/Resolving - Other Medically Important Condition)	ALUNBRIG 90 MG [BRIGATINIB] (S - Non-small cell lung cancer - Unknown - [34d - 90mg - Oral - More in ICSR])|COMIRNATY [TOZINAMERAN] (S - Product used for unknown indication - Not applicable - [n/a - n/a - Unknown])|SPIKEVAX [COVID-19 MRNA VACCINE MODERNA (CX-024414)] (S - Product used for unknown indication - Unknown - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010444321	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010444374	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (1d - Recovered/Resolved - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010444469	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[LORATADINE] (C - n/a - Unknown - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444469&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444497	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Generalised tonic-clonic seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444562	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Haemoptysis (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Hyperpyrexia (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444685	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (n/a - Unknown - );Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444715	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444717	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaginal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444721	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Rectal haemorrhage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444723	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (1955min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (1955min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (1955min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Feeling cold (1955min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hyperhidrosis (1955min - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pallor (1955min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE BESILATE, AZILSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])|[FEBUXOSTAT] (C - Gout - n/a - [n/a - n/a - Oral])|[TRICHLORMETHIAZIDE] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444727	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444729	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Diarrhoea (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444735	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444735&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444739	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal abscess (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Bladder disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fournier's gangrene (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Gallbladder rupture (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Scrotal cellulitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444740	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Visual impairment (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444746	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diabetes mellitus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444747	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (0d - Recovered/Resolved - );Tremor (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010444759	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac flutter (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444760	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[LATANOPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010444762	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444769	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blindness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444770	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444777	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444785	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Heart rate decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444786	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (6d - Recovered/Resolved - Other Medically Important Condition);Diarrhoea (5d - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Dizziness postural (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Weight decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444791	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444797	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444804	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin I increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444813	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (2min - Recovered/Resolved - Other Medically Important Condition);Tremor (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444815	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444821	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444822	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness neurosensory (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	DULOXETINE HYDROCHLORIDE [DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACLIDINIUM BROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444824	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444826	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gynaecomastia (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010444829	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - Other Medically Important Condition);Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444833	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Not Specified	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Other Medically Important Condition);Cold sweat (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Flatulence (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	APIXABAN [APIXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CEFALEXIN] (C - n/a - n/a - [n/a - n/a - n/a])|[FOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - n/a - n/a - [n/a - n/a - n/a])|[LACTULOSE] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444838	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444840	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444844	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444847	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444849	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444851	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444852	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Body temperature increased (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444868	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444873	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Axillary pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypokinesia (n/a - Unknown - );Swelling (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444880	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444881	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444886	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dermatitis bullous (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (3d - Recovered/Resolved - );Impetigo (n/a - Unknown - );Malaise (3d - Recovered/Resolved - );Oropharyngeal pain (3d - Recovered/Resolved - );Rash vesicular (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010444891	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Depression (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Suicidal ideation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444892	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cutaneous vasculitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Petechiae (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Purpura (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444898	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleuritic pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444906	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444910	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444931	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444945	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Other Medically Important Condition);Troponin increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444948	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Unknown - Other Medically Important Condition);Chest pain (2d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Memory impairment (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Migraine (1d - Recovering/Resolving - Other Medically Important Condition);Visual impairment (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444948&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010444954	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444957	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Unknown - );Chills (n/a - Recovering/Resolving - );Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dysstasia (n/a - Unknown - );Feeling abnormal (n/a - Not Recovered/Not Resolved - );Formication (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Gait inability (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Monoplegia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Taste disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	JANUVIA [SITAGLIPTIN, SITAGLIPTIN PHOSPHATE, SITAGLIPTIN PHOSPHATE MONOHYDRATE] (C - Blood glucose abnormal - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - Blood pressure abnormal - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010444962	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444967	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444972	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Throat tightness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444977	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444987	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444988	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444988&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444990	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010444997	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis bacterial (n/a - Unknown - Other Medically Important Condition);Arthropathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Infection (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site erythema (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444997&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010444999	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood sodium increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cystitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Polydipsia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Polyuria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010444999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445000	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Flatulence (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010445002	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445005	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	CANNABIDIOL [CANNABIDIOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010445009	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bone pain (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Inflammation (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Unknown - );Peripheral swelling (n/a - Unknown - );Swelling (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010445011	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Thrombocytopenia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010445023	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445026	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445028	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dysphagia (n/a - Unknown - Life Threatening);Haemorrhage intracranial (n/a - Unknown - Life Threatening);Hemiparesis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445028&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010445054	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445056	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nausea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445064	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010445066	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Supraventricular tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445067	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Blood pressure decreased (n/a - Unknown - );Blood pressure systolic increased (1mo - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - Cough - n/a - [n/a - 40mg - n/a])|[CARBAMAZEPINE] (C - Seizure - n/a - [n/a - 400mg - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM] (C - Autoimmune thyroiditis - n/a - [n/a - n/a - n/a])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - Blood cholesterol increased - n/a - [n/a - 10mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445160	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain lower (n/a - Not Recovered/Not Resolved - Disabling);Faeces hard (n/a - Not Recovered/Not Resolved - Disabling);Gastrointestinal pain (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Musculoskeletal stiffness (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010445214	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445250	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening);Chills (n/a - Not Recovered/Not Resolved - Life Threatening);Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - Life Threatening);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening);Headache (n/a - Not Recovered/Not Resolved - Life Threatening);Injection site reaction (n/a - Not Recovered/Not Resolved - Life Threatening);Malaise (n/a - Not Recovered/Not Resolved - Life Threatening);Myalgia (n/a - Not Recovered/Not Resolved - Life Threatening);Nausea (n/a - Not Recovered/Not Resolved - Life Threatening);Pyrexia (n/a - Not Recovered/Not Resolved - Life Threatening);Skin disorder (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010445419	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pruritus (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445475	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown - More in ICSR])|[PARACETAMOL] (S - Product used for unknown indication - Unknown - [n/a - n/a - Unknown])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Heart rate - Unknown - [n/a - n/a - Unknown])|[GABAPENTIN] (C - Pain - Unknown - [n/a - n/a - Unknown])|[OXYCODONE HYDROCHLORIDE] (C - Pain - Unknown - [n/a - n/a - Unknown])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010445522	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010445528	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (0d - Recovered/Resolved - );Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - Disabling);Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010445569	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovering/Resolving - );Syncope (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010445574	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445598	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (4d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445602	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Rash (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Respiratory tract infection (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010445607	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010445608	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Frequent bowel movements (1d - Recovering/Resolving - );Myalgia (0d - Not Recovered/Not Resolved - );Nausea (1d - Recovering/Resolving - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445609	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (1d - Recovered/Resolved - );Pain in extremity (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445632	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Burning sensation (36d - Unknown - );Erythema (36d - Unknown - );Rash (36d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010445635	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (6d - Not Recovered/Not Resolved - );Thrombosis (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010445636	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site bruising (n/a - Unknown - );Injection site pain (n/a - Unknown - );Injection site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445647	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445665	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445665&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445668	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vascular disorder (0d - Recovering/Resolving - );Tachycardia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445668&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010445671	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (38d - Recovered/Resolved - );Menstrual disorder (38d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010445676	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (1d - Not Recovered/Not Resolved - );Abnormal faeces (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445676&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445698	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445701	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Influenza like illness (2d - Not Recovered/Not Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445717	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445718	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Colitis ulcerative (42d - Not Recovered/Not Resolved - );Injection site pain (42d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445718&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010445734	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445734&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445741	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (3d - Recovering/Resolving - );Rash (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010445777	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445778	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445786	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010445792	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (20d - Not Recovered/Not Resolved - );Pyrexia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445824	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Vaccination site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445826	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (33d - Recovered/Resolved - );Dizziness (33d - Recovered/Resolved - );Nausea (33d - Recovered/Resolved - );Weight decreased (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010445831	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (31d - Recovering/Resolving - );Gastrointestinal pain (31d - Recovering/Resolving - );Influenza (31d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010445835	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericardial effusion (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010445842	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010445844	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010445863	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Back pain (3d - Not Recovered/Not Resolved - );Fatigue (4d - Not Recovered/Not Resolved - );Limb discomfort (3d - Not Recovered/Not Resolved - );Nuchal rigidity (3d - Not Recovered/Not Resolved - );Pyrexia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010445863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446041	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (8d - Recovered/Resolved - );Pain in extremity (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446046	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fibrin D dimer increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010446049	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Amaurosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arterial occlusive disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446058	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446066	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Asthenia (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Hyperhidrosis (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446069	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446088	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446143	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - );Discomfort (n/a - Unknown - );Dizziness (n/a - Recovered/Resolved - );Memory impairment (n/a - Recovered/Resolved - );Nausea (n/a - Unknown - );Vertigo positional (17d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446244	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446247	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pallor (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446252	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pancreatitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446253	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446258	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Lacrimation increased (n/a - Unknown - Other Medically Important Condition);Ocular hyperaemia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446260	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446262	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Periorbital oedema (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition);Vasculitic rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446297	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446299	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Seizure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446299&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446300	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446304	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446304&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446309	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446310	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .03mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446311	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010446352	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Allodynia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|IMFINZI 50 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION [DURVALUMAB] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446364	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446378	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446391	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (4d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (5d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446418	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446443	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446445	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immune thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446446	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446447	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446450	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446450&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446451	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Appendicitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446452	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Embolism venous (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446454	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446456	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446457	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446459	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446460	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446466	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446467	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Electrocardiogram ST segment elevation (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446470	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Appendicitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010446475	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446477	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446478	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010446550	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])|[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])|[FENOFIBRATE, FENOFIBRATE (NANONISED)] (C - n/a - n/a - [n/a - n/a - Oral])|[LORATADINE] (C - n/a - n/a - [n/a - n/a - Oral])|[SULPIRIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446556	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446556&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446624	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (4d - Recovering/Resolving - Disabling);Cough (4d - Recovering/Resolving - Disabling);Fatigue (4d - Recovering/Resolving - Disabling);Nasal congestion (4d - Recovering/Resolving - Disabling);Pyrexia (4d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010446635	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vitiligo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [23mo - 7000[iU] - Oral])|[DUTASTERIDE] (C - Benign prostatic hyperplasia - n/a - [108d - .5mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446637	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446691	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010446799	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010446799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447134	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eye pain (n/a - Recovered/Resolved - );Gait inability (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Loss of consciousness (5h - Recovered/Resolved - Other Medically Important Condition);Swelling (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447219	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447340	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447342	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447344	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447345	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Paraesthesia oral (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447345&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447350	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Contusion (n/a - Unknown - Other Medically Important Condition);Decreased appetite (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447354	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nightmare (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447369	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperthyroidism (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447370	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Deafness (n/a - Recovered/Resolved - Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447373	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447374	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Capillary nail refill test abnormal (n/a - Unknown - Other Medically Important Condition);Cold sweat (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Heart rate decreased (n/a - Recovering/Resolving - Other Medically Important Condition);Hypersensitivity (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447375	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute stress disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Anxiety (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Asthma (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Paraesthesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Suicidal ideation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[PROPANTHELINE BROMIDE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447375&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447379	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Blood creatinine increased (n/a - Unknown - );Blood parathyroid hormone increased (n/a - Unknown - );Blood sodium decreased (n/a - Unknown - );Eosinophil count increased (n/a - Unknown - );Eye pain (n/a - Recovered/Resolved - );Haematocrit decreased (n/a - Unknown - );Haemoglobin decreased (n/a - Unknown - );Herpes zoster (n/a - Recovered/Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Lymphocyte count increased (n/a - Unknown - );Mean platelet volume increased (n/a - Unknown - );Monocyte count increased (n/a - Unknown - );Neutrophil percentage decreased (n/a - Unknown - );Ophthalmic herpes zoster (n/a - Recovered/Resolved - Other Medically Important Condition);Red blood cell count decreased (n/a - Unknown - );White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	LUCENTIS [RANIBIZUMAB] (C - n/a - n/a - [n/a - .005mg - Intraocular])|LYRICA [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - Blood pressure measurement - n/a - [n/a - 1{DF} - n/a])|[CLONAZEPAM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447380	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Decreased appetite (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447388	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Chills (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Influenza (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447392	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Condition aggravated (n/a - Unknown - Other Medically Important Condition);Muscle twitching (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447396	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447397	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447398	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Bacterial diarrhoea (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CREATINE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLUTAMINE] (C - n/a - n/a - [n/a - n/a - n/a])|[LEVOGLUTAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010447402	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447403	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Hot flush (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447418	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Life Threatening, Other Medically Important Condition);Confusional state (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Headache (n/a - Unknown - Life Threatening, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Muscular weakness (n/a - Unknown - Life Threatening, Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition);Pain in extremity (n/a - Unknown - Life Threatening, Other Medically Important Condition);Paraesthesia (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Pericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010447420	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Monoplegia (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Unknown - );Pruritus (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447423	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Contusion (n/a - Unknown - );Dysstasia (n/a - Recovering/Resolving - );Fall (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - );Muscular weakness (n/a - Recovering/Resolving - );Pain in extremity (n/a - Unknown - );Paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Somnolence (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[ATENOLOL, ATENOLOL BP] (C - Blood pressure abnormal - n/a - [n/a - 100mg - n/a])|[ATORVASTATIN CALCIUM] (C - Blood cholesterol - n/a - [n/a - 40mg - n/a])|[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 25mg - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447427	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Bronchial injury (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Depression (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Restless legs syndrome (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Seizure (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition);Tremor (n/a - Recovered/Resolved With Sequelae - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010447431	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447433	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea exertional (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea paroxysmal nocturnal (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Orthopnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Wheezing (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447434	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447435	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gait disturbance (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypotension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Persistent postural-perceptual dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Rash papular (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447437	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447445	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447447	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447448	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447453	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematochezia (n/a - Unknown - Other Medically Important Condition);Influenza like illness (n/a - Unknown - );Malaise (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447456	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Lethargy (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447459	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Inappropriate schedule of product administration (n/a - Unknown - );Menstruation irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447459&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447461	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovered/Resolved - );Back pain (n/a - Recovered/Resolved - );Decreased appetite (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - );Weight decreased (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[LULICONAZOLE] (C - Dermatophytosis of nail - n/a - [n/a - n/a - Topical])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447462	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Concomitant disease aggravated (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447465	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Seizure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447466	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Throat irritation (n/a - Unknown - );Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447472	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447477	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Brain stem infarction (n/a - Unknown - Other Medically Important Condition);Vaccination site erythema (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site pruritus (n/a - Unknown - );Vaccination site swelling (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447478	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac discomfort (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447482	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Balance disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Costochondritis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cyanosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447486	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Ear discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vitreous floaters (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447486&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010447490	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Electrocardiogram ST segment elevation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fibrin D dimer increased (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447500	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447500&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447612	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 3{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447616	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - );Sleep disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447620	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (2d - Recovering/Resolving - );Chills (2d - Recovering/Resolving - );Eye swelling (2d - Recovering/Resolving - );Influenza like illness (2d - Recovering/Resolving - );Nausea (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447623	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Vaccination site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447654	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (0d - Not Recovered/Not Resolved - );Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447669	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447669&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447708	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (36d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Recovered/Resolved - );Swelling face (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447711	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447722	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447736	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Unknown - );Vaccination site pain (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447790	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Amenorrhoea (n/a - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010447842	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447850	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cardiac disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010447867	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Evans syndrome (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Thrombocytopenia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010447870	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (1890min - Recovered/Resolved - Other Medically Important Condition);Fatigue (1d - Recovered/Resolved - );Muscle twitching (1d - Recovered/Resolved - );Sleep disorder (1d - Recovered/Resolved - );Tremor (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial fibrillation - n/a - [n/a - n/a - Oral])|MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - n/a - n/a])|[A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/7/2009 (H1N1)PDM09-DERIVED STRAIN USED (NYMC X-181), A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, X-263B), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR-180), INFLUENZA VACCINE] (C - Influenza immunisation - n/a - [1d - n/a - Intramuscular])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [7d - n/a - n/a])|[BUDESONIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Asthma - n/a - [n/a - n/a - Oral])|[PREDNISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010447870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448101	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Injection site reaction (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448101&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448103	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Coronary artery occlusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocardial infarction (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448103&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448108	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Discharge (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448115	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cardiac disorder (n/a - Unknown - );Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448115&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448121	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Unknown - );Neck pain (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448123	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Electrocardiogram abnormal (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448125	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cerebral infarction (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Paresis (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - n/a])|[BETAHISTINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LINACLOTIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MAGNESIUM OXIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[MECOBALAMIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448129	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hypertension (n/a - Unknown - );Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448140	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fall (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448142	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Blood pressure systolic increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448143	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pneumothorax spontaneous (19d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448143&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448209	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[PARACETAMOL, PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448237	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - Other Medically Important Condition);Cataplexy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Delirium (n/a - Recovering/Resolving - Other Medically Important Condition);Narcolepsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Parasomnia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448244	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Migraine (n/a - Recovered/Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448257	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic shock (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448263	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448268	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Acute abdomen (n/a - Recovering/Resolving - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (1d - Recovered/Resolved - Other Medically Important Condition);Dyspepsia (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448280	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448283	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448310	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovering/Resolving - );COVID-19 immunisation (n/a - Unknown - );Dizziness (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Unknown - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010448404	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448473	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Seasonal allergy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448491	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle twitching (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448495	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Plasma cell myeloma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010448509	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448711	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (8d - Recovered/Resolved - );Asthenia (8d - Recovered/Resolved - );Nausea (8d - Recovered/Resolved - );Pyrexia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448712	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[LORATADINE] (C - n/a - Unknown - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448727	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Recovered/Resolved - );Facial paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Paralysis (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448736	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Anal incontinence (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Balance disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Depressed level of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Disorientation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pruritus (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Somnolence (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tremor (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site cellulitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site erythema (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site pruritus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site rash (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination site urticaria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448748	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - );Chest pain (n/a - Unknown - Other Medically Important Condition);Heart rate irregular (n/a - Unknown - );Musculoskeletal discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448749	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (n/a - Recovered/Resolved - );Cardiac flutter (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Unknown - );Chest pain (n/a - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Erythema (n/a - Recovered/Resolved - );Feeling abnormal (n/a - Recovered/Resolved - );Feeling of relaxation (3d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Loss of personal independence in daily activities (n/a - Recovered/Resolved - );Nausea (6h - Recovered/Resolved - );Rash macular (1h - Recovered/Resolved - );Swelling (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ODEFSEY [EMTRICITABINE, TENOFOVIR ALAFENAMIDE, RILPIVIRINE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALACICLOVIR, VALACICLOVIR HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448749&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448752	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Unknown - );White blood cell count decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[RAMIPRIL] (C - n/a - n/a - [n/a - 10mg - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 75mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010448760	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448762	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature abnormal (n/a - Unknown - Disabling);Cough (n/a - Unknown - Disabling);Headache (n/a - Unknown - Disabling);Immunisation (n/a - Unknown - );Influenza (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - );Pain in extremity (n/a - Unknown - Disabling);Rhinorrhoea (n/a - Unknown - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010448763	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448772	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Diarrhoea (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448778	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Choking (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Reflux gastritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448778&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448783	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Asthma (n/a - Unknown - );Cough (n/a - Unknown - );Dysstasia (n/a - Unknown - );Eczema (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - );Eye pain (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Hand dermatitis (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448783&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448792	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Azotaemia (n/a - Unknown - Other Medically Important Condition);Deafness unilateral (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Tinnitus (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Chronic kidney disease - n/a - [n/a - n/a - n/a])|[CANDESARTAN, CANDESARTAN CILEXETIL] (C - Essential hypertension - n/a - [n/a - n/a - n/a])|[ERGOCALCIFEROL] (C - n/a - n/a - [n/a - 10mg - n/a])|[FERROUS GLUCONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[MENAQUINONE 6] (C - n/a - n/a - [n/a - n/a - n/a])|[MENAQUINONE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Chronic kidney disease - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448858	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Interchange of vaccine products (n/a - Unknown - );Ischaemic stroke (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - Unknown - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448895	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oropharyngeal pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448895&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010448926	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Anaphylactic shock (0d - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Loss of consciousness (1min - Recovered/Resolved - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448934	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure congestive (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dehydration (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Gastroenteritis (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Renal failure (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010448942	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Death (n/a - Fatal - Results in Death);Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Myalgia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010448946	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010448994	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010448994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449036	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449050	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Gait disturbance (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449060	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysphonia (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Unknown - );Impaired work ability (n/a - Unknown - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449084	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site reaction (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449152	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449159	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449159&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449214	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Superficial vein thrombosis (3d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449219	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Venous thrombosis (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010449228	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Rash (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449252	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449252&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449310	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rhinorrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449321	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|PRADAXA 150 MG HARD CAPSULES [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449389	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pleural effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449391	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449396	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - )|[LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS, SERENOA REPENS, SERENOA REPENS (BARTRAM) SMALL.] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449417	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acute coronary syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449417&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449418	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac flutter (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449419	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovered/Resolved - Other Medically Important Condition);Lymphoid tissue hyperplasia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449422	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Intraocular pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [43d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449424	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysphagia (2h - Recovered/Resolved - Other Medically Important Condition);Pharyngeal oedema (2h - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449437	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449441	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	COMIRNATY [TOZINAMERAN] (C - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449460	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449463	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449472	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449476	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449481	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449503	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pancreatitis (3wk - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449506	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449513	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449594	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Pain in extremity (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449597	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Demyelination (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010449604	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Recovering/Resolving - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449608	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Antinuclear antibody positive (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nephrotic syndrome (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449612	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL] (C - Vitamin D deficiency - n/a - [n/a - 50000[iU] - Oral])|[METHYLPHENIDATE HYDROCHLORIDE] (C - Attention deficit hyperactivity disorder - n/a - [n/a - 36mg - Oral])|[OMEPRAZOLE] (C - Gastric ulcer - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449623	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (4704min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urticaria (4704min - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[DONEPEZIL] (C - n/a - n/a - [n/a - n/a - Oral])|[MEMANTINE] (C - n/a - n/a - [n/a - n/a - Oral])|[SULPIRIDE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449625	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010449627	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vision blurred (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Visual field defect (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010449628	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449644	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[PAROXETINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449645	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (4d - Unknown - );Rectal haemorrhage (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449647	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449649	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chalazion (n/a - Unknown - );Migraine (n/a - Unknown - );Nasopharyngitis (n/a - Unknown - );Sleep apnoea syndrome (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[DESLORATADINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449662	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypertension (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Pericardial rub (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449663	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449663&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449678	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Muscle contractions involuntary (14d - Recovered/Resolved - );Sleep disorder (1d - Recovered/Resolved - );Tremor (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449681	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449686	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (6d - Recovered/Resolved - );Dyspnoea (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449689	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .6mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449696	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pre-existing condition improved (n/a - Not Recovered/Not Resolved - );Skin hyperpigmentation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449705	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis chronic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449705&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449716	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Pain in extremity (2d - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449717	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449723	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449724	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449729	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449729&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449738	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449739	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449742	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pruritus (n/a - Recovering/Resolving - );Injection site rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449748	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Vision blurred (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449750	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Mobility decreased (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449752	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449754	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449754&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449756	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Seronegative arthritis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449759	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Visual acuity reduced (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449762	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[D,L-LYSINE ACETYLSALICYLATE] (C - Cardiovascular event prophylaxis - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - Cardiovascular event prophylaxis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449764	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449765	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash papular (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449769	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - );Lymphadenopathy (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449774	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Influenza like illness (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449775	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gout (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449780	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449782	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449785	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449787	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[DESLORATADINE] (C - Product used for unknown indication - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449790	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intraocular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449796	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449796&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449797	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449798	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449798&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449810	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Muscle fatigue (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449811	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449812	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Vaccination site erythema (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449815	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449822	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449826	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449829	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449832	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449835	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449837	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449838	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449848	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449855	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449856	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site swelling (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449858	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Orthostatic hypotension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449858&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449860	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hepatitis (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449873	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010449874	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Infant	Yes	Not Specified	Rash papular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449877	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449881	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Breast pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010449884	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Influenza like illness (3d - Recovered/Resolved - );Skin reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	XARELTO [RIVAROXABAN] (C - n/a - n/a - )|[AMIODARONE, AMIODARONE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010449884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450169	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fall (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Loss of control of legs (n/a - Unknown - Caused/Prolonged Hospitalisation);Product use issue (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|[INFLUENZA VIRUS] (S - Immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450171	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450176	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Not Specified	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450213	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Mental impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450223	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Coronary artery occlusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450227	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thunderclap headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450227&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450272	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Shunt occlusion (n/a - Recovered/Resolved - Other Medically Important Condition);Thrombosis (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALFACALCIDOL] (C - n/a - n/a - [n/a - .25ug - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[BACILLUS SUBTILIS, LACTOMIN, BIFIDOBACTERIUM] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[CARBOCISTEINE, L-CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERRIC CITRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PITAVASTATIN CALCIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450275	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (2d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450276	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ASCORBIC ACID, CALCIUM ASCORBATE] (C - n/a - n/a - [n/a - n/a - n/a])|[THIAMINE, PYRIDOXINE HYDROCHLORIDE, VITAMIN B] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450279	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450282	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovering/Resolving - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010450312	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovering/Resolving - Disabling);Fatigue (2d - Recovering/Resolving - Disabling);Palpitations (2d - Recovering/Resolving - Disabling);Pyrexia (2d - Recovering/Resolving - Disabling);Tachycardia (2d - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010450372	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Anxiety (n/a - Recovering/Resolving - Other Medically Important Condition);Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Confusional state (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Delirium (n/a - Recovering/Resolving - Other Medically Important Condition);Depressed level of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Influenza like illness (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovering/Resolving - Other Medically Important Condition);Periorbital oedema (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Recovering/Resolving - Other Medically Important Condition);Wheezing (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450412	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450414	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	KETOCONAZOLE [KETOCONAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[ASCORBIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[VITAMIN D] (C - n/a - n/a - [n/a - n/a - n/a])|[ZINC] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450414&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450415	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Depersonalisation/derealisation disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Generalised tonic-clonic seizure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450418	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (6h - Recovered/Resolved - );Fatigue (8h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450423	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Libido increased (2mo - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450424	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bone pain (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450453	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Heart rate irregular (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450553	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Hypokinesia (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Puncture site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450571	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (4d - Recovered/Resolved - );Chills (4h - Recovered/Resolved - );Tremor (4h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010450618	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450620	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );C-reactive protein increased (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Iron deficiency (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - );Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450622	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Muscle tightness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pallor (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Restlessness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Skin wrinkling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sleep disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450633	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450636	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010450675	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450697	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Extrasystoles (n/a - Recovering/Resolving - );Ventricular extrasystoles (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010450717	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450744	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash pustular (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010450769	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010450795	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450800	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450904	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Abdominal pain upper (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Dehydration (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - );Faeces discoloured (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pollakiuria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Rash (n/a - Not Recovered/Not Resolved - );Skin lesion (n/a - Not Recovered/Not Resolved - );Thirst (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Weight decreased (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[HYPERICUM, ST. JOHN'S WORT DRY EXTRACT (3.5-6.0:1), EXTRACTION SOLVENT: ETHANOL 60% (M/M)] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450906	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dysgeusia (n/a - Unknown - );Taste disorder (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010450913	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Confusional state (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450920	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ALFACALCIDOL] (C - n/a - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[BACILLUS SUBTILIS, LACTOMIN, BIFIDOBACTERIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBAMAZEPINE, CARBAMAZEPINE (PH. EUR.)] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE, L-CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[FERRIC CITRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[PITAVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010450955	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination failure (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[CHLORPHENAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN, IBUPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010450966	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Periorbital oedema (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	NOT AVAILABLE (C - Blood pressure measurement - n/a - )|UROREC 4 MG [SILODOSIN] (C - n/a - n/a - )|[ALLOPURINOL, ALLOPURINOL BP] (C - Gout - n/a - )|[FLUOROURACIL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010450966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451009	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010451025	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (18d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1mo - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451049	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arrhythmia (14d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010451051	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Ataxia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Lethargy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Memory impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination site pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Visual impairment (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451069	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451125	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451125&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451127	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451128	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451139	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451139&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451261	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451264	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina pectoris (n/a - Recovered/Resolved - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010451290	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Heart rate irregular (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451295	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451301	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451303	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Illness (n/a - Unknown - );Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010451305	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eosinophilia (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Tachycardia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Troponin increased (n/a - Not Recovered/Not Resolved - );Wheezing (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451307	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Feeding disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Feeling cold (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Illness (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Vomiting (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 80mg - n/a])|[CARVEDILOL] (C - Hypertension - n/a - [n/a - 6.25mg - n/a])|[FLUCONAZOLE] (C - Bacterial infection - n/a - [n/a - 200mg - n/a])|[GLIPIZIDE] (C - Diabetes mellitus - n/a - [n/a - 2.5mg - n/a])|[GLIPIZIDE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Gastrooesophageal reflux disease - n/a - [n/a - 20mg - n/a])|[TICAGRELOR] (C - n/a - n/a - [n/a - 90mg - n/a])|[VALSARTAN] (C - Hypertension - n/a - [n/a - 320mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451308	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal distension (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Anxiety (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Balance disorder (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);C-reactive protein increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Depressed level of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Facial discomfort (n/a - Unknown - );Facial paralysis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Unknown - );Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - );Nausea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swelling (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Transient ischaemic attack (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Urinary tract infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vision blurred (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451308&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451312	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451317	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451318	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Hyperhidrosis (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451325	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Speech disorder (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451325&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451365	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Rash macular (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451381	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451413	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[CALCIUM LEVOFOLINATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451415	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451427	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Otitis externa (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451427&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451483	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Pallor (n/a - Recovering/Resolving - Other Medically Important Condition);Psychogenic seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451491	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Magnetic resonance imaging abnormal (n/a - Unknown - );Musculoskeletal stiffness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LOXOPROFEN, LOXOPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451491&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451616	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Superficial vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Venous thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451642	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451644	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitation (n/a - Unknown - );Arthralgia (n/a - Unknown - );Disorientation (n/a - Unknown - );Dizziness (n/a - Unknown - );Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hyperthyroidism (n/a - Recovering/Resolving - Other Medically Important Condition);Insomnia (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Thyroid disorder (n/a - Recovering/Resolving - );Thyrotoxic crisis (n/a - Unknown - Other Medically Important Condition);Vertigo (n/a - Not Recovered/Not Resolved - );Vestibular neuronitis (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 75ug - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451686	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451686&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451690	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451694	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451696	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451766	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451768	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451775	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451815	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010451816	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (n/a - Unknown - Other Medically Important Condition);Vaccination site reaction (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451830	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Mobility decreased (n/a - Unknown - );Pruritus (20d - Recovered/Resolved - Other Medically Important Condition);Rash (19d - Recovered/Resolved - );Scab (n/a - Unknown - );Urticaria (20d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451834	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010451849	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451868	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010451912	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Troponin increased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451918	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451989	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - );Paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010451995	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010451995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452051	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Renal pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010452147	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperhidrosis (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010452156	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Ischaemic stroke (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Uveitis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling);Visual impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452156&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010452203	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovering/Resolving - Other Medically Important Condition);Mechanical urticaria (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Papule (n/a - Recovering/Resolving - Other Medically Important Condition);Pruritus (49495min - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovering/Resolving - Other Medically Important Condition);Urticaria (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452206	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eyelid infection (11d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Malaise (6d - Recovered/Resolved - );Palpitations (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452206&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010452255	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452261	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452305	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452307	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010452406	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452411	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Extra dose administered (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Overdose (n/a - Unknown - Caused/Prolonged Hospitalisation);Product preparation error (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010452419	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010452421	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (7d - Recovered/Resolved - Other Medically Important Condition);Extra dose administered (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Off label use (n/a - Unknown - );Suspected COVID-19 (7d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INSULIN, INSULIN HUMAN] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452421&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452435	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Eyelid oedema (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Oropharyngeal erythema (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Rash (n/a - Unknown - Caused/Prolonged Hospitalisation);Urticaria (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010452474	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest discomfort (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010452478	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452488	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452488&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452502	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010452569	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010452571	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452577	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452579	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452582	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452610	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - Other Medically Important Condition);Hypersensitivity (n/a - Recovered/Resolved - Other Medically Important Condition);Pruritus (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452618	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (2mo - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452618&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452689	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452693	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Heavy menstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Intermenstrual bleeding (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010452695	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (14d - Recovered/Resolved - );Vaccination failure (14d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452697	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (11d - Recovered/Resolved - );Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452736	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (0d - Recovering/Resolving - );Chills (0d - Recovering/Resolving - );Fatigue (0d - Recovering/Resolving - );Myalgia (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452751	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Myocarditis (n/a - Unknown - Other Medically Important Condition);Nocturnal hypertension (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452751&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010452756	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Deafness unilateral (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nerve injury (n/a - Not Recovered/Not Resolved - Disabling);Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010452761	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Dysgeusia (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Hot flush (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Muscle tightness (n/a - Recovering/Resolving - );Nausea (2d - Recovered/Resolved - );Restlessness (2d - Recovered/Resolved - );Tremor (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010452762	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Back pain (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452766	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452767	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Balance disorder (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010452771	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovering/Resolving - );Feeling cold (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Tremor (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452771&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010452794	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452799	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Haematoma (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010452812	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Recovered/Resolved - );Headache (6d - Recovered/Resolved - );Oropharyngeal pain (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452812&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452825	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (8h - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vaccination site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452830	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Not Recovered/Not Resolved - );Vision blurred (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452838	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452846	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dehydration (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);General physical condition abnormal (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Multisystem inflammatory syndrome in children (10d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Nausea (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Rash (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Renal impairment (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory failure (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010452851	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cough (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452855	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010452857	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Oropharyngeal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452922	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Recovered/Resolved - );No adverse event (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452922&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452957	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010452965	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010452972	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452977	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452980	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (n/a - Unknown - );Vaccination site lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010452982	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nasal congestion (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010452982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453005	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (2d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453017	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (33d - Recovered/Resolved - );Headache (33d - Recovered/Resolved - );Pain in extremity (33d - Recovered/Resolved - );Tongue eruption (33d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010453025	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453030	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (123d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - Drug withdrawn - [123d - n/a - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453033	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (3d - Recovered/Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453043	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (22d - Recovered/Resolved - );Ear pain (22d - Recovered/Resolved - );Headache (22d - Recovered/Resolved - );Neck pain (22d - Recovered/Resolved - );Tinnitus (22d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453043&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010453046	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453060	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Temperature regulation disorder (n/a - Unknown - );Vision blurred (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453060&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453077	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])|GLIVEC 400 MG FILM-COATED TABLETS [IMATINIB, IMATINIB MESILATE] (S - Chronic myeloid leukaemia - Not applicable - [n/a - 400mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453090	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010453100	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovered/Resolved - );Lymphadenopathy (7d - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453100&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453108	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453111	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453111&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010453122	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010453127	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453132	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453133	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453147	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Nausea (n/a - Unknown - );Pyrexia (n/a - Unknown - );Vaccination site inflammation (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453152	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453160	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453169	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (15d - Recovered/Resolved - );Vaccination failure (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453172	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angioedema (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010453223	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Phlebitis (n/a - Not Recovered/Not Resolved - );Thrombophlebitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010453296	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Back pain (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Neuropathy peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	MELATONIN [MELATONIN] (C - n/a - n/a - [n/a - 5mg - Oral])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - 40mg - Oral])|[FINASTERIDE] (C - n/a - n/a - [n/a - 5mg - Oral])|[FISH OIL] (C - n/a - n/a - [n/a - 1000mg - Oral])|[GABAPENTIN] (C - n/a - n/a - [n/a - 100mg - n/a])|[GLYCERYL TRINITRATE] (C - n/a - n/a - [n/a - .4mg - Sublingual])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 100mg - Oral])|[METHYLPREDNISOLONE] (C - n/a - n/a - [n/a - 4mg - Oral])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - 25mg - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 25mg - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - 650mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453296&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010453301	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Constipation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Decreased appetite (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gait disturbance (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Lethargy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Musculoskeletal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Neck pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pain in extremity (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Weight decreased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010453358	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453360	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Heart rate decreased (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Night sweats (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010453445	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (n/a - Not Recovered/Not Resolved - );Eye disorder (n/a - Not Recovered/Not Resolved - );Facial nerve disorder (n/a - Not Recovered/Not Resolved - );Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - );Musculoskeletal stiffness (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Vascular pain (n/a - Not Recovered/Not Resolved - );Vasodilatation (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	OTEZLA [APREMILAST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453451	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453468	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Other Medically Important Condition);Depressed mood (n/a - Unknown - );Headache (n/a - Unknown - );Myocarditis (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453477	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Hypotonia (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Presyncope (1d - Recovered/Resolved - Other Medically Important Condition);Throat tightness (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453477&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010453479	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453509	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain in extremity (4d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453532	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453536	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lymph node pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453540	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (6d - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Pain (6d - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453540&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453574	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperventilation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Influenza like illness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Lymphadenopathy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Right ventricular failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010453576	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anxiety (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Heart rate irregular (n/a - Recovering/Resolving - );Hypertension (n/a - Recovering/Resolving - );Inflammation (n/a - Recovering/Resolving - );Insomnia (n/a - Recovering/Resolving - );Nasal congestion (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Panic disorder (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - );Stress (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453576&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453626	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453667	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Lethargy (n/a - Recovered/Resolved - );Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453692	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Vaccination site reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453703	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Urticaria (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[METOPROLOL SUCCINATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TOPIRAMATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453759	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Feeling cold (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453761	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovered/Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - );Withdrawal syndrome (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	TOZINAMERAN [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])|[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010453770	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Heart rate increased (1d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010453801	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (1d - Not Recovered/Not Resolved - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010453881	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Lethargy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Seizure (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010453938	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010453938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454011	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[OXAZEPAM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010454033	Spontaneous	2021-10-26 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Neoplasm progression (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|XALKORI [CRIZOTINIB] (S - n/a - Unknown - [n/a - n/a - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010454071	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (n/a - Recovered/Resolved - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010454107	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Anaphylactic reaction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Choking sensation (n/a - Unknown - Caused/Prolonged Hospitalisation);Cough (n/a - Unknown - Other Medically Important Condition);Dysphoria (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypoxia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Nasal congestion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Oropharyngeal discomfort (n/a - Unknown - Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Productive cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiratory distress (n/a - Unknown - Other Medically Important Condition);Swelling face (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ATORVASTATIN] (C - Dyslipidaemia - n/a - [n/a - 10mg - Oral])|[BACILLUS MESENTERICUS, CLOSTRIDIUM BUTYRICUM, LACTOMIN] (C - n/a - n/a - [n/a - n/a - n/a])|[BUTYLSCOPOLAMINE, HYOSCINE BUTYLBROMIDE] (C - n/a - n/a - [n/a - 10mg - n/a])|[LOXOPROFEN, LOXOPROFEN SODIUM] (C - Headache - n/a - [n/a - 60mg - n/a])|[NIFEDIPINE] (C - Hypertension - n/a - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010454149	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lethargy (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010454154	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Feeling cold (n/a - Unknown - Caused/Prolonged Hospitalisation);Respiration abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010454224	Spontaneous	2021-10-26 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010454224&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411892	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Plasma cell myeloma (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Drug withdrawn - [n/a - n/a - Unknown])|TYSABRI [NATALIZUMAB] (S - Multiple sclerosis - Drug withdrawn - [n/a - n/a - Unknown])|[GLATIRAMER, GLATIRAMER ACETATE] (S - Multiple sclerosis - Not applicable - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411892&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411964	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Vaccination site reaction (n/a - Not Recovered/Not Resolved - )	MAVENCLAD [CLADRIBINE] (S - Relapsing-remitting multiple sclerosis - Unknown - [n/a - n/a - n/a])|TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010412034	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010412036	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Nasal congestion (n/a - Recovering/Resolving - );Nasopharyngitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010412037	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Effusion (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010412090	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010412157	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010412161	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010412203	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	METHOTREXATE [METHOTREXATE] (C - n/a - n/a - [n/a - 17.5mg - n/a])|ORENCIA [ABATACEPT] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412203&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412229	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - );Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010412230	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Extrasystoles (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Heart rate increased (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010412479	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412480	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412502	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Unknown - );Contusion (n/a - Unknown - );Dizziness (n/a - Unknown - );Heart rate decreased (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Nausea (n/a - Unknown - );Wound (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010412508	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling);Pericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010412516	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agitated depression (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412516&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010412519	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymph node pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Peripheral swelling (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010412520	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Hyperpyrexia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412527	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Headache (10d - Recovered/Resolved - Other Medically Important Condition);Influenza like illness (10d - Recovered/Resolved - Other Medically Important Condition);Persistent postural-perceptual dizziness (10d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412615	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412631	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure systolic increased (2h - Recovered/Resolved - Other Medically Important Condition);Erythema (n/a - Recovered/Resolved - );Headache (9200min - Recovered/Resolved - );Hypertension (2h - Recovered/Resolved - );Malaise (9200min - Recovered/Resolved - );Urticaria (560min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412681	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Angina bullosa haemorrhagica (3mo - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412681&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010412689	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Gastrointestinal disorder (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hypokinesia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Muscular weakness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010412696	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412698	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412699	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412704	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412707	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412708	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412788	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arthralgia (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Gingival pain (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412789	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Child	Yes	Male	Exposure via breast milk (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412826	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412828	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412831	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412832	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412898	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010412935	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412938	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412942	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Impaired work ability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010412951	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412952	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412953	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412954	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010412993	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010412993&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010413148	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Asthma (n/a - Not Recovered/Not Resolved - Disabling);Diarrhoea (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Heart rate increased (n/a - Not Recovered/Not Resolved - Disabling);Hypogeusia (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Migraine (n/a - Not Recovered/Not Resolved - Disabling);Nasopharyngitis (n/a - Not Recovered/Not Resolved - Disabling);Neck pain (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [78d - n/a - Intramuscular])	[BECLOMETASONE DIPROPIONATE, BECLOMETASONE DIPROPIONATE ANHYDROUS] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])|[EBASTINE] (C - n/a - n/a - [n/a - n/a - Oral])|[PARACETAMOL] (C - Migraine - n/a - [n/a - n/a - Oral])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - n/a - n/a - [n/a - n/a - Respiratory (inhalation)])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010413172	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413180	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413182	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413182&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413183	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413186	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413186&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413189	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413189&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413190	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413193	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413194	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413211	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413211&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413257	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010413275	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ATORVASTATIN, EZETIMIBE] (C - Hyperlipidaemia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413275&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413335	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413339	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413339&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413341	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413346	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413346&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413349	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413423	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Costochondritis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010413465	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Haematoma (n/a - Recovered/Resolved - );Internal haemorrhage (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010413468	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413502	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Hypersomnia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413507	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Condition aggravated (n/a - Unknown - );Eosinophil count increased (n/a - Unknown - );Immunodeficiency (n/a - Unknown - Other Medically Important Condition);Insomnia (n/a - Unknown - );Natural killer T cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413509	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413515	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010413522	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Hypertension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling);Palpitations (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling);Sleep disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling);Vision blurred (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010413524	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Tonsillar disorder (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[KETOPROFEN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413530	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Charles Bonnet syndrome (n/a - Not Recovered/Not Resolved - );Glaucoma (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413539	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abscess (n/a - Unknown - Other Medically Important Condition);Erythema (n/a - Unknown - );Induration (n/a - Unknown - );Inflammation (n/a - Unknown - );Nodule (n/a - Unknown - );Oedema (n/a - Unknown - );Pain (n/a - Unknown - );Sensitive skin (n/a - Unknown - );Vaccination site erythema (n/a - Unknown - );Vaccination site inflammation (n/a - Unknown - );Vaccination site pain (n/a - Unknown - );Vaccination site warmth (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413547	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (10d - Recovered/Resolved - Other Medically Important Condition);Primary stabbing headache (10d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413547&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413593	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413596	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413600	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413607	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413609	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Application site pain (n/a - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413612	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413614	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413623	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Discomfort (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Feeling cold (1d - Recovered/Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Formication (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Rhinorrhoea (1d - Recovered/Resolved - );Thirst (1d - Recovered/Resolved - );Urticaria (1d - Recovered/Resolved - );Vision blurred (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413631	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation reaction (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413760	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413760&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413762	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413768	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413768&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413770	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413773	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413773&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413775	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010413794	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - );SARS-CoV-2 test positive (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413837	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010413851	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Facial paralysis (42d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010413852	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombocytopenic purpura (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413852&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010413874	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved With Sequelae - Disabling);Diarrhoea (n/a - Recovered/Resolved With Sequelae - Disabling);Eye pain (n/a - Recovered/Resolved With Sequelae - Disabling);Eye pruritus (n/a - Recovered/Resolved With Sequelae - Disabling);Fatigue (n/a - Recovered/Resolved With Sequelae - Disabling);Pyrexia (n/a - Recovered/Resolved With Sequelae - Disabling);Vision blurred (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413874&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010413885	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (15d - Recovered/Resolved - );Paraesthesia (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413888	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ear pain (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413924	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413966	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematospermia (n/a - Not Recovered/Not Resolved - );Spermatocele (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010413990	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010413990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414029	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414038	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414041	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414048	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414183	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414220	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Recovered/Resolved With Sequelae - Disabling);Malaise (n/a - Recovered/Resolved With Sequelae - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [93d - n/a - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - Depression - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])|[TESTOSTERONE UNDECANOATE] (C - Androgen deficiency - n/a - [n/a - n/a - Intramuscular])|[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Sequelae
EU-EC-10010414242	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414248	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ASCORBIC ACID] (C - n/a - n/a - )|[CRANBERRY] (C - n/a - n/a - )|[GARLIC POWDER] (C - n/a - n/a - )|[VITAMIN D] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414253	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiac failure (n/a - Unknown - Other Medically Important Condition);Cardiac fibrillation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414271	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lacrimation increased (4d - Recovered/Resolved With Sequelae - );Pruritus (4d - Recovered/Resolved With Sequelae - );Swelling face (4d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[BUPROPION HYDROCHLORIDE] (C - Anxiety, Depression - n/a - [31d - n/a - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM OXALATE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010414278	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414284	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Muscle spasms (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414287	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	TRESIBA 100 UNITS/ML [INSULIN DEGLUDEC] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414289	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Headache (n/a - Unknown - );Influenza like illness (n/a - Unknown - );Osteitis (8d - Recovered/Resolved - );Pain in jaw (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414289&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414291	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (4h - Recovered/Resolved - );Anosmia (1d - Recovered/Resolved - );COVID-19 immunisation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414291&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010414302	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Heart rate increased (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	TELMISARTAN ACTAVIS 40 MG TABLETS [TELMISARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])|[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010414305	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010414307	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysuria (n/a - Recovered/Resolved - );Groin pain (n/a - Recovered/Resolved - );Penile pain (n/a - Recovered/Resolved - );Pollakiuria (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular - More in ICSR])	NOVORAPID 100 U/ML SOLUTION FOR INJECTION IN VIAL. [INSULIN ASPART] (C - n/a - n/a - )|TRESIBA 100 UNITS/ML [INSULIN DEGLUDEC] (C - n/a - n/a - )|[EZETIMIBE] (C - n/a - n/a - )|[KETOPROFEN] (C - n/a - n/a - )|[NITRAZEPAM] (C - n/a - n/a - )|[OXYCODONE HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414314	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (1d - Recovered/Resolved - );Pain in extremity (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414314&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414316	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414326	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414327	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414340	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[METHYLPHENIDATE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414352	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[DOCONEXENT, ICOSAPENT, FISH OIL, ICOSAPENT ETHYL, DOCOSAHEXAENOIC ACID ETHYL ESTER, OMEGA-3-ACID ETHYL ESTERS 90, OMEGA-3-ACID ETHYL ESTERS 90, DOCOSAHEXAENOIC ACID ETHYL ESTER] (C - n/a - n/a - )|[THIAMINE HYDROCHLORIDE, RETINOL] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414354	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414356	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414365	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[METFORMIN] (C - Type 2 diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414369	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (10d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Drug ineffective (10d - Fatal - Results in Death, Caused/Prolonged Hospitalisation);Vaccine breakthrough infection (10d - Fatal - Results in Death, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010414379	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (50d - Recovered/Resolved With Sequelae - );C-reactive protein increased (48d - Recovered/Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Not Recovered/Not Resolved - );Headache (50d - Recovered/Resolved With Sequelae - );Hospitalisation (6d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Liver function test increased (48d - Recovered/Resolved With Sequelae - );Myalgia (48d - Recovered/Resolved With Sequelae - );Polymyalgia rheumatica (2d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (50d - Recovered/Resolved With Sequelae - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414401	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vertigo positional (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ALIMEMAZINE TARTRATE] (C - Insomnia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414415	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414420	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[CETIRIZINE, CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414423	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Impaired healing (n/a - Unknown - );Ketoacidosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Mental impairment (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Skin wound (n/a - Unknown - );Vomiting (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CANNABIS SATIVA] (C - Polyneuropathy - n/a - [n/a - n/a - n/a])|[CETIRIZINE DIHYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414425	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414430	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary nerve injury (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Injection site nerve damage (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414431	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[CANDESARTAN CILEXETIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414433	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Coordination abnormal (n/a - Not Recovered/Not Resolved - );Leukaemia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414433&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010414476	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fear (n/a - Not Recovered/Not Resolved - Disabling);Feeling hot (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Muscle spasms (n/a - Not Recovered/Not Resolved - Disabling);Myokymia (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Panic attack (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414476&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010414492	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414522	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Urinary tract infection (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414527	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414532	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Eye pain (n/a - Recovered/Resolved - Disabling);Eye swelling (n/a - Recovered/Resolved - Disabling);Facial paralysis (n/a - Recovered/Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Disabling);Swelling face (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010414535	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Feeling hot (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Hyperhidrosis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pruritus (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010414536	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	Yes	Male	Exposure via breast milk (n/a - Unknown - );Infant irritability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414538	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Chills (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dizziness (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414549	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Drug interaction (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Rash erythematous (n/a - Recovering/Resolving - Other Medically Important Condition)	HYDROCORTISONE [HYDROCORTISONE, HYDROCORTISONE SODIUM SUCCINATE] (I - Addison's disease - Unknown - [n/a - n/a - Unknown])|TOZINAMERAN [TOZINAMERAN] (I - COVID-19 immunisation - Not applicable - [1d - n/a - Unknown])|[TRIMETHOPRIM] (I - Acne - Unknown - [n/a - n/a - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414551	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414552	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414555	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Nausea (n/a - Recovered/Resolved - );Seizure (n/a - Recovered/Resolved - Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414562	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood glucose fluctuation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Body temperature fluctuation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Food craving (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Heart rate increased (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Influenza (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Night sweats (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleural effusion (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleuritic pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pollakiuria (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Type 2 diabetes mellitus (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mL - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414567	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Viral infection (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414568	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Unknown - );Dizziness (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition);Vision blurred (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414569	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Nausea (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Sensitive skin (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414569&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414572	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cardiac failure congestive (n/a - Unknown - Other Medically Important Condition);Migraine (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414574	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Lower respiratory tract infection (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (C - Neck pain - n/a - [n/a - n/a - n/a])|[DIAZEPAM] (C - Generalised anxiety disorder - n/a - [n/a - n/a - n/a])|[THIAMINE] (C - Alcohol use - n/a - [n/a - n/a - n/a])|[VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE] (C - Generalised anxiety disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414575	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Autoimmune haemolytic anaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Haemolytic anaemia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Ocular icterus (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414581	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414582	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperhidrosis (1d - Recovered/Resolved - );Syncope (n/a - Unknown - Other Medically Important Condition);Vomiting (1d - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414585	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Central serous chorioretinopathy (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Eye pain (n/a - Not Recovered/Not Resolved - Disabling);Retinal oedema (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010414588	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Catheterisation cardiac (n/a - Unknown - Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Cold sweat (n/a - Unknown - Caused/Prolonged Hospitalisation);Coronary artery stenosis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Stent placement (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414588&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414590	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414594	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414597	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Body temperature increased (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Muscle twitching (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414601	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate abnormal (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Nausea (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414602	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414609	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Hypotension (n/a - Unknown - Caused/Prolonged Hospitalisation);Nausea (n/a - Unknown - Caused/Prolonged Hospitalisation);Pallor (n/a - Unknown - Caused/Prolonged Hospitalisation);Syncope (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414613	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Seizure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414613&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414616	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthritis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARBOCISTEINE] (C - n/a - n/a - [n/a - n/a - n/a])|[DOCUSATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LANSOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])|[PREDNISOLONE] (C - Rheumatoid arthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414616&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414626	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Condition aggravated (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dysstasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myositis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414626&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414628	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414632	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Pain in extremity (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414632&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010414647	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414647&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414651	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Peroneal nerve palsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	BRILIQUE 90 MG FILM-COATED TABLETS [TICAGRELOR] (C - Anticoagulant therapy - n/a - [366d - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - Thrombosis prophylaxis - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - n/a - n/a])|[PANTOPRAZOLE] (C - Gastric ulcer - n/a - [366d - n/a - n/a])|[RIBOFLAVIN SODIUM PHOSPHATE, CYANOCOBALAMIN, THIAMINE, FERROUS GLUCONATE, PYRIDOXINE HYDROCHLORIDE] (C - n/a - n/a - )|[VALSARTAN] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010414657	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Atrial flutter (0d - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	ELIQUIS [APIXABAN] (C - Atrial flutter - n/a - [n/a - n/a - Oral])|[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - Atrial flutter - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414659	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Inappropriate schedule of product administration (n/a - Unknown - );Palpitations (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414660	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414660&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414671	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[BENSERAZIDE HYDROCHLORIDE, LEVODOPA, BENSERAZIDE, LEVODOPA] (C - n/a - Unknown - [n/a - n/a - n/a])|[CAPTOPRIL] (C - n/a - Unknown - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - )|[EZETIMIBE] (C - n/a - Unknown - [n/a - n/a - n/a])|[FENOFIBRATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414677	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chillblains (1wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414677&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414690	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Neuralgic amyotrophy (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[LISINOPRIL, LISINOPRIL DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414697	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414697&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010414702	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Transient ischaemic attack (1wk - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010414711	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Cerebral ischaemia (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414711&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010414721	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Hypertension (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414721&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414790	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414792	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010414803	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paresis (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010414873	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - );Vaccination failure (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, BISOPROLOL HEMIFUMARATE] (C - n/a - n/a - )|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414946	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414959	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia oral (n/a - Recovering/Resolving - Congenital Anomaly);Lymphadenopathy (n/a - Recovering/Resolving - Congenital Anomaly)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010414969	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010414974	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscular weakness (60d - Not Recovered/Not Resolved - );Pain in extremity (60d - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010414974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010415025	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415027	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415030	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415032	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415032&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415035	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415037	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415038	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415038&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415039	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415040	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415044	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dilated cardiomyopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - n/a])	[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010415086	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (60d - Recovering/Resolving - );Asthenia (60d - Recovering/Resolving - );Cough (n/a - Recovering/Resolving - );Fatigue (60d - Recovering/Resolving - );Oropharyngeal pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010415089	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010415127	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[FINASTERIDE] (C - Prostatic disorder - n/a - [n/a - 5mg - n/a])|[GLUCOSAMINE HYDROCHLORIDE] (C - Osteoarthritis - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415147	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Eye pain (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Rash (1d - Recovered/Resolved - );Rash macular (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415152	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415154	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010415162	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (4d - Recovered/Resolved - );Vaccination site reaction (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415164	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bronchitis (8d - Not Recovered/Not Resolved - );Cough (8d - Not Recovered/Not Resolved - );Dyspnoea (3d - Recovering/Resolving - );Injection site pain (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415220	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415245	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010415246	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (7d - Unknown - );Fatigue (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415263	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (4d - Recovering/Resolving - );Tachycardia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415264	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 immunisation (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010415273	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysphagia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Guillain-Barre syndrome (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Quadriparesis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010415274	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (45d - Recovered/Resolved With Sequelae - );Blood pressure increased (45d - Recovered/Resolved With Sequelae - );Dizziness (45d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010415302	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415305	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415317	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Monoparesis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415319	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hemiparesis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415319&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010415335	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Paraesthesia (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415340	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (1d - Not Recovered/Not Resolved - );Influenza like illness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415340&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415343	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (n/a - Recovered/Resolved With Sequelae - );Seasonal allergy (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010415373	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (19d - Recovered/Resolved - );Rash (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415409	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombophlebitis (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415412	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	PANTOPRAZOLE 20 MG - GASTRO-RESISTANT TABLET  (C - n/a - n/a - [n/a - n/a - n/a])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010415452	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (4d - Not Recovered/Not Resolved - );Rash (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415456	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Apathy (0d - Recovering/Resolving - );Dizziness (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Vomiting (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415463	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415464	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415480	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Asthenia (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415481	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Oropharyngeal pain (0d - Not Recovered/Not Resolved - );Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415490	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Not Recovered/Not Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415509	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Vaccination site movement impairment (1d - Recovered/Resolved - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415510	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Muscle spasms (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415522	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (8d - Recovered/Resolved - );Injection site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415524	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Asthenia (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415531	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415542	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (4d - Recovering/Resolving - );Pyrexia (9d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415560	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Body temperature increased (1d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Joint swelling (3d - Recovering/Resolving - );Malaise (0d - Recovered/Resolved - );Paraesthesia (4d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Tinnitus (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415571	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Coma (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Encephalopathy (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010415578	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (17d - Unknown - );Pain in extremity (17d - Unknown - );Paraesthesia (17d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415586	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Balance disorder (n/a - Recovered/Resolved With Sequelae - Life Threatening);Chills (n/a - Recovered/Resolved With Sequelae - Life Threatening);Dizziness (n/a - Recovered/Resolved With Sequelae - Life Threatening);Dyspnoea (n/a - Recovered/Resolved With Sequelae - Life Threatening);Pyrexia (n/a - Recovered/Resolved With Sequelae - Life Threatening);Visual impairment (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	XARELTO [RIVAROXABAN] (C - n/a - n/a - [n/a - n/a - Oral])|[ISOSORBIDE MONONITRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[SPIRONOLACTONE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010415590	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac discomfort (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415603	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415605	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415606	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415609	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415610	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010415671	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hypertension (n/a - Not Recovered/Not Resolved - );Impatience (3d - Recovered/Resolved - );Tension headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])|[TESTOSTERONE UNDECANOATE] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415671&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415691	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Irritability (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pallor (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415764	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Dose not changed - [n/a - 40mg - Oral])|[PROPRANOLOL HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415767	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthritis (n/a - Not Recovered/Not Resolved - Disabling);Neuralgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [85d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010415815	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Muscle spasms (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Oropharyngeal pain (3d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - );Vomiting (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010415818	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010415842	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Insomnia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010415842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010416010	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (14h - Recovered/Resolved - );Chills (14h - Recovered/Resolved - );Decreased appetite (14h - Recovered/Resolved - );Fatigue (14h - Recovered/Resolved - );Pyrexia (14h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - Dose not changed - [n/a - 40mg - Oral])|[PROPRANOLOL HYDROCHLORIDE] (C - n/a - Dose not changed - [n/a - 40mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416010&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010416084	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition);Vision blurred (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010416085	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010416120	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Bladder catheterisation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dysarthria (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Urinary retention (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[ETHANOL (96 PER CENT), BORIC ACID] (C - n/a - n/a - [n/a - n/a - Auricular (otic)])|[HYDROCORTISONE] (C - n/a - n/a - [n/a - n/a - Auricular (otic)])|[MONTELUKAST, MONTELUKAST SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010416242	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Osteoarthritis (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site inflammation (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010416440	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010416443	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010416455	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Drug ineffective (3d - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (2d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Suspected COVID-19 (3d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	[INFLUENZA VIRUS] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416455&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416464	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Chest pain (n/a - Unknown - );Chills (n/a - Unknown - );Cough (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dizziness (n/a - Unknown - );Dysgeusia (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Odynophagia (n/a - Unknown - );Pyrexia (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416464&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010416482	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416482&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010416483	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Liver injury (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010416498	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (5min - Recovered/Resolved - );Dysgeusia (n/a - Not Recovered/Not Resolved - );Feeling hot (5min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010416533	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010416570	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cellulitis (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Rash (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416574	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Sinus tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010416585	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416592	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416593	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416593&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416599	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416600	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416610	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Puncture site pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010416644	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cardiovascular disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Coagulopathy (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea exertional (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[DILTIAZEM HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[FENOFIBRATE, FENOFIBRATE MICRONISED] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[MOLSIDOMINE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010416716	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010416724	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010416725	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Monoplegia (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Not Recovered/Not Resolved - );Rhinorrhoea (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010416727	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Drug ineffective (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416744	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Abnormal dreams (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Back pain (n/a - Recovering/Resolving - Other Medically Important Condition);Brain fog (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Confusional state (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dysgeusia (n/a - Recovering/Resolving - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hot flush (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (n/a - Recovering/Resolving - Other Medically Important Condition);Miliaria (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Taste disorder (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416744&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010416861	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Chest pain (n/a - Unknown - Other Medically Important Condition);Injection site pain (n/a - Unknown - );Musculoskeletal pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Unknown - Other Medically Important Condition);Paraesthesia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416861&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416971	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416973	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416977	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416977&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416980	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416982	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416989	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416989&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010416999	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	[ALLOPURINOL] (C - n/a - n/a - )|[ROSUVASTATIN] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010416999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417133	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epididymitis (n/a - Recovering/Resolving - Other Medically Important Condition);Hydrocele (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	CELECOXIB [CELECOXIB] (C - n/a - n/a - [n/a - n/a - Oral])|METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN [METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])|VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - Oral])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE, CIPROFLOXACIN LACTATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417142	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417142&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417158	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417166	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417169	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Seizure (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417173	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417174	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Myocardial infarction (n/a - Unknown - Other Medically Important Condition);Near death experience (n/a - Unknown - Other Medically Important Condition);Off label use (n/a - Unknown - );Peripheral swelling (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417176	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417180	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - );Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dyspnoea (n/a - Not Recovered/Not Resolved - );Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417191	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Malaise (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417215	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (40d - Recovered/Resolved - );Myalgia (40d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010417220	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (5d - Recovering/Resolving - );Hypotonia (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417222	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site erythema (0d - Not Recovered/Not Resolved - );Injection site reaction (0d - Not Recovered/Not Resolved - );Injection site swelling (0d - Not Recovered/Not Resolved - );Injection site warmth (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417222&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417225	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Feeling hot (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417225&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010417240	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - );Illusion (n/a - Unknown - );Malaise (n/a - Unknown - );Psychotic disorder (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417272	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral haemorrhage (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417272&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010417276	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417297	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash vesicular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417326	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417326&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417366	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Unknown - );Local reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417377	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Hypertension (2d - Recovered/Resolved - );Visual impairment (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417404	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site erythema (0d - Not Recovered/Not Resolved - );Injection site reaction (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417406	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza like illness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 2{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417410	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417418	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417430	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417505	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417511	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417511&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417512	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417512&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417524	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blindness transient (1d - Recovered/Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417525	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling abnormal (n/a - Recovered/Resolved - );Heart rate decreased (n/a - Recovered/Resolved - );Hyperhidrosis (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417528	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Appendicitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417528&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417664	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure decreased (10min - Recovered/Resolved - );Cold sweat (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pallor (n/a - Recovered/Resolved - );Visual field defect (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417673	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bell's palsy (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417678	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Unknown - );Gait disturbance (n/a - Unknown - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Vomiting (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417679	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - );Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417680	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute myocardial infarction (n/a - Unknown - Other Medically Important Condition);Back pain (n/a - Unknown - Other Medically Important Condition);Hypotension (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myocardial infarction (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417716	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[ESCITALOPRAM] (C - Anxiety - n/a - [n/a - 10mg - n/a])|[TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417719	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Influenza like illness (5d - Recovered/Resolved - );Lymph node pain (6d - Recovered/Resolved - );Lymphadenopathy (6d - Recovered/Resolved - );Pain (n/a - Unknown - );Rash macular (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417741	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[INSULIN LISPRO] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010417785	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Injection site reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010417855	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417857	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417870	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Linear IgA disease (1mo - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	TRIMBOW [BECLOMETASONE DIPROPIONATE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - 1.25mg - n/a])|[EZETIMIBE, ROSUVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - 20mg - n/a])|[PERINDOPRIL TERT-BUTYLAMINE] (C - n/a - n/a - [n/a - 8mg - n/a])|[TORASEMIDE] (C - n/a - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010417924	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (4d - Not Recovered/Not Resolved - );Vaccination failure (4d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417936	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Unknown - Other Medically Important Condition);Rash (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417937	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010417945	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Anaphylactic reaction (n/a - Unknown - Other Medically Important Condition);Loss of consciousness (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417949	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bradycardia (0d - Recovered/Resolved - Other Medically Important Condition);Hypotension (0d - Recovered/Resolved - Other Medically Important Condition);Loss of consciousness (0d - Recovered/Resolved - Other Medically Important Condition);Paralysis (0d - Recovered/Resolved - Other Medically Important Condition);Syncope (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010417950	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chest pain (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Parenteral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010417950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010418172	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (5d - Not Recovered/Not Resolved - );Vaccination failure (5d - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010418193	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418279	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010418281	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418281&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010418283	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010418302	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Musculoskeletal discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Off label use (n/a - Unknown - );Ventricular arrhythmia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418383	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Colitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418383&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418592	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Motor dysfunction (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tinnitus (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418739	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418776	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418777	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418785	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (2d - Not Recovered/Not Resolved - );Malaise (2d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418785&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418822	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418871	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418871&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418883	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418884	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418886	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418910	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (3d - Recovered/Resolved - );Influenza (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418910&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418913	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418915	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418920	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418936	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (1d - Recovered/Resolved - Other Medically Important Condition);Dyspnoea (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Myalgia (1d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010418944	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Back pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418949	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site erythema (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010418951	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418956	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Erectile dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Induration (n/a - Unknown - Caused/Prolonged Hospitalisation);Inflammation (n/a - Unknown - );Limb discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation);Spinal osteoarthritis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	IMBRUVICA [IBRUTINIB] (C - Chronic lymphocytic leukaemia - n/a - [n/a - 420mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418979	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Ear pain (8d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Facial paresis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Hypoaesthesia oral (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Paraesthesia (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010418982	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait inability (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - );Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[TESTOSTERONE CIPIONATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010418984	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Abdominal hernia (n/a - Unknown - );Activated partial thromboplastin time shortened (n/a - Unknown - );Anuria (n/a - Unknown - Other Medically Important Condition);Aortic arteriosclerosis (n/a - Unknown - );Asthenia (n/a - Unknown - );Atrial fibrillation (n/a - Unknown - Other Medically Important Condition);Blood creatinine increased (n/a - Unknown - );Blood glucose increased (n/a - Unknown - );Blood immunoglobulin G increased (n/a - Unknown - );Blood pressure fluctuation (n/a - Unknown - );Blood sodium decreased (n/a - Unknown - );Blood urea increased (n/a - Unknown - );C-reactive protein increased (n/a - Unknown - );COVID-19 pneumonia (n/a - Unknown - Other Medically Important Condition);Cardiac disorder (n/a - Unknown - Other Medically Important Condition);Cardiac failure (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Circulatory collapse (n/a - Fatal - Results in Death, Other Medically Important Condition);Cough (n/a - Unknown - Caused/Prolonged Hospitalisation);Disease recurrence (n/a - Unknown - Other Medically Important Condition);Dyspnoea (n/a - Unknown - Caused/Prolonged Hospitalisation);Ejection fraction decreased (n/a - Unknown - );Eosinophil count increased (n/a - Unknown - );Exercise tolerance decreased (n/a - Unknown - );Fatigue (n/a - Unknown - );Fibrin D dimer increased (n/a - Unknown - );Full blood count abnormal (n/a - Unknown - );Fungal test positive (n/a - Unknown - );General physical health deterioration (n/a - Unknown - Other Medically Important Condition);Glomerular filtration rate decreased (n/a - Unknown - );Haematocrit decreased (n/a - Unknown - );Haemoglobin decreased (n/a - Unknown - );Hypertension (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Inflammation (n/a - Unknown - );Interstitial lung disease (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Joint injury (n/a - Unknown - Other Medically Important Condition);Joint stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Leukocytosis (n/a - Unknown - );Loss of personal independence in daily activities (n/a - Unknown - );Lung disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Lymphopenia (n/a - Unknown - );Malaise (n/a - Unknown - );Mean cell haemoglobin concentration decreased (n/a - Unknown - );Mean cell volume increased (n/a - Unknown - );Metabolic acidosis (n/a - Unknown - );Mitral valve incompetence (n/a - Unknown - Other Medically Important Condition);Monocyte count decreased (n/a - Unknown - );Multiple organ dysfunction syndrome (n/a - Unknown - Other Medically Important Condition);Narcolepsy (n/a - Unknown - Other Medically Important Condition);Neutrophilia (n/a - Unknown - );Normocytic anaemia (n/a - Unknown - );Oedema peripheral (n/a - Recovered/Resolved - );Oxygen saturation decreased (n/a - Unknown - Other Medically Important Condition);PCO2 decreased (n/a - Unknown - );Pain (n/a - Unknown - );Platelet count decreased (n/a - Unknown - );Pneumocystis jirovecii infection (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - Anticoagulant therapy - n/a - [n/a - n/a - n/a])|[AMLODIPINE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[FINASTERIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])|[LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, HYDRATE] (C - Thyroid therapy - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - Blood cholesterol - n/a - [n/a - n/a - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010418985	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Discomfort (n/a - Unknown - Other Medically Important Condition);Dizziness (n/a - Unknown - );Fatigue (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Sensitive skin (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010418985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419047	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419050	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419050&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419053	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419079	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419080	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419088	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (20d - Not Recovered/Not Resolved - );Fatigue (17d - Not Recovered/Not Resolved - );Headache (14d - Not Recovered/Not Resolved - );Malaise (14d - Not Recovered/Not Resolved - );Pyrexia (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419124	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419127	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419128	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419131	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419135	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419135&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419155	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dermatitis contact (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419199	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419199&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419226	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Injection site swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419239	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - );Muscular weakness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{total} - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - 1{total} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419245	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paresis (19d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010419274	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419274&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419280	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419283	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419288	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419292	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Visual impairment (1d - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419293	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419293&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419294	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Recovered/Resolved - Other Medically Important Condition);Stress (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419294&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419301	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419305	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419305&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419309	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Recovering/Resolving - Disabling);Asthenia (n/a - Recovering/Resolving - Disabling);Gait disturbance (n/a - Recovering/Resolving - Disabling);Pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010419320	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Inflammation (n/a - Unknown - Caused/Prolonged Hospitalisation);Neck pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Neutrophilia (n/a - Unknown - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombocytosis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419327	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myositis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419333	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (5d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419378	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster meningitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Varicella zoster pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [41d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419381	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419451	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Blood pressure decreased (1h - Recovered/Resolved - );Bradycardia (1h - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419454	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovered/Resolved - Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Palpitations (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419461	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cardiac arrest (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419461&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010419497	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010419499	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral haematoma (n/a - Recovered/Resolved With Sequelae - Life Threatening);Cerebral venous sinus thrombosis (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010419507	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [27d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419513	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Haematuria (n/a - Recovering/Resolving - Other Medically Important Condition);Urinary bladder haemorrhage (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419518	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419523	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 pneumonia - Not applicable - [n/a - 1{DF} - Intramuscular])	[ATORVASTATIN, ATORVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419530	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myelitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	AVASTIN 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION [BEVACIZUMAB] (S - Chemotherapy - Drug withdrawn - [133d - n/a - Intravenous drip])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])|[PACLITAXEL] (S - Chemotherapy - Drug withdrawn - [133d - n/a - Intravenous drip])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419539	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419545	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Paraesthesia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419549	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419549&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419553	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ankylosing spondylitis (n/a - Not Recovered/Not Resolved - Disabling);Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010419558	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (4d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419559	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419560	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rectal haemorrhage (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])|METHOTREXATE [METHOTREXATE] (S - Spondylitis - Not applicable - [n/a - 5mg - Oral])|SIMPONI 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [GOLIMUMAB] (S - Spondylitis - Not applicable - [n/a - 1{DF} - Subcutaneous])|[ENOXAPARIN, ENOXAPARIN SODIUM] (S - Thrombosis prophylaxis - Not applicable - [n/a - n/a - Subcutaneous])|[ETHAMBUTOL HYDROCHLORIDE] (S - Tuberculosis - Not applicable - [n/a - 500mg - Oral])|[ISONIAZID] (S - Tuberculosis - Not applicable - [n/a - 300mg - Oral])|[PYRAZINAMIDE] (S - Tuberculosis - Not applicable - [n/a - 2000mg - Oral])|[RIFAMPICIN] (S - Tuberculosis - Not applicable - [n/a - 600mg - Oral])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010419568	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cheilitis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419575	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Deep vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419577	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419579	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovered/Resolved With Sequelae - );Rash (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010419581	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419582	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Disease recurrence (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419592	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Ophthalmic herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419600	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Cardio-respiratory arrest (n/a - Recovering/Resolving - Life Threatening);Seizure (1h - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010419601	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419602	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419603	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [26d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419603&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419604	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419608	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hemiparesis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Seizure (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (1h - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419614	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010419619	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombocytopenia (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010419656	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419662	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419664	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Immune thrombocytopenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BISOPROLOL FUMARATE] (C - Ventricular extrasystoles - n/a - [n/a - 3.75mg - Oral])|[HYDROXYCHLOROQUINE SULFATE] (C - Lupus-like syndrome - n/a - [n/a - 200mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419716	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Autoimmune thyroiditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010419737	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010419752	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Herpes zoster (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010419758	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419758&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419761	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419762	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419762&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419763	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419763&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419770	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (4d - Unknown - );Nausea (4d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419787	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - );Rhinitis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419793	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419834	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthmatic crisis (1d - Recovered/Resolved - );Cough (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419857	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010419863	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dysphonia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419865	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010419867	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoacusis (1mo - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419878	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419896	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Orchitis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419900	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Facial paralysis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010419906	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vertigo (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419911	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Vitreous floaters (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419927	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (58d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010419951	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Dysaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419951&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419957	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [42d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419957&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419962	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419968	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	[PARACETAMOL] (C - Product used for unknown indication - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419969	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419969&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419972	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419974	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419980	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419980&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419987	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Erectile dysfunction (n/a - Not Recovered/Not Resolved - );Libido decreased (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[MANIDIPINE DIHYDROCHLORIDE] (C - Hypertension - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010419992	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010419992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420005	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420005&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420007	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420011	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420013	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420015	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (1mo - Not Recovered/Not Resolved - );Pyrexia (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420015&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420016	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420018	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420018&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420022	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420022&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420024	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - Disabling);Taste disorder (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010420037	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420044	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420046	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420047	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420049	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2h - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (60h - Recovered/Resolved - );Migraine (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420054	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovering/Resolving - );Hyperventilation (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420076	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Angioedema (n/a - Not Recovered/Not Resolved - );Injection site oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420076&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420079	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (8mo - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420088	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420090	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420102	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420102&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420106	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420107	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420121	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420121&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420122	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420122&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420123	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420127	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Haematochezia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Vomiting (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010420128	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420128&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420132	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010420133	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebrovascular accident (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420138	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Burning sensation (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Decreased vibratory sense (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral sensory neuropathy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	CELECOXIB [CELECOXIB] (C - n/a - n/a - [n/a - n/a - Oral])|METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN [METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN] (C - n/a - n/a - [n/a - n/a - Oral])|PANTOPRAZOLE [PANTOPRAZOLE, PANTOPRAZOLE SODIUM SESQUIHYDRATE] (C - n/a - n/a - [n/a - n/a - Oral])|PREGABALIN [PREGABALIN] (C - n/a - n/a - [n/a - n/a - Oral])|VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE [VALSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - n/a - Oral])|[CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE, CIPROFLOXACIN LACTATE] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE] (C - n/a - n/a - [n/a - n/a - Oral])|[METOPROLOL, METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - n/a - Oral])|[ROSUVASTATIN, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010420140	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010420144	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Presyncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010420145	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - );Illness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Infant irritability (n/a - Unknown - Other Medically Important Condition);Infantile vomiting (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010420151	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Encephalitis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010420155	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (8d - Recovered/Resolved - Other Medically Important Condition);Pulmonary embolism (n/a - Unknown - Other Medically Important Condition);Thrombosis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ASCORBIC ACID, BIOTIN, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, CALCIUM HYDROGEN PHOSPHATE (ANHYDROUS), MANGANESE SULPHATE MONOHYDRATE, THIAMINE NITRATE, COPPER SULFATE, FERROUS SULFATE, LECITHIN, MAGNESIUM SULFATE, PYRIDOXINE HYDROCHLORIDE, SODIUM SELENITE, ZINC SULPHATE MONOHYDRATE, GINSENG EXTRACTUM SICCUM NORMATUM, VITAMIN A CONCENTRATE (OILY FORM), SYNTHETIC, BIOTIN, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, CALCIUM HYDROGEN PHOSPHATE (ANHYDROUS), COPPER SULPHATE, ANHYDROUS, THIAMINE NITRATE, L-ASCORBIC ACID, DRIED FERROUS SULFATE, LECITHIN, PYRIDOXINE HYDROCHLORIDE, COLECALCIFEROL CONCENTRATE (OILY FORM), ZINC SULPHATE MONOHYDRATE, DL-ALPHA TOCOPHEROL ACETATE, MAGNESIUM SULPHATE ANHYDROUS, VITAMIN A CONCENTRATE (OILY FORM), SYNTHETIC, SODIUM SELENITE ANHYDROUS, G115 PANAX GINSENG EXTRACT [DRY EXTRACT ETHANOLIC 40%: 1.3 – 3:1], BIOTIN, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, ZINC, L-ASCORBIC ACID, CALCIUM, COPPER, IRON, LECITHIN, MAGNESIUM, PYRIDOXINE HYDROCHLORIDE, SELENIUM, COLECALCIFEROL CONCENTRATE (OILY FORM), DL-ALPHA TOCOPHEROL ACETATE, VITAMIN A CONCENTRATE (OILY FORM), SYNTHETIC, G115 PANAX GINSENG EXTRACT [DRY EXTRACT ETHANOLIC 40%: 1.3 – 3:1], CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE, DEANOL BITARTRATE, THIAMINE NITRATE, GINSENG, RETINOL PALMITATE, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, COPPER SULFATE, LECITHIN, MAGNESIUM SULFATE, MANGANESE SULFATE, PANAX GINSENG, PYRIDOXINE HYDROCHLORIDE, SODIUM SELENITE, ALPHATOCOPHEROL ACETATE, CALCIUM HYDROGEN PHOSPHATE, FERRIC SULFATE, ZINC SULPHATE MONOHYDRATE, RETINOL PALMITATE, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, COPPER SULFATE, LECITHIN, MAGNESIUM SULFATE, MANGANESE SULFATE, PYRIDOXINE HYDROCHLORIDE, SODIUM SELENITE, ALPHATOCOPHEROL ACETATE, CALCIUM HYDROGEN PHOSPHATE, FERRIC SULFATE, ZINC SULPHATE MONOHYDRATE, G115 PANAX GINSENG EXTRACT [DRY EXTRACT ETHANOLIC 40%: 1.3 – 3:1], RETINOL PALMITATE, ASCORBIC ACID, BIOTIN, COLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, NICOTINAMIDE, RIBOFLAVIN, THIAMINE NITRATE, COPPER SULFATE, LECITHIN, MAGNESIUM SULFATE, MANGANESE SULFATE, PYRIDOXINE HYDROCHLORIDE, SODIUM SELENITE, ALPHATOCOPHEROL ACETATE, CALCIUM HYDROGEN PHOSPHATE, FERRIC SULFATE, ZINC SULPHATE MONOHYDRATE, GINSENG EXTRACTUM SICCUM NORMATUM, THIAMINE HYDROCHLORIDE, NICOTINAMIDE, RIBOFLAVIN, CALCIUM CHLORIDE, LYSINE HYDROCHLORIDE, PANTHENOL, PYRIDOXINE HYDROCHLORIDE] (C - Vitamin supplementation - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420157	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cerebral disorder (n/a - Unknown - Other Medically Important Condition);Respiratory disorder (n/a - Unknown - );Sleep disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420161	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Back injury (n/a - Unknown - Other Medically Important Condition);Presyncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved With Sequelae - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010420168	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420179	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420179&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420180	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420180&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420185	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420185&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010420188	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420188&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420190	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420190&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420192	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420195	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420197	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420201	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (6h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420213	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420213&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420217	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420220	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (36h - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420223	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420229	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420229&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420232	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1h - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420239	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420239&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420241	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420242	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420245	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420250	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (1h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420255	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420255&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420266	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (3d - Recovered/Resolved - );Dysgeusia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420267	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ventricular tachycardia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010420273	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Eye pain (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420279	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420303	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Recovering/Resolving - );Anosmia (n/a - Recovering/Resolving - );Asthenia (n/a - Recovering/Resolving - );Depression (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420327	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420327&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010420333	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420334	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420338	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - );Parosmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	[DIAZEPAM] (C - n/a - n/a - [n/a - n/a - n/a])|[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420338&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420341	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Menstrual disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420343	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420344	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vaccination failure (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [42d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420352	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (5h - Recovered/Resolved - );Painful erection (5h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420366	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocardial infarction (n/a - Recovered/Resolved With Sequelae - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[ENALAPRIL MALEATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420366&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010420377	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Immunisation reaction (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420378	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Otitis externa (n/a - Recovered/Resolved - );Otitis media acute (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 2{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420378&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420379	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Palatal oedema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420379&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420391	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420395	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420397	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420399	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Influenza like illness (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420399&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420400	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (3d - Recovered/Resolved - );Pruritus (3d - Recovered/Resolved - );Rash macular (3d - Recovered/Resolved - );Vaccination site oedema (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420400&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420405	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420406	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Herpes zoster (21d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420419	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010420470	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420489	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pulmonary embolism (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010420701	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hyperglycaemia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	HUMALOG [INSULIN LISPRO] (C - Type 1 diabetes mellitus - n/a - [n/a - 32[iU] - n/a])|LANTUS [INSULIN GLARGINE] (C - Type 1 diabetes mellitus - n/a - [n/a - 44[iU] - n/a])|[ENALAPRIL, ENALAPRIL MALEATE] (C - Hypertension - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420719	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Recovering/Resolving - );Sensitive skin (n/a - Recovering/Resolving - );Syncope (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - );Vision blurred (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420748	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site reaction (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (24h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420808	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420816	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (2d - Recovered/Resolved - );Vaccination site lymphadenopathy (n/a - Not Recovered/Not Resolved - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420816&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420835	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420843	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (3wk - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nasopharyngitis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[AMMONIUM CHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ANISE OIL] (C - n/a - n/a - [n/a - n/a - n/a])|[LIQUORICE ROOT] (C - n/a - n/a - [n/a - n/a - n/a])|[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420853	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry throat (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Throat tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420853&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420859	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420859&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420868	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3wk - Not Recovered/Not Resolved - );Hypotension (3wk - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420881	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010420884	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Subcutaneous])	[FELODIPINE, METOPROLOL, METOPROLOL SUCCINATE, FELODIPINE, METOPROLOL TARTRATE, FELODIPINE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420884&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420896	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420916	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (5d - Recovered/Resolved - );Influenza like illness (5d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420921	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dysgeusia (n/a - Not Recovered/Not Resolved - );Epistaxis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010420923	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Spinal pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420926	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420928	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [24d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420939	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (n/a - Not Recovered/Not Resolved - );Vaccination site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010420994	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010420995	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (11d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Oral pain (n/a - Unknown - Other Medically Important Condition);Petechiae (11d - Recovered/Resolved - Other Medically Important Condition);Purpura (11d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010420995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010421001	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anosmia (n/a - Recovering/Resolving - );Drug ineffective (n/a - Unknown - Other Medically Important Condition);Parosmia (n/a - Not Recovered/Not Resolved - );Suspected COVID-19 (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010421065	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Epilepsy (n/a - Recovering/Resolving - Other Medically Important Condition);Seizure (n/a - Recovering/Resolving - Other Medically Important Condition);Syncope (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421065&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010421070	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Alpha 1 globulin increased (n/a - Recovering/Resolving - );Alpha 2 globulin increased (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Arthritis (n/a - Recovering/Resolving - );Atrial fibrillation (n/a - Recovering/Resolving - Other Medically Important Condition);Blood immunoglobulin A increased (n/a - Recovering/Resolving - );Blood immunoglobulin E increased (n/a - Recovering/Resolving - );Chest pain (n/a - Recovering/Resolving - );Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Disease recurrence (n/a - Recovering/Resolving - Other Medically Important Condition);Dizziness (n/a - Recovering/Resolving - );Dyspnoea (n/a - Not Recovered/Not Resolved - Disabling);Fall (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Myositis (n/a - Recovering/Resolving - );Neuropathy peripheral (n/a - Recovering/Resolving - Other Medically Important Condition);Platelet count increased (n/a - Recovering/Resolving - );Pneumonia (n/a - Recovering/Resolving - Other Medically Important Condition);Pneumonitis (n/a - Recovering/Resolving - Other Medically Important Condition);Prostatitis (n/a - Recovering/Resolving - Other Medically Important Condition);Pulmonary mass (n/a - Recovering/Resolving - );Sciatica (n/a - Recovering/Resolving - );Thyroiditis acute (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	TRELEGY ELLIPTA [UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL] (C - Chronic obstructive pulmonary disease - n/a - [n/a - n/a - n/a])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood cholesterol - n/a - [n/a - n/a - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Prostatomegaly - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010421169	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	BARICITINIB [BARICITINIB] (C - n/a - n/a - [n/a - n/a - n/a])|INSULIN GLARGINE [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|INSULIN LISPRO [INSULIN LISPRO] (C - Diabetes mellitus - n/a - [n/a - n/a - n/a])|[ATENOLOL, ATENOLOL BP] (C - n/a - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Micturition urgency - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010421173	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site warmth (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421181	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Bradycardia (n/a - Recovered/Resolved - Other Medically Important Condition);Cold sweat (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - Other Medically Important Condition);Pallor (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010421302	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Chills (n/a - Recovering/Resolving - Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421302&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421435	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Groin pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Rash (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421470	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Rash erythematous (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421470&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421507	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Takasaki, N.. A case of hepatic function disorder observed after administration of COVID-19 vaccine. The 36th Annual Meeting of Japanese Society for Infection Prevention and Control. 2021;36:268	18-64 Years	Not Specified	No	Male	Drug-induced liver injury (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010421546	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ear pain (n/a - Recovering/Resolving - );Eyelid ptosis (n/a - Recovering/Resolving - Other Medically Important Condition);Facial paresis (n/a - Recovering/Resolving - Other Medically Important Condition);Lip disorder (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Recovering/Resolving - );Toothache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[BUDESONIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010421571	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Condition aggravated (24h - Unknown - );Migraine (24h - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a - More in ICSR])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421574	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site erythema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site movement impairment (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421580	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscular weakness (n/a - Not Recovered/Not Resolved - Disabling);Musculoskeletal discomfort (n/a - Not Recovered/Not Resolved - Disabling);Neurological symptom (n/a - Not Recovered/Not Resolved - Disabling);Pain (n/a - Not Recovered/Not Resolved - Disabling);Vaccination site pain (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010421594	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010421607	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [29d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421662	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Unknown - );Movement disorder (n/a - Unknown - Other Medically Important Condition);Swelling (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421662&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421702	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Visual field defect (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421717	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421717&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421767	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421786	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421786&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421792	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421792&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421793	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421794	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010421800	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421802	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421803	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421809	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421810	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421810&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421814	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421818	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421818&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421822	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421827	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421830	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421836	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421838	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Malaise (5d - Not Recovered/Not Resolved - );Tachycardia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010421841	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovering/Resolving - );Vaccination site reaction (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421849	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421864	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dyspnoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421864&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010421881	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram PR shortened (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram ST segment abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pericardial effusion (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421881&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010421937	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	SUBRAMANIAN, L.. SEVERE COVID-19 PNEUMONIA IN A FULLY VACCINATED IMMUNOCOMPROMISED PATIENT.. chest. 2021;160 (4Suppleme):A482. doi:10.1016/j.chest.2021.07.472	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010421949	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421950	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421950&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421959	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421964	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010421966	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010421966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422000	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422000&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422007	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422017	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422017&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422026	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422026&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422031	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422033	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (25d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422033&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010422034	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (21d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010422037	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422041	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422042	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422042&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422044	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422049	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422049&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422051	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Injection site pain (1d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422052	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422055	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422055&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422056	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422058	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422064	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Recovered/Resolved - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422066	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422068	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422069	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422072	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Not Recovered/Not Resolved - );Headache (5d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422072&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422074	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422080	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422082	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422082&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422085	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422085&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422088	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422120	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422131	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422131&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422144	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422210	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422220	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Superficial vein thrombosis (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422246	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422250	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422250&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422267	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422268	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422283	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422287	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Anosmia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422307	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Recovered/Resolved - );Fatigue (5d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - );Nausea (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422323	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Blood creatine phosphokinase increased (n/a - Unknown - );Erythema (n/a - Unknown - );Insomnia (n/a - Unknown - );Myalgia (n/a - Unknown - );Weight increased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - n/a - [n/a - 40mg - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 160mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422323&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010422331	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422334	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - );Nausea (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422334&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422342	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypertension (1d - Recovered/Resolved - );Ocular hyperaemia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422358	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010422367	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422377	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422377&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422380	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422380&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422382	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422391	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422391&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422395	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422403	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422405	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422406	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422406&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422412	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422412&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422419	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422420	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422420&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422422	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422423	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site swelling (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422430	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422430&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422440	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422446	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (6d - Not Recovered/Not Resolved - );Fatigue (6d - Not Recovered/Not Resolved - );Nausea (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422447	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422447&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422454	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422493	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422496	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422499	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (4d - Recovering/Resolving - );Cough (3d - Recovering/Resolving - );Fatigue (4d - Not Recovered/Not Resolved - );Pyrexia (2d - Recovering/Resolving - );Rash (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422499&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422513	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422519	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422520	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422525	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Axillary pain (n/a - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422525&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422529	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Electrocardiogram abnormal (n/a - Unknown - Other Medically Important Condition);Immunisation (n/a - Unknown - );Myopericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422529&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010422535	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422535&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422542	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422542&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422545	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422548	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422548&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422550	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422563	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422564	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422564&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422565	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Neutrophil count increased (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition);Tachycardia (n/a - Recovered/Resolved - Other Medically Important Condition);White blood cell count increased (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010422572	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422573	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (0d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422578	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site reaction (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422578&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422579	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422586	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Feeling hot (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (3d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422596	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422597	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422600	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422600&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422601	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422602	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422604	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422607	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422607&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422612	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422622	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Not Recovered/Not Resolved - );Rash (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422622&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422624	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422627	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422627&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422628	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422628&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422631	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422635	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (8d - Unknown - );Fatigue (9d - Unknown - );Tachycardia (9d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422638	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422638&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422639	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422639&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422641	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422642	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422642&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422643	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422644	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (4d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422644&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422645	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (3d - Recovered/Resolved - );Rash (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422652	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010422658	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (73d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010422670	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422670&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422673	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422691	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422702	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422702&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422722	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422724	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422726	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422726&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422731	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Injection site swelling (5d - Recovered/Resolved - );Lymphadenopathy (7d - Not Recovered/Not Resolved - );Malaise (2d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422745	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovering/Resolving - );Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Malaise (0d - Recovering/Resolving - );Nausea (0d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422746	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422746&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422750	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422759	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422766	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Unknown - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422776	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422784	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422784&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422790	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422793	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422795	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Unknown - );Injection site pain (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422801	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acute generalised exanthematous pustulosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pruritus (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010422809	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422813	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422817	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422817&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422825	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site swelling (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422825&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422827	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422827&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422830	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422833	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Headache (2d - Not Recovered/Not Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422835	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422842	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422865	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422865&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422868	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422873	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422873&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010422875	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (9d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422876	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (26d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010422883	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pleuritic pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010422888	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422898	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Malaise (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422899	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422902	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422911	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422912	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422917	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422919	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422920	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (14d - Not Recovered/Not Resolved - );Feeling hot (14d - Not Recovered/Not Resolved - );Injection site swelling (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422927	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Headache (30d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010422945	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422945&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422953	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422953&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422955	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422955&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422959	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422964	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dizziness (7d - Not Recovered/Not Resolved - );Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422967	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422972	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422972&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422983	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422983&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422986	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422987	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site erythema (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010422996	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010422996&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423002	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Lymphadenopathy (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423006	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Myalgia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423006&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423021	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423023	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423029	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423031	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423037	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (5d - Recovering/Resolving - );Headache (10d - Recovering/Resolving - );Pyrexia (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423039	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423039&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423051	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423051&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423052	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (9d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423058	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423059	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423069	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423078	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423080	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423080&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423081	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423083	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423087	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423088	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423090	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423090&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423093	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423097	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423098	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423098&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423106	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423114	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423114&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423119	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - );Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423146	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423157	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423187	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423187&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423197	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - );Injection site swelling (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423197&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423198	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423198&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423208	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423220	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chills (3d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Limb discomfort (5d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423233	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423233&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423238	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (2d - Recovered/Resolved - );Influenza (4d - Not Recovered/Not Resolved - );Injection site pain (3d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423238&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423241	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423241&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423247	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423254	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Injection site swelling (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423259	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423259&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423268	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423268&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423276	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423280	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423287	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423287&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423288	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Headache (3d - Recovering/Resolving - );Injection site swelling (2d - Recovered/Resolved - );Limb discomfort (n/a - Recovering/Resolving - );Malaise (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423292	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423297	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423297&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423300	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423300&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423306	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (46d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010423311	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423320	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (4d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423320&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423322	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423330	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423330&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423333	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423336	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423336&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423342	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation);Vaccination failure (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423342&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423347	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423353	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423356	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Rash (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423356&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010423357	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (1d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423358	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Cough (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rhinorrhoea (n/a - Unknown - );Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010423372	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Cough (8d - Recovering/Resolving - );Fatigue (5d - Recovered/Resolved - );Feeling hot (8d - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Influenza (3d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423373	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423384	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Paraesthesia (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423386	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Dizziness (1d - Recovered/Resolved - );Fatigue (6d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423386&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423392	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423397	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423398	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Tachycardia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423411	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423415	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423415&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423418	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Not Recovered/Not Resolved - );Fatigue (8d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423423	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arrhythmia (29d - Not Recovered/Not Resolved - );Dizziness (19d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423424	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423424&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423426	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423434	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423434&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423438	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423439	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (1d - Not Recovered/Not Resolved - );Chills (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - );Tachycardia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423439&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423441	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423441&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423443	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423443&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423448	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Cough (n/a - Recovered/Resolved - );Influenza (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovered/Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423452	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423452&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423453	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423454	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423458	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Influenza (8d - Not Recovered/Not Resolved - );Injection site erythema (9d - Not Recovered/Not Resolved - );Injection site pain (2d - Recovered/Resolved - );Injection site swelling (9d - Not Recovered/Not Resolved - );Malaise (6d - Recovered/Resolved - );Vaccination site reaction (9d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423467	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423480	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423483	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423489	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Ischaemic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423493	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423493&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423496	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423507	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423507&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423509	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423515	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dyspnoea (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010423522	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423531	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Fatigue (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423532	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Feeling hot (0d - Not Recovered/Not Resolved - );Nausea (0d - Not Recovered/Not Resolved - );Vomiting (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423532&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423538	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423538&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423546	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (7d - Recovering/Resolving - );Headache (6d - Recovering/Resolving - );Injection site pain (6d - Recovering/Resolving - );Injection site swelling (5d - Recovered/Resolved - );Limb discomfort (6d - Recovering/Resolving - );Myalgia (6d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423555	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423567	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423567&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423568	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423568&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010423571	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423573	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423575	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (14d - Recovered/Resolved - );Myalgia (10d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423577	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423583	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423586	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423590	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423590&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423597	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (20d - Recovering/Resolving - );Malaise (20d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423598	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423608	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423621	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423624	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423624&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423629	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423629&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423635	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423646	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423651	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423652	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423652&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423656	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423656&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423659	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423659&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423674	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Influenza (1d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423679	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423679&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423691	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423691&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423694	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - );Myalgia (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423694&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423695	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423701	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423716	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (11d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423724	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423733	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423737	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423738	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423738&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423741	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Influenza (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423741&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423755	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Rash (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423757	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423765	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423767	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423772	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Akathisia (n/a - Recovered/Resolved - );Blood pressure systolic decreased (n/a - Recovered/Resolved - );Circulatory collapse (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - );Head injury (n/a - Unknown - );Heart rate decreased (n/a - Recovered/Resolved - );Hypertonia (n/a - Recovered/Resolved - );Hypopnoea (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Unknown - Other Medically Important Condition);Malaise (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Seizure (n/a - Unknown - Other Medically Important Condition);Somnolence (n/a - Recovered/Resolved - );Unresponsive to stimuli (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010423789	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423789&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423790	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423799	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423799&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423800	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423807	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423813	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (4d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Myalgia (15d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423822	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Influenza (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423822&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423823	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423824	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423824&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010423829	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423832	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423835	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423839	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423849	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[ALFUZOSIN HYDROCHLORIDE] (C - Lower urinary tract symptoms - n/a - [n/a - n/a - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Hypertension - n/a - [n/a - 10mg - n/a])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - Diuretic therapy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423849&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423850	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423854	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423854&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423856	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Deep vein thrombosis (n/a - Unknown - Caused/Prolonged Hospitalisation);Peripheral swelling (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423862	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Anaphylactic reaction (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Angioedema (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Throat tightness (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [1min - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423872	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Thrombosis (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	[SILDENAFIL] (C - Erectile dysfunction - n/a - [n/a - n/a - Oral])|[TERBINAFINE, TERBINAFINE HYDROCHLORIDE] (C - Fungal infection - n/a - [n/a - n/a - Cutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423877	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral thrombosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423885	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hypersensitivity (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Pharyngeal swelling (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Swollen tongue (1d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tongue spasm (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Trismus (0d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	BUPRENORPHINE [BUPRENORPHINE] (C - Drug dependence - n/a - [n/a - n/a - n/a])|IBUPROFEN [IBUPROFEN, IBUPROFEN SODIUM] (C - Pain - n/a - [n/a - 400mg - n/a])|[CARVEDILOL] (C - Cardiac failure - n/a - [n/a - 25mg - n/a])|[CLOZAPINE] (C - Schizophrenia - n/a - [n/a - 25mg - n/a])|[RAMIPRIL] (C - Cardiac disorder - n/a - [n/a - 5mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423885&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010423891	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	LANTUS SOLOSTAR [INSULIN GLARGINE] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|NOVORAPID PENFILL [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|NOVORAPID [INSULIN ASPART] (C - Diabetes mellitus - n/a - [n/a - n/a - Subcutaneous])|[GLUCAGON, GLUCAGON HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Intramuscular])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423891&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423900	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Headache (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423905	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pruritus (n/a - Not Recovered/Not Resolved - );Rash pruritic (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423905&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423918	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arthralgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423933	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymph node pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - n/a])	EPIVIR [LAMIVUDINE] (C - HIV infection - n/a - [n/a - n/a - n/a])|PIFELTRO [DORAVIRINE] (C - HIV infection - n/a - [n/a - n/a - n/a])|VIREAD [TENOFOVIR DISOPROXIL, TENOFOVIR DISOPROXIL FUMARATE] (C - HIV infection - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423933&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423939	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423942	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Purpura (n/a - Not Recovered/Not Resolved - );Rash papular (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423959	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Myalgia (18d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423962	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (7d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423971	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423971&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423978	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423978&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010423986	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Influenza (0d - Not Recovered/Not Resolved - );Malaise (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010423986&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424016	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (15d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424016&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424029	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovering/Resolving - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424029&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424030	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (12d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424036	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Dizziness (6d - Not Recovered/Not Resolved - );Dyspnoea (2d - Not Recovered/Not Resolved - );Fatigue (10d - Not Recovered/Not Resolved - );Headache (10d - Not Recovered/Not Resolved - );Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424036&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424037	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424041	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424047	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (n/a - Recovered/Resolved - );Vaccination site reaction (n/a - Recovered/Resolved - );Vomiting (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424052	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424054	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Unknown - );Limb discomfort (n/a - Unknown - );Pyrexia (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424054&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424057	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (18d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424059	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Tachycardia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424059&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424063	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424066	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424068	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424068&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424078	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424079	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424081	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424081&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424097	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424106	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (15d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424107	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424123	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424129	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424134	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (7d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (9d - Recovering/Resolving - );Tachycardia (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424136	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (8d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Headache (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424157	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424157&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424162	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424162&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424163	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424163&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424170	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424172	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424174	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424176	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (43d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424176&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010424183	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424202	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424215	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Malaise (0d - Not Recovered/Not Resolved - );Pyrexia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424217	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Nausea (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424219	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424226	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424228	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424230	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424230&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424232	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424242	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424248	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424248&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424257	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (2d - Recovered/Resolved - );Lymphadenopathy (6d - Not Recovered/Not Resolved - );Myalgia (3d - Not Recovered/Not Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424262	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424271	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424271&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424273	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (14d - Recovered/Resolved With Sequelae - );Headache (14d - Recovered/Resolved With Sequelae - );Nausea (14d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010424288	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424292	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424292&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424295	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424306	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovering/Resolving - );Fatigue (3d - Recovered/Resolved - );Feeling hot (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424306&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424317	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424318	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Feeling hot (3d - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424318&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424321	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424321&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424322	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010424328	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424333	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424333&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424347	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424347&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424351	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424365	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424371	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424371&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424373	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovered/Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424373&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424385	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (5d - Recovered/Resolved - );Vaccination site reaction (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424392	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424392&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424396	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Dizziness (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424401	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424401&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424403	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424409	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (44d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424409&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010424418	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (97d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424418&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010424419	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424419&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424435	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site swelling (17d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424440	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (1d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424440&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424448	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424448&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424454	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424458	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424467	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424475	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424475&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424481	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Paraesthesia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424481&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424485	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - );Tachycardia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010424490	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (3d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424490&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424497	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424498	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424498&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424503	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - );Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424527	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424536	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424536&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424546	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424552	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Not Recovered/Not Resolved - );Fatigue (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424555	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424558	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424558&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424566	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424566&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424571	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424573	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424573&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424577	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424577&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424585	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[ANHYDROUS LEVOTHYROXINE SODIUM, LEVOTHYROXINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS EP] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010424595	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424605	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424619	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Limb discomfort (24d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010424633	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Dizziness (0d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovering/Resolving - );Myalgia (1d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424633&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424675	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424685	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424688	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424688&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424699	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424699&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424700	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424713	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424732	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424733	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424733&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424752	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Musculoskeletal stiffness (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424752&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424756	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424756&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424761	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Pain of skin (n/a - Recovering/Resolving - );Pruritus (n/a - Recovering/Resolving - );Rash papular (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - );Vaccination site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424767	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424769	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (0d - Recovered/Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Limb discomfort (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424769&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424770	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (4d - Recovered/Resolved - );Vaccination site swelling (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424779	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424779&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424788	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424793	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	3-11 Years	Child	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Pain of skin (n/a - Recovered/Resolved - );Pruritus (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Rash papular (n/a - Recovered/Resolved - );Urticaria (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424793&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424794	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424813	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Conjunctivitis (n/a - Unknown - );Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424813&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424829	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424829&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424830	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424830&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424838	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	Asthenia (n/a - Fatal - Results in Death);Mental impairment (n/a - Fatal - Results in Death);Renal failure (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CLOPIDOGREL [CLOPIDOGREL, CLOPIDOGREL BESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|JENTADUETO 2.5 MG/850 MG FILM-COATED TABLETS [METFORMIN HYDROCHLORIDE, LINAGLIPTIN] (C - n/a - Drug withdrawn - [n/a - n/a - n/a])|[PITAVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010424841	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424841&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424855	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	AMGEVITA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN. [ADALIMUMAB] (C - Psoriasis - Dose not changed - [n/a - 40mg - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424860	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424868	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - Congenital Anomaly, Other Medically Important Condition);Tinnitus (n/a - Not Recovered/Not Resolved - Congenital Anomaly, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424868&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	
EU-EC-10010424870	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Anosmia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010424872	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424872&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010424880	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424880&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424898	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424903	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (40d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424903&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010424908	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424908&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010424911	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424911&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424913	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424913&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010424921	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424921&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010424926	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424936	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424937	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site erythema (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424937&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424941	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (9d - Not Recovered/Not Resolved - );Injection site pain (13d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424941&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424959	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010424985	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (21d - Recovered/Resolved With Sequelae - );Myalgia (21d - Recovered/Resolved With Sequelae - );Tachycardia (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424985&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010424995	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424995&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010424999	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010424999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425009	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myopericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010425013	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425013&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425027	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Migraine (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Vomiting (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425047	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425057	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Back pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [1d - 1{DF} - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Rhinitis allergic - Dose not changed - [n/a - n/a - n/a])|[BILASTINE] (C - Rhinitis allergic - Dose not changed - [n/a - n/a - n/a])|[LORAZEPAM] (C - Anxiety - Dose not changed - [n/a - n/a - n/a])|[LORMETAZEPAM] (C - Anxiety - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425057&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425062	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Myocarditis (7d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010425066	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Malaise (n/a - Unknown - );Pyrexia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Unknown])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425066&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425191	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425191&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425209	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425266	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - );Injection site swelling (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425266&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010425270	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425278	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Influenza (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Malaise (1d - Recovering/Resolving - );Myalgia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425280	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425280&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425282	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425282&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425283	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Injection site erythema (1d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Not Recovered/Not Resolved - );Paraesthesia (1d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425288	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425288&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425290	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425290&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425310	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425335	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425350	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (6d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425350&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425351	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010425357	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425359	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425362	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Limb discomfort (23d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425362&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010425367	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (4d - Recovered/Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425367&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425381	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425381&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425385	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425388	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425413	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Influenza (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425413&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425428	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010425435	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425435&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425437	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Asthenia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Atrioventricular block second degree (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Blood pressure decreased (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Chills (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Heart rate increased (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hyperhidrosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pallor (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Palpitations (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary vascular disorder (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Supraventricular tachycardia (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Systemic inflammatory response syndrome (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[IBUPROFEN, IBUPROFEN LYSINE] (C - Pain - n/a - [n/a - 600mg - Oral])|[IBUPROFEN] (C - Pain - n/a - [n/a - 600mg - Oral])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - 10mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425437&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010425438	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425472	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425472&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010425492	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425492&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425496	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425497	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (42d - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425497&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010425502	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (4d - Recovering/Resolving - );Limb discomfort (1d - Recovered/Resolved - );Malaise (0d - Recovered/Resolved - );Myalgia (4d - Recovering/Resolving - );Nausea (0d - Recovered/Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425502&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425510	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb discomfort (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425543	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (3d - Not Recovered/Not Resolved - );Headache (5d - Not Recovered/Not Resolved - );Influenza (3d - Not Recovered/Not Resolved - );Paraesthesia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425545	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425551	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovering/Resolving - );Fatigue (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425553	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425554	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (0d - Recovering/Resolving - );Influenza (0d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (0d - Recovering/Resolving - );Pyrexia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425586	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425586&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425598	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425599	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (17d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425599&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425614	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (2d - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Malaise (2d - Recovering/Resolving - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425636	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425637	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425637&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425646	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425651	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010425654	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425655	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010425680	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425680&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010425685	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (2d - Recovered/Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425690	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425690&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425700	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425707	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425707&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425708	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425724	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425724&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425727	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Tachycardia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425727&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010425737	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425753	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (10d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425764	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425787	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425787&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425850	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Injection site swelling (1d - Recovering/Resolving - );Limb discomfort (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425850&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425862	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425862&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425869	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425944	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425944&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425947	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425947&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425961	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (1d - Recovering/Resolving - );Limb discomfort (1d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425964	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425974	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425981	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425981&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425992	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (4d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425992&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010425994	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Trismus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010425994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426008	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426008&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426011	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (48d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010426031	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (33d - Recovered/Resolved - );Injection site pain (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426031&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010426040	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426047	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426053	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426053&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426064	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovering/Resolving - );Injection site pain (2d - Recovering/Resolving - );Limb discomfort (2d - Recovering/Resolving - );Lymphadenopathy (2d - Recovering/Resolving - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426067	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Lymphadenopathy (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426067&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426073	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Unknown - );Limb discomfort (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426073&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426091	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426091&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426097	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426113	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426113&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426136	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426144	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Not Specified	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426154	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arrhythmia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426154&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010426169	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (495h - Recovered/Resolved With Sequelae - Other Medically Important Condition);Blister (20d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Erythema (20d - Recovered/Resolved With Sequelae - Other Medically Important Condition);Herpes zoster (495h - Recovered/Resolved With Sequelae - Other Medically Important Condition);Neck pain (495h - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pain in extremity (495h - Recovered/Resolved With Sequelae - Other Medically Important Condition);Pyrexia (20d - Recovered/Resolved With Sequelae - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Sequelae
EU-EC-10010426184	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426184&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426192	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010426196	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (8d - Not Recovered/Not Resolved - );Headache (8d - Not Recovered/Not Resolved - );Tachycardia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426196&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010426234	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426235	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (1d - Not Recovered/Not Resolved - );Limb discomfort (1d - Recovered/Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426240	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426260	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426262	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Limb discomfort (0d - Recovering/Resolving - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426264	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426264&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010426276	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426279	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426295	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426295&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426301	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426301&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426312	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426316	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426324	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426329	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426332	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426332&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426344	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426365	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (4d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426365&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426372	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426376	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (6d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Limb discomfort (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426389	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Electrocardiogram abnormal (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010426395	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Recovering/Resolving - Other Medically Important Condition);Nasal congestion (n/a - Recovering/Resolving - );Vaccination failure (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010426397	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Pyrexia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426410	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426410&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426416	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426416&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426422	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site erythema (4d - Recovered/Resolved - );Lymphadenopathy (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426422&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426426	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426445	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426474	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Feeling hot (1d - Recovering/Resolving - );Headache (1d - Recovering/Resolving - );Injection site pain (1d - Not Recovered/Not Resolved - );Malaise (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426480	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (39d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010426483	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Feeling hot (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site swelling (3d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426483&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426505	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - );Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426505&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426543	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (1d - Not Recovered/Not Resolved - );Influenza (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426543&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426559	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Feeling hot (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426560	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426560&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426563	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426563&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426617	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426687	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426687&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426693	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426693&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426703	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426742	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Asthenia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chills (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dizziness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426742&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010426743	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426743&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010426800	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010426800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010427099	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427099&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010427152	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (0d - Recovering/Resolving - );Headache (0d - Recovering/Resolving - );Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427232	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427232&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427343	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427403	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427404	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427454	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Arthralgia (3d - Recovered/Resolved - );Chills (3d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Hyperventilation (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - );Nausea (3d - Recovered/Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427513	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Not Recovered/Not Resolved - );Lymphadenopathy (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427513&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427737	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (0d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Rash (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427842	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010427843	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (29d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010427843&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010428123	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovered/Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428123&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428303	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balanoposthitis (n/a - Recovering/Resolving - );Erectile dysfunction (n/a - Recovering/Resolving - Other Medically Important Condition);Feeling abnormal (n/a - Recovering/Resolving - );Inappropriate schedule of product administration (n/a - Unknown - );Painful ejaculation (n/a - Recovering/Resolving - );Paraesthesia (n/a - Unknown - );Penile pain (n/a - Recovering/Resolving - );Penile vascular disorder (n/a - Recovering/Resolving - );Penis disorder (n/a - Recovering/Resolving - );Product administered at inappropriate site (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428303&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010428610	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dyspnoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428610&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010428713	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428714	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428714&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428715	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428715&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428767	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Not Recovered/Not Resolved - );Injection site swelling (2d - Not Recovered/Not Resolved - );Limb discomfort (2d - Not Recovered/Not Resolved - );Paraesthesia (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428834	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428855	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428877	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428900	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428926	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Headache (3d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428935	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428939	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chills (1d - Recovered/Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Not Recovered/Not Resolved - );Injection site pain (1d - Recovered/Resolved - );Malaise (0d - Recovering/Resolving - );Vomiting (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428939&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010428960	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Tachycardia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428960&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010428962	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Epistaxis (10min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010428962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429004	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429004&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429009	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (0d - Not Recovered/Not Resolved - );Myalgia (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429014	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (3d - Recovering/Resolving - );Injection site erythema (0d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429014&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429077	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429092	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429092&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429097	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429124	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429220	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (15d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010429262	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Influenza (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429262&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429269	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429357	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (n/a - Recovering/Resolving - );Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429395	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (2d - Recovering/Resolving - );Headache (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429398	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429408	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Not Recovered/Not Resolved - );Headache (0d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429408&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429423	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429454	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429463	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovering/Resolving - );Injection site pain (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429463&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429466	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429468	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429468&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429474	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429474&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429480	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Influenza (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429504	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429504&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429506	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429506&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429508	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429508&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429510	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429517	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429518	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Influenza (0d - Recovered/Resolved - );Rash (22d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010429519	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429519&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429522	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429527	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429527&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429544	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429544&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429546	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429554	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site swelling (4d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - );Vaccination site reaction (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429554&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429655	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429678	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - );Injection site swelling (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429678&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010429692	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429692&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429695	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Headache (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429695&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429703	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Limb discomfort (0d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429703&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429704	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429713	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (4d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429808	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429808&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429838	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Influenza (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - );Nausea (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429869	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010429990	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010429990&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010430027	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Caused/Prolonged Hospitalisation);Encephalitis (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Pyrexia (n/a - Unknown - Caused/Prolonged Hospitalisation);Speech disorder (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010430035	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430035&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010430110	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430110&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010430183	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	Cytokine increased (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Hepatic failure (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Multisystem inflammatory syndrome in children (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Polyserositis (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal failure (42d - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010430267	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Somnolence (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010430307	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Influenza (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430307&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010430311	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site erythema (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010430374	Spontaneous	2021-10-25 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);COVID-19 pneumonia (9d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Dependence on oxygen therapy (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Drug ineffective (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Oxygen saturation decreased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Tachypnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1min - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010430388	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010430531	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest discomfort (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Chills (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Immunisation (n/a - Unknown - );Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Off label use (n/a - Unknown - );Pyrexia (3d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010430552	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (7d - Not Recovered/Not Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010430552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010431357	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (16d - Not Recovered/Not Resolved - );Influenza (2d - Recovered/Resolved - );Myalgia (35d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010431357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010432153	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (59d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010432173	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432173&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432235	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432322	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432322&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432335	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (16d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432335&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432390	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Nausea (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432390&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432514	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432514&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432601	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (2d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Influenza (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432601&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432604	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432604&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432608	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432608&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432609	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432614	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432614&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432623	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (0d - Not Recovered/Not Resolved - );Injection site swelling (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432623&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432654	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432654&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432658	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Not Recovered/Not Resolved - );Injection site pain (0d - Not Recovered/Not Resolved - );Nausea (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432770	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (8d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432828	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432832	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - );Lymphadenopathy (0d - Not Recovered/Not Resolved - );Paraesthesia (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432832&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432878	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432917	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - );Paraesthesia (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432917&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432930	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Rash (10d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432930&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432974	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010432991	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010432991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433002	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433002&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433011	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433019	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433019&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433023	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433023&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433024	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (7d - Recovered/Resolved - );Fatigue (7d - Recovered/Resolved - );Headache (7d - Recovered/Resolved - );Limb discomfort (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433024&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010433030	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Rash (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433058	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (0d - Recovered/Resolved - );Fatigue (0d - Recovered/Resolved - );Headache (0d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Limb discomfort (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433058&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433079	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Dizziness (3d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433079&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433087	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (4d - Recovered/Resolved - );Fatigue (4d - Recovered/Resolved - );Headache (4d - Recovered/Resolved - );Injection site pain (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433093	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433106	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovering/Resolving - );Feeling hot (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433106&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433107	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (0d - Recovered/Resolved - );Injection site pain (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433107&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433124	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433127	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Vaccination site reaction (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433133	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (2d - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (2d - Recovering/Resolving - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (2d - Recovering/Resolving - );Pyrexia (1d - Recovered/Resolved - );Rash (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433133&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433134	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433134&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433147	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433155	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Influenza (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433155&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433164	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433169	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (1d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433181	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Arrhythmia (7d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010433183	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433183&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433192	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (6d - Recovered/Resolved - );Limb discomfort (4d - Recovered/Resolved - );Lymphadenopathy (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433192&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433202	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovered/Resolved - );Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433208	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433208&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433209	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433209&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433242	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (2d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433244	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433245	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Limb discomfort (5d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433245&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433258	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433258&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433270	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (1d - Recovering/Resolving - );Headache (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433273	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (11d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433279	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Injection site pain (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433279&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433284	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433364	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433364&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433372	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Fatigue (2d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433398	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Malaise (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433398&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433411	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (0d - Recovering/Resolving - );Injection site pain (0d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433411&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433426	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433426&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433431	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Lymphadenopathy (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	COMIRNATY [TOZINAMERAN] (C - Immunisation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433431&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433606	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433606&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010433906	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (2d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010433906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434170	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434200	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434200&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434402	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - );Injection site swelling (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434402&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434572	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434572&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434615	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434615&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434621	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (0d - Recovered/Resolved - );Feeling hot (0d - Recovered/Resolved - );Influenza (2d - Recovering/Resolving - );Injection site pain (3d - Recovered/Resolved - );Pyrexia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434621&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434643	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Nausea (6d - Recovering/Resolving - );Vomiting (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434643&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434651	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434651&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434655	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (3d - Not Recovered/Not Resolved - );Malaise (3d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434655&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434657	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Limb discomfort (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434657&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010434674	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hot flush (89d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Parosmia (79d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Weight bearing difficulty (89d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434674&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010434888	Spontaneous	2021-10-25 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (1d - Unknown - );Headache (0d - Recovered/Resolved - );Injection site pain (1d - Recovered/Resolved - );Limb discomfort (2d - Recovered/Resolved - );Middle insomnia (1d - Recovered/Resolved - );Tachycardia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010434888&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410907	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Expired product administered (n/a - Unknown - );No adverse event (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410915	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	CYMBALTA [DULOXETINE, DULOXETINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|ESOMEPRAZOLE [ESOMEPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|EXFORGE [VALSARTAN, AMLODIPINE, VALSARTAN, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - n/a])|[ALENDRONATE SODIUM, ALENDRONIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - Hyperlipidaemia - n/a - [n/a - n/a - n/a])|[BETAHISTINE DIHYDROCHLORIDE, BETAHISTINE HYDROCHLORIDE] (C - Vertigo positional - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE PROPIONATE, SALMETEROL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[SALBUTAMOL] (C - Asthma - n/a - [n/a - n/a - n/a])|[SODIUM HYALURONATE] (C - Dry eye - n/a - [n/a - n/a - n/a])|[SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MACROGOL 3350] (C - Constipation - n/a - [n/a - n/a - n/a])|[WARFARIN, WARFARIN SODIUM] (C - Atrial fibrillation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410920	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Arthralgia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410931	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoacusis (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410931&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410942	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - Disabling);Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Somnolence (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling);Vision blurred (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[IRBESARTAN] (C - Hypertension - n/a - [n/a - 150mg - Oral])|[SIMVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410942&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010410956	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Mouth haemorrhage (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010410959	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tachyarrhythmia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410959&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010410961	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Disabling);Coronary artery disease (n/a - Unknown - Disabling);Ischaemia (n/a - Unknown - Disabling);Paraesthesia (n/a - Unknown - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 100mg - Oral])|[ATORVASTATIN] (C - Hypercholesterolaemia - n/a - [n/a - 10mg - Oral])|[OLMESARTAN MEDOXOMIL, AMLODIPINE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 20mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010410964	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Atrial fibrillation (n/a - Not Recovered/Not Resolved - Life Threatening);Pericardial effusion (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410964&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010410967	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ageusia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010410975	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410975&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010410979	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Migraine (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410979&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410991	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (4d - Recovered/Resolved - );Loss of consciousness (4d - Recovered/Resolved - );Malaise (4d - Recovered/Resolved - );Vomiting (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410991&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411009	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Injection site swelling (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411011	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Chills (1d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411011&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411153	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Acne (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411158	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Asthenia (1d - Recovered/Resolved - );Chest pain (4d - Recovered/Resolved - );Chills (2d - Recovered/Resolved - );Dyspnoea (3d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (5d - Recovered/Resolved - );Myalgia (n/a - Recovering/Resolving - );Palpitations (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411215	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411215&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411216	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411226	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411246	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411251	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411256	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411257	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411261	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411261&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411263	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411263&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411265	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411267	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411267&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411310	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411310&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411382	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (5d - Recovered/Resolved - );Asthenia (5d - Recovered/Resolved - );Job dissatisfaction (5d - Recovered/Resolved - );Pyrexia (4d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411382&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411384	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411384&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411458	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site induration (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Muscle spasms (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Vasodilatation (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411473	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411473&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411480	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Unknown - Other Medically Important Condition);Chills (n/a - Unknown - );Muscular weakness (n/a - Unknown - );Pyrexia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411480&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411495	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypothyroidism (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411495&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411496	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - );Syncope (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411496&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411510	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Anosmia (n/a - Unknown - );Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );Crying (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Induration (n/a - Unknown - );Inflammation (n/a - Unknown - );Irritability (n/a - Unknown - );Myalgia (n/a - Unknown - );Nodule (n/a - Unknown - );Oedema (n/a - Unknown - );Oxygen saturation decreased (n/a - Unknown - );Pain (n/a - Unknown - );Pruritus (n/a - Unknown - );Pyrexia (n/a - Unknown - );Rash (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Sensitive skin (n/a - Unknown - );Tachycardia (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411510&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411515	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411517	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Unknown - );Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Bronchospasm (n/a - Unknown - Other Medically Important Condition);Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Irritability (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411523	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Myocarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Presyncope (0d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	CIRCADIN [MELATONIN] (C - Poor quality sleep - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411523&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411524	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - Other Medically Important Condition);Blood pressure increased (n/a - Recovered/Resolved - Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Other Medically Important Condition);Headache (n/a - Recovered/Resolved - Other Medically Important Condition);Induration (n/a - Recovered/Resolved - Other Medically Important Condition);Inflammation (n/a - Recovered/Resolved - Other Medically Important Condition);Nodule (n/a - Recovered/Resolved - Other Medically Important Condition);Oedema (n/a - Recovered/Resolved - Other Medically Important Condition);Pain (n/a - Recovered/Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Pyrexia (n/a - Recovered/Resolved - Other Medically Important Condition);Sensitisation (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site oedema (n/a - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411530	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Unknown - );Cerebrovascular accident (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Embolic stroke (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Muscular weakness (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 81mg - Oral])|[CANDESARTAN] (C - Hypertension - n/a - [n/a - 8mg - Oral])|[FUROSEMIDE, FUROSEMIDE SODIUM] (C - Fluid retention - n/a - [n/a - 10mg - Oral])|[GABAPENTIN] (C - Neuropathy peripheral - n/a - [n/a - 600mg - Oral])|[PRAVASTATIN, PRAVASTATIN SODIUM] (C - Blood pressure measurement, Hypercholesterolaemia - n/a - [n/a - 40mg - Oral])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - Benign prostatic hyperplasia, Prostatomegaly - n/a - [n/a - .4mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411530&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010411531	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Syncope (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411534	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Dry mouth (n/a - Unknown - Other Medically Important Condition);Gait disturbance (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Urinary incontinence (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411545	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - Other Medically Important Condition);Body temperature increased (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - Other Medically Important Condition);Inflammation (n/a - Unknown - Other Medically Important Condition);Myalgia (n/a - Unknown - Other Medically Important Condition);Oedema (n/a - Unknown - Other Medically Important Condition);Pain (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);Sensitisation (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411545&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411552	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - Caused/Prolonged Hospitalisation);Chills (n/a - Unknown - Caused/Prolonged Hospitalisation);Dizziness (n/a - Unknown - Caused/Prolonged Hospitalisation);Fatigue (n/a - Unknown - Caused/Prolonged Hospitalisation);Haemorrhagic disorder (n/a - Unknown - Caused/Prolonged Hospitalisation);Headache (n/a - Unknown - Caused/Prolonged Hospitalisation);Lip haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation);Malaise (n/a - Unknown - Caused/Prolonged Hospitalisation);Petechiae (n/a - Unknown - Caused/Prolonged Hospitalisation);Purpura (n/a - Unknown - Caused/Prolonged Hospitalisation);Thrombocytopenic purpura (n/a - Unknown - Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010411553	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Skin lesion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411559	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Unknown - );Asthenia (n/a - Unknown - );Crying (n/a - Unknown - );Fatigue (n/a - Unknown - );Haematochezia (n/a - Unknown - Other Medically Important Condition);Headache (n/a - Unknown - );Induration (n/a - Unknown - );Irritability (n/a - Unknown - );Myalgia (n/a - Unknown - );Nodule (n/a - Unknown - );Pruritus (n/a - Unknown - );Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411559&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411562	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Abdominal distension (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Abdominal pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Abdominal pain lower (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Constipation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Diarrhoea (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Skin odour abnormal (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411562&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010411574	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Seizure (2010min - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID] (C - Cardiac disorder - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010411575	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Chest pain (n/a - Unknown - );Diarrhoea (n/a - Unknown - );Dyspnoea (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Myalgia (n/a - Unknown - );Nausea (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain (n/a - Unknown - );Pyrexia (n/a - Unknown - );Respiratory distress (n/a - Unknown - Other Medically Important Condition);Rhinorrhoea (n/a - Unknown - );Sensitisation (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010411591	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Chills (n/a - Recovering/Resolving - Disabling);Diarrhoea (n/a - Recovering/Resolving - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Fatigue (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Hypoaesthesia (n/a - Not Recovered/Not Resolved - Disabling);Malaise (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling);Paraesthesia (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411591&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010411597	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Heart rate increased (n/a - Recovered/Resolved - );Immunisation (n/a - Unknown - );Influenza (n/a - Recovered/Resolved - );Insomnia (n/a - Recovered/Resolved - );Off label use (n/a - Unknown - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411597&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411605	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411612	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411619	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411619&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411634	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - );Disturbance in attention (n/a - Unknown - );Fatigue (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Muscle tightness (n/a - Unknown - );Palpitations (n/a - Unknown - );Tinnitus (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411634&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411640	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010411641	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411641&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411645	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411658	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411658&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411661	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411661&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411664	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411664&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411666	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411666&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411689	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411689&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411696	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411698	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Rash (3d - Recovered/Resolved - );Tension headache (n/a - Recovered/Resolved - );Vertigo (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411706	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Vaccination failure (11d - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	PREGABALIN [PREGABALIN] (C - n/a - Unknown - [n/a - n/a - n/a])|[ALPRAZOLAM] (C - n/a - n/a - [n/a - n/a - n/a])|[CYAMEMAZINE] (C - n/a - Unknown - [n/a - n/a - n/a])|[FLUOXETINE, FLUOXETINE HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[LEVOTHYROXINE SODIUM] (C - n/a - Unknown - [n/a - n/a - n/a])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411706&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010411712	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411712&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411722	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site erythema (n/a - Recovering/Resolving - );Injection site inflammation (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Skin odour abnormal (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411722&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411725	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Psoriasis (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	STELARA CONCENTRATE FOR SOLUTION FOR INFUSION [USTEKINUMAB] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411725&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411728	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411728&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411732	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Condition aggravated (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411732&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411737	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Extensive swelling of vaccinated limb (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site swelling (n/a - Recovering/Resolving - );Injection site warmth (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (2d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411737&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411745	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Heart rate increased (72d - Recovered/Resolved - );Malaise (63d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411745&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411759	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411764	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411764&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411765	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411765&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411767	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411767&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411770	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411774	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411774&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411775	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411775&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411776	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Unknown - );Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411781	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411781&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411797	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411797&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010411809	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411823	Spontaneous	2021-10-24 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411823&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010411826	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Burning sensation (0d - Recovered/Resolved - );Cardiac discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411826&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411833	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Throat tightness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010411856	Spontaneous	2021-10-24 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - n/a - Unknown - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010411856&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408007	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Rash pruritic (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408007&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408034	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (4d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [0d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408034&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408044	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (8d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [21d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408044&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408062	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408062&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408071	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Injection site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408077	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408077&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408078	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408078&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408119	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (0d - Recovered/Resolved - );Pallor (0d - Recovered/Resolved - );Vomiting (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408119&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408127	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Fatigue (n/a - Unknown - );Headache (n/a - Unknown - );Insomnia (n/a - Unknown - );Tachycardia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408127&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010408129	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Administration site pain (1d - Recovered/Resolved - );Oropharyngeal pain (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408140	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia oral (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408140&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408149	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Confusional state (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408149&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408169	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408169&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408223	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408226	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Paraesthesia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408226&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010408228	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408228&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408247	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408247&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408253	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408254	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Not Recovered/Not Resolved - );Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408257	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408257&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408260	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408260&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408298	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dry mouth (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408298&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408331	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Diarrhoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408331&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408485	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408485&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010408489	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Migraine (n/a - Not Recovered/Not Resolved - );Q fever (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408489&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408503	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408517	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408517&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408522	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Ocular hyperaemia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	IVABRADINE [IVABRADINE, IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ACETAZOLAMIDE, ACETAZOLAMIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[BARNIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL] (C - n/a - n/a - [n/a - n/a - n/a])|[POTASSIUM CANRENOATE] (C - n/a - n/a - [n/a - n/a - n/a])|[TAFLUPROST] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408522&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408553	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Antiphospholipid syndrome (n/a - Unknown - Life Threatening);Cerebrovascular accident (n/a - Unknown - Life Threatening);Myocarditis (n/a - Unknown - Life Threatening);Pulmonary embolism (n/a - Unknown - Life Threatening);Venous thrombosis (n/a - Unknown - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408553&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010408574	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (3d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Migraine (3d - Recovered/Resolved - );Oropharyngeal pain (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408580	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site pain (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408582	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Back pain (n/a - Recovering/Resolving - );Confusional state (n/a - Recovering/Resolving - );Dry mouth (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Tachycardia (n/a - Recovering/Resolving - );Tinnitus (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	[LEVOTHYROXINE SODIUM] (C - Hypothyroidism - n/a - [n/a - 25ug - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408582&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010408587	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Dyspepsia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408587&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408589	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408589&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408592	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Headache (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408595	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408596	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408596&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408612	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Joint lock (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408612&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408617	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Back pain (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010408625	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Influenza like illness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408625&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408640	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408640&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408648	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010408696	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Musculoskeletal chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408696&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010408698	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408698&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408700	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408700&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408701	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypertensive crisis (n/a - Not Recovered/Not Resolved - Life Threatening);Myocarditis (n/a - Not Recovered/Not Resolved - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408701&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010408704	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Hyperpyrexia (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation);Myopericarditis (10d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408704&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408709	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (0d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 300uL - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - Type 2 diabetes mellitus - n/a - [n/a - 1000mg - Oral])|[TIMOLOL, TIMOLOL MALEATE] (C - Ocular hypertension - n/a - [n/a - n/a - Ophthalmic])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408709&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408716	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Sudden death (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408716&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408719	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardiac arrest (8d - Fatal - Results in Death);Tachycardia (8d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408719&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408740	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypotension (n/a - Recovering/Resolving - Other Medically Important Condition);Loss of consciousness (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	PROCORALAN [IVABRADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - Oral])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - Oral])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[CANRENONE] (C - n/a - n/a - [n/a - n/a - Oral])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - Oral])|[PANTOPRAZOLE] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - Oral])|[TIOTROPIUM, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408740&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010408747	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Oedema peripheral (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Peripheral vein thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010408753	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Uveitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408753&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010408755	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408755&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408759	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation);Penile oedema (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408759&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408761	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Branchial cyst (17d - Fatal - Results in Death);Chest pain (17d - Fatal - Results in Death);Lymphadenopathy (17d - Fatal - Results in Death);Pericarditis (17d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408761&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408766	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Deep vein thrombosis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408766&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010408776	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericardial effusion (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408788	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])|COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408788&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408795	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenitis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408795&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408802	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (48d - Fatal - Results in Death);Respiratory failure (48d - Fatal - Results in Death);Vasculitis (48d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408802&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408804	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Ischaemia (37d - Fatal - Results in Death);Renal failure (37d - Fatal - Results in Death);Respiratory failure (37d - Fatal - Results in Death);Vasculitis (37d - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408804&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010408805	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Bell's palsy (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408805&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010408811	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408811&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408819	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408819&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408820	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Amnesia (n/a - Not Recovered/Not Resolved - );Disorientation (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408820&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408834	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408835	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408835&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408836	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Disabling);Crohn's disease (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling);Rash (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010408847	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthritis infective (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408847&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010408848	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Confusional state (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Headache (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Loss of consciousness (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Migraine (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Tachycardia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Urticaria (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vertigo (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408848&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408855	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408863	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408863&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408904	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Nausea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Presyncope (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Vomiting (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408904&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010408912	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Testicular hypertrophy (n/a - Recovered/Resolved With Sequelae - );Testicular pain (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408912&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010408923	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (11d - Recovered/Resolved - );Feeling cold (11d - Recovered/Resolved - );Pyrexia (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408935	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408935&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408973	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010408999	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010408999&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409064	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Acrosclerosis (n/a - Not Recovered/Not Resolved - Disabling);Arthralgia (n/a - Not Recovered/Not Resolved - );Arthritis (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409064&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010409070	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409070&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409083	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );General physical health deterioration (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409083&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409089	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Extensive swelling of vaccinated limb (17d - Recovered/Resolved - );Injection site swelling (17d - Recovered/Resolved - );Lymphadenopathy (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409089&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010409132	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cerebral infarction (n/a - Recovering/Resolving - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409132&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010409164	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409164&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409171	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409172	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409172&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409207	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409207&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409210	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL [UMECLIDINIUM BROMIDE, FLUTICASONE FUROATE, VILANTEROL] (C - n/a - n/a - [n/a - n/a - n/a])|[FLUTICASONE, SALMETEROL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409216	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Headache (1d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409216&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409236	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Ear pain (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pain (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409243	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409243&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409253	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409253&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409265	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pruritus (n/a - Not Recovered/Not Resolved - );Injection site warmth (n/a - Not Recovered/Not Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409265&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409270	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409270&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010409284	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (1d - Recovered/Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409284&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409309	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409309&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409315	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (2d - Recovered/Resolved - );Nausea (4h - Recovered/Resolved - );Palpitations (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010409329	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Parosmia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409329&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409341	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Atrial fibrillation (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409341&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010409344	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Myalgia (3d - Recovered/Resolved - );Nausea (1d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409353	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Parosmia (n/a - Not Recovered/Not Resolved - );Taste disorder (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409353&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409363	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (1d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Pyrexia (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409369	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (1d - Recovered/Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Injection site inflammation (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Injection site warmth (n/a - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409369&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409370	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409370&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409374	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Injection site haematoma (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409403	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409403&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409867	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bradyphrenia (n/a - Not Recovered/Not Resolved - );Depressed mood (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Irritability (n/a - Not Recovered/Not Resolved - );Vision blurred (n/a - Not Recovered/Not Resolved - );Visual impairment (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409867&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409876	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409883	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Eye swelling (n/a - Unknown - );Rhinitis allergic (n/a - Unknown - );Urticaria (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409883&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010409898	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - );Rash pruritic (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409898&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409928	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Influenza like illness (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409928&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409946	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Not Recovered/Not Resolved - );Diarrhoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (7d - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (10d - Recovered/Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409946&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409949	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409949&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409952	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409952&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010409961	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010409968	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010409968&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410009	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Brain fog (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Gait disturbance (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410009&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410041	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (6h - Recovered/Resolved - );Headache (24h - Recovered/Resolved - );Myalgia (12h - Recovered/Resolved - );Pyrexia (6h - Recovered/Resolved - );Syncope (30min - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410041&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410045	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410045&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410124	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Skin haemorrhage (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410124&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410148	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410148&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410168	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Blood pressure increased (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	[FOSINOPRIL SODIUM] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410251	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Neck pain (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410251&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410352	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Chills (5d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Hyperhidrosis (5d - Recovered/Resolved - );Malaise (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410352&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410357	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Eczema (n/a - Recovering/Resolving - );Herpes zoster (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	BRILIQUE 90 MG FILM-COATED TABLETS [TICAGRELOR] (C - n/a - n/a - [n/a - n/a - n/a])|NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[RABEPRAZOLE SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410357&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410363	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Injection site pain (3d - Recovered/Resolved - );Malaise (3d - Recovered/Resolved - );Myalgia (3d - Recovered/Resolved - );Pain in extremity (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410363&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410374	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Lymphadenopathy (n/a - Unknown - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410423	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410423&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410479	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])|[TRIHEXYPHENIDYL HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410534	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Chills (2d - Unknown - );Hyperhidrosis (2d - Unknown - );Pyrexia (2d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410534&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410574	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Extensive swelling of vaccinated limb (8d - Recovered/Resolved - );Hypoaesthesia (n/a - Not Recovered/Not Resolved - );Injection site erythema (8d - Recovered/Resolved - );Injection site pain (8d - Recovered/Resolved - );Injection site swelling (8d - Recovered/Resolved - );Injection site warmth (8d - Recovered/Resolved - );Myalgia (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410574&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410605	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (10d - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410605&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410631	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410667	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Not Specified	Asthenopia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410667&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410708	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410708&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410713	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410713&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410720	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Drug ineffective (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410720&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410731	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410731&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410791	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410791&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410800	Spontaneous	2021-10-23 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410833	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Herpes zoster (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010410834	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Genital infection fungal (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[HYDROCORTISONE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410834&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410837	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (1d - Recovered/Resolved - );Headache (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])|[NOT AVAILABLE] (S - Rheumatic disorder - Dose not changed - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410837&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410877	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Fatigue (288h - Recovered/Resolved - );Headache (288h - Recovered/Resolved - );Malaise (96h - Recovered/Resolved - );Myalgia (36h - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	[PARACETAMOL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410877&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010410887	Spontaneous	2021-10-23 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest discomfort (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010410887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010394879	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Facial paralysis (n/a - Recovering/Resolving - Other Medically Important Condition);Malaise (17d - Recovered/Resolved - );Paraesthesia (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Drug withdrawn - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010394879&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010395855	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Altered state of consciousness (n/a - Unknown - );Asthenia (n/a - Unknown - );Chills (n/a - Unknown - );General physical health deterioration (n/a - Unknown - );Heart rate increased (n/a - Unknown - );Illness (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Interchange of vaccine products (n/a - Unknown - );Malaise (n/a - Unknown - );Off label use (n/a - Unknown - );Pyrexia (n/a - Unknown - );Respiration abnormal (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (I - n/a - Unknown - [n/a - n/a - n/a])|VAXZEVRIA [COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)] (S - COVID-19 immunisation - Dose not changed - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010395855&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010395982	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Hyperhidrosis (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010395982&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010395987	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Palpitations (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Dose not changed - [n/a - .3mg - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010395987&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396001	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Unknown - );Myalgia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396001&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396084	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396084&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396086	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Contusion (n/a - Recovering/Resolving - );Urticaria (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396086&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396096	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Injection site pain (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - );Somnolence (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396153	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Urticaria (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	RANEXA [RANOLAZINE] (C - n/a - n/a - [n/a - n/a - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[CARVEDILOL] (C - n/a - n/a - [n/a - n/a - n/a])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - n/a - n/a])|[LERCANIDIPINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[VALSARTAN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396160	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Erythema (n/a - Not Recovered/Not Resolved - );Pruritus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396160&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396161	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	SARS-CoV-2 test positive (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396161&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396165	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gait disturbance (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Unknown - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396170	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Dyspnoea exertional (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396170&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396171	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Limb injury (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396171&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396194	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396194&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396202	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - );Muscle contractions involuntary (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396214	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Muscle spasms (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396214&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396219	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Malaise (0d - Recovered/Resolved - );Syncope (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396223	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Bone pain (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Decreased appetite (n/a - Not Recovered/Not Resolved - );Eye irritation (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - );Vomiting (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396223&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396244	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Gingival bleeding (n/a - Unknown - );Lymphadenopathy (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396244&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396246	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396246&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396254	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Chills (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396254&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396269	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - );Malaise (n/a - Recovering/Resolving - );Musculoskeletal discomfort (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396269&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396273	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Axillary pain (n/a - Not Recovered/Not Resolved - );Paraesthesia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396273&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396276	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (151d - Recovered/Resolved - );Swelling (151d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396276&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010396278	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Tachycardia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396278&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396317	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Malaise (n/a - Recovered/Resolved - );Vaccination site pain (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396324	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vision blurred (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396324&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396343	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (3d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Pyrexia (3d - Recovered/Resolved - );Vertigo (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396343&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396349	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Venous thrombosis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010396358	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396358&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396359	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - );Asthenia (n/a - Not Recovered/Not Resolved - );Blood pressure abnormal (n/a - Not Recovered/Not Resolved - );Heart rate abnormal (n/a - Not Recovered/Not Resolved - );Insomnia (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396360	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dysgeusia (n/a - Recovered/Resolved With Sequelae - );Salivary hypersecretion (n/a - Recovered/Resolved With Sequelae - );Throat tightness (n/a - Recovered/Resolved With Sequelae - );Vertigo (n/a - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396360&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010396376	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	[AMOXICILLIN, AMOXICILLIN TRIHYDRATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396376&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396404	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Neuropathy peripheral (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396404&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396405	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396405&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396407	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Amnesia (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Disturbance in attention (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Fibromyalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396407&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396444	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - );Lymphadenopathy (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396444&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396454	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling);Blood pressure increased (n/a - Not Recovered/Not Resolved - Disabling);Cardiac failure (n/a - Not Recovered/Not Resolved - Disabling);Ear discomfort (n/a - Not Recovered/Not Resolved - Disabling);Epistaxis (n/a - Not Recovered/Not Resolved - Disabling);Eye haemorrhage (n/a - Not Recovered/Not Resolved - Disabling);Gait disturbance (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Vertigo (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010396509	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blister (n/a - Recovered/Resolved - );Oedema peripheral (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396509&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396515	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396515&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396531	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[LEUPRORELIN, LEUPRORELIN ACETATE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396570	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (2d - Recovered/Resolved - );Hyperhidrosis (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 30ug - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396570&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396575	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Herpes zoster (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - 1{DF} - Intramuscular])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396575&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010396579	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Pyrexia (n/a - Recovering/Resolving - );Weight decreased (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396579&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396581	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396581&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010396583	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Lymphadenopathy (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396583&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396594	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Renal failure (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - n/a])	[ALLOPURINOL] (C - n/a - n/a - [n/a - n/a - n/a])|[CALCIUM CARBONATE] (C - n/a - n/a - [n/a - n/a - n/a])|[FUROSEMIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[OLMESARTAN MEDOXOMIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396594&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010396598	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Asthenia (n/a - Recovered/Resolved - );Chills (n/a - Recovered/Resolved - );Loss of consciousness (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396598&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010396602	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	2 Months - 2 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - );Crying (n/a - Recovering/Resolving - );Restlessness (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396617	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Pityriasis rosea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396617&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396620	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chills (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Recovering/Resolving - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396620&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396645	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Vaccination failure (10d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396645&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010396673	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396673&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010396675	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010396675&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397025	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Ventricular arrhythmia (n/a - Fatal - Results in Death, Other Medically Important Condition);Ventricular tachycardia (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397025&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010397027	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Guillain-Barre syndrome (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397027&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010397030	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397030&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010397047	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Immunisation (n/a - Unknown - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Off label use (n/a - Unknown - );Pain (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010397052	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Not Recovered/Not Resolved - );Head injury (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - );Loss of consciousness (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Thrombosis (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397052&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010397063	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Anaphylactic reaction (1d - Recovered/Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397063&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010397074	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Hyperactive pharyngeal reflex (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Insomnia (n/a - Unknown - );Nasal congestion (n/a - Recovering/Resolving - Other Medically Important Condition);Off label use (n/a - Unknown - );Oropharyngeal discomfort (n/a - Unknown - );Oropharyngeal pain (n/a - Unknown - );Pain in extremity (n/a - Unknown - );Vomiting (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397074&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397144	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Hypoaesthesia (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397144&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397152	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397152&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010397158	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain in extremity (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397158&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397166	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Lip swelling (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Recovering/Resolving - );Stomatitis (n/a - Recovered/Resolved - );Swelling face (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397166&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397167	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure decreased (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397167&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397168	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - Other Medically Important Condition);Joint stiffness (n/a - Recovering/Resolving - Other Medically Important Condition);Joint swelling (n/a - Recovering/Resolving - Other Medically Important Condition);Synovitis (132d - Recovering/Resolving - Other Medically Important Condition);Vaccination site pain (n/a - Recovering/Resolving - Other Medically Important Condition);Vaccination site swelling (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[AMITRIPTYLINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[FLUTICASONE PROPIONATE] (C - n/a - n/a - [n/a - 2{DF} - n/a])|[LOSARTAN, LOSARTAN POTASSIUM] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[METOPROLOL TARTRATE] (C - n/a - n/a - [n/a - 1{DF} - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397168&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Duration
EU-EC-10010397174	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition);Pericarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397174&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010397177	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Gastrooesophageal reflux disease (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Headache (n/a - Recovering/Resolving - Other Medically Important Condition);Limb discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Panic attack (n/a - Recovering/Resolving - Other Medically Important Condition);Weight decreased (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397177&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397201	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Foetus	Yes	Not Specified	Cleft lip and palate (n/a - Unknown - Congenital Anomaly, Other Medically Important Condition);Tremor (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Transplacental])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397201&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Congenital Anomaly	Severe reaction
EU-EC-10010397220	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cold sweat (n/a - Unknown - Other Medically Important Condition);Hyperhidrosis (n/a - Unknown - Other Medically Important Condition);Vision blurred (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397220&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397234	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Gait inability (n/a - Recovering/Resolving - );Joint range of motion decreased (n/a - Unknown - );Neck pain (n/a - Recovering/Resolving - );Pyrexia (n/a - Unknown - );Rheumatoid arthritis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Temporomandibular pain and dysfunction syndrome (n/a - Recovering/Resolving - );Tendon pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397234&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397428	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Arthralgia (7d - Recovered/Resolved - );Myalgia (7d - Recovered/Resolved - );Pyrexia (7d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	ACTELSAR HCT 80 MG/12.5 MG TABLETS [HYDROCHLOROTHIAZIDE, TELMISARTAN] (C - Hypertension - n/a - [n/a - 1{DF} - n/a])|OPRYMEA 0.088 MG TABLETS [PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE] (C - Restless legs syndrome - n/a - [n/a - n/a - n/a])|TOVIAZ 4 MG PROLONGED-RELEASE TABLETS [FESOTERODINE, FESOTERODINE FUMARATE] (C - Incontinence - n/a - [n/a - 4mg - n/a])|[ACETYLSALICYLIC ACID] (C - Antiplatelet therapy - n/a - [n/a - 75mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - 5mg - n/a])|[ASCORBIC ACID, MAGNESIUM OXIDE, HEAVY, MAGNESIUM] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[CYANOCOBALAMIN] (C - Vitamin B12 deficiency - n/a - [n/a - 1mg - n/a])|[PARACETAMOL] (C - Pain - n/a - [n/a - 1000mg - n/a])|[ROSUVASTATIN] (C - Blood cholesterol increased - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397428&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397438	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[LOPERAMIDE, LOPERAMIDE HYDROCHLORIDE] (C - Gastrointestinal disorder - n/a - [n/a - n/a - n/a])|[SOTALOL HYDROCHLORIDE] (C - Cardiac disorder - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397451	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - );Fatigue (n/a - Unknown - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397451&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397454	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Vaccination site pain (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	SIMPONI 50 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE [GOLIMUMAB] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])|[DICLOFENAC SODIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[METHOTREXATE] (C - Psoriatic arthropathy - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397454&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397465	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (2d - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (3d - Recovered/Resolved - );Myalgia (5d - Recovered/Resolved - );Somnolence (n/a - Recovering/Resolving - );Vaccination site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[OMEGA-3 FATTY ACIDS] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010397539	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dyspnoea (n/a - Unknown - );Feeling abnormal (n/a - Unknown - );Inappropriate schedule of product administration (n/a - Unknown - );Myocardial ischaemia (n/a - Fatal - Results in Death, Life Threatening, Other Medically Important Condition);Syncope (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation, Immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397539&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010397609	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Recovered/Resolved With Sequelae - Life Threatening);Chest pain (n/a - Recovered/Resolved With Sequelae - Life Threatening);Extrasystoles (n/a - Recovered/Resolved With Sequelae - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397609&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010397723	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal discomfort (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Abscess limb (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Oedema peripheral (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])|[CEFALEXIN] (S - n/a - n/a - [n/a - n/a - n/a])	[KETOPROFEN] (C - n/a - n/a - [4d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397723&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010397782	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Not Specified	Dyspnoea (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010397790	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood glucose decreased (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[METFORMIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE BP] (C - n/a - n/a - [n/a - n/a - n/a])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - n/a])|[SERTRALINE, SERTRALINE HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[SIMVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397790&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397814	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397814&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010397869	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Inappropriate schedule of product administration (n/a - Unknown - );Lymphoedema (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Vaccination site reaction (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397870	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Abortion spontaneous (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397870&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010397878	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Blood bilirubin increased (n/a - Unknown - );Blood potassium decreased (n/a - Unknown - );Blood pressure increased (n/a - Unknown - );Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Unknown - );Red cell distribution width increased (n/a - Unknown - );Tachycardia (n/a - Recovered/Resolved - Life Threatening, Other Medically Important Condition);White blood cell count increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397878&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010397886	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Thrombosis (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397886&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010397900	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cellulitis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397900&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397901	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Hypoaesthesia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010397902	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Malaise (n/a - Unknown - );Myocardial injury (n/a - Unknown - Other Medically Important Condition);Pulmonary embolism (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397902&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010397994	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Anxiety (n/a - Recovered/Resolved - );Chest discomfort (n/a - Recovered/Resolved - );Dizziness (n/a - Recovered/Resolved - );Dyspnoea (n/a - Recovered/Resolved - );Ear discomfort (n/a - Recovered/Resolved - );Hypoaesthesia (n/a - Recovered/Resolved - );Presyncope (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397994&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010397998	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010397998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010398021	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Cerebral artery occlusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Cerebral infarction (n/a - Unknown - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398021&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010398040	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chills (n/a - Recovered/Resolved - );Fatigue (n/a - Recovered/Resolved - );Headache (n/a - Recovered/Resolved - );Myalgia (n/a - Recovered/Resolved - );Nausea (n/a - Recovered/Resolved - );Pyrexia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398040&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398046	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398046&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010398087	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - );Confusional state (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010398093	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Myopericarditis (n/a - Not Recovered/Not Resolved - Life Threatening, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398093&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010398096	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Angina pectoris (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398096&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398097	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Myositis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398097&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010398108	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Chest pain (n/a - Not Recovered/Not Resolved - );Dizziness (n/a - Not Recovered/Not Resolved - );Dyspnoea (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Palpitations (n/a - Not Recovered/Not Resolved - );Vertigo (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398108&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010398112	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Therapeutic response unexpected (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398112&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398150	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pulmonary embolism (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	[ESCITALOPRAM, ESCITALOPRAM OXALATE] (C - n/a - n/a - [n/a - 20mg - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010398153	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Arrhythmia (n/a - Not Recovered/Not Resolved - Disabling);Condition aggravated (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398153&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010398193	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398193&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010398217	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	[LOSARTAN, LOSARTAN POTASSIUM] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398217&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010398236	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	More than 85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398236&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010398237	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Fatal - Results in Death);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398237&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010398240	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Acute myocardial infarction (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	PRADAXA 110 MG [DABIGATRAN ETEXILATE] (C - n/a - n/a - [n/a - 110mg - Oral])|[DOXAZOSIN, DOXAZOSIN MESILATE] (C - n/a - n/a - [n/a - 4mg - Oral])|[LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE] (C - n/a - n/a - [n/a - 1{DF} - Oral])|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - 500mg - Oral])|[METILDIGOXIN] (C - n/a - n/a - [n/a - .1mg - Oral])|[MICRONISED SPIRONOLACTONE, SPIRONOLACTONE] (C - n/a - n/a - [n/a - 50mg - Oral])|[NAPROXEN SODIUM] (C - n/a - n/a - [n/a - n/a - Oral])|[PRAVASTATIN SODIUM] (C - n/a - n/a - [n/a - 20mg - Oral])|[PROPAFENONE, PROPAFENONE HYDROCHLORIDE] (C - n/a - n/a - [n/a - 150mg - Oral])|[SOTALOL HYDROCHLORIDE] (C - n/a - n/a - [n/a - 80mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398240&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010398256	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Lymphadenopathy (n/a - Not Recovered/Not Resolved - Disabling);Myalgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398256&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010398317	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Vestibular neuronitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398317&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010398438	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398438&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398445	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cardiac failure acute (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398445&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010398446	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Cardiac failure (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398446&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010398449	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398449&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010398457	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398457&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398462	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pain (n/a - Unknown - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	[COD-LIVER OIL] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398462&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398465	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398465&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398466	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Recovered/Resolved - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovered/Resolved - );Malaise (n/a - Recovering/Resolving - );Nausea (n/a - Recovering/Resolving - );Somnolence (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398467	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Not Recovered/Not Resolved - );Vaccination site nodule (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398478	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398478&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398479	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Hypoaesthesia (n/a - Unknown - );Hypoaesthesia oral (n/a - Unknown - );Nausea (n/a - Unknown - );Paraesthesia (n/a - Unknown - );Photophobia (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398479&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398592	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fall (n/a - Unknown - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010398649	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fluid retention (n/a - Recovering/Resolving - );Wheezing (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398649&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398730	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Balance disorder (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398730&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010398794	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Chest pain (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Decreased appetite (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Headache (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hyperhidrosis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Night sweats (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398794&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010398831	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epistaxis (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Haemoptysis (2d - Recovered/Resolved - Disabling, Other Medically Important Condition);Petechiae (2d - Recovered/Resolved - Disabling, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398831&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010398846	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398857	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Ear pain (n/a - Recovering/Resolving - Other Medically Important Condition);Lethargy (n/a - Recovered/Resolved - Other Medically Important Condition);Vertigo (n/a - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398857&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010398860	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Cardiac failure acute (n/a - Fatal - Results in Death, Other Medically Important Condition);Cardio-respiratory arrest (n/a - Fatal - Results in Death, Other Medically Important Condition);Disease recurrence (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Embolism (n/a - Fatal - Results in Death, Other Medically Important Condition);Pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Thrombosis (n/a - Fatal - Results in Death, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[AMLODIPINE, AMLODIPINE BESILATE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[ZOPICLONE] (C - Insomnia - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398860&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010398876	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthma (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Costochondritis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Fatigue (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Gastrointestinal disorder (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypoaesthesia (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Hypotension (35d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Inflammation (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Oropharyngeal pain (n/a - Unknown - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Pericarditis (59d - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Syncope (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition);Vomiting (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010398887	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398887&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010398894	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Pericarditis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398894&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398897	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Cough (n/a - Recovered/Resolved - Other Medically Important Condition);Eye pruritus (n/a - Recovered/Resolved - Other Medically Important Condition);Seasonal allergy (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Sneezing (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398897&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010398915	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398915&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398918	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398918&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010398920	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Thrombosis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398936	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010398954	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398954&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398956	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Endo, B.. Central retinal vein occlusion after mRNA SARS-CoV-2 vaccination: A Case Report. Indian Journal of Ophthalmology. 2021;69(10):2865-2866. doi:10.4103/ijo.IJO_1477_21	Not Specified	Not Specified	No	Male	Retinal vein occlusion (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398956&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398967	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure abnormal (n/a - Unknown - );Illness (n/a - Unknown - Other Medically Important Condition);Pneumonia (n/a - Unknown - Other Medically Important Condition);Pulmonary oedema (n/a - Unknown - Other Medically Important Condition);Vaccination site pain (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID PH. EUR., ASPIRIN BP] (C - n/a - n/a - [n/a - 81mg - Oral])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - Blood pressure measurement - n/a - [n/a - 5mg - Oral])|[ATORVASTATIN] (C - Blood cholesterol - n/a - [n/a - 40mg - Oral])|[CARVEDILOL] (C - Blood pressure measurement - n/a - [n/a - 25mg - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398967&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398974	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Cardiac disorder (n/a - Unknown - );Extrasystoles (n/a - Unknown - );Lung disorder (n/a - Unknown - );Peripheral swelling (n/a - Recovering/Resolving - );Scleroderma (n/a - Unknown - Other Medically Important Condition);Skin hypertrophy (n/a - Recovering/Resolving - );Skin tightness (n/a - Recovering/Resolving - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010398984	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398984&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010398998	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Blood pressure increased (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010398998&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010399056	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - );Peripheral coldness (n/a - Unknown - );Syncope (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399056&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399069	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Pyrexia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399069&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399071	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (31d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399095	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Fatigue (n/a - Not Recovered/Not Resolved - );Pyrexia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399095&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399120	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Adult	No	Male	Medication error (n/a - Recovered/Resolved - )	COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399120&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399151	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Hypoaesthesia (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399151&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399165	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Tinnitus (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399165&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010399195	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (107d - Recovered/Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399195&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399218	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Cerebrovascular accident (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Fatigue (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation);Headache (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Hypertension (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Malaise (n/a - Recovering/Resolving - Life Threatening, Caused/Prolonged Hospitalisation);Pyrexia (6d - Recovered/Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399218&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010399231	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399231&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010399235	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - );Drug ineffective (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [28d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399235&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399242	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Not Recovered/Not Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399242&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010399283	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Vision blurred (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399283&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399316	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Myalgia (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - );Pain in extremity (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - Dose not changed - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399316&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399337	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Body temperature decreased (n/a - Recovering/Resolving - Life Threatening);Hypoglycaemia (n/a - Recovering/Resolving - Life Threatening)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	INSULATARD FLEXPEN 100 IE/ML INJEKTIONSVÄTSKA, SUSPENSION I FÖRFYLLD INJEKTIONSPENNA [INSULIN HUMAN ISOPHANE (RDNA)] (C - n/a - n/a - [n/a - 8{DF} - Subcutaneous])|NOVORAPID FLEXPEN 100 E/ML INJEKTIONSVÄTSKA, LÖSNING, I FÖRFYLLD INJEKTIONSPENNA [INSULIN ASPART] (C - n/a - n/a - [n/a - 6{DF} - Subcutaneous])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399337&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Life Threatening	Hospitalisation
EU-EC-10010399351	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Loss of consciousness (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Polymyalgia rheumatica (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399351&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399374	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399374&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399385	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010399555	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Hyperhidrosis (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Pyrexia (1d - Recovered/Resolved - );Vaccination site pain (3d - Recovered/Resolved - );Vaccination site reaction (3d - Recovered/Resolved - );Vaccination site swelling (3d - Recovered/Resolved - )	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - COVID-19 - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399561	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	12-17 Years	Not Specified	No	Male	Chest pain (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 prophylaxis - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399561&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399636	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399636&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010399646	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399646&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010399685	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Gait disturbance (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Impaired driving ability (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Loss of personal independence in daily activities (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399685&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010399736	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (0d - Recovered/Resolved With Sequelae - );Fatigue (0d - Recovered/Resolved With Sequelae - );Gastrointestinal pain (0d - Recovered/Resolved With Sequelae - );Myalgia (0d - Recovered/Resolved With Sequelae - );Nausea (0d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399736&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010399739	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abnormal faeces (3d - Recovering/Resolving - );Disturbance in attention (3d - Recovered/Resolved - );Hyperhidrosis (3d - Recovering/Resolving - );Injection site pain (3d - Recovering/Resolving - );Malaise (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399739&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399747	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Asthenia (1d - Not Recovered/Not Resolved - );Cardiovascular disorder (1d - Not Recovered/Not Resolved - );Fatigue (1d - Not Recovered/Not Resolved - );Headache (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Oropharyngeal pain (1d - Not Recovered/Not Resolved - );Pain in extremity (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intravenous (not otherwise specified)])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399747&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399748	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal distension (n/a - Recovering/Resolving - );Dizziness (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Headache (n/a - Recovering/Resolving - );Injection site erythema (n/a - Recovering/Resolving - );Injection site pain (n/a - Recovering/Resolving - );Injection site swelling (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399748&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399750	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Fatigue (0d - Recovered/Resolved - );Pain in extremity (0d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399750&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399757	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Blister (n/a - Recovering/Resolving - Disabling);Body temperature decreased (n/a - Recovering/Resolving - Disabling);Erythema (n/a - Recovering/Resolving - Disabling);Headache (n/a - Recovering/Resolving - Disabling);Oropharyngeal pain (n/a - Recovering/Resolving - Disabling);Pain in extremity (n/a - Recovering/Resolving - Disabling);Paraesthesia (n/a - Recovering/Resolving - Disabling);Pruritus (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Vision blurred (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - Oral])|[RAMIPRIL] (C - n/a - n/a - [n/a - n/a - Oral])|[SILDENAFIL, SILDENAFIL CITRATE] (C - n/a - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399757&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010399770	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Fatigue (n/a - Recovering/Resolving - );Hot flush (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399770&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399800	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399800&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399801	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Feeling hot (n/a - Recovered/Resolved - );Vaginal haemorrhage (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399801&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399803	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chronic fatigue syndrome (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Headache (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Hypertension (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Palpitations (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Tinnitus (139d - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399803&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399807	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (0d - Not Recovered/Not Resolved - );Fatigue (3d - Not Recovered/Not Resolved - );Seizure (0d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399807&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399809	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pruritus (6d - Recovered/Resolved - );Rash (6d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399809&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399815	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Elderly	No	Male	Polymyalgia rheumatica (120d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399815&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010399838	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (28d - Recovering/Resolving - );Fatigue (2d - Recovered/Resolved - );Feeling hot (1d - Recovered/Resolved - );Headache (1d - Recovered/Resolved - );Hyperhidrosis (1d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - );Insomnia (n/a - Unknown - );Limb discomfort (2d - Recovered/Resolved - );Malaise (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399842	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Abdominal pain upper (n/a - Recovering/Resolving - );Diarrhoea (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399842&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399875	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovering/Resolving - );Cough (1d - Not Recovered/Not Resolved - );Dyspnoea (1d - Not Recovered/Not Resolved - );Influenza (1d - Not Recovered/Not Resolved - );Injection site pain (1d - Not Recovered/Not Resolved - );Pulmonary pain (1d - Not Recovered/Not Resolved - );Pyrexia (1d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399875&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399876	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest discomfort (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Dyspnoea (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hypotension (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Paraesthesia oral (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Swollen tongue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399876&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399896	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	12-17 Years	Adolescent	No	Not Specified	Myalgia (1d - Recovered/Resolved - );Vaccination site reaction (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399896&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399899	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Dyspepsia (40d - Recovering/Resolving - );Nausea (40d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399899&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Duration
EU-EC-10010399901	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Diarrhoea (12d - Recovering/Resolving - );Headache (12d - Recovering/Resolving - );Influenza like illness (12d - Recovering/Resolving - );Mood swings (12d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399901&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399906	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Nausea (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399906&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399907	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Cough (1d - Not Recovered/Not Resolved - );Influenza (0d - Not Recovered/Not Resolved - );Oropharyngeal pain (1d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399907&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399916	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Pain (n/a - Recovered/Resolved - );Pain in extremity (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399916&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399919	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399919&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399920	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	Not Specified	Not Specified	No	Male	COVID-19 (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	[COLECALCIFEROL, CALCIUM, COLECALCIFEROL, CALCIUM CARBONATE] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[METHYLPREDNISOLONE] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399920&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399923	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - );Myalgia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399923&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399924	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (2d - Recovered/Resolved - );Chest pain (2d - Recovered/Resolved - );Fatigue (3d - Recovered/Resolved - );Hypoaesthesia (1d - Recovered/Resolved - );Limb discomfort (1d - Recovered/Resolved - );Paraesthesia (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399924&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399925	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Chest discomfort (1d - Recovered/Resolved - );Chills (1d - Recovered/Resolved - );Dysphagia (1d - Recovered/Resolved - );Dyspnoea (1d - Recovered/Resolved - );Sense of oppression (1d - Recovered/Resolved - );Swelling (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399925&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399927	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399934	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arthralgia (2d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (6d - Recovered/Resolved - );Malaise (2d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399934&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399936	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Epilepsy (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399936&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399938	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Disturbance in attention (8d - Recovering/Resolving - );Fatigue (19d - Recovering/Resolving - );Headache (8d - Recovering/Resolving - );Migraine with aura (8d - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399938&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399961	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Aphthous ulcer (5d - Not Recovered/Not Resolved - );Injection site pain (5d - Not Recovered/Not Resolved - );Lymphadenopathy (5d - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399961&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399962	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Not Specified	Abnormal faeces (1d - Unknown - );Back pain (1d - Unknown - );Influenza like illness (1d - Unknown - );Myalgia (n/a - Unknown - );Nausea (1d - Unknown - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399962&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010399963	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Apathy (n/a - Not Recovered/Not Resolved - );Arrhythmia (n/a - Not Recovered/Not Resolved - );Fatigue (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399963&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010399965	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Arrhythmia (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399965&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010399966	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Decreased appetite (n/a - Unknown - );Fatigue (11d - Recovered/Resolved - );Sleep disorder (11d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010399966&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400071	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Adult	No	Male	Fatigue (3d - Recovered/Resolved - );Headache (5d - Recovered/Resolved - );Injection site erythema (3d - Recovered/Resolved - );Nausea (2d - Recovered/Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400071&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400087	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Unknown - );Fatigue (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400087&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400129	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Asthenia (n/a - Not Recovered/Not Resolved - );Blood thyroid stimulating hormone decreased (n/a - Recovering/Resolving - );Fatigue (n/a - Not Recovered/Not Resolved - );Weight decreased (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400129&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400181	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myalgia (n/a - Recovering/Resolving - Disabling);Pyrexia (n/a - Recovering/Resolving - Disabling);Vomiting (n/a - Recovering/Resolving - Disabling)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400181&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010400202	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Feeling hot (n/a - Unknown - );Sensation of foreign body (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400202&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400210	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400210&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400219	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400219&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400277	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Myocarditis (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Palpitations (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400277&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010400354	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Peripheral vein thrombosis (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation);Pulmonary embolism (n/a - Recovered/Resolved With Sequelae - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400354&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010400372	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Asthmatic crisis (n/a - Recovering/Resolving - Other Medically Important Condition);Respiratory disorder (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400372&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010400453	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400453&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400458	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400458&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400460	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400460&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400466	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400466&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400467	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400467&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400772	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	Administration site bruise (n/a - Unknown - );Condition aggravated (n/a - Fatal - Results in Death);Hepatic fibrosis marker increased (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - Intramuscular])	INVOKANA [CANAGLIFLOZIN] (C - n/a - n/a - )|[ACETYLSALICYLIC ACID] (C - n/a - n/a - )|[ATORVASTATIN] (C - n/a - n/a - )|[GLIMEPIRIDE] (C - n/a - n/a - )|[INDAPAMIDE, AMLODIPINE BESILATE, PERINDOPRIL ARGININE] (C - n/a - n/a - )|[METFORMIN HYDROCHLORIDE] (C - n/a - n/a - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400772&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010400777	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Pain (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	NOT AVAILABLE (C - n/a - Unknown - [n/a - n/a - n/a])|[GLICLAZIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[NEBIVOLOL] (C - n/a - Unknown - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400777&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400821	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Loss of consciousness (0d - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400821&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010400828	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Injection site pain (n/a - Not Recovered/Not Resolved - );Tinnitus (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400828&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400833	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (n/a - Unknown - );Headache (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400833&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400844	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Herpes zoster (3wk - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010400869	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (4mo - Recovered/Resolved - );Gait disturbance (n/a - Recovering/Resolving - );Muscular weakness (n/a - Recovering/Resolving - );Myalgia (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	NOT AVAILABLE (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400869&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010400926	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400926&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400927	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400927&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400929	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400929&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010400940	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010400940&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401037	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Agranulocytosis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Bone marrow disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Fatigue (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);General physical health deterioration (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hepatitis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Leukopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Pyrexia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Thrombocytopenia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401037&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401047	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericardial effusion (n/a - Unknown - Caused/Prolonged Hospitalisation);Pericarditis (n/a - Unknown - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401047&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401048	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401048&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401088	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Adult	No	Male	Arthralgia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Breath holding (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Fatigue (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Hypokinesia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Insomnia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Joint range of motion decreased (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Nodule (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Pain in extremity (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Periarthritis (n/a - Recovering/Resolving - Disabling, Other Medically Important Condition);Productive cough (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Stress (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Syncope (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Tenosynovitis (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - Product used for unknown indication - Unknown - [1d - n/a - n/a])|[CODEINE PHOSPHATE BP, PARACETAMOL PH. EUR., PARACETAMOL, CODEINE PHOSPHATE] (S - Pain - Unknown - [n/a - n/a - n/a])|[ZOLPIDEM TARTRATE] (S - Insomnia - Unknown - [n/a - n/a - n/a])	[BISOPROLOL FUMARATE] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401088&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010401136	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401136&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401137	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401137&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401138	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401138&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401145	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401145&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401146	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Elderly	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401146&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401147	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401147&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401150	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401150&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401311	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Circulatory collapse (0d - Recovered/Resolved - );Injection site pain (n/a - Recovering/Resolving - );Malaise (3d - Recovered/Resolved - );Myalgia (1d - Recovered/Resolved - );Nausea (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401311&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401312	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chills (1d - Recovered/Resolved - );Vaccination site pain (1d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401312&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401315	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Chest pain (4d - Recovered/Resolved - );Dizziness (4d - Recovered/Resolved - );Fatigue (2d - Recovered/Resolved - );Headache (2d - Recovered/Resolved - );Injection site pain (3d - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401315&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401328	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Herpes zoster (n/a - Recovering/Resolving - );Rash (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401328&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Severe reaction
EU-EC-10010401344	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Muscle twitching (n/a - Recovering/Resolving - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401344&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401349	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Headache (n/a - Not Recovered/Not Resolved - );Injection site pain (n/a - Not Recovered/Not Resolved - );Malaise (n/a - Not Recovered/Not Resolved - );Palatal disorder (n/a - Not Recovered/Not Resolved - );Wound (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401349&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401359	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Paraesthesia (1d - Recovered/Resolved With Sequelae - )	COMIRNATY [TOZINAMERAN] (S - Immunisation - n/a - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401359&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		Sequelae
EU-EC-10010401385	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Infant	Yes	Not Specified	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Exposure via breast milk (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Transmammary])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401385&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401387	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401387&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401388	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	C-reactive protein increased (n/a - Unknown - );Chest pain (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);Haemoglobin decreased (n/a - Unknown - );Hyperhidrosis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation);International normalised ratio decreased (n/a - Unknown - );Lymphocyte count decreased (n/a - Unknown - );Myocardial necrosis marker increased (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Myocarditis (n/a - Recovered/Resolved - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Neutrophil count increased (n/a - Unknown - );Troponin I increased (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401388&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401389	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Angina pectoris (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401389&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401395	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Psoriasis (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401395&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401396	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Dizziness (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Heart rate decreased (n/a - Unknown - Other Medically Important Condition);Hypertension (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Pain (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[INFLUENZA VIRUS] (C - Influenza immunisation - n/a - [1d - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401396&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401397	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Diarrhoea (1d - Recovered/Resolved - Other Medically Important Condition);Headache (1d - Recovered/Resolved - Other Medically Important Condition);Insomnia (1d - Recovered/Resolved - Other Medically Important Condition);Interchange of vaccine products (n/a - Unknown - );Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Off label use (n/a - Unknown - );Pain (2d - Recovered/Resolved - Other Medically Important Condition);Pyrexia (1d - Recovered/Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE DIHYDRATE] (C - Asthma - n/a - [n/a - n/a - n/a])|[FEXOFENADINE, FEXOFENADINE HYDROCHLORIDE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[MONTELUKAST, MONTELUKAST SODIUM] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[SALBUTAMOL, SALBUTAMOL SULFATE] (C - Asthma - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401397&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401425	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 pneumonia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401425&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401456	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Dizziness (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - 1{DF} - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401456&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401503	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	Alopecia (n/a - Not Recovered/Not Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401503&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401518	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Pericarditis (n/a - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401518&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401520	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Dementia (n/a - Not Recovered/Not Resolved - Disabling, Other Medically Important Condition);Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401520&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010401524	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Recovered/Resolved - Other Medically Important Condition);Myalgia (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Pain in extremity (n/a - Recovered/Resolved - Other Medically Important Condition);Peripheral swelling (1d - Recovered/Resolved - Other Medically Important Condition);Vaccination site pain (n/a - Not Recovered/Not Resolved - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401524&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401531	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Arrhythmia (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401531&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401533	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Diarrhoea (n/a - Recovering/Resolving - Other Medically Important Condition);Pyrexia (n/a - Recovering/Resolving - Other Medically Important Condition);Vomiting (n/a - Recovering/Resolving - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401533&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401546	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Recovering/Resolving - Other Medically Important Condition);Dyspnoea (n/a - Recovered/Resolved - Other Medically Important Condition);Feeling abnormal (n/a - Unknown - Other Medically Important Condition);Hypoaesthesia (n/a - Recovering/Resolving - Other Medically Important Condition);Neck pain (n/a - Unknown - Other Medically Important Condition);Pain in extremity (n/a - Recovering/Resolving - Other Medically Important Condition);Palpitations (n/a - Recovering/Resolving - Other Medically Important Condition);Vision blurred (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401546&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401550	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Retinal haemorrhage (n/a - Unknown - Caused/Prolonged Hospitalisation, Other Medically Important Condition);Visual impairment (n/a - Unknown - Other Medically Important Condition);Vitreous haemorrhage (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - .3mL - n/a])	[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])|[BISOPROLOL FUMARATE] (C - n/a - n/a - [n/a - n/a - n/a])|[CLOBAZAM] (C - n/a - n/a - [n/a - n/a - n/a])|[EZETIMIBE, ROSUVASTATIN CALCIUM] (C - n/a - n/a - [n/a - n/a - n/a])|[NICORANDIL] (C - n/a - n/a - [n/a - n/a - n/a])|[TAMSULOSIN, TAMSULOSIN HYDROCHLORIDE] (C - n/a - n/a - [n/a - n/a - n/a])|[ZONISAMIDE] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401550&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401551	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Chest pain (n/a - Not Recovered/Not Resolved - Caused/Prolonged Hospitalisation);Myocarditis (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401551&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401552	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Confusional state (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Disturbance in attention (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Hypoaesthesia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Insomnia (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Mastication disorder (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Mental impairment (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Myositis (n/a - Unknown - Life Threatening, Caused/Prolonged Hospitalisation);Respiratory rate decreased (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401552&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010401555	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Male	Immunisation (n/a - Unknown - );Leukocytosis (n/a - Not Recovered/Not Resolved - );Off label use (n/a - Unknown - );Pericardial effusion (n/a - Unknown - Other Medically Important Condition);Tachyarrhythmia (n/a - Recovered/Resolved - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401555&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401565	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Cough (n/a - Recovering/Resolving - );Fatigue (n/a - Recovering/Resolving - );Influenza like illness (n/a - Recovering/Resolving - );Myocardial infarction (n/a - Fatal - Results in Death, Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401565&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010401571	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Adult	No	Male	Facial paralysis (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401571&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401580	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - Other Medically Important Condition);Nausea (1d - Recovered/Resolved - Other Medically Important Condition);Sleep disorder (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401580&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401585	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Not Specified	Cerebrovascular accident (n/a - Unknown - Other Medically Important Condition);Injury (n/a - Unknown - );Pain (n/a - Unknown - );Vitamin D deficiency (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401585&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401592	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Abdominal pain (n/a - Recovering/Resolving - Other Medically Important Condition);COVID-19 (n/a - Recovered/Resolved - Other Medically Important Condition);Chest discomfort (n/a - Recovering/Resolving - Other Medically Important Condition);Chest pain (n/a - Recovering/Resolving - Other Medically Important Condition);Cough (n/a - Recovering/Resolving - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - );Myocarditis (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401592&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401595	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401595&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401602	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	Not Specified	Not Specified	No	Not Specified	Chest pain (n/a - Unknown - Disabling, Other Medically Important Condition);Chills (n/a - Not Recovered/Not Resolved - Disabling);Dizziness (n/a - Unknown - Disabling, Other Medically Important Condition);Dry eye (n/a - Not Recovered/Not Resolved - Disabling);Dyspnoea (n/a - Unknown - Disabling, Other Medically Important Condition);Ear congestion (n/a - Not Recovered/Not Resolved - Disabling);Headache (n/a - Not Recovered/Not Resolved - Disabling);Nasal congestion (n/a - Not Recovered/Not Resolved - Disabling);Nausea (n/a - Not Recovered/Not Resolved - Disabling);Oropharyngeal pain (n/a - Not Recovered/Not Resolved - Disabling);Presyncope (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Not Recovered/Not Resolved - Disabling);Rhinorrhoea (n/a - Not Recovered/Not Resolved - Disabling);Sinus congestion (n/a - Not Recovered/Not Resolved - Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401602&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	Severe reaction
EU-EC-10010401631	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Fatigue (n/a - Unknown - Other Medically Important Condition);Muscle fatigue (n/a - Recovering/Resolving - Other Medically Important Condition);Myalgia (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401631&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401635	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	12-17 Years	Not Specified	No	Not Specified	Collagen disorder (n/a - Unknown - Other Medically Important Condition);Platelet count decreased (n/a - Unknown - Other Medically Important Condition);Pyrexia (n/a - Unknown - Other Medically Important Condition);White blood cell count decreased (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401635&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401648	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Acute kidney injury (n/a - Fatal - Results in Death, Other Medically Important Condition);Bacteraemia (n/a - Fatal - Results in Death, Other Medically Important Condition);COVID-19 pneumonia (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition);Vaccination failure (n/a - Fatal - Results in Death, Caused/Prolonged Hospitalisation, Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - Intramuscular])	BUMETANIDE [BUMETANIDE] (C - n/a - n/a - [n/a - 1mg - n/a])|MYCOPHENOLATE MOFETIL [MYCOPHENOLATE MOFETIL] (C - n/a - n/a - [n/a - n/a - n/a])|TACROLIMUS [TACROLIMUS, TACROLIMUS MONOHYDRATE] (C - n/a - n/a - [n/a - 12mg - n/a])|[ACETYLSALICYLIC ACID] (C - n/a - n/a - [n/a - 75mg - n/a])|[AMLODIPINE, AMLODIPINE BESILATE, AMLODIPINE MALEATE, AMLODIPINE MESILATE] (C - n/a - n/a - [n/a - 5mg - n/a])|[ATORVASTATIN] (C - n/a - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - n/a - n/a - [n/a - 20mg - n/a])|[URSODEOXYCHOLIC ACID] (C - n/a - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401648&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010401776	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401776&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401780	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401780&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401782	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (n/a - Unknown - Other Medically Important Condition);Vaccination failure (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - n/a - n/a - [n/a - n/a - Intramuscular])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401782&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401836	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Dizziness (n/a - Unknown - );Feeling cold (n/a - Unknown - );Head injury (n/a - Unknown - Other Medically Important Condition);Palpitations (n/a - Unknown - );Syncope (n/a - Unknown - Other Medically Important Condition)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401836&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	Severe reaction
EU-EC-10010401838	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Aphasia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Coagulopathy (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Confusional state (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Hemiplegia (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Ischaemic stroke (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation);Nervous system disorder (n/a - Recovering/Resolving - Caused/Prolonged Hospitalisation)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - n/a])	LANTUS [INSULIN GLARGINE] (C - n/a - Unknown - [n/a - 8[iU] - n/a])|[BISOPROLOL, BISOPROLOL FUMARATE, BISOPROLOL HEMIFUMARATE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[BUMETANIDE] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[DUTASTERIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[METFORMIN, METFORMIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - 2{DF} - n/a])|[PANCREALIPASE, PANCREAS POWDER, PANCREATIN] (C - n/a - Unknown - [n/a - 3{DF} - n/a])|[PANTOPRAZOLE, PANTOPRAZOLE SODIUM] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[RAMIPRIL] (C - n/a - Unknown - [n/a - n/a - n/a])|[SPIRONOLACTONE, SPIRONOLACTONE BP] (C - n/a - Unknown - [n/a - 1{DF} - n/a])|[TAMSULOSIN HYDROCHLORIDE] (C - n/a - Unknown - [n/a - n/a - n/a])|[URSODEOXYCHOLIC ACID] (C - n/a - Unknown - [n/a - 1{DF} - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401838&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Caused/Prolonged Hospitalisation	Life Threatening
EU-EC-10010401839	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	COVID-19 (n/a - Not Recovered/Not Resolved - Other Medically Important Condition);Drug ineffective (n/a - Unknown - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[CLOZAPINE] (C - Schizophrenia - n/a - [n/a - n/a - n/a])|[COLECALCIFEROL] (C - Hypovitaminosis - n/a - [n/a - n/a - n/a])|[FLUTICASONE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[LORATADINE] (C - Hypersensitivity - n/a - [n/a - n/a - n/a])|[MEBEVERINE] (C - Irritable bowel syndrome - n/a - [n/a - n/a - n/a])|[OMEPRAZOLE] (C - Reflux gastritis - n/a - [n/a - n/a - n/a])|[SENNA ALEXANDRIAN] (C - Constipation - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401839&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401840	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	Not Specified	Elderly	No	Male	Arthralgia (n/a - Recovered/Resolved - );Fatigue (1d - Recovered/Resolved - );Herpes simplex (n/a - Recovered/Resolved - );Pain (n/a - Recovered/Resolved - );Spinal pain (n/a - Recovered/Resolved - Disabling)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	[OLMESARTAN, OLMESARTAN MEDOXOMIL] (C - Hypertension - n/a - [n/a - n/a - n/a])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401840&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling	
EU-EC-10010401844	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	18-64 Years	Not Specified	No	Male	Atrial flutter (n/a - Not Recovered/Not Resolved - Life Threatening, Caused/Prolonged Hospitalisation, Disabling)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401844&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Disabling,Caused/Prolonged Hospitalisation,Life Threatening	Life Threatening
EU-EC-10010401846	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Immunisation (n/a - Unknown - );Off label use (n/a - Unknown - );Vertigo positional (n/a - Recovering/Resolving - Other Medically Important Condition)	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401846&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401851	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	More than 85 Years	Not Specified	No	Male	Platelet count decreased (n/a - Fatal - Results in Death)	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [n/a - n/a - Intramuscular])	[BENIDIPINE] (C - Hypertension - n/a - [n/a - n/a - Oral])|[QUETIAPINE, QUETIAPINE FUMARATE] (C - Restlessness - n/a - [n/a - n/a - Oral])|[RISPERIDONE] (C - Restlessness - n/a - [n/a - n/a - Oral])|[RIVASTIGMINE] (C - Dementia Alzheimer's type - n/a - [n/a - n/a - Transdermal])|[TIAPRIDE] (C - Restlessness - n/a - [n/a - n/a - Oral])	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401851&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Results in Death	
EU-EC-10010401893	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	European Economic Area	Not available	18-64 Years	Adult	No	Male	COVID-19 (12d - Recovered/Resolved - );Vaccination failure (12d - Recovered/Resolved - Other Medically Important Condition)	COMIRNATY COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) CONCENTRATE FOR DISPERSION FOR INJECTION [TOZINAMERAN] (S - Immunisation - Not applicable - [n/a - .3mL - Intramuscular])	[MOMETASONE FUROATE] (C - n/a - Not applicable - )	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401893&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401973	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	European Economic Area	Not available	65-85 Years	Not Specified	No	Male	Headache (n/a - Unknown - );Lethargy (n/a - Unknown - );Malaise (n/a - Unknown - );Nausea (n/a - Unknown - )	COMIRNATY [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401973&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07		
EU-EC-10010401974	Spontaneous	2021-10-22 00:00:00	Healthcare Professional	Non European Economic Area	Not available	65-85 Years	Not Specified	No	Male	COVID-19 (14d - Recovered/Resolved - Other Medically Important Condition);Drug ineffective (14d - Recovered/Resolved - Other Medically Important Condition);Inappropriate schedule of product administration (n/a - Unknown - )	TOZINAMERAN [TOZINAMERAN] (S - COVID-19 immunisation - Not applicable - [1d - n/a - n/a])	Not reported	<a target=_blank href=https://dap.ema.europa.eu/xmlpserver/PHV%20DAP/Reports/ICSR.xdo?_xpf=&_xt=form&SR_ID=10010401974&_xpt=1&_xf=pdf>ICSR</a>	BioNTech	2026-03-30T07	Other Medically Important Condition	
EU-EC-10010401997	Spontaneous	2021-10-22 00:00:00	Non Healthcare Professional	Europ